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The Changing Political Geography of COVID-19 Over the Last Two Years

Over the past two years, the official count of coronavirus deaths in the United States has risen and is now approaching 1 million lives. Large majorities of Americans say they personally know someone who has been hospitalized or died of the coronavirus , and it has impacted – in varying degrees – nearly every aspect of life .

A new Pew Research Center analysis of official reports of COVID-19-related deaths across the country, based on mortality data collected by The New York Times, shows how the dynamics of the pandemic have shifted over the past two years.

A timeline of the shifting geography of the pandemic

Pew Research Center conducted this analysis to understand how the geography of the coronavirus outbreak has changed over its course. For this analysis, we relied on official reports of deaths attributed to the novel coronavirus collected and maintained by The New York Times .

The estimates provided in this report are subject to several sources of error. There may be significant differences between the true number of deaths due to COVID-19 and the official reported counts of those deaths. There may also be variation across the states in the quality and types of data reported. For example, most states report deaths based on the residency of the deceased person rather than the location where they died. The New York Times collects data from many different local health agencies, and this likely leads to some additional measurement error.

This analysis relies on county-level data. Counties in the United States vary widely in their population sizes, so in many places in the essay, we divide counties into approximately equal-sized groups (in terms of their population) for comparability or report on population adjusted death rates rather than total counts of deaths.

The pandemic has rolled across the U.S. unevenly and in waves. Today, the death toll of the pandemic looks very different from how it looked in the early part of 2020 . The first wave (roughly the first 125,000 deaths from March 2020 through June 2020) was largely geographically concentrated in the Northeast and in particular the New York City region. During the summer of 2020, the largest share of the roughly 80,000 deaths that occurred during the pandemic’s second wave were in the southern parts of the country.

The fall and winter months of 2020 and early 2021 were the deadliest of the pandemic to date. More than 370,000 Americans died of COVID-19 between October 2020 and April 2021; the geographic distinctions that characterized the earlier waves became much less pronounced.

By the spring and summer of 2021, the nationwide death rate had slowed significantly, and vaccines were widely available to all adults who wanted them. But starting at the end of the summer, the fourth and fifth waves (marked by new variants of the virus, delta and then omicron) came in quick succession and claimed more than 300,000 lives.

In many cases, the characteristics of communities that were associated with higher death rates at the beginning of the pandemic are now associated with lower death rates (and vice versa). Early in the pandemic, urban areas were disproportionately impacted. During the first wave, the coronavirus death rate in the 10% of the country that lives in the most densely populated counties was more than nine times that of the death rate among the 10% of the population living in the least densely populated counties. In each subsequent wave, however, the nation’s least dense counties have registered higher death rates than the most densely populated places.

Despite the staggering death toll in densely populated urban areas during the first months of the pandemic (an average 36 monthly deaths per 100,000 residents), the overall death rate over the course of the pandemic is slightly higher in the least populated parts of the country (an average monthly 15 deaths per 100,000 among the 10% living in the least densely populated counties vs. 13 per 100,000 among the 10% in the most densely populated counties).

As the relationship between population density and coronavirus death rates has changed over the course of the pandemic, so too has the relationship between counties’ voting patterns and their death rates from COVID-19.

In the spring of 2020, the areas recording the greatest numbers of deaths were much more likely to vote Democratic than Republican. But by the third wave of the pandemic, which began in fall 2020, the pattern had reversed: Counties that voted for Donald Trump over Joe Biden were suffering substantially more deaths from the coronavirus pandemic than those that voted for Biden over Trump. This reversal is likely a result of several factors including differences in mitigation efforts and vaccine uptake, demographic differences, and other differences that are correlated with partisanship at the county level.

During this third wave – which continued into early 2021 – the coronavirus death rate among the 20% of Americans living in counties that supported Trump by the highest margins in 2020 was about 170% of the death rate among the one-in-five Americans living in counties that supported Biden by the largest margins.

As vaccines became more widely available, this discrepancy between “blue” and “red” counties became even larger as the virulent delta strain of the pandemic spread across the country during the summer and fall of 2021, even as the total number of deaths fell somewhat from its third wave peak.

During the fourth wave of the pandemic, death rates in the most pro-Trump counties were about four times what they were in the most pro-Biden counties. When the highly transmissible omicron variant began to spread in the U.S. in late 2021, these differences narrowed substantially. However, death rates in the most pro-Trump counties were still about 180% of what they were in the most pro-Biden counties throughout late 2021 and early 2022.

The cumulative impact of these divergent death rates is a wide difference in total deaths from COVID-19 between the most pro-Trump and most pro-Biden parts of the country. Since the pandemic began, counties representing the 20% of the population where Trump ran up his highest margins in 2020 have experienced nearly 70,000 more deaths from COVID-19 than have the counties representing the 20% of population where Biden performed best. Overall, the COVID-19 death rate in all c ounties Trump won in 2020 is substantially higher than it is in counties Biden won (as of the end of February 2022, 326 per 100,000 in Trump counties and 258 per 100,000 in Biden counties).

Partisan divide in COVID-19 deaths widened as more vaccines became available

Partisan differences in COVID-19 death rates expanded dramatically after the availability of vaccines increased. Unvaccinated people are at far higher risk of death and hospitalization from COVID-19, according to the Centers for Disease Control and Prevention, and vaccination decisions are strongly associated with partisanship . Among the large majority of counties for which reliable vaccination data exists, counties that supported Trump at higher margins have substantially lower vaccination rates than those that supported Biden at higher margins.

Counties with lower rates of vaccination registered substantially greater death rates during each wave in which vaccines were widely available.

During the fall of 2021 (roughly corresponding to the delta wave), about 10% of Americans lived in counties with adult vaccination rates lower than 40% as of July 2021. Death rates in these low-vaccination counties were about six times as high as death rates in counties where 70% or more of the adult population was vaccinated.

More Americans were vaccinated heading into the winter of 2021 and 2022 (roughly corresponding to the omicron wave), but nearly 10% of the country lived in areas where less than half of the adult population was vaccinated as of November 2021. Death rates in these low-vaccination counties were roughly twice what they were in counties that had 80% or more of their population vaccinated. ( Note: The statistics here reflect the death rates in the county as a whole, not rates for vaccinated and unvaccinated individuals, though individual-level data finds that death rates among unvaccinated people are far higher than among vaccinated people.)

This analysis relies on official reports of deaths attributed to COVID-19 in the United States collected and reported by The New York Times .

COVID-19 deaths in Puerto Rico and other U.S. territories are not included in this analysis. Additionally, deaths without a specific geographic location have been excluded.

Data was pulled from the GitHub repository maintained by The New York Times on March 1, 2022, and reflects reported coronavirus deaths through Feb. 28.

There are several anomalies in the deaths data. Many locales drop off their reporting on the weekends and holidays. In addition to the rhythm of the reporting cycle, there are many instances where a locality will revise the count of its deaths downward (usually only by a small amount) or release a large batch of previously unreported deaths on a single day. The downward revisions were identified and retroactively applied to earlier days.

Large batches of cases were identified by finding days that increased by more than 10 deaths and were 10 standard deviations above the norm for a county within a 30-day window. Deaths reported in these anomalous batches were then evenly distributed across the days leading up to when they were released.

Population data for U.S. counties comes from the 2015-2019 American Community Survey estimates published by the Census Bureau (accessed through the tidycensus package in R on Feb. 21). The 2020 vote share for each county was purchased from Dave Leip’s Election Atlas (downloaded on Nov. 21, 2021).

The analysis looks at deaths among counties based on their 2020 vote. Counties were grouped into five groups with approximately equal population. For analyses that include 2020 vote, Alaskan counties are excluded because Alaska does not report its election results at the county level. The table below provides more details.

This essay benefited greatly from thoughtful comments and consultation with many individuals around Pew Research Center. Jocelyn Kiley, Carroll Doherty and Jeb Bell provided invaluable editorial guidance. Peter Bell and Alissa Scheller contributed their expertise in visualization, Ben Wormald built the map animation, and Reem Nadeem did the digital production. Andrew Daniller provided careful attention to the quality check process, and David Kent’s watchful copy editing eye brought clarity to some difficult concepts.

Lead photo: Kent Nishimura/Los Angeles Times via Getty Images

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ABOUT PEW RESEARCH CENTER  Pew Research Center is a nonpartisan fact tank that informs the public about the issues, attitudes and trends shaping the world. It conducts public opinion polling, demographic research, media content analysis and other empirical social science research. Pew Research Center does not take policy positions. It is a subsidiary of  The Pew Charitable Trusts .

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Home — Essay Samples — Nursing & Health — Public Health Issues — Vaccination

Essays on Vaccination

Vaccines essay topics and outline examples, essay title 1: "the vital role of vaccines in public health: debunking myths and upholding science".

Thesis Statement: Vaccines are a cornerstone of public health, and it is crucial to dispel misinformation and emphasize the overwhelming scientific evidence supporting their safety and efficacy.

Essay Outline:

• Introduction
• The History and Impact of Vaccines
• Common Vaccine Myths and Misconceptions
• Scientific Evidence Supporting Vaccines
• Vaccine Safety and Adverse Effects
• The Importance of Herd Immunity
• Addressing Vaccine Hesitancy

Essay Title 2: "Vaccination Mandates: Balancing Individual Rights with Public Health"

Thesis Statement: While respecting individual rights is essential, vaccination mandates are a legitimate measure to safeguard public health and prevent outbreaks of vaccine-preventable diseases.

• The Concept of Vaccination Mandates
• Individual Rights and Autonomy
• Public Health Concerns and Disease Prevention
• Legal and Ethical Considerations
• Case Studies of Vaccine Mandates
• Opposition and Challenges to Mandates

Essay Title 3: "The Impact of Vaccine Disinformation on Public Health: A Global Challenge"

Thesis Statement: The proliferation of vaccine disinformation poses a significant threat to public health, and addressing this challenge is vital to ensure widespread vaccine acceptance and disease control.

• The Spread and Impact of Vaccine Disinformation
• Factors Contributing to Vaccine Hesitancy
• The Role of Social Media and Online Platforms
• Countering Vaccine Disinformation Efforts
• Global Initiatives and Collaborations
• Case Studies on Successful Interventions

The Benefits of Vaccination

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The Problem of The Vaccine War in The World

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Advantages and Disadvantages of The Various Types of Vaccines

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Vaccination, also known as immunization, is a medical procedure that involves the administration of a vaccine to stimulate the immune system and provide protection against specific infectious diseases. It is a preventive measure designed to enhance the body's natural defenses by introducing harmless fragments of the disease-causing agent or weakened or inactivated forms of the pathogen.

The mechanism of vaccination involves introducing a weakened or inactivated form of a disease-causing agent, such as a virus or bacterium, into the body. This prompts the immune system to recognize and respond to the pathogen. When a vaccine is administered, it stimulates the immune system to produce an immune response, similar to what would happen during a natural infection. The immune system recognizes the foreign antigens present in the vaccine and mounts a defense by producing antibodies and activating immune cells. These immune responses help the body develop immunity against the specific pathogen. Vaccination can also involve the use of genetically engineered proteins or pieces of the pathogen to stimulate an immune response. These components are known as antigens and can be derived from the outer coats of viruses or the cell walls of bacteria. By introducing these harmless components of the pathogen into the body, vaccines help the immune system recognize and remember the specific pathogen. This way, if the individual is later exposed to the actual disease-causing agent, their immune system can mount a rapid and effective response to neutralize or eliminate the pathogen, preventing the development of the disease or reducing its severity.

1. Inactivated Vaccines 2. Live Attenuated Vaccines 3. Subunit, Recombinant, and Conjugate Vaccines 4. mRNA Vaccines 5. Viral Vector Vaccines

The origin of vaccination can be traced back to ancient times, although the concept was not fully understood at the time. The practice of vaccination, as we know it today, began with the discovery of immunization against smallpox by Edward Jenner in the late 18th century. Jenner, an English physician, observed that milkmaids who had contracted cowpox, a much milder disease, seemed to be protected against smallpox. In 1796, he conducted an experiment where he took material from a cowpox sore and inoculated it into an eight-year-old boy named James Phipps. Afterward, Jenner exposed the boy to smallpox, but he did not develop the disease. This groundbreaking experiment led to the development of the smallpox vaccine. The term "vaccination" itself comes from the Latin word "vacca," meaning cow, as the original smallpox vaccine was derived from cowpox. Jenner's work paved the way for the development of vaccines against other infectious diseases, and vaccination quickly became a widely accepted method for preventing and controlling the spread of deadly diseases.

Public opinion on vaccination varies across different societies and individuals. Overall, vaccination has been widely accepted and supported by the majority of the population, recognizing its significant role in preventing and controlling infectious diseases. Vaccines have been instrumental in eradicating or significantly reducing the impact of diseases such as smallpox, polio, measles, and more. However, there are also pockets of skepticism and opposition towards vaccination, driven by various factors such as misinformation, fear, religious beliefs, or concerns about vaccine safety. This has led to the emergence of anti-vaccine movements and vaccine hesitancy in some communities. Public opinion on vaccination is influenced by various factors, including access to accurate information, trust in healthcare professionals and scientific research, cultural and religious beliefs, personal experiences, and the influence of social media and other communication channels. Efforts to promote vaccination and address vaccine hesitancy involve public health campaigns, education, and communication strategies to provide accurate information about vaccines, address concerns, and emphasize the importance of vaccination in protecting individual and public health.

1. Disease prevention 2. Herd immunity 3. Public health impact 4. Safety and effectiveness 5. Global impact

1. Vaccine safety concerns 2. Personal freedom and choice 3. Misinformation and skepticism 4. Religious or philosophical objections 5. Perception of low disease risk

1. According to the World Health Organization (WHO), vaccines prevent between 2-3 million deaths worldwide every year. 2. Smallpox is the only disease that has been totally eradicated through vaccination. 3. Vaccines have significantly reduced the global burden of infectious diseases. For instance, measles deaths decreased by 73% worldwide between 2000 and 2018. 4. The influenza vaccine helps reduce the risk of severe illness and hospitalization. In the United States, annual flu vaccination prevented an estimated 7.5 million flu illnesses during the 2019-2020 season. 5. The average vaccine takes around 10-15 years of research and development before it is widely available.

The topic of vaccination is of paramount importance when considering the impact it has had on public health. Writing an essay about vaccination provides an opportunity to explore the profound significance of this medical intervention. Vaccination has played a pivotal role in preventing and controlling infectious diseases, saving countless lives worldwide. By delving into the subject, one can highlight the historical development of vaccines, their mechanisms of action, and the scientific evidence supporting their effectiveness. Furthermore, examining the topic of vaccination allows for an exploration of the public health implications, including the concept of herd immunity and the role of vaccination in disease eradication efforts. It also provides a platform to address the various arguments surrounding vaccine hesitancy and vaccine refusal, shedding light on the importance of accurate information, education, and communication. Moreover, the essay can delve into the ethical considerations surrounding vaccination policies, such as balancing individual autonomy with the collective responsibility for public health. By exploring these aspects, one can foster a deeper understanding of the challenges, controversies, and potential solutions in promoting vaccination uptake.

1. American Academy of Pediatrics. (2018). Immunization information for parents. https://www.healthychildren.org/English/safety-prevention/immunizations/Pages/default.aspx 2. Centers for Disease Control and Prevention. (2021). Vaccines & immunizations. https://www.cdc.gov/vaccines/index.html 3. Gust, D. A., Darling, N., Kennedy, A., & Schwartz, B. (2008). Parents with doubts about vaccines: Which vaccines and reasons why. Pediatrics, 122(4), 718-725. https://doi.org/10.1542/peds.2007-0538 4. Larson, H. J., de Figueiredo, A., Xiahong, Z., Schulz, W. S., Verger, P., Johnston, I. G., Cook, A. R., Jones, N. S., & the SAGE Working Group on Vaccine Hesitancy. (2016). The state of vaccine confidence 2016: Global insights through a 67-country survey. EBioMedicine, 12, 295-301. https://doi.org/10.1016/j.ebiom.2016.08.042 5. MacDonald, N. E., Hesitancy SAGE Working Group. (2015). Vaccine hesitancy: Definition, scope and determinants. Vaccine, 33(34), 4161-4164. https://doi.org/10.1016/j.vaccine.2015.04.036 6. Offit, P. A., Quarles, J., Gerber, M. A., Hackett, C. J., & Marcuse, E. K. (2002). Addressing parents' concerns: Do vaccines cause allergic or autoimmune diseases? Pediatrics, 110(6), 1113-1116. https://doi.org/10.1542/peds.110.6.1113 7. Omer, S. B., Salmon, D. A., Orenstein, W. A., deHart, M. P., & Halsey, N. (2009). Vaccine refusal, mandatory immunization, and the risks of vaccine-preventable diseases. New England Journal of Medicine, 360(19), 1981-1988. https://doi.org/10.1056/NEJMsa0806477 8. Smith, P. J., Humiston, S. G., Parnell, T., Vannice, K. S., & Salmon, D. A. (2011). The association between intentional delay of vaccine administration and timely childhood vaccination coverage. Public Health Reports, 126(Suppl 2), 135-146. https://doi.org/10.1177/00333549111260S219 9. World Health Organization. (2019). Ten threats to global health in 2019. https://www.who.int/news-room/spotlight/ten-threats-to-global-health-in-2019 10. World Health Organization. (2021). Immunization coverage. https://www.who.int/news-room/fact-sheets/detail/immunization-coverage

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There has been confusion and misunderstandings about vaccines. But vaccinations are an important part of family and public health. Vaccines prevent the spread of contagious, dangerous, and deadly diseases. These include measles, polio, mumps, chicken pox, whooping cough, diphtheria, HPV, and COVID-19.

The first vaccine discovered was the smallpox vaccine. Smallpox was a deadly illness. It killed 300 million to 500 million people around the world in the last century. After the vaccine was given to people, the disease was eventually erased. It’s the only disease to be completely destroyed. There are now others close to that point, including polio.

When vaccination rates decline, cases of preventable diseases go up. This has been happening in recent years with measles. As of July 7, 2023, the Centers for Disease Control has been notified of 18 confirmed cases in 12 U.S. jurisdictions. That may not seem like a lot but compare it with just 3 cases during the same time in 2022. By the end of 2022, there were 121 cases. Almost all those cases could have been prevented with vaccines.

What are vaccines?

A vaccine (or immunization) is a way to build your body’s natural immunity to a disease before you get sick. This keeps you from getting and spreading the disease.

For some vaccines, a weakened form of the disease germ is injected into your body. This is usually done with a shot in the leg or arm. Your body detects the invading germs (antigens) and produces antibodies to fight them. Those antibodies then stay in your body for a long time. In many cases, they stay for the rest of your life. If you’re ever exposed to the disease again, your body will fight it off without you ever getting the disease.

Some illnesses, like strains of cold viruses, are fairly mild. But some, like COVID-19, smallpox or polio, can cause life-altering changes. They can even result in death. That’s why preventing your body from contracting these illnesses is very important.

How does immunity work?

Your body builds a defense system to fight foreign germs that could make you sick or hurt you. It’s called your immune system. To build up your immune system, your body must be exposed to different germs. When your body is exposed to a germ for the first time, it produces antibodies to fight it. But that takes time, and you usually get sick before the antibodies have built up. But once you have antibodies, they stay in your body. So, the next time you’re exposed to that germ, the antibodies will attack it, and you won’t get sick.

Path to improved health

Everyone needs vaccines. They are recommended for infants, children, teenagers, and adults. There are widely accepted immunization schedules available. They list what vaccines are needed, and at what age they should be given. Most vaccines are given to children. It’s recommended they receive 12 different vaccines by their 6th birthday. Some of these come in a series of shots. Some vaccines are combined so they can be given together with fewer shots.

The American Academy of Family Physicians (AAFP) believes that immunization is essential to preventing the spread of contagious diseases. Vaccines are especially important for at-risk populations such as young children and older adults. The AAFP offers vaccination recommendations,  immunization schedules , and information on disease-specific vaccines.

Being up to date on vaccines is especially important as children head back to school. During the 2021 school year, state-required vaccines among kindergarteners dropped from 95% to 94%. In the 2021-2022 year it fell again to 93%. Part of this was due to disruptions from the COVID-19 pandemic.

Is there anyone who can’t get vaccines?

Some people with certain immune system diseases should not receive some types of vaccines and should speak with their health care providers first.  There is also a small number of people who don’t respond to a particular vaccine. Because these people can’t be vaccinated, it’s very important everyone else gets vaccinated. This helps preserve the “herd immunity” for the vast majority of people. This means that if most people are immune to a disease because of vaccinations, it will stop spreading.

Are there side effects to vaccines?

There can be side effects after you or your child get a vaccine. They are usually mild. They include redness or swelling at the injection site. Sometimes children develop a low-grade fever. These symptoms usually go away in a day or two. More serious side effects have been reported but are rare.

Typically, it takes years of development and testing before a vaccine is approved as safe and effective. However, in cases affecting a global, public health crisis or pandemic, it is possible to advance research, development, and production of a vaccine for emergency needs. Scientists and doctors at the U.S. Food and Drug Administration (FDA) study the research before approving a vaccine. They also inspect places where the vaccines are produced to make sure all rules are being followed. After the vaccine is released to the public, the FDA continues to monitor its use. It makes sure there are no safety issues.

The benefits of their use far outweigh any risks of side effects.

What would happen if we stopped vaccinating children and adults?

If we stopped vaccinating, the diseases would start coming back. Aside from smallpox, all other diseases are still active in some part of the world. If we don’t stay vaccinated, the diseases will come back. There would be epidemics, just like there used to be.

This happened in Japan in the 1970s. They had a good vaccination program for pertussis (whooping cough). Around 80% of Japanese children received a vaccination. In 1974, there were 393 cases of whooping cough and no deaths. Then rumors began that the vaccine was unsafe and wasn’t needed. By 1976, the vaccination rate was 10%. In 1979, there was a pertussis epidemic, with more than 13,000 cases and 41 deaths. Soon after, vaccination rates improved, and the number of cases went back down.

Things to consider

There have been many misunderstandings about vaccines. There are myths and misleading statements that spread on the internet and social media about vaccines. Here are answers to 5 of the most common questions/misconceptions about vaccines.

Vaccines do NOT cause autism.

Though multiple studies have been conducted, none have shown a link between autism and vaccines.  The initial paper that started the rumor has since been discredited.

Vaccines are NOT too much for an infant’s immune system to handle.

Infants’ immune systems can handle much more than what vaccines give them. They are exposed to hundreds of bacteria and viruses every day. Adding a few more with a vaccine doesn’t add to what their immune systems are capable of handling.

Vaccines do NOT contain toxins that will harm you.

Some vaccines contain trace amounts of substances that could be harmful in a large dose. These include formaldehyde, aluminum, and mercury. But the amount used in the vaccines is so small that the vaccines are completely safe. For example, over the course of all vaccinations by the age of 2, a child will take in 4mg of aluminum. A breast-fed baby will take in 10mg in 6 months. Soy-based formula delivers 120mg in 6 months. In addition, infants have 10 times as much formaldehyde naturally occurring in their bodies than what is contained in a vaccine. And the toxic form of mercury has never been used in vaccines.

Vaccines do NOT cause the diseases they are meant to prevent.

This is a common misconception, especially about the flu vaccine. Many people think they get sick after getting a flu shot. But flu shots contain dead viruses—it’s impossible to get sick from the shot but mild symptoms can occur because the vaccine may trigger an immune response, which is normal. Even with vaccines that use weakened live viruses, you could experience mild symptoms similar to the illness. But you don’t actually have the disease.

We DO still need vaccines in the U.S., even though infection rates are low.

Many diseases are uncommon in the U.S. because of our high vaccination rate. But they haven’t been eliminated from other areas of the world. If a traveler from another country brings a disease to the U.S., anyone who isn’t vaccinated is at risk of getting that disease. The only way to keep infection rates low is to keep vaccinating.

Questions to ask your doctor

• Why does my child need to be vaccinated?
• What are the possible side effects of the vaccination?
• What do I do if my child experiences a side effect from the vaccine?
• What happens if my child doesn’t get all doses of the recommended vaccines? Will he or she be able to go to daycare or school?
• We missed a vaccination. Can my child still get it late?
• Are there new vaccines that aren’t on the immunization schedules for kids?
• What should I do if I don’t have health insurance, or my insurance doesn’t cover vaccinations?
• What vaccinations do I need as an adult?
• Why do some people insist they became sick after getting the flu vaccine?

Centers for Disease Control and Prevention: Vaccines & Immunizations

Last Updated: August 10, 2023

This article was contributed by familydoctor.org editorial staff.

Copyright © American Academy of Family Physicians

This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.

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There are plenty of moral reasons to be vaccinated – but that doesn’t mean it’s your ethical duty

Director of the Master of Bioethics degree program at the Berman Institute of Bioethics, Johns Hopkins University

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Travis N. Rieder does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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With the news that all U.S. adults are now eligible to receive the COVID-19 vaccine, the holy grail of infectious disease mitigation – herd immunity – feels tantalizingly close. If enough people take the vaccine, likely at least 70% of the population, disease prevalence will slowly decline and most of us will safely get back to normal. But if not enough people get vaccinated, COVID-19 could stick around indefinitely.

The urgency of reaching that milestone has led some to claim that individuals have a civic duty or moral obligation to get vaccinated.

As a moral philosopher who has written on the nature of obligation in other contexts, I want to explore how the seemingly straightforward ethics of vaccine choice is in fact rather complex.

The simple argument

The discussion of whether or not one should take the COVID-19 vaccine is often framed in terms of individual self-interest: The benefits outweigh the risk, so you should do it.

That’s not a moral argument.

Most people likely believe that others have wide latitude in determining how they care for their own health, so it can be permissible to engage in risky activities – such as motorcycling or base jumping – even when it’s not in one’s interest. Whether one should get vaccinated, however, is a moral issue because it affects others, and in a couple of ways.

First, effective vaccines are expected to decrease not only rates of infection but also rates of virus transmission . This means that getting the vaccine can protect others from you and contribute to the population reaching herd immunity.

Second, high disease prevalence allows for more genetic mutation of a virus, which is how new variants arise. If enough people aren’t vaccinated quickly, new variants may develop that are more infectious, are more dangerous or evade current vaccines.

The straightforward ethical argument, then, says: Getting vaccinated isn’t just about you. Yes, you have the right to take risks with your own safety. But as the British philosopher John Stuart Mill argued in 1859, your freedom is limited by the harm it could do to others. In other words, you do not have the right to risk other people’s health, and so you are obligated to do your part to reduce infection and transmission rates.

It’s a plausible argument. But the case is rather more complicated.

Individual action, collective good

The first problem with the argument above is that it moves from the claim that “My freedom is limited by the harm it would cause others” to the much more contentious claim that “My freedom is limited by very small contributions my action might make to large, collective harms.”

Refusing to be vaccinated does not violate Mill’s harm principle , as it does not directly threaten some particular other with significant harm. Rather, it contributes a very small amount to a large, collective harm.

Since no individual vaccination achieves herd immunity or eliminates genetic mutation, it is natural to wonder: Could we really have a duty to make such a very small contribution to the collective good?

A version of this problem has been well explored in the climate ethics literature, since individual actions are also inadequate to address the threat of climate change. In that context, a well-known paper argues that the answer is “no”: There is simply no duty to act if your action won’t make a meaningful difference to the outcome.

Others, however, have explored a variety of ways to rescue the idea that individuals must not contribute to collective harms.

One strategy is to argue that small individual actions may actually make a difference to large collective effects, even if it’s difficult to see.

For instance: Although it appears that an individual getting vaccinated doesn’t make a significant difference to the outcome, perhaps that is just the result of uncareful moral mathematics. One’s chance of saving a life by reducing infection or transmission is very small, but saving a life is very valuable. The expected value of the outcome, then, is still high enough to justify taking it to be a moral requirement.

Another strategy concedes that individual actions don’t make a meaningful difference to large, structural problems, but this doesn’t mean morality must be silent with regard to those actions. Considerations of fairness , virtue and integrity all might recommend taking individual action toward a collective goal – even if that action did not by itself make a difference.

In addition, these and other considerations can provide reasons to act , even if they don’t imply an obligation to act.

The contours of obligation

There is yet another challenge in justifying an obligation to get vaccinated, which has to do with the very nature of obligations.

Obligations are requirements on actions, and, as such, those actions often seem demandable by members of the moral community. If a person is obligated to donate to charity, then other members of the community have the moral standing to demand a percentage of their income. That money is owed to others.

The relevant question here, then, is: Are there moral grounds to demand another person get vaccinated?

Philosopher Margaret Little has argued that very intimate actions, such as sex and gestation – the continuation of a pregnancy – are not demandable. In my own work, I’ve suggested that this is also true for deciding how to form a family – for example, adopting a child versus procreating. The intimacy of the actions, I argue, make it the case that no one is entitled to them. Someone can ask you for sex, and there are good reasons to adopt rather than procreate; but no one in the community has the moral standing to demand that you do either. These sorts of examples suggest that particularly intimate actions are not the appropriate targets of obligation.

Is getting vaccinated intimate? While it may not appear so at first blush, it involves having a substance injected into your body, which is a form of bodily intimacy. It requires allowing another to puncture the barrier between your body and the world. In fact, most medical procedures are the sort of thing that it seems inappropriate to demand of someone, as individuals have unilateral moral authority over what happens to their bodies.

The argument presented here objects to intimate duties because they seem too invasive. However, even if members of the moral community don’t have the standing to demand that others vaccinate, they are not required to stay silent; they may ask, request or entreat, based on very good reasons. And of course, no one is required to interact with those who decline.

I am certainly not trying to convince anyone that it’s OK not to get vaccinated. Indeed, the arguments throughout indicate, I think, that there is overwhelming reason to get vaccinated. But reasons – even when overwhelming – don’t constitute a duty, and they don’t make an action demandable.

Acting as though the moral case is straightforward can be alienating to those who disagree. And minimizing the moral stakes when we ask others to have a substance injected into their body can be disrespectful. A much better way, I think, is to engage others rather than demand from them, even if the force of reason ends up clearly on one side.

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Importance Of Vaccination Essay

A vaccination is a treatment that increases immunity to a specific illness. It is a biologically produced item that includes typical components resembling a disease-causing bacteria, generated from weak or dead versions of the microbe. It aids in immune system stimulation, identifies invasive bacteria as foreign invaders, and helps eradicate them so that the immune system can detect and eradicate any microorganism it encounters. Here are a few sample essays on ‘Importance Of Vaccination’.

100 Words Essay On Importance Of Vaccination

Vaccinations are a critical aspect of modern medicine, designed to protect individuals from harmful illnesses. They work by introducing a small, harmless dose of a microbe or its components, such as a protein or toxin, into the body. This exposure triggers the immune system to recognize and respond to the invader, allowing it to quickly identify and eliminate the pathogen if encountered again in the future.

One of the main reasons why vaccination is so important is that it helps to prevent the spread of infectious diseases. By providing immunity to a specific illness, vaccinations can help to reduce the number of people who become sick from that disease. This not only benefits the individuals who are vaccinated, but also those around them, particularly those who are unable to receive the vaccine due to underlying health conditions or other reasons.

Vaccination also plays a crucial role in herd immunity. Herd immunity is achieved when a large percentage of a population is vaccinated, making it difficult for a disease to spread. This protects not only the vaccinated individuals but also those who are unable to be vaccinated, such as newborns and people with certain medical conditions.

In conclusion, vaccinations are a safe and effective way to protect ourselves and our communities from harmful illnesses. They are a crucial tool in the fight against the spread of infectious diseases and help to ensure the health and well-being of all individuals.

200 Words Essay On Importance Of Vaccination

To prevent hazardous infections, vaccination is a simple, secure, reliable method that can be applied before you are exposed to them. As a result, your immune system is boosted, and your body's natural defences to infection are reinforced. Vaccines train your immune system to produce antibodies when exposed to a disease. A vaccine, however, does not cause an illness or increase your risk of contracting it since it only contains dead or weakened versions of bacteria or viruses.

How It Works

Natural defences of your body work together with vaccines to create immunity. Your immune system reacts when you receive a vaccination . It recognizes the bacterium or virus that is causing the invasion. Generated antibodies Proteins called antibodies are naturally created by the immune system to combat disease. In the future, if you are exposed to the pathogen, your immune system can quickly wipe it out before you get sick.

To receive the vaccine, individuals must regularly check with their local and state health departments. When the opportunity presents itself, they must take advantage of it. Some persons with specific immune system problems shouldn't have particular vaccines, and they should first see their doctors. Additionally, a small percentage of people do not react to a certain vaccine. It's crucial that everyone else have vaccinations because these people cannot be immunized. The great majority of people's "herd immunity" is preserved as a result. This implies that a disease will stop spreading if the majority of people are immune to it as a result of vaccination.

500 Words Essay On Importance Of Vaccination

The primary purpose of vaccinations is to protect by identifying and combating diseases like viruses or bacteria. Measles, polio, tetanus, diphtheria, meningitis, influenza, typhoid, and cervical cancer are among the deadly illnesses that can be avoided with vaccination . The substance used for immunization is the vaccine. The vaccine is made from weakened or dead microorganisms and contains components comparable to those found in the microbe that uses one of its toxins or surface proteins to cause the disease. The vaccine aids in boosting the immune system's ability to recognize and eliminate foreign objects. The Smallpox vaccine was the first to be developed.

Secure And Reliable

Vaccines are the best defence against a potentially fatal, preventable, and contagious disease. Although vaccines are among the safest medical medicines on the market, some precautions should be taken. People can make decisions regarding vaccinations with the help of precise information on the benefits and potential adverse effects of vaccines.

Do Vaccines Work?

Most vaccines provide immunity in 90–100% of cases. At the same time, improved sanitation and hygiene can undoubtedly contribute to preventing disease and the microorganisms that cause conditions to remain. As long as bacteria exist, people will continue to get sick.

You can see that once a vaccine is approved, the number of cases of diseases that can be prevented by vaccination begins to decline. Every year, vaccines save millions of lives. The number of people in the same community is protected from diseases when a specific area of a city or town is vaccinated against a contagious disease since the likelihood of an outbreak is reduced. The concept of immunity deals with preventing infectious diseases like rabies, measles, mumps, influenza, and pneumococcal disease.

History Of Vaccination

Before the first vaccines, humans were injected against smallpox in China and other places using cowpox, a practice known as variolation. This practice was copied in the west. The first mention of variolation as a treatment for smallpox dates back to China in the 10th century.

In 1796, a physician named Edward Jenner from Berkeley, Gloucestershire, England, tested the theory that someone with cowpox would be resistant to smallpox. To test the idea, he gave cowpox vesicles from a milkmaid named Sarah Nelmes to an eight-year-old boy named James Phipps. Two months later, he gave the child a smallpox injection, but smallpox did not manifest. There was a lot of interest in Jenner's 1798 Inquiry into the Causes and Effects of the Variolae Vaccine.

He distinguished between "real" and "false" cowpox (which did not give the desired effect). He created an "arm-to-arm" technique to spread the vaccine from a vaccinated person's pustules. Smallpox contamination delayed early attempts at confirmation, but by 1801, his paper had been translated into six other languages, and more than 100,000 people had received vaccinations, despite controversy in the medical field and religious opposition to the use of animal products. The term "vaccination" was created by surgeon Richard Dunning and was first used in his 1800 book ‘Some notes on immunization’.

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Vaccine Persuasion

Many vaccine skeptics have changed their minds.

By David Leonhardt

When the Kaiser Family Foundation conducted a poll at the start of the year and asked American adults whether they planned to get vaccinated, 23 percent said no.

But a significant portion of that group — about one quarter of it — has since decided to receive a shot. The Kaiser pollsters recently followed up and asked these converts what led them to change their minds . The answers are important, because they offer insight into how the millions of still unvaccinated Americans might be persuaded to get shots, too.

First, a little background: A few weeks ago, it seemed plausible that Covid-19 might be in permanent retreat, at least in communities with high vaccination rates. But the Delta variant has changed the situation. The number of cases is rising in all 50 states .

Although vaccinated people remain almost guaranteed to avoid serious symptoms, Delta has put the unvaccinated at greater risk of contracting the virus — and, by extension, of hospitalization and death. The Covid death rate in recent days has been significantly higher in states with low vaccination rates than in those with higher rates:

(For more detailed state-level charts, see this piece by my colleagues Lauren Leatherby and Amy Schoenfeld Walker. The same pattern is evident at the county level, as the health policy expert Charles Gaba has been explaining on Twitter.)

Nationwide, more than 99 percent of recent deaths have occurred among unvaccinated people, and more than 97 percent of recent hospitalizations have occurred among the unvaccinated, according to the C.D.C. “Look,” President Biden said on Friday, “the only pandemic we have is among the unvaccinated.”

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Benefits of Getting A COVID-19 Vaccine

There are many benefits of getting vaccinated against COVID-19.

• Prevents serious illness: COVID-19 vaccines available in the United States  are safe and effective  at protecting people from getting seriously ill, being hospitalized, and dying.
• A safer way to build protection: Getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19.
• Offers added protection: COVID-19 vaccines can  offer added protection to people who had COVID-19, including protection against being hospitalized from a new infection.

How to be best protected: As with vaccines for other diseases, people are  best protected when they  stay up to date .

COVID-19 Vaccines Protect Your Health

COVID 19-vaccines are effective at protecting people from getting seriously ill, being hospitalized, and dying. Vaccination remains the safest strategy for avoiding hospitalizations, long-term health outcomes, and death.

What You Can Do Now to Prevent Severe Illness, Hospitalization, and Death

Use Vaccines.gov  – to find a COVID-19 vaccine near you.

CDC recommends everyone aged 5 years and older get 1 updated COVID-19 vaccine . Children aged 6 months – 4 years may need more than 1 dose of updated COVID-19 to stay up to date . People aged 65 years and older who received 1 dose of any updated 2023-2024 COVID-19 vaccine (Pfizer-BioNTech, Moderna or Novavax) should receive 1 additional dose of an updated COVID-19 vaccine at least 4 months after the previous updated dose. For more Novavax information, click or tap here .

Severe Illness

COVID-19 vaccines are highly effective in preventing the most severe outcomes from a COVID-19 infection.

Myocarditis is a condition where the heart becomes inflamed in response to an infection or some other trigger. Myocarditis after COVID-19 vaccination is rare. This study shows that patients with COVID-19 had nearly 16 times the risk for myocarditis compared with patients who did not have COVID-19 .

Hospitalization

COVID-19 vaccines can help prevent you from becoming hospitalized if you do get infected with COVID-19.

COVID-19 vaccines can help prevent you from dying if you do get infected with COVID-19.

COVID-19 Vaccination is a Safer, More Reliable Way to Build Protection

Getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19. COVID-19 vaccination helps protect people by creating an immune response without the potentially severe illness or post-COVID conditions that can be associated with COVID-19 infection.

• Getting sick with COVID-19 can cause severe illness or death, even in children, but it is not possible to determine who will experience mild or severe illness from COVID-19 infection.
• People may have long-term health issues after having COVID-19. Even people who do not have symptoms when they are first infected with COVID-19 can experience long-term health problems, also known as long COVID or post-COVID conditions .
• Complications can appear after mild or severe COVID-19, or after multisystem inflammatory syndrome in children (MIS-C) .

While people can get some protection from having COVID-19, the level and length of that protection varies, especially as  COVID-19 variants continue to emerge .

• Immunity (protection) from infection can vary depending on how mild or severe someone’s illness was and their age.
• Immunity from infection decreases over time.

Importantly, there is no antibody test  available that can reliably determine if a person is protected from further infection.

After vaccination, continue to follow all current prevention measures recommended by CDC based on latest COVID-19 hospital admission levels. Learn more about protecting your family from COVID-19.

• Facts about COVID-19 Vaccines
• Frequently Asked Questions about COVID-19 Vaccination
• COVID-19 Vaccines for People Who Would Like to Have a Baby

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What you need to know about covid-19 vaccines, answers to the most common questions about coronavirus vaccines..

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Vaccines save millions of lives each year. The development of safe and effective COVID-19 vaccines are a crucial step in helping us get back to doing more of the things we enjoy with the people we love.

We’ve gathered the latest expert information to answer some of the most common questions about COVID-19 vaccines. Keep checking back as we will update this article as more information becomes available.

What are the benefits of getting vaccinated?

Vaccines save millions of lives each year and a COVID-19 vaccine could save yours. The COVID-19 vaccines are safe and effective, providing strong protection against serious illness and death. WHO reports that unvaccinated people have at least 10 times higher risk of death from COVID-19 than someone who has been vaccinated. 

It is important to be vaccinated as soon as it’s your turn, even if you already had COVID-19. Getting vaccinated is a safer way for you to develop immunity from COVID-19 than getting infected.

The COVID-19 vaccines are highly effective, but no vaccine provides 100 per cent protection. Some people will still get ill from COVID-19 after vaccination or pass the virus onto someone else. 

Therefore, it is important to continue practicing safety precautions to protect yourself and others, including avoiding crowded spaces, physical distancing, hand washing and wearing a mask.

Who should be vaccinated first?

Each country must identify priority populations, which WHO recommends are frontline health workers (to protect health systems) and those at highest risk of death due to COVID-19, such as older adults and people with certain medical conditions. Other essential workers, such as teachers and social workers, should then be prioritized, followed by additional groups as more vaccine doses become available.

The risk of severe illness from COVID-19 is very low amongst healthy children and adolescents, so unless they are part of a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than these priority groups.

Children and adolescents who are at higher risk of developing severe illness from COVID-19, such as those with underlying illnesses, should be prioritized for COVID-19 vaccines.  

When shouldn’t you be vaccinated against COVID-19?

If you have any questions about whether you should receive a COVID-19 vaccine, speak to your healthcare provider. At present, people with the following health conditions should not receive a COVID-19 vaccine to avoid any possible adverse effects:

• If you have a history of severe allergic reactions to any ingredients of a COVID-19 vaccine.
• If you are currently sick or experiencing symptoms of COVID-19 (although you can get vaccinated once you have recovered and your doctor has approved).

Should I get vaccinated if I already had COVID-19?

Yes, you should get vaccinated even if you’ve previously had COVID-19. While people who recover from COVID-19 may develop natural immunity to the virus, it is still not certain how long that immunity lasts or how well it protects you against COVID-19 reinfection. Vaccines offer more reliable protection, especially against severe illness and death. Vaccination policies after COVID-19 infection vary by country. Check with your health care provider on the recommendation where you live.

Which COVID-19 vaccine is best for me?

All WHO-approved vaccines have been shown to be highly effective at protecting you against severe illness and death from COVID-19. The best vaccine to get is the one most readily available to you.

You can find a list of those approved vaccines on WHO’s site .  

Remember, if your vaccination involves two doses, it’s important to receive both to have the maximum protection. 

How do COVID-19 vaccines work?

Vaccines work by mimicking an infectious agent – viruses, bacteria or other microorganisms that can cause a disease. This ‘teaches’ our immune system to rapidly and effectively respond against it.

Traditionally, vaccines have done this by introducing a weakened form of an infectious agent that allows our immune system to build a memory of it. This way, our immune system can quickly recognize and fight it before it makes us ill. That’s how some of the COVID-19 vaccines have been designed.

Other COVID-19 vaccines have been developed using new approaches, which are called messenger RNA, or mRNA, vaccines. Instead of introducing antigens (a substance that causes your immune system to produce antibodies), mRNA vaccines give our body the genetic code it needs to allow our immune system to produce the antigen itself. mRNA vaccine technology has been studied for several decades. They contain no live virus and do not interfere with human DNA.

For more information on how vaccines work, please visit WHO .

Are COVID-19 vaccines safe?

Yes, COVID-19 vaccines have been safely used to vaccinate billions of people. The COVID-19 vaccines were developed as rapidly as possible, but they had to go through rigorous testing in clinical trials to prove that they meet internationally agreed benchmarks for safety and effectiveness. Only if they meet these standards can a vaccine receive validation from WHO and national regulatory agencies.

UNICEF only procures and supplies COVID-19 vaccines that meet WHO’s established safety and efficacy criteria and that have received the required regulatory approval.

How were COVID-19 vaccines developed so quickly?

Scientists were able to develop safe effective vaccines in a relatively short amount of time due to a combination of factors that allowed them to scale up research and production without compromising safety: 

• Because of the global pandemic, there was a larger sample size to study and tens of thousands of volunteers stepped forward 
• Advancements in technology (like mRNA vaccines) that were years in the making 
• Governments and other bodies came together to remove the obstacle of funding research and development 
• Manufacturing of the vaccines occurred in parallel to the clinical trials to speed up production 

Though they were developed quickly, all COVID-19 vaccines approved for use by the WHO are safe and effective.

What are the side effects of COVID-19 vaccines?

Vaccines are designed to give you immunity without the dangers of getting the disease. Not everyone does, but it’s common to experience some mild-to-moderate side effects that go away within a few days on their own.

Some of the mild-to-moderate side effects you may experience after vaccination include:

• Arm soreness at the injection site
• Muscle or joint aches

You can manage any side effects with rest, staying hydrated and taking medication to manage pain and fever, if needed.

If any symptoms continue for more than a few days then contact your healthcare provider for advice. More serious side effects are extremely rare, but if you experience a more severe reaction, then contact your healthcare provider immediately.

>> Read: What you need to know before, during and after receiving a COVID-19 vaccine

How do I find out more about a particular COVID-19 vaccine?

You can find out more about COVID-19 vaccines on WHO’s website .  

Can I stop taking precautions after being vaccinated?

Keep taking precautions to protect yourself, family and friends if there is still COVID-19 in your area, even after getting vaccinated. The COVID-19 vaccines are highly effective against serious illness and death, but no vaccine is 100% effective.  

The vaccines offer less protection against infection from the Omicron variant, which is now the dominant variant globally, but remain highly effective in preventing hospitalization, severe disease, and death. In addition to vaccination, it remains important to continue practicing safety precautions to protect yourself and others. These precautions include avoiding crowded spaces, physical distancing, hand washing, and wearing a mask (as per local policies).  

Can I still get COVID-19 after I have been vaccinated? What are ‘breakthrough cases’?

A number of vaccinated people may get infected with COVID-19, which is called a breakthrough infection. In such cases, people are much more likely to only have milder symptoms. Vaccine protection against serious illness and death remains strong.

With more infectious virus variants such as Omicron, there have been more breakthrough infections. That’s why it's recommended to continue taking precautions such as avoiding crowded spaces, wearing a mask and washing your hands regularly, even if you are vaccinated. 

And remember, it’s important to receive all of the recommended doses of vaccines to have the maximum protection.

How long does protection from COVID-19 vaccines last?

According to WHO, the effectiveness of COVID-19 vaccines wanes around 4-6 months after the primary series of vaccination has been completed. Taking a booster to strengthen your protection against serious disease is recommended if it is available to you. 

Do the COVID-19 vaccines protect against variants?

The WHO-approved COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

However, the vaccines offer less protection against infection from Omicron, which is the dominant variant globally. That's why it's important to get vaccinated and continue measures to reduce the spread of the virus – which helps to reduce the chances for the virus to mutate – including physical distancing, mask wearing, good ventilation, regular handwashing and seeking care early if you have symptoms. 

Do I need to get a booster shot?  

Booster doses play an important role in protecting against severe disease, hospitalization and death. 

WHO recommends that you take all COVID-19 vaccine doses recommended to you by your health authority as soon as it is your turn, including a booster dose if recommended. 

Booster shots should be given first to high priority groups. Data shows that a booster shot plays a significant role in boosting waning immunity and protecting against severe disease from highly transmissible variants like Omicron. 

If available, an additional second booster shot is also recommended for some groups of people, 4-6 months after the first booster. That includes older people, those who have weakened immune systems, pregnant women and healthcare workers. 

Check with your local health authorities for guidance and the availability of booster shots where you live.  

What do we know about the bivalent COVID-19 booster doses that have been developed to target Omicron?

Bivalent COVID-19 booster shots have now been developed with both the original strain of the coronavirus and a strain of Omicron. These have been designed to better match the Omicron subvariants that have proven to be particularly transmissible. Lab studies have shown that these doses help you to mount a higher antibody response against Omicron. Both Moderna and Pfizer have developed these bivalent vaccines, and some countries have now approved their use.  

Check with your local health authorities for information about the availability of these doses and who can get them where you live. And it’s important to note that the original COVID-19 vaccines continue to work very well and provide strong protection against severe illness from Omicron.  

Can I receive different types of COVID-19 vaccines?  

Yes, however, policies on mixing vaccines vary by country. Some countries have used different vaccines for the primary vaccine series and the booster. Check with your local health authorities for guidance where you live and speak with your healthcare provider if you have any questions on what is best for you. 

I’m pregnant. Can I get vaccinated against COVID-19?

Yes, you can get vaccinated if you are pregnant. COVID-19 during pregnancy puts you at higher risk of becoming severely ill and of giving birth prematurely. 

Many people around the world have been vaccinated against COVID-19 while pregnant or breastfeeding. No safety concerns have been identified for them or their babies. Getting vaccinated while pregnant helps to protect your baby. For more information about receiving a COVID-19 vaccination while pregnant, speak to your healthcare provider.

>> Read: Navigating pregnancy during the COVID-19 pandemic

I’m breastfeeding. Should I get vaccinated against COVID-19?

Yes, if you are breastfeeding you should take the vaccine as soon as it is available to you. It is very safe and there is no risk to the mother or baby. None of the current COVID-19 vaccines have live virus in them, so there is no risk of you transmitting COVID-19 to your baby through your breastmilk from the vaccine. In fact, the antibodies that you have after vaccination may go through the breast milk and help protect your baby. >> Read: Breastfeeding safely during the COVID-19 pandemic

Can COVID-19 vaccines affect fertility?

No, you may have seen false claims on social media, but there is no evidence that any vaccine, including COVID-19 vaccines, can affect fertility in women or men. You should get vaccinated if you are currently trying to become pregnant.

Could a COVID-19 vaccine disrupt my menstrual cycle?

Some people have reported experiencing a disruption to their menstrual cycle after getting vaccinated against COVID-19. Although data is still limited, research is ongoing into the impact of vaccines on menstrual cycles.

Speak to your healthcare provider if you have concerns or questions about your periods.

Should my child or teen get a COVID-19 vaccine?

An increasing number of vaccines have been approved for use in children. They’ve been made available after examining the data on the safety and efficacy of these vaccines, and millions of children have been safely vaccinated around the world. Some COVID-19 vaccines have been approved for children from the age of 6 months old. Check with your local health authorities on what vaccines are authorized and available for children and adolescents where you live.  

Children and adolescents tend to have milder disease compared to adults, so unless they are part of a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers. 

Remind your children of the importance of us all taking precautions to protect each other, such as avoiding crowded spaces, physical distancing, hand washing and wearing a mask. 

It is critical that children continue to receive the recommended childhood vaccines. 

How do I talk to my kids about COVID-19 vaccines?

News about COVID-19 vaccines is flooding our daily lives and it is only natural that curious young minds will have questions – lots of them. Read our explainer article for help explaining what can be a complicated topic in simple and reassuring terms.

It’s important to note that from the millions of children that have so far been vaccinated against COVID-19 globally, we know that side effects are very rare. Just like adults, children and adolescents might experience mild symptoms after receiving a dose, such as a slight fever and body aches. But these symptoms typically last for just a day or two. The authorized vaccines for adolescents and children are very safe.  

My friend or family member is against COVID-19 vaccines. How do I talk to them?

The development of safe and effective COVID-19 vaccines is a huge step forward in our global effort to end the pandemic. This is exciting news, but there are still some people who are skeptical or hesitant about COVID-19 vaccines. Chances are you know a person who falls into this category.

We spoke to Dr. Saad Omer, Director at the Yale Institute for Global Health, to get his tips on how to navigate these challenging conversations. >> Read the interview

How can I protect my family until we are all vaccinated?

Safe and effective vaccines are a game changer, but even once vaccinated we need to continue taking precautions for the time being to protect ourselves and others. Variants like Omicron have proven that although COVID-19 vaccines are very effective at preventing severe disease, they’re not enough to stop the spread of the virus alone. The most important thing you can do is reduce your risk of exposure to the virus. To protect yourself and your loved ones, make sure to:

• Wear a mask where physical distancing from others is not possible.
• Keep a physical distance from others in public places.
• Avoid poorly ventilated or crowded spaces.
• Open windows to improve ventilation indoors.
• Try and focus on outdoor activities if possible.  
• Wash your hands regularly with soap and water or an alcohol-based hand rub.

If you or a family member has a fever, cough or difficulty breathing, seek medical care early and avoid mixing with other children and adults.  

Can COVID-19 vaccines affect your DNA?

No, none of the COVID-19 vaccines affect or interact with your DNA in any way. Messenger RNA, or mRNA, vaccines teach the cells how to make a protein that triggers an immune response inside the body. This response produces antibodies which keep you protected against the virus. mRNA is different from DNA and only stays inside the cell for about 72 hours before degrading. However, it never enters the nucleus of the cell, where DNA is kept.

Do the COVID-19 vaccines contain any animal products in them?

No, none of the WHO-approved COVID-19 vaccines contain animal products.

I’ve seen inaccurate information online about COVID-19 vaccines. What should I do?

Sadly, there is a lot of inaccurate information online about the COVID-19 virus and vaccines. A lot of what we’re experiencing is new to all of us, so there may be some occasions where information is shared, in a non-malicious way, that turns out to be inaccurate.

Misinformation in a health crisis can spread paranoia, fear and stigmatization. It can also result in people being left unprotected or more vulnerable to the virus. Get verified facts and advice from trusted sources like your local health authority, the UN, UNICEF, WHO.

If you see content online that you believe to be false or misleading, you can help stop it spreading by reporting it to the social media platform.

What is COVAX?

COVAX is a global effort committed to the development, production and equitable distribution of vaccines around the world. No country will be safe from COVID-19 until all countries are protected.

There are 190 countries and territories engaged in the COVAX Facility, which account for over 90 per cent of the world’s population. Working with CEPI, GAVI, WHO and other partners, UNICEF is leading efforts to procure and supply COVID-19 vaccines on behalf of COVAX.  

Learn more about COVAX .

This article was last updated on 25 October 2022. It will continue to be updated to reflect the latest information. 

Related topics

More to explore, covid-19 response.

Resources and information about UNICEF’s response to the COVID-19 pandemic

How to talk to your children about COVID-19 vaccines

Tips for navigating the conversation

How to talk to friends and family about vaccines

Tips for handling tough conversations with your loved ones

COVAX information centre

UNICEF and partners led the largest vaccine procurement and supply operation in history

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Getting the COVID-19 Vaccine

This article is part of a series of explainers on vaccine development and distribution. Learn more about vaccines – from how they work and how they’re made to ensuring safety and equitable access – in WHO’s Vaccines Explained series.

Vaccines are a critical tool in the battle against COVID-19, and getting vaccinated is one of the best ways to protect yourself and others from COVID-19.

Getting vaccinated is safer than getting infected 

Vaccines train our immune system to recognize the targeted virus and create antibodies to fight off the disease without getting the disease itself. After vaccination, the body is ready to fight the virus if it is later exposed to it, thereby preventing illness.

Most people who are infected with SARS-CoV-2, the virus that causes COVID-19, develop an immune response within the first few weeks, but we are still learning how strong and lasting that immune response is, and how it varies between different people.

People who have already been infected with SARS-CoV-2 should still get vaccinated unless told otherwise by their health care provider. Even if you’ve had a previous infection, the vaccine acts as a booster that strengthens the immune response. There have also been some instances of people infected with SARS-CoV-2 a second time, which makes getting vaccinated even more important.

What to expect during vaccination

Medical professionals can best advise individuals on whether or not, and when, they should receive a vaccine. A health worker will administer the vaccine, and the person receiving it will be asked to wait for 15–30 minutes before leaving the vaccination site. This is so that health workers can observe individuals for any unexpected reactions following vaccination.

Like any vaccine, COVID-19 vaccines can cause mild-to-moderate side effects, such as a low-grade fever or pain or redness at the injection site. These should go away on their own within a few days. See WHO’s Safety of COVID-19 Vaccines explainer and Vaccines Safety Q&A to learn more about common side effects and find out who should consult with a doctor before vaccination.

Vaccine doses

For some COVID-19 vaccines, two doses are required . It’s important to get the second dose if the vaccine requires two doses.

For vaccines that require two doses, the first dose presents antigens – proteins that stimulate the production of antibodies – to the immune system for the first time. Scientists call this priming the immune response. The second dose acts as a booster, ensuring the immune system develops a memory response to fight off the virus if it encounters it again.

Because of the urgent need for a COVID-19 vaccine, initial clinical trials of vaccine candidates were performed with the shortest possible duration between doses. Therefore an interval of 21–28 days (3–4 weeks) between doses is recommended by WHO. Depending on the vaccine, the interval may be extended for up to 42 days – or even up to 12 weeks for some vaccines – on the basis of current evidence.

There are many COVID-19 vaccines being developed and produced by different manufacturers around the world. WHO recommends that a vaccine from the same manufacturer be used for both doses if you require two doses. This recommendation may be updated as further information becomes available.

Safety against infection and transmission after vaccination

Available clinical trials have shown COVID-19 vaccines to be safe and highly effective at preventing severe disease. Given how new COVID-19 is, researchers are still looking into how long a vaccinated person is likely to be protected from infection, and whether vaccinated people can still transmit the virus to others. As the vaccine rollout expands, WHO will continue to monitor the data alongside regulatory authorities.

Safe and effective vaccines are making a significant contribution to preventing severe disease and death from COVID-19. As vaccines are rolling out and immunity is building, it is important to continue to follow all of the recommended measures that reduce the spread of SARS-CoV-2. This includes physically distancing yourself from others; wearing a mask, especially in crowded and poorly ventilated settings; cleaning your hands frequently; covering any cough or sneeze in your bent elbow; and opening windows when indoors.

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• Published: 20 July 2023

Advances in vaccines: revolutionizing disease prevention

• Timir Tripathi   ORCID: orcid.org/0000-0001-5559-289X 1  

Scientific Reports volume  13 , Article number:  11748 ( 2023 ) Cite this article

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Vaccines have revolutionized modern medicine by preventing infectious diseases and safeguarding public health. This Collection showcases cutting-edge research on advancements in vaccine development and their impact on disease prevention. The papers presented here report various facets of vaccine efficacy, immunological responses, and design, providing insight into future immunization strategies. I believe this Collection will serve as a catalyst for further advancements in the field of vaccine research.

Vaccines have long been credited as the most effective tool in preventing and managing infectious diseases. They have drastically reduced the global disease burden 1 . Over the years, significant progress has been made in understanding the immune system and developing novel vaccine design and delivery platforms 2 , 3 . From developing mRNA vaccines 4 that offer rapid response to identifying novel antigenic targets for broader protection, we have been at the forefront of innovation. Furthermore, the exploration of advanced adjuvants and delivery systems is enhancing vaccine efficacy and accessibility 5 . These cutting-edge technologies and advancements in vaccine research hold immense potential for tackling infectious diseases and improving global public health. In this Collection, I am delighted to present research articles highlighting the latest advances in vaccine development, shedding light on innovative vaccine design and delivery strategies, novel targets, and promising candidates. These breakthrough articles have the potential to revolutionize the field of vaccines and move us one step closer to a world free from the grip of devastating infectious diseases and outbreaks 6 .

Early strategies for investigating new vaccine targets or developing formulations increasingly rely on sophisticated computational approaches. These approaches help save resources and refine in vitro and in vivo studies. For example, in one of the papers in this Collection, Goodswen et al. 7 present a state-of-the-art methodology for high-throughput in silico vaccine discovery against protozoan parasites, exemplified by discovered candidates for Toxoplasma gondii . Vaccine discovery against protozoan parasites is challenging due to the limited number of current appropriate vaccines compared to the number of protozoal diseases that need one. The group generated a ranked list of T. gondii vaccine candidates and proposed a workflow integrating parasite biology, host immune system defences, and bioinformatics programs to predict vaccine candidates. Although testing in animal models is required to validate these predictions, most of the top-ranked candidates are supported by publications reinforcing the confidence in the approach.

In another paper showcasing the benefits of an in silico approach, Palatnik‐de‐Sousa et al. 8 report the design and development of a multiepitope multivariant vaccine based on highly conserved epitopes of multiple proteins of all SARS-CoV-2 variants. The authors propose that this could offer more long-lasting protection against different strains of SARS-CoV-2 compared with current vaccines. The vaccine was developed based on highly promiscuous and robust HLA binding CD4 + and CD8 + T cell epitopes of the S, M, N, E, ORF1ab, ORF 6 and ORF8 proteins of SARS-CoV-2 variants Alpha to Omicron. The study found that the selected epitopes were 100% conserved among all 10 studied variants, supporting the potential efficacy of the multivariant multiepitope vaccine in generating cross-protection against infections by viruses of different human SARS-CoV-2 clades. The use of immunoinformatics and in silico approaches to design the vaccines in these articles could be a cost-effective and time-efficient method for developing vaccines for other infectious diseases in the future.

The translation of scientific discoveries into practical applications ensures the successful development and evaluation of effective vaccines, such as those reported by Quach et al. 9 and Uddin et al. 10 . Quach et al. 9 report the development of a peptide-based smallpox vaccine by identifying and evaluating immunogenic peptides from vaccinia-derived peptides. They assessed the immunogenicity of these T-cell peptides in both transgenic mouse models and human peripheral blood mononuclear cells. The vaccine, based on four selected peptides, provided 100% protection against a lethal viral challenge and induced a long-term memory T-cell response, highlighting the potential of peptide-based vaccines for infectious diseases. Uddin et al. 10 developed and evaluated a mucosal vaccine against the bovine respiratory pathogen Mannheimia haemolytica using Bacillus subtilis spores as an adjuvant. They found that intranasal immunization of spore-bound antigens generated the best secretory IgA-specific response against both PlpE and LktA in all bronchoalveolar lavage, saliva, and faeces samples. The spore-based vaccine may offer protection in cattle by limiting colonization and subsequent infection, and Spore-MhCP warrants further evaluation in cattle as a mucosal vaccine against M. haemolytica . This technology has potential commercial benefits as production of B. subtilis is well established and has low-cost inputs, and B. subtilis is recognized as a probiotic that has generally regarded as safe status, used commercially in food/feed products for human beings, poultry, cattle, swine, and fish. The use of oral administration of the vaccine would allow for large-scale administration, which is especially important as livestock management strategies, including vaccination, are cost- and ease-of-use dependent. The work highlights innovative approaches to address pressing challenges in vaccine development.

Understanding cellular responses following the administration of vaccines is crucial in assessing their efficacy and safety and in the development of improved vaccine strategies. Gmyrek et al. 11 characterize the B cell response in mice vaccinated with a live-attenuated HSV-1 mutant, 0ΔNLS, and compare it to the parental virus, GFP105. The study found that 0ΔNLS vaccination resulted in a more robust B cell response, including an increase in CD4 + follicular helper T cells, germinal B cells, and class-switched B cells, as well as an elevated titer of HSV-1-specific antibody. The study reports that HSV-1 thymidine kinase and glycoprotein M are likely expendable components in the efficacy of a humoral response to ocular HSV-1 infection. Lunardelli et al. 12 provide a detailed assessment of the immune responses induced after immunization with different regions of the ZIKV envelope protein. The study found that immunization with E ZIKV, EDI/II ZIKV, and EDIII ZIKV proteins induced specific IFNγ-producing cells and polyfunctional CD4 + and CD8 + T cells. The study also identified four peptides present in the envelope protein capable of inducing a cellular immune response to the H-2Kd and H-2Kb haplotypes. The results suggest that the ZIKV envelope glycoprotein is highly immunogenic and could be a potential target for developing a vaccine against ZIKV. A paper by Suryadevara et al. 13 contributes to understanding the molecular signature of CD8 + Trm cells elicited by subunit vaccination and their potential to protect against respiratory infectious diseases. The molecular signature of subunit vaccine-elicited CD8 + Trm cells resembles those elicited by virus infection or vaccination, with distinct molecular signatures distinguishing lung interstitial CD8 + Trm cells from effector memory and splenic memory counterparts. The transcriptome signature of the elicited CD8 + Trm cells provided clues to the basis of their tissue residence and function. Insights into cellular responses, such as those provided by the studies mentioned above, can not only help us understand tissue-specific responses to diseases but also how to harness them to promote resistance or treatment.

The advancements in vaccine research are transforming the landscape of disease prevention. From mRNA vaccines to novel antigenic targets, adjuvants, and delivery systems, these breakthroughs offer new avenues for combating infectious diseases and improving global public health 2 , 3 , 5 , 6 , 14 , 15 . Addressing vaccine hesitancy 16 , 17 and ensuring equitable access to vaccines are also top priorities 18 . Continued investment in research, collaboration, and development is essential to drive innovation and overcome challenges. The Collection highlights the innovative strategies, novel technologies, and cutting-edge research in vaccine technology, formulation, and delivery systems that have revolutionized vaccine development. With these advancements, we are inching closer to a future where the burden of preventable diseases is significantly reduced, paving the way for healthier communities and a safer world.

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Uddin, M. S. et al. Development of a spore-based mucosal vaccine against the bovine respiratory pathogen Mannheimia haemolytica. Sci. Rep. https://doi.org/10.1038/s41598-023-29732-4 (2023).

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Acknowledgements

On behalf of all the editors of this Collection, I extend my deepest appreciation to the authors for their invaluable contributions. I appreciate the peer reviewers who generously dedicated their time to evaluate and help improve these articles. I am also grateful to Nature Research and the editorial team at Scientific Reports for extending me an invitation to organize and edit this Collection.

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Tripathi, T. Advances in vaccines: revolutionizing disease prevention. Sci Rep 13 , 11748 (2023). https://doi.org/10.1038/s41598-023-38798-z

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• v.114(16); 2017 Apr 18

Simply put: Vaccination saves lives

Walter a. orenstein.

a Department of Medicine, Emory Vaccine Center, Emory University School of Medicine, Atlanta, GA, 30322;

b Department of Microbiology & Immunology, Emory Vaccine Center, Emory University School of Medicine, Atlanta, GA, 30322

Author contributions: W.A.O. and R.A. wrote the paper.

Few measures in public health can compare with the impact of vaccines. Vaccinations have reduced disease, disability, and death from a variety of infectious diseases. For example, in the United States, children are recommended to be vaccinated against 16 diseases ( 1 ). Table 1 highlights the impact in the United States of immunization against nine vaccine-preventable diseases, including smallpox and a complication of one of those diseases, congenital rubella syndrome, showing representative annual numbers of cases in the 20th century compared with 2016 reported cases ( 2 , 3 ). All of the diseases have been reduced by more than 90% and many have either been eliminated or reductions of 99% or more have been achieved. A recent analysis of vaccines to protect against 13 diseases estimated that for a single birth cohort nearly 20 million cases of diseases were prevented, including over 40,000 deaths ( 4 ). In addition to saving the lives of our children, vaccination has resulted in net economic benefits to society amounting to almost $69 billion in the United States alone. A recent economic analysis of 10 vaccines for 94 low- and middle-income countries estimated that an investment of $34 billion for the immunization programs resulted in savings of $586 billion in reducing costs of illness and $1.53 trillion when broader economic benefits were included ( 5 ). The only human disease ever eradicated, smallpox, was eradicated using a vaccine, and a second, polio, is near eradication, also using vaccines ( 6 , 7 ).

Comparison of 20th century annual morbidity and current estimates vaccine-preventable diseases

Vaccines not only provide individual protection for those persons who are vaccinated, they can also provide community protection by reducing the spread of disease within a population ( Fig. 1 ). Person-to-person infection is spread when a transmitting case comes in contact with a susceptible person. If the transmitting case only comes in contact with immune individuals, then the infection does not spread beyond the index case and is rapidly controlled within the population. Interestingly, this chain of human-to-human transmission can be interrupted, even if there is not 100% immunity, because transmitting cases do not have infinite contacts; this is referred to as “herd immunity” or “community protection,” and is an important benefit of vaccination.

( A ) A highly susceptible population in which a transmitting case is likely to come in contact with a susceptible person leading to a chain of person-to-person transmission. ( B ) A highly immune population in which a transmitting case is unlikely to come in contact with a susceptible person, thereby breaking the chain of transmission and achieving indirect protection of remaining susceptibles because they are not exposed.

Mathematical modelers can estimate on average how many persons the typical transmitting case is capable of infecting if all of the contacts were susceptible (i.e., a population of 100% susceptibility). This number is known as R 0 , or the basic reproductive number. The immunity threshold needed within the population for terminating transmission can be calculated in percent as ( R 0 − 1)/ R 0 × 100 and is a guide to setting immunity levels and vaccination coverage targets for various diseases ( 8 ). For example, measles is one of the most contagious of vaccine-preventable diseases, with an estimated immunity threshold of 92–94%. In contrast, the protection threshold for rubella is estimated at 83–85%. Thus, eliminating rubella transmission is easier than measles, and when there are gaps in immunization coverage leading to accumulation of susceptibles, measles is often the first vaccine-preventable disease identified. Because of community protection induced by vaccines, persons who cannot be vaccinated (e.g., have contraindications or are younger than the age for whom vaccines are recommended), as well as persons who fail to make an adequate immune response to the vaccine (although most vaccines are highly effective, they are not 100% effective), can be protected indirectly because they are not exposed ( Fig. 1 ). Thus, for most vaccines, achieving high levels of coverage is important not only for individual protection but in preventing disease in vulnerable populations that cannot be directly protected by vaccination. This provides the rationale for interventions to achieve high population immunity, such as removing barriers that may prevent access to vaccines (e.g., providing recommended vaccines without cost), as well as mandates for immunization requirements for attending school ( 9 ). There are many reasons why vaccinations may not be received as recommended. One extreme is outright opposition to vaccines. Probably even more common may be that making the effort to receive vaccines (e.g., making the healthcare visits at the appropriate time so vaccines can be administered) may be a low priority compared with other issues, so in the absence of having a mandate for vaccination, other things take priority. Thus, appropriate mandates could help in making vaccination a priority for all ( 10 ).

It’s often said that vaccines save lives, but this is not strictly true; it is vaccination that saves lives. A vaccine that remains in the vial is 0% effective even if it is the best vaccine in the world. Thus, it is imperative that we all work together to assure that a high level of coverage is obtained among populations for whom vaccines are recommended. In some sense, vaccines have become victims of their own success. Diseases that once induced fear and sparked desire for vaccines are now rare, and there is a false and dangerous sense of complacency among the public.

In addition, in recent years, growing numbers of persons have become hesitant about vaccines, fearing side effects and not appreciative of the enormous health and economic benefits that vaccines provide. A CDC report on 159 measles cases reported between January 4 and April 2, 2015, showed that 68 United States residents with measles were unvaccinated, and of these 29 (43%) cited philosophical or religious objections to vaccination ( 11 ). A 2014 national web-based poll of parents in the United States estimated that 90.8% (89.3–92.1%) reported accepting or planning to accept all recommended noninfluenza childhood vaccines, 5.6% (4.6–6.9%) reported intentionally delaying one or more, and 3.6% (2.8–4.5%) reported refusing one or more vaccines ( 12 ). A national survey of pediatricians in the United States reported that the proportion of pediatricians reporting parental vaccine refusals increased from 74.5% in 2006 to 87.0% in 2013 ( 13 ). A 67-country survey on the state of vaccine confidence reported an average of 5.8% of respondents globally were skeptical about the importance of vaccines, with that proportion rising to more than 15% in some countries ( 14 ). One of the major concerns in recent years has been the allegations that vaccines can cause autism. There are three major theories advanced on the role of vaccines in causing autism: ( i ) measles, mumps, rubella vaccine (MMR); ( ii ) thimerosal, an ethyl mercury containing preservative in many vaccines in the United States in the past, now mostly out of vaccines recommended for children; and ( iii ) too many vaccines ( 15 ). There have been multiple well-conducted studies and independent reviews of those studies by the Institute of Medicine (now the National Academy of Medicine) that do not support a role for vaccines in causing autism ( 16 ). Independent evaluation of the safety of the immunization schedule has found it to be extremely safe ( 17 ). However, translating the science into information capable of influencing vaccine skeptics has been difficult.

The National Vaccine Advisory Committee (NVAC) in the United States issued a report in 2015, with 23 recommendations to assure high levels of vaccine confidence ( 18 ). The recommendations have five focus areas: ( i ) measuring and tracking vaccine confidence, ( ii ) communication and community strategies to increase vaccine confidence, ( iii ) healthcare provider strategies to increase vaccine confidence, ( iv ) policy strategies to increase vaccine confidence, and ( v ) continued support and monitoring of the state of vaccine confidence. Critical to assuring confidence is evidence-based research to evaluate which interventions are most effective. The NVAC recommended that a repository of evidence-based best practices for informing, educating, and communicating with parents and others in ways that foster or increase vaccine confidence be created. And while we have focused on children, vaccine preventable diseases exact a substantial health burden in adults and immunization coverage rates for most recommended vaccines are substantially lower for adults than those achieved for recommended vaccines in children. Thus, there is need not only in enhancing immunization rates in children but also in adults.

In summary, vaccines are some of the most effective and also cost-effective prevention tools we have. But vaccines that are not administered to persons for whom they are recommended are not useful. It is incumbent upon all of us who work in the healthcare setting, as well as community leaders, to stress to our friends and colleagues the importance of vaccination both for the individual vaccinated as well as for the communities in which the individuals live. Also critically important, there remains an urgent need for greater emphasis on research to develop vaccines for global diseases for which vaccines either do not exist or need improvement.

Acknowledgments

The authors thank Dianne Miller, Ali Ellebedy, and Sandra Roush for their assistance in preparation of the manuscript.

See Perspective on page 4055 .

MANDATORY VACCINATION: WHY WE STILL GOT TO GET FOLKS TO TAKE THEIR SHOTS

Ben Balding

Class of 2006

April 27, 2006

This paper is submitted in satisfaction of the Food and Drug Law course paper and the Harvard Law School 3L Written Work Requirement

Vaccination is widely considered one of the greatest medical achievements of modern civilization. Childhood diseases that were commonplace less than a generation ago are now increasingly rare because of vaccines. In order to be effective at eliminating communicable diseases, vaccines must be administered to sufficient levels of persons in the community. Because of this, public health officials have mandated vaccination for certain diseases as a condition to school attendance. The overwhelming effectiveness of vaccination programs may lead individuals to ignore the benefits of vaccination and focus more on the risk of side effects. Moreover, some have criticized the coercive nature of these programs. These objections may lead to an unacceptably high number of exemptions, which can compromise vaccination programs and leave the population susceptible to outbreaks.

This paper explores vaccination programs with an eye toward greater public safety without ignoring the reality of a small but committed group of vaccine critics. The paper begins with a discussion of the historical development of mandatory vaccination policies and the issues posed by exemptions. It then addresses some of these issues in the context of vaccine safety. It also seeks solution by framing the discussion in economic terms. It concludes by recommending stricter enforcement of mandatory requirements for most vaccines and greater dissemination of information on the continued importance of vaccination.

TABLE OF CONTENTS

Introduction.

Vaccination is widely considered one of the greatest medical achievements of modern civilization. Childhood diseases that were commonplace less than a generation ago are now increasingly rare because of vaccines. The smallpox vaccine has eradicated a disease that was responsible for centuries of outbreaks and had a 30% fatality rate. [1] Physical handicaps resulting from polio can still be observed on some of those who were children before Jonas Salk developed a vaccine in 1955. Formerly common childhood diseases are now rarely observed. Even ear infections may soon be prevented by vaccination. [2] The widespread success of vaccinations has led one medical report to comment that “[n]ext to clean water, no single intervention has had so profound an effect on reducing mortality from childhood diseases as has the widespread introduction of vaccines.” [3]

The story of modern vaccination begins with Edward Jenner’s development of the vaccine for smallpox, one of the most feared diseases in recent history. At first, vaccination was optional and not everyone chose to vaccinate. [4] In time, states would allow municipalities to mandate vaccination in time of outbreak in order to protect the public from epidemics. [5] A further step was taken when states imposed smallpox vaccination as a prerequisite for attending public schools. [6] These requirements were amended in time as new vaccines were developed. [7] At some point actual outbreaks and epidemics ceased to be the trigger for mandatory vaccination, and prevention became the overriding justification. [8] Most states today require vaccination for a multitude of childhood diseases, including measles, diphtheria, pertussis, polio, and now even chickenpox. [9]

Because of the success and the mandatory nature of vaccination, most people would probably not consider vaccination an optional method of medical treatment. For most parents, the “decision” to vaccinate is equivalent to the “decision” to feed one’s child. [10] Typically, a doctor informs parents of the school vaccination schedule and the parents consent to having their child vaccinated. Since the vaccination schedule usually corresponds to the scheduled doctor visits for infants, full compliance with mandatory vaccination schedules is typically not a problem and can usually be substantially accomplished by age two. [11]

For some parents, however, vaccination is no routine matter. [12] From the time of Jenner’s smallpox vaccine, vaccination has had its critics. [13] In the two centuries since that time, many different types of objections have been raised. Some have questioned the scientific qualifications of mass immunization. [14] Others have focused on the personal liberty interests at stake and have objected to the paternalistic nature of government imposition of what is viewed as a personal medical choice. [15] Still others have opposed vaccination for personal or religious reasons. [16]

Today, some parents raise similar objections. The idea that a potentially harmful substance is being placed directly into the bloodstream raises a red flag for some. Additionally, the decline of many diseases for which vaccination is still mandated may make some parents skeptical of the continued wisdom of subjecting a child to a vaccine, even if the vaccine is considered extremely safe. This skepticism grows when some point to the correlation between vaccinations and conditions such as SIDS and autism. Whether or not such a correlation is scientifically significant, many parents simply wonder if it is wise to vaccinate against a disease unlikely to afflict their child if any chance exists that the vaccine will cause autism, SIDS, or any other side effect. [17]

Since the efficacy of a particular vaccine corresponds directly with the percentage of a given population that has been vaccinated, proponents of mandatory vaccination have sought to convince those with reservations about vaccines that vaccination is the right choice. The Center for Disease Control has attempted to allay possible reservations parents may have with vaccinations by rebutting some of the commonly held fears about vaccines. [18] The CDC has pointed out, for example, that most adverse effects from vaccines are “minor and temporary, such as a sore arm or mild fever.” [19] Because vaccination often involves the introduction of a harmful live (although seriously weakened) organism into the patient, vaccination can never be 100% safe. Serious side effects usually occur only between one per thousands to one per millions of doses, while some serious reactions and death occur so rarely that accurate risk assessment is difficult. [20] The CDC has also responded to many of the other concerns raised about the need for vaccination, and the FDA continually works to ensure vaccine safety and efficacy, but many still harbor reservations toward vaccination.

This paper will endeavor to discuss some of the most common objections to vaccination programs in general while trying to shed light on the veracity and tenability of these objections. Part I will discuss the nature of mandatory vaccination programs in this country; both scientific and historical issues will play a key part in this discussion. Part II will describe the role of the FDA and other governmental bodies in the overall vaccination picture. Part III will attempt to utilize multiple analytical tools in search of possible solutions to the dangers posed by those who may attempt to opt out of vaccination programs. It will first examine vaccination through the lens of an old television show episode. It will then adopt an economic analytical framework to discuss the balance between individual and general welfare in the context of vaccination. Part IV will conclude with some observations on how the goal of greater public health might be achieved without completely neglecting the concerns of many in the community regarding the prudence of using a medical technique that by definition relies on a degree of coercion.

I. MANDATORY VACCINATION

Historical background.

Jenner’s smallpox vaccine led to the research and development of vaccines for other widespread and epidemic diseases. The twentieth century saw the development of vaccines for such diseases as polio, diphtheria, tetanus, pertussis, measles, and others. [21] As with the smallpox vaccine, many of these vaccines soon found their way into vaccination programs mandated by the government, albeit through a somewhat different pathway.

Mandatory smallpox vaccination programs typically arose through state police power legislation authorizing municipalities to deal with outbreaks. [22] Typically, when a local municipality decided that the threat of outbreak was sufficient to exercise this authority it would require vaccination of everyone in the community (with a possible exception for individuals who could demonstrate uncommonly high health risks from receiving the vaccine, although this exception sometimes applied only to children) and fine and/or quarantine those who refused to be vaccinated. [23] When other diseases became preventable by vaccination, outbreak ceased to be the trigger for mandatory vaccination. Rather, because of their cost-efficiency and their ability to reduce and ultimately eliminate disease, vaccination programs became an important part of general public health policy. [24]

Most of the time, vaccination programs are accomplished through the dual efforts of national entities (which tend to develop and recommend vaccines) and state legislatures and local boards of health (which usually implement these recommended vaccines through vaccination programs). [25] It is not entirely accurate to refer to this as “mandatory vaccination,” as typically individual states will not criminally punish parents for not vaccinating their children or forcefully subject individuals to vaccination. [26] Instead, states typically condition school enrollment on proof of vaccination. [27] Though it may be a high price to pay, home schooling is usually an available means parents have if they wish to bypass these vaccination requirements. Moreover, most states grant exemptions to vaccination requirements for religious reasons and some even grant exemptions for philosophical reasons (in addition, every state exempts from school vaccination requirements individuals who cannot be vaccinated for medical reasons). [28]

The connection between school enrollment and vaccination programs may now seem obvious. Public health officials, faced with a means of protecting the general population from the harmful disease smallpox, realized that mass vaccination could lead to a sufficient level of immunity to eliminate the risk of outbreak, even for those in the community unable to vaccinate (because of medical reasons, for instance). [29] Because of the concept of herd immunity, public health officials considering the proper utilization of vaccines were dealing with a medical procedure quite out of the ordinary. Since vaccination itself does not typically provide 100% immunity to a disease, vaccinated individuals can still contract the disease. [30] Yet because of herd immunity, if a sufficient level of vaccination within a population is attained, the entire population will no longer be susceptible to the disease. In this way, vaccination came to be viewed not only as a personal medical choice but also as a step taken to improve the overall health of the population.

With the rise of public schooling in the mid- to late-nineteenth century, cities decided to condition public school attendance on smallpox vaccination. [31] By the latter part of the century, many states had adopted this practice. [32] Such a policy makes sense when one considers the increased risk of infectious disease in public areas like cities in general and schools in particular. By mandating vaccination for school attendance, of course, the state would eventually have ensured the vaccination of the entire population by the time the initially vaccinated generation became the oldest living one.

These vaccination schemes have faced challenges, both legal and social, throughout their existence. [33] The reasons for such challenges have ranged from personal liberty interests to doubts about the efficacy of vaccines. [34] State courts in the nineteenth century typically upheld both the enactment of mandatory vaccination programs and the delegation of power to local authorities. [35] More importantly for the future of mandatory vaccination policy, two important Supreme Court decisions in the early part of the twentieth century affirmed the power of state governments both to mandate vaccination and to delegate a broad degree of authority to local municipalities and health boards to carry out particular vaccination programs.

Judicial Approval

In 1905 the Court held in Jacobson v. Massachusetts [36] that the general police power of states is broad enough to overcome a Due Process claim brought by an individual who claimed his personal liberty interests were unconstitutionally invaded by the mandatory smallpox vaccination program in question. [37] In an opinion by Justice Harlan, the Court ruled that the constitutional guarantee of liberty “does not import an absolute right in each person, to be, at all times and in all circumstances wholly free from restraint.” [38]

This case still represents the initial constitutional basis of most mandatory vaccination legislation. Many states still provide for the governor or a public health official to mandate vaccination for all in the event of an outbreak. [39] Individuals who cannot vaccinate for health reasons or who refuse to vaccinate may be quarantined in order to protect the population in some states. [40] These laws gained greater relevance following the terrorist attacks of 9/11 and the increased public concerns regarding bioterrorism. For the most part, however, mandatory vaccination laws in the name of outbreak control have given way to vaccination requirements as a prerequisite for school attendance.

The issue of school vaccination came before the Court nearly two decades after Jacobson . In Zucht v. King [41] , the plaintiff challenged a general grant of authority from Texas to local boards of health to condition school entry on proof of vaccination. [42] To differentiate the case from Jacobson , the plaintiff noted that the San Antonio ordinances mandated vaccination even in the absence of evidence of outbreak. [43] The Court, speaking this time through Justice Brandeis, upheld the validity of the ordinances as well as the broad grant of authority to local health boards. [44] On the issue of the state’s power to mandate vaccination, he merely cited Jacobson : “[l]ong before this suit was instituted, Jacobson v. Massachusetts...had settled that it is within the police power of a state to provide for compulsory vaccination.” [45] As for entrusting a broad degree of authority on local health officials, he noted that Jacobson and other cases had affirmed that a state may “delegate to a municipality authority to determine under what conditions health regulations shall become operative.” [46] This delegation includes the permission to vest municipal officials with “broad discretion in matters affecting the application and enforcement of a health law.” [47] In summary, the Court found that these ordinances were valid assignments of “that broad discretion required for the protection of the public health.” [48] The language of the opinion emphasizes the importance of the public health as the key justification for mandatory vaccination.

Zucht , along with Jacobson , thus became the legal foundation for the mandatory vaccination laws of the twentieth century. Modern school vaccination laws and policies have grown from early mandatory smallpox vaccination laws:

The early successes of school vaccination laws against most political, legal, and social challenges helped lay the foundation for modern immunization statutes. Since the introduction of smallpox vaccination policies in the mid-to-late 1800s, states have amended them to include additional diseases as new vaccines become available. [49]

Though various amendments and additions have been made to mandatory vaccination laws throughout their history, the past half century has experienced the true culmination of mandatory vaccination policy. Public health officials have been able to institute a scheme for near-universal vaccination:

Many existing school vaccination laws were enacted in response to the transmission of measles in schools in the 1960s and 1970s. State legislatures at that time were influenced by the significantly lower incidence rates of measles among school children in states that strictly enforced vaccination requirements and school exclusions in outbreak situations without significant community opposition. Rather than having health departments require immunization in emergency conditions, legislatures acted to prevent disease by mandatory immunization as a condition of enrollment or attendance in schools or licensed day care facilities. [50]

Moreover, states have not been completely left to implement the recommended immunization schedule. [51] Though school requirements are still a state matter, national public health officials are typically able to enact their recommendations through federally funded immunization plans. [52] These plans require states to implement and enforce federally recommended immunization requirements before the states can receive federal funds. [53] The current recommended vaccination schedule appears below.

Recommended Childhood and Adolescent Immunization Schedule [54]

Challenges and Concessions

While school vaccination requirements have been credited with bringing about the control and elimination of many devastating childhood diseases, critics have continued to voice concerns and raise legal and political challenges to the entire process of mandatory vaccination.

Personal Liberty Concerns

One key argument against mandatory school vaccination has always focused on government intrusion into what is considered a personal medical choice. [55] Just as the government cannot force a person to have surgery to repair a torn ligament, for example, the government should not be able to force parents to vaccinate their children if the parents believe that vaccination is not the best medical decision. One prominent critic of mandatory vaccination has stated her organization’s goal as simply providing parents with choices: “[w]e believe that health care consumers should have the right to choose the type of preventive health care that they want to use – including choosing whether to use one, ten, or no vaccines.” [56] Other objections along similar bases argue that mandatory vaccination violates the medical ethic of informed consent or even that school district control over mandatory vaccination policies amounts to the unlawful practice of medicine without a license. [57]

The typical counterargument given by the public health officials is to point out that one’s decision to vaccinate, unlike one’s decision whether to undergo surgery, affects the health of others in the community. [58] To allow parents the right to choose not to vaccinate is to infringe on the ability of other parents to raise their children in a society free of certain deadly diseases. From a legal standpoint, Jacobson still seems to have settled the issue that at least under some circumstances, the government may force an individual to receive a vaccination.

Although public health officials have the legal authority to mandate vaccination for the public health under Jacobson, they should be very mindful of the personal liberty concerns just stated. Those with such views often cling to them vigorously. [59] As certain vaccine-preventable diseases decline, such concerns become even stronger. For this reason, it is important for public health officials to support their mandatory vaccination programs with justifiable arguments rather than simply citing legal precedent or historical tradition in support of their exercise of power. Fortunately for public health officials, the benefits provided by vaccination programs can be utilized to justify the existence of such programs.

Safety Accountability Concerns

A variation on the consumer choice challenge to mandatory school vaccination requirements tends to accuse the public health community of conspiring with or at least willfully acquiescing to powerful vaccine manufacturers at the expense of citizens. [60] Mandatory programs, the argument goes, eliminate any accountability from vaccine manufacturers that the free market might otherwise provide. [61] Both the safety and efficacy of vaccines fail to improve because manufacturers do not have to respond to consumer concerns. [62] Mandatory programs thus prevent better vaccines. A prominent critic of these programs has stated that if mandatory vaccination programs are ended, “we will have the ability to put economic pressure on the drug companies and on the health agencies to do a better job with vaccine safety and efficacy.” [63]

The strength of this argument lies in its apparent lack of hostility toward vaccines per se. Given the historical success of vaccination in eradicating smallpox and in reducing or eliminating the risk of other childhood diseases, any critique of mandatory vaccination programs that focuses on the use of vaccines generally is likely to be dismissed by those in the field of public health. By focusing on the economic drawbacks inherent in a mandatory vaccination program and how those drawbacks can negatively affect the quality of vaccines, this argument may gain more traction. Indeed, all sides of this debate claim to desire both safer and more effective vaccines.

The response to this argument, I would imagine, would be to emphasize the drawbacks of opening up the “market” in this case. Because vaccination programs depend on a sufficient percentage of the community being vaccinated, complete consumer choice carries with it problems that might be absent in a standard market. As for vaccine quality, FDA regulation is in place to ensure a sufficient level of safety and efficacy to accomplish the goals of vaccination. [64] The pressure faced by vaccine manufacturers to obtain and maintain FDA approval should provide a check sufficient to guarantee proper vaccine quality. If not, the answer should be to raise FDA standards, rather than to jettison the entire mandatory vaccination process and with it the likelihood of maintaining a sufficient level of immunity among the population.

This response might be unacceptable to those concerned. If the connection between public health officials entrusted with implementing the mandatory vaccination schedule and FDA regulators entrusted with ensuring the safety and efficacy of vaccines is seen as too close, proposing higher FDA standards as a solution may not allay concerns. The independence and integrity of FDA is therefore critical in this arena, just as it is in other areas of public health.

Concern of Unknown Risks

In what may be a combination of the two challenges previously discussed, many individuals challenge vaccine programs because of a lack of information about vaccines. [65] Many people, for example, legitimately question the wisdom of forced vaccination before long-term effects of a vaccine are studied. One website that purports “to provide a wide range of news and views on vaccination and vaccination policy” has summarized this challenge to vaccines simply as opposing the idea of “a parent, any parent, being forced to do something that has even a remote chance of harming their child.” [66] Since long-term (ten or more years down the road) and low-risk (on the order of one-per-million or less, for example) side effects may truly be unknown, this concern does present a challenge for public health officials. [67]

Unfortunately, even the best studies are unable to fully determine all long-term consequences of vaccination. In addition, “[t]here is no such thing as a ‘perfect’ vaccine which protects everyone who receives it AND is entirely safe for everyone.” [68] Therefore, it is true that mandatory vaccination probably forces some parents to inject their children with a substance that will cause some unknown harm.

As with the other objections to mandatory vaccination, however, this objection suffers from a critical flaw. Mandatory school vaccination requirements are not justified solely on the benefit they provide to the recipient. Instead, it is the benefit they provide to the community as a whole by ensuring a sufficient level of vaccination to prevent outbreak that justifies their intrusive nature on individual medical decision-making. [69] For this reason, if public health officials did not enact the mandatory vaccination program, they would be forcing on parents a system that had at least a “remote chance of harming their child.” [70] Because the decision to enact a community-wide vaccination program must be made at the general level if it is to be made at all, and because some children will undoubtedly suffer some health consequences regardless of which policy is chosen, individuals will always be able to raise this argument against mandatory vaccination programs.

A better critique of these programs would focus on whether mandatory vaccination causes more overall harm than a voluntary system; that is, is it better when viewed at the general, rather than the individual, level? Ironically, the very success of vaccination programs in reducing the incidence of once-prominent diseases has led some to ignore the overall and continuing benefit of community vaccination (herd immunity). [71] But for parents to decry the “remote chance” of harm from vaccination while ignoring the very real chance of outbreak in an under-vaccinated population is to reframe the issue entirely.

Other Concerns

Other challenges to vaccination laws have cited strongly held religious or philosophical positions against vaccination in general. Such challenges require a different type of response from public health officials; often the options are limited to overriding such objections and excluding children of parents adhering to such positions from public schools (which is constitutionally permissible under Jacobson and its progeny) or creating exemptions to vaccination requirements (which is detrimental to the overall goals of mandatory vaccination if a sufficient number of exemptors exist). Reactions to such religious and philosophical concerns vary from state to state, with a general trend toward greater accommodation of objectors.

In response to these and other challenges to mandatory vaccination laws, states have enacted various exemptions to vaccination requirements for school entry. Actual enforcement varies by state.

All states provide exemptions for those with medical risks associated with vaccines. [72] If certain contraindications indicate a likelihood of harm from a particular vaccine, the exemption will be allowed. [73] Because such cases are rare and exemptions relatively easy to enforce, there usually is very little risk of compromising the efficacy of the overall vaccination program by granting these exemptions. [74] The ability to grant medical exemptions while still maintaining sufficient levels of vaccination to provide community-wide immunity is one of the great accomplishments of the vaccination system. [75]

In addition to medical exemptions, almost every state grants religious exemptions for those with sincere religious beliefs opposing vaccination. [76] Individual states tend to vary with regard to the level of religious conviction necessary to obtain a religious exemption. Such exemptions reflect the sometimes uneasy balance between mandatory vaccination programs and First Amendment Free Exercise rights, even though the Supreme Court has validated the right of states to mandate vaccination without providing for such exemptions. [77] West Virginia, for example, does not provide religious exemptions. [78]

Some religious exemption statutes have spurred challenges on Establishment Clause grounds by those who claim they favor organized or recognized religions over the sincerely held religious views of others. [79] These challenges, if successful, would lead to the invalidation of many religious exemption statutes. Rather than decrease the number of religious exemptors, however, this may actually lead to more religious exemptors. The political climate of our day, along with the experience of a few states already (such as Arkansas), suggests that legislatures may respond to invalidation of religious exemption statutes that require adherence to an organized religion by drafting more general and expansive religious exemption statutes. [80] By subjugating religion to compulsory vaccination, courts may actually be helping to bring about a system with even more religious exemptors, thereby harming the very vaccination programs to which religious objections had been subordinated. [81]

Philosophical

The possibility that some parents who strongly oppose vaccination for other than religious reasons has led to other means of exempting from mandatory vaccination programs. In some states, people may avoid vaccination requirements by way of philosophical exemptions. [82] In California, for example, a parent need only “submit a letter or affidavit stating that the immunization is contrary to his or her beliefs” to exempt their child from vaccination requirements. [83] “Where available, parents are taking advantage of such exemptions with growing regularity; and in states offering both exemptions, the number of philosophical exemptions far exceeds the number of religious and medical exemptions.” [84]

States without philosophical exemptions, moreover, are often lax with their enforcement of religious exemptions. [85] Because of this, parents in these states can usually submit insincere affidavits purporting to object to vaccination for religious reasons and local health officials, unconcerned with delving into the sincerity of such affidavits, will widely grant exemptions. [86] In most states, therefore, persistent parents can usually find some way to exempt their children from vaccination requirements. If all else fails and vaccination is still regarded as unacceptable to the parent, the option of home schooling may provide a final avenue of evading these school vaccination requirements.

Dangers of Widespread Exemptions

The ease with which non-medical exemptions can typically be obtained has raised concerns among many that the benefits of widespread immunization are being compromised. [87] Because of the nature of medical exemptions, unvaccinated persons in a community with only medical exemptions would be expected to be few and dispersed. Herd immunity can be attained, and protection is ensured for both the vaccinated majority and the unvaccinated few. [88] Broadly granted philosophical and religious exemptions make herd immunity more difficult to attain and increase the risk to the community. This risk is exacerbated by the fact that many of those who apply for such exemptions “will cluster together in one geographic area.” [89] This cluster effect tends to increase the likelihood of serious outbreaks:

Recent studies have shown that clusters of exemptors, who are significantly more susceptible to contracting vaccine preventable illnesses, pose an increased risk of spread of diseases not only to their unimmunized peers, but also to the surrounding, largely vaccinated population. [90]

Given that many childhood diseases seem to be in decline, exemptors may fail to realize the continued value of vaccination. As the mumps outbreak in Iowa makes clear, however, vaccination programs take time and are at risk if vaccination rates fall. Other diseases are still prevalent in other parts of the world, and outbreaks can still occur in this country due to the prevalence of international travel. Ever though measles is rarely observed in the US, for example, the World Health Organization has reported that nearly 900,000 measles-related deaths occurred in developing countries in 1999. [91] Until diseases are eradicated globally, it may be necessary to continue vaccination.

Because many of the aforementioned risks are frequently underappreciated by those who seek exemptions, some have suggested a combination of stricter enforcement of exemption requirements and increased public knowledge of the reasons underlying childhood vaccination requirements. [92] Knowledge is indeed essential to the resolution of this problem. The easier it is to obtain an exemption, the less likely individuals are to understand and appreciate the importance of widespread participation to the success of a vaccination program. Greater public appreciation of the need for such participation (even for diseases that seem to be in retreat), along with greater information on the safety of vaccines can go a long way toward increasing public health in this area. [93]

Partial Exemptors – A Modern Phenomenon

The availability of exemptions has led to other interesting developments in the vaccination debate. Recently, for example, challenges have been raised against the need for mandatory chickenpox and hepatitis B vaccines. Diseases such as these, which are either not greatly feared (chickenpox) or transmitted primarily through voluntary rather than involuntary contact (hepatitis B), do not fit neatly into the typical justification for mandatory vaccination. [94] Nevertheless, public health officials have decided that recently-developed vaccines for these diseases should be placed on the recommended schedule. This has given rise to a significant number of partial exemptors – those who are not opposed to vaccination requirements per se, but who oppose particular vaccines on the schedule. Such a position may not have been comprehended by those who drafted the religious and philosophical exemptions, which seem to assume that a parent’s opposition is to vaccination generally, rather than to a specific vaccine. [95]

Because the religious exemption is usually constructed to apply to those who oppose vaccination generally because of sincere religious beliefs, would-be partial exemptors have difficulty fulfilling their optimal desires. In states without a philosophical objection, parents must choose either to accept the entirety of the recommended schedule of vaccines or to obtain a religious exemption for all vaccinations. [96] Parents who live in states with a philosophical exemption are much more able to tailor their objection to those vaccines with which they disagree. [97]

From the standpoint of a public health official, this presents two possible worlds. In the world with traditional religious exemptors but no philosophical exemptors, overall percentages of vaccinations would be relatively equal from vaccine to vaccine, and higher vaccination rates would be obtained for diseases associated with more objectionable vaccines at the expense of lower vaccination rates for diseases associated with less objectionable vaccines. [98] By contrast, in the world with philosophical exemptors, the public health official would observe higher vaccination rates for the less objectionable vaccines and lower vaccination rates for the more objectionable vaccines. [99]

The difference between these two worlds can have far-reaching implications. If parents are forced to make the all-or-nothing choice, a significant enough number could choose to forego vaccines (including some which they would otherwise accept) that herd immunity is lost, even for less objectionable vaccinations. On the other hand, a significant enough number could accept the more objectionable vaccinations to bring about herd immunity for those diseases. Though the public health official might prefer a world in which neither religious nor philosophical exemptions exist, such a world may not be possible. Therefore, the official should determine which of the two possible worlds provides a greater overall level of safety for the society. In addition, potential public reaction to a vaccine should cause the public health official to consider the ramifications the addition of a vaccine to the schedule will have on those vaccines already on the schedule.

Because partial exemptors have the potential to sway the balance between herd immunity and vulnerability, public health officials must take account of their concerns. Unlike in years past, today the development of a new vaccine presents public health officials with a choice that can affect other vaccines on the recommended schedule. Though the possibility for a chickenpox- and Hepatitis-B-free nation may seem tempting, officials should now consider the possible consequences of mandating such “borderline” vaccines. Parents who might otherwise vaccinate according to the old schedule might have second thoughts about the new vaccines on the schedule and seek means of avoiding the new requirements. If no means exist for avoiding the new vaccines other than complete exemption on religious grounds, parents who would subsequently pursue such exemptions would bring about a lower level of immunization for older diseases.

Studies may be necessary in the above situation to determine whether herd immunity status could be in jeopardy for those diseases for which vaccines are already on the schedule. While one solution might be to provide parents with greater ability to tailor their individual vaccination desires, such a solution would undermine the efficacy of newly scheduled vaccines. In addition, greater levels of flexibility in vaccination choice would undermine public understanding of the community-based nature of vaccination. I think it might be worth sacrificing the efficacy of the newer vaccines in order to maintain that of the more established ones. The public might be willing to suffer the possibility of chickenpox outbreaks, for example, in order to prevent an even minor epidemic of diphtheria or the measles.

Again, information should play a key role in the resolution of this issue. Many of the websites urging parents to carefully consider the vaccination decision do not inform parents that their decision to vaccinate may affect the overall health of the community. [100] The CDC, for its part, does urge parents to take note of this concern. [101] The very persons who most need to know of this concern (those seeking exemptions), however, are often those most likely to distrust CDC publications. For supposed citizen-oriented websites to urge individuals to make vaccination choices without considering how such decisions affect the community is irresponsible, especially given the scientific stability of the concept of herd immunity.

II. THE ROLE OF THE FEDERAL GOVERNMENT

Some of the problems posed to vaccination programs by exemptors and others could be partially solved through greater public awareness of the stringent safety and efficacy testing done on vaccines before they may enter the market. This section summarizes the role of FDA in the context of vaccination programs. In addition, this section will discuss other ways in which the federal government gets involved in the vaccination issue, concluding with a brief synopsis of the no-fault compensation scheme enacted pursuant to the National Childhood Vaccine Injury Act of 1986. [102]

FDA Regulation

Though state governments determine which vaccinations are mandatory for school attendance, the federal government plays a key role in vaccination. Perhaps most importantly, the federal government regulates the safety and effectiveness of all vaccines. The FDA’s Center for Biologics Evaluation and Research (CBER) is charged with this critical task. [103] The role of CBER ranges from pre-approval testing of potential vaccines to facility inspection to continued oversight and sampling after approval. [104] Regulation of vaccines can be more stringent than for other biologics or drugs. [105] Even after a vaccine is licensed, for example, FDA oversight is prevalent. [106] Since vaccines are derived from living organisms and are particularly susceptible to contamination and other environmental factors, manufacturers usually must submit samples of each vaccine lot for testing before release. [107]

Before a vaccine can even be licensed for distribution and use, it must go through an extensive testing process relatively similar to that of drugs and other biologics. [108] First, a new vaccine must be tested for safety on animals. [109] The vaccine manufacturer next must file an Investigational New Drug application (IND) with the FDA. [110] Studies are then undertaken to ensure safety before any human testing takes place. [111] In addition, the IND must describe the studies intended for humans. [112]

Once these initial steps are completed, proposed vaccines must undergo three phases of clinical trials, in which the vaccine is tested on humans. [113] Phase 1 testing looks only for very serious or very common problems. [114] A small number of subjects (usually less than 100) are closely monitored, usually for only a few months. [115] Testing expands in Phase 2 to begin evaluating efficacy, as well as to further test safety. [116] Phase 2 trials can last up to two years and typically include hundreds of subjects. [117] The final stage of testing, Phase 3, further studies safety and effectiveness. [118] Thousands of people may be involved in this stage of testing, and if successful it can lead to application for FDA licensing. [119]

Once the clinical trials are completed, the FDA can examine the results of the tests to determine whether the vaccine is safe and effective enough to be placed on the market. [120] At any point in the process, the FDA may halt ongoing studies if safety concerns require such action. [121] The FDA also reviews the data from the studies and inspects the manufacturing facility. [122] At this point the vaccine may be licensed.

As stated above, the FDA’s role in protecting the safety and effectiveness of vaccines does not end at the licensing stage. [123] Before any vaccines from a particular lot can be released, the manufacturer must typically submit samples for potency, safety, and purity testing. [124] Periodic facility inspections also continue for the duration of the license. [125] Furthermore, formal post-market studies may be conducted in order to identify problems that would not show up in pre-market clinical testing. [126] These tests are referred to as Phase 4 tests and are not mandatory, but can help identify problems that may only occur very infrequently. [127] Post-marketing surveillance programs are important because manufacturers are “never going to be able to do studies big enough to detect risks that might happen at a level of one in 100,000 or one in 1 million.” [128]

The Vaccine Adverse Event Reporting System (VAERS) is another valuable tool in identifying problems with a vaccine once it has been approved for the market. [129] VAERS was developed following Congress’s enactment of the National Childhood Vaccine Injury Act of 1986 and has become a very useful tool for identifying possible adverse effects that would otherwise escape detection. [130] VAERS allows anyone to report a problem that may be associated with any vaccine. [131]

It is important to keep in mind that VAERS is simply a reporting system. Experts and others use the data in VAERS to attempt to determine whether a vaccine actually causes a particular adverse effect, but the events that VAERS documents are not all caused by vaccines. It is therefore easy to understand why VAERS encourages doctors and others to report any adverse event that may be related to a vaccine. “VAERS is designed to detect signals or warnings that there might be a problem rather than to answer questions about what caused the adverse event.” [132] It is important to keep these facts in mind when looking at VAERS data, as many of the adverse effects may be completely unrelated to the vaccine in question. Often the effects are correlated with, but unrelated to, vaccination simply because many of the problems reported are those usually associated with events happening during the vaccination period (the first few years of life). [133]

Used correctly, VAERS can lead to useful studies and the discovery of potentially rare adverse effects. [134] VAERS can also be used to monitor individual lots of a vaccine. [135] Unfortunately, by encouraging individuals to report any adverse effect that may possibly have been caused by a vaccine, VAERS can provide ammunition for those claiming a definite link between a vaccine and a particular adverse effect, even if the data is silent on whether such a link exists. [136] While VAERS is in place to help identify actual risks associated with vaccines, these risks cannot be accurately assessed solely on the basis of reported incidents of adverse effects. [137]

The real value of VAERS lies in the testing and hypotheses that are developed in response to the data that has been reported. Because of the serious adverse effects already occurring during the typical vaccination period, it will often be easy and convenient to point to the correlation between vaccines and reported adverse events. Lost in the picture is the foundational proposition that VAERS is, at its core, a data collection system. To forego scientific inquiry and point instead to simple correlation may be convenient, but it is unwise. [138]

The recent public discussion surrounding the use of thimerosal as a preservative in vaccines helps to illustrate the importance of the FDA and other factors in furthering the goals of vaccine safety and public confidence in the entire safety regulatory process. Thimerosal is a mercury-containing organic compound that for many years has been used as a preservative in vaccines to help prevent contamination with microbes that could potentially be fatal. [139] Recently, fears that mercury at very low levels may be toxic to the brain have raised concern among many in the public about allowing the use of thimerosal in vaccines. [140] Many began to fear a connection between thimerosal and autism. [141] Standard FDA testing of lots, as well as studies measuring the amount of mercury contained in the standard immunization schedule versus accepted safe amounts, did not lead to safety concerns sufficient to pull thimerosal from the market. [142] Though one committee (the Immunization Safety Review Committee, commissioned by the Institute of Medicine) concluded that a theoretical link between thimerosal and autism was biologically plausible, most health experts continue to assert that there simply is no scientific evidence of a link between the two. [143]

During this time period FDA performed additional tests to verify or refute the supposed link between thimerosal and autism. [144] In 1999, FDA performed a comprehensive study and review of thimerosal use in vaccines for children. This review revealed no risk from thimerosal use, other than “local hypersensitivity reactions.” [145] Indeed, none of the standard safety protocols in place suggested or required that FDA pull thimerosal from the market. This is not to say, however, that no risk existed. As is clear from the foregoing summary of FDA vaccine approval, not all adverse effects will be known from clinical trials. [146] It may take years or longer to assess some of the risks of vaccines, including the risk of thimerosal as a preservative. [147]

Continued public concern over the safety of thimerosal caused FDA to begin to work with vaccine manufacturers in order to reduce or eliminate thimerosal from vaccines as a precautionary measure. [148] About this time, the American Academy of Pediatrics and the Public Health Service urged the removal of thimerosal from vaccines. [149] Today, with the exception of the inactivated influenza vaccine, all recommended childhood vaccines are either thimerosal free or contain only trace amounts of the compound. [150] Even though the risk may not have been as great as feared by the public or even existent at all, if the new vaccines are equally effective, the elimination of thimerosal from vaccines can probably be seen as a safety improvement, albeit at the expense of the added research and development needed to create the new thimerosal-free vaccines.

Rather than quell the existing safety concerns, this action led many of those who had decried the use of thimerosal to accuse FDA of participating in a cover-up to protect vaccine manufacturers. [151] Government agencies, for their part, continue to claim that vaccines with thimerosal are as safe as thimerosal-free vaccines, suggesting that the added development may have been superfluous. [152] While this may be so, the availability and now prevalence of thimerosal-free vaccines does provide the scientific and medical community with a new means of assessing the possible autism-causing effects of thimerosal. Namely, since thimerosal is suspected to cause autism within the first few years of life (the routine vaccination calendar), those who were vaccinated in the years since thimerosal-free vaccines have comprised the overwhelming majority of vaccines (that is, those born after 2001) would be expected to experience lower incidences of autism than the groups vaccinated with thimerosal-containing vaccines. [153]

In spite of the potentially costly decision to encourage the development of thimerosal-free vaccines when there is no sufficient safety concern to pull thimerosal from the market, FDA and other government officials have had little success in assuaging the fears and concerns of thimerosal critics. [154] Scientific arguments often fail to persuade, either because they are inconclusive or because of a perceived bias favoring vaccine manufacturers. [155] To back up their own arguments, thimerosal critics rarely point to scientific studies. [156] Instead, their reasoning seems to stem more from anecdotal evidence and comparison of thimerosal (which contains ethyl-mercury) to methyl-mercury-containing fish. [157] Representative Dan Burton (R-Indiana), a key supporter of the fight against thimerosal, explained that his belief in the toxicity of thimerosal stemmed from a personal episode: “[m]y grandson received nine shots in one day, seven of which contained thimerosal, which is 50 percent mercury as you know, and he became autistic a short time later.” [158] Others point to the rise in autism rates in the past twenty years and put the onus on the medical community to prove that this rise is not due to thimerosal. [159]

The response of health officials has been to ask why the burden should be placed on them to disprove a link between thimerosal and autism; cell phones, ultrasound, or diet soda could just as easily be the culprit. [160] Indeed, the typical response to those charging vaccination with causing many of the adverse effects occurring in life’s first few years is to point out that usually such accusations are based on nothing more than the temporal proximity of the vaccine and the illness. Some have suggested that the rates of autism may be on the rise not because of thimerosal, but because of generally more accurate diagnosis of the affliction. [161] In the past, an autistic child may have been wrongfully diagnosed with other mental disorders. [162] Figures showing a correlation between the rise in autism and the drop in other diagnosed mental disorders bolster such assertions, and suggest that vaccination may simply be a convenient scapegoat. [163]

As the thimerosal issue makes clear, vaccines often provoke strong feelings amongst various segments of the population. [164] Proper consideration of public reaction to its actions is a delicate aspect of FDA regulation of vaccine safety. To complicate matters further, one can easily imagine an equally vehement response and similar claims of conspiracy had the FDA not worked to reduce thimerosal from vaccines as a precautionary measure. Indeed, public confidence in the safety of vaccines is often influenced by factors outside the typical FDA calculus. Though FDA must act in the interests of the general safety regardless of public opinion, it may sometimes be necessary for FDA to consider public opinion, at least when exercising discretionary oversight. After all, the entire VAERS system is to a large extent dependant on public cooperation. Nevertheless, when the choice is between FDA popularity and doing what is right for the safety of Americans, the FDA should not allow itself to be swayed by a misinformed public.

Vaccine Injury Compensation Program

Congressional reaction to safety concerns goes beyond the adverse reporting system VAERS. The National Childhood Vaccine Injury Act of 1986, which created VAERS, also created a no-fault compensation scheme for people injured or killed by vaccines as an alternative to the traditional tort system. [165] This system was intended to efficiently and rapidly compensate those who are actually injured by vaccines while maintaining an environment in which further vaccine research and safety improvement could exist. The situation giving rise to this compensation program sounds remarkably similar to the more recent concerns surrounding thimerosal:

In the early 1980's, reports of harmful side effects following the DTP (diphtheria, tetanus, pertussis) vaccine posed major liability concerns for vaccine companies and health care providers, and caused many to question the safety of the DTP vaccine. Parents began filing many more lawsuits against vaccine companies and health care providers. Vaccination rates among children began to fall and many companies that develop and produce vaccines decided to leave the marketplace, creating significant vaccine shortages and a real threat to the Nation’s health. [166]

Funding for the no-fault compensation scheme initially came from Congressional grants of federal tax dollars totaling $110 million per year. [167] Since October 1, 1988, funding has proceeded from the Vaccine Injury Compensation Trust Fund, which is funded by a $0.75 excise tax on all doses of vaccines covered under the program. [168]

One may wonder what makes vaccines worthy of an alternative dispute resolution system. Perhaps it is the result of the power of the vaccine manufacturing lobby or simply an attempt by Congress to pass some legislation in the face of strong public sentiment. Although these reasons may appear plausible, it seems more likely to me that the Act created this no-fault compensation scheme because of the mandatory nature of vaccination. For those injured by other medical devices or drugs, the traditional tort system or medical insurance seem the proper means of addressing the issue. When people are told to undertake a medical procedure they may not agree with because it helps further a public goal, however, it may make sense to have a system in place whereby they can obtain relief quickly if harmed by the procedure. Moreover, because certain vaccines may be closely associated with particular adverse effects, the efficiency of a no-fault scheme may trump the standard fact-finding processes of the legal system. The government has chosen to enact such a no-fault scheme, and err on the side of compensation.

III. ANALYTICAL MEANS OF ADDRESSING THE ISSUE

The concerns and problems raised in the context of mandatory vaccination programs do not readily suggest a simple answer. In examining the issue, I came across two particularly useful tools for analyzing the problem. The first comes from an old episode of The Andy Griffith Show in which a local farmer refused to accept a vaccination from the local nurse. In addition to providing substantial entertainment to the viewer, the characters can be viewed metaphorically to represent the various parties in the mandatory vaccination debate. The episode’s solution, in turn, sheds some light on the current debate.

This section will also utilize the analytical framework of economic analysis. Though not as enjoyable a topic as The Andy Griffith Show, economic theory helps to reshape the vaccination discussion and greatly facilitates the process of assessing the various positions.

“We got to get folks to take their shots” – Sheriff Andy Taylor [169]

The Andy Griffith Show addressed the concept of popular resistance to universal vaccination over forty years ago. In “The County Nurse,” Sheriff Andy Taylor confronted a local nurse who was trying to bring everyone up to date on their tetanus shots. Not surprisingly, at least to Andy, many of the mountain farmers had not been inoculated. The naïve nurse would soon discover the reason for the low vaccination rate.

Rafe Hollister, one of the leading farmers in Mayberry, had little use for modern medicine or doctors in general. “We don’t need any nurse, nobody gets sick up here.” [170] Thermometers? “I know when I got a fever, I’m hot.” [171] Stethoscopes? “I know my heart’s beating, I’m alive ain’t I?” [172] But his strongest objection was saved for vaccinations: “I ain’t never been jabbed and I ain’t fixin’ to be.” [173] Such were the views that the nurse was up against in her attempt to achieve 100% vaccination rates.

Rafe Hollister

Rafe Hollister’s reasons for opposing vaccination went beyond his desire to avoid getting “jabbed.” He was a farmer who lived off the land, and when he got sick he let his body fight the sickness naturally. His daddy had lived to the age of hundred and he aimed to do the same. [174] The concept of a vaccination was certainly something foreign to him, as was the idea that a health official could force him to do anything. Even in the wake of the nurse’s impassioned plea to accept a shot that could someday save his life, he retorted simply, “I done alright before you come around and I’m doing alright now.” [175]

Although the county nurse was not acting pursuant to a mandatory vaccination program, under the circumstances her attempts to get Rafe inoculated were pretty forceful. The nurse was accompanied by the local sheriff to Rafe’s farm to try to convince him to take the shot, and when he refused, the sheriff and nurse continued to attempt to make him acquiesce. When Deputy Barney Fife heard of Rafe’s stubbornness, he insisted the nurse return to Rafe’s farm with him to force Rafe to take the shot. After all, boasted the deputy, “Rafe Hollister’s like a child and he’s gotta be treated like one...I’ll make him take his shot.” [176] When the deputy arrived at Rafe’s farm yelling that he was forcing Rafe to accept the vaccination, Rafe decided to fight the mandatory vaccination by drawing his rifle and forcing the deputy to leave the farm.

In a classic manifestation of the early spirit of the television series, Sheriff Andy Taylor finally convinced Rafe to take the shot through a little reverse psychology. Andy began by facetiously praising Rafe’s refusal to take the shot as stemming from Rafe’s desire for immortality. Namely, by refusing to take the shot, Rafe was sure to become the impetus for all the other townspeople not to neglect to take their shots. Unfortunately for Rafe, this heroic stature would only be achieved posthumously, as he will have succumbed to a violent and painful death from tetanus. As Andy explained to Rafe, someday, after getting cut by a rusty saw or bitten by an animal, without the shot he’ll “be a cinch to go.” [177] Eschewing the chance to be a dead hero, Rafe finally took the shot.

Sheriff Andy Taylor

Vaccination has changed the modern world. Indeed, it has led to the elimination or significant decline of many diseases that once posed significant and potentially deadly health risks. Public health officials in the United States have managed to institute a program that, though subject to variations on a state by state basis, essentially mandates certain vaccinations as a requirement for school attendance. While these vaccination programs are touted by most public health officials, a significant number of people oppose mandatory vaccination. The County Nurse episode helps illuminate the perspectives of the various sides of the issue, as well as one possible solution.

The nurse herself represents the public health officials. Though she is not implementing a mandatory vaccination program, her stated goal is to inoculate 100% of the population. [178] As mentioned above, she has the assistance of local law enforcement and she is quite persistent. Rafe Hollister, the stubborn farmer, represents those within the community who oppose or resist mandatory vaccination programs. His reasons initially rest on a general reluctance to stray from natural medicine. In this way he represents the contingent of society that scientists and medical researchers will always find difficult to convince of any developments in the medical field. In many ways, he is comparable to the plaintiff in Jacobson . Andy and Barney can be seen as the arms of the state that are entrusted with carrying out the general vaccination plan. Their varying styles can be seen as varying state requirements and enforcement options for vaccination.

Though these comparisons may seem elementary and of little value, the character development that the characters undertake during the episode greatly increases the episode’s usefulness as a surrogate for real world concerns and issues. Rafe resists the shot initially not only because he distrusts medicine in general, but also because he resents the idea that a county nurse can make him do anything. Many who resist mandatory vaccination schemes do so because of personal liberty concerns; they do not want the government to tell them what to do, especially in the context of personal medical decisions. Just as Rafe’s stance becomes more vehement the harder the nurse attempts to convince him, many who oppose mandatory vaccination see the persistence of the medical community as evidence of blind adherence to a potentially dangerous system, or worse yet as an active promotion of the special interests of the vaccine manufacturers. [179] The episode does not paint the nurse in this way at all, however. Rather, after seeing how strongly Rafe opposes vaccination, the nurse passionately pleads with him to reconsider. Her stance truly seems to stem from a genuine concern that he not suffer the potentially terrible effects of the disease. [180] As before, he refuses; this seems to illustrate that the stance of some may be so strong that they will never accept vaccination on the basis of arguments advanced by government officials.

Barney Fife’s insistence that Rafe accept the shot demonstrates the lack of understanding among many in the government and in the general population as to the vehemence with which those opposing mandatory vaccination hold to their views. His paternalistic stand only serves to exacerbate the situation with Rafe. Indeed, Barney Fife helps to illustrate that there cannot be a one-way solution to the issue of mandatory vaccination.

Andy Taylor’s method of convincing, which eventually carried the day, may not be very conducive to real-world implementation. After all, it is unrealistic to think that reverse psychology will convince those currently opposed to vaccination programs to change their minds. What I think is important to notice, however, is the role information can play in this issue. Andy finally convinces Rafe Hollister to take his shot after describing the horrible effects of the disease and how likely Rafe is to contract it. Similarly, any solution to the issue of mandatory vaccination holdouts must rely on increased information dissemination. That the information in the episode came from a trustworthy source may also have been crucial, which seems to imply that public health officials may need to work more closely with local personnel in order to obtain higher vaccination rates.

Because this episode deals with the vaccine for tetanus, a non-communicable disease, the usual community-based arguments in favor of vaccination do not enter the equation. Extra-personal consequences of Rafe’s decision to vaccinate do exist, however. Most importantly, as the unofficial leader of the farming community, his decision will be followed by the other farmers. This is shown both in Andy’s assurances to the nurse that Rafe is the most important of the farmers to convince on the issue and later, after Rafe has decided to get the shot, in his promise to the nurse that all she has to do is come with him and he’ll get all the farmers to take their shots. Perhaps those parents who support vaccination can help bring about higher vaccination rates by being more vocal and persistent with their neighbors who oppose vaccination programs.

Economic Analysis

Economic analysis [181] provides a useful theoretical basis for evaluating the competing sides of the vaccination debate. Arguments regarding the wisdom of the current vaccination policy can often be recast as economic questions involving a cost-benefit analysis.

When an epidemic breaks out, for example, the benefits of vaccination (protection from the disease both for the individual and for society through herd immunity) seem more clearly to outweigh the costs (potential side effects of the vaccine, decreased ability of the immune system to defend the body from variant strands of the disease, or personal or religious objection). Vaccination rates would, therefore, be expected to be highest during such epidemics. Consequently, those few who continue to oppose vaccination during such epidemics would be expected to do so for only the strongest reasons. This is due to the fact that in economic terms, the opponent of vaccination would have to believe that the benefits of vaccination still do not outweigh the costs, even during an epidemic. This might stem from a relative undervaluation of the benefits of vaccination (perhaps due to a belief that contracting the disease would not be so bad) or a relative overvaluation of the costs of vaccination (possibly due to the greater cost to the conscience of the personal or religious opponent of vaccination) or some combination of both. Medical exemptions directly illustrate this cost-benefit analysis: for a person likely to suffer serious side effects from a vaccine, the cost of vaccination is much greater than the cost to the average individual. Even in a time of epidemic, therefore, vaccination might not be rational for such an individual.

This economic analysis of vaccination is well illustrated by the facts of Jacobson v. Massachusetts [182] , the first Supreme Court case addressing the constitutionality of mandatory vaccination legislation. The case involved a Massachusetts statute allowing local authorities to mandate vaccination for smallpox if necessary for the public health and safety. [183] Subsequently, and upon a determination that smallpox was “prevalent to some extent” and “continues to increase,” the city of Cambridge passed a mandatory vaccination ordinance. [184] This ordinance represented the economic determination that the benefit of mandatory vaccination outweighed the cost of supplying vaccines, finding and prosecuting holdouts (such as Jacobson), and the decreased liberty of individuals to be permitted to decide whether to vaccinate.

Jacobson subsequently challenged his prosecution under the ordinance by claiming it to be an unconstitutional denial of his liberty under the 14th Amendment (as well as in violation of the Preamble and the “spirit” of the Constitution, arguments that were summarily dismissed). [185] In economic terms, this may simply indicate that he viewed the cost of accepting a forced vaccination (perhaps of any kind, in any circumstance) as greater than any possible benefit. A closer look at his arguments, however, suggests that he may have performed a more detailed cost-benefit analysis. One can easily convert the various arguments he attempted to advance into economic costs. Among these arguments were the likelihood of vaccination to bring about “serious and permanent injury” and occasional death, the inability of an individual to assess the risk of vaccination in a particular case, and the potential impurity of vaccines and inability to test such impurity, among others. [186] At the very least, it would appear that Jacobson attributed a greater than average cost to vaccination.

The statute also provided that ordinances mandating vaccination provide an exception for “children who present a certificate, signed by a registered physician, that they are unfit subjects for vaccination.” [187] This reflects the state’s determination that the cost of forcing vaccination upon those more likely to suffer adverse side effects outweighed the benefit of completely universal vaccination. Given the determination that near-universal vaccination was required to provide the desired benefit, one would expect that the state expected to grant relatively few medical exemptions (or at least few enough not to seriously compromise the goal of providing protection against smallpox through vaccination).

In rejecting Jacobson’s liberty challenge to the ordinance, the Court endorsed the concept that the State’s cost-benefit analysis can supersede that of the individual, at least in the area of public health. The Court’s decision, in fact, makes irrelevant any individual cost-benefit analysis in the face of a comprehensive mandatory vaccination program.

Various vaccination-related developments in the century since Jacobson can also be cast in an economic analytical framework. Certainly the benefit from vaccination disappears when a disease has been eradicated, which explains why the smallpox vaccine is no longer mandated. Any cost greater than zero (the likely benefit of smallpox vaccination at this point, barring of course a reintroduction of the disease using laboratory samples) will suffice to outweigh this benefit. [188] The success of vaccination policies, however, may lead to an undervaluation of the benefit of continuing to vaccinate due to the lack of visible instances of the disease. [189] This problem may be compounded when vaccines are mandated for diseases which are not associated with high mortality rates, such as chickenpox. A further complication to the cost-benefit analysis arises when assessing vaccination policy for diseases such as Hepatitis B, which is spread typically through voluntary contact. In such a case, an individual who feels highly unlikely to engage in the behavior giving rise to the risk of the disease might rationally see very minimal benefit from vaccination, while the state may view widespread vaccination as the most cost-effective method of dealing with the disease. [190]

Altruism and Free Riding

Given the continuing policy of vaccinating for diseases that have become relatively rare in recent decades, one might expect individual cost-benefit analyses to increasingly come into conflict with the societal policy. Several factors, however, serve to counteract this possibility. Perhaps most significantly, it is likely that many parents defer on the question of vaccination and accept the cost-benefit analysis of the state (communicated to the individual through the vaccination schedule and through doctor’s recommendations) as their own. Along the same lines, many individuals might not strongly consider the pros and cons involved in vaccinating; if the possibility exists for contracting a disease, and a vaccination is available, the decision may already be made. [191] A third possibility implicates a factor that I have not yet mentioned in relation to the individual cost-benefit analysis: altruism.

Some have proposed that altruism may bridge the gap between incompatible cost-benefit analyses of states and individuals. [192] Whereas typical medical decisions affect only the patient making the decision, it is pointed out, medical decisions regarding vaccine-preventable diseases usually implicate outside interests. [193] A patient thinking only of his own interests may forego vaccination if he feels the risk from vaccination outweighs the personal benefit. Altruism, it is argued, may present a separate benefit for such an individual. [194] Though the individual may not consider the risk of contracting the disease high enough by itself to justify vaccination, he may still vaccinate in order to help accomplish the public goal of eliminating the threat of an epidemic. Public health officials hope that comprehensive vaccination will produce herd immunity. [195] Thus the individual who may otherwise forego vaccination might undertake it in order to “do his part” for the community at large. Individuals who cannot vaccinate are particularly dependent on this sort of altruistic behavior, as they often have no other protection from the disease. [196]

Working against this altruistic behavior is the temptation of individuals to enjoy the benefit conferred on them by herd immunity without undertaking the cost of being vaccinated personally. [197] This is widely referred to as “free riding,” and greatly undermines the goal of comprehensive vaccination. Since herd immunity is supposed to create a level of protection sufficient for even those few who are not vaccinated, a small number of free riders might not pose a significant problem. As described earlier in this paper, comprehensive vaccination programs are designed to work even though some members of society cannot be vaccinated. [198] The problem arises when the number of free riders becomes sufficiently high to compromise the ability of the society to achieve herd immunity. Since the average citizen (one with no greater reason to avoid vaccination than any other member of society) could always choose to free ride if immunization were voluntary, herd immunity might never be achieved. This is one of the key arguments advanced in support of government mandated vaccinations. [199]

Ex Ante Versus Ex Post

The concepts of altruism and especially free riding emphasize the importance of ex ante (before the fact) versus ex post (after the fact) decision making in the context of vaccination. One of the main benefits of economic analysis is that it requires decisions to be justified ex ante. Public health officials, for example, are faced with the decision of whether to mandate vaccination for a particular disease at a time when all adverse effects cannot be known. They must weigh the possible consequences of allowing a disease to continue against the possible known and unknown adverse effects of a vaccine that may have just entered the market. When this decision is made properly, the benefit of the vaccination program will have outweighed the cost. The benefit is manifested in lower or no occurrences of the disease, while the cost is seen most directly in those children who have actually experienced adverse effects as a result of the vaccine. If the benefit is greater than the cost from an ex ante perspective, to the economist there should be no second-guessing of the vaccination program. [200]

The economist, of course, is not the parent. Parents who decry mandatory vaccination as the cause of their child’s adverse reaction are typically viewing the situation ex post. That the program has been implemented assumes that the sum of these adverse reactions was an acceptable alternative to non-implementation, and should therefore not be allowed to undermine public confidence in the program. When one surveys the landscape of the vaccination issue, however, objections are usually of the ex post variety. Since it is harder to appreciate the absence of an epidemic than the presence of a child suffering a vaccine-related injury, it is easy to look at the issue solely ex post. In the interests of public safety, such reasoning should be avoided.

This is not to imply that all critics of mandatory vaccination are on unsound theoretical footing. In fact, those whose objections are marked by a distrust of the government authorities in charge of implementing vaccination programs can be seen as questioning only the ex ante judgment of the officials. If this is so, they are actually on firmer ground than those who object to the programs because they feel their child was harmed by the vaccine. Ex ante critiques are valuable because they can bring about change in the system at a time when it can still prove useful.

The National Vaccine Injury Compensation Program represents a theoretically sound program under these criteria. Economically, it represents the idea that some of the costs of mandatory vaccination programs known only ex post will be compensated by all those who share the benefits ex ante. The excise tax, paid ex ante by all who receive the vaccine, is used to compensate anyone who experiences certain adverse effects ex post. This is simply an example of the government distributing the costs of the vaccination program across the spectrum of those who receive the benefit, rather than an ex post complaint by those on whom the costs have fallen.

Other Issues

The modern trend toward more widely-granted exemptions represents government acquiescence toward a certain degree of free riding. Should such exemptions proliferate too widely, herd immunity may indeed be lost and a recalculation of the cost-benefit analysis of individuals will be necessary. In the face of a greater potential to contract disease, the benefit of vaccination grows significantly, while the cost of accepting the vaccine remains the same. Likewise, from the standpoint of the government, the cost of allowing widespread exemptions will eventually overtake the benefit of permitting such exemptions if that cost suddenly includes serious risk of epidemic.

The risks associated with non-vaccination can be illustrated through a rather simplified mathematical example. [201] Suppose a school with 1,000 students is exposed to a measles outbreak. 990 of the students have received all of their measles shots, and so are fully immunized. Suppose further that the measles vaccine is 99% effective; that is, it produces complete immunity in 99% of patients. [202] Therefore, 10 out of the 990 who have been fully immunized will be susceptible to the disease. In addition, all 10 of the 1,000 students who had not been fully immunized will be susceptible to measles. Therefore, 20 out of 1,000 students will get the disease. Although the number of infected students who were vaccinated is equal to the number who were not, this example demonstrates that vaccination can be very effective even if it sometimes does not produce immunity in an individual. If no one had been vaccinated, 980 more students would probably have caught the measles. It is also important to note that this example assumes an epidemic; in reality, herd immunity would probably be attained at this level of inoculation and none of the 1,000 students would have caught the disease.

IV. CONCLUSION

Vaccines have immeasurably improved our quality of life. They have led to the eradication of deadly diseases like smallpox and the near elimination of diseases such as diphtheria, polio, and measles. Outbreaks of vaccine-preventable diseases, such as mumps, are infrequent and are also quite newsworthy on the rare occasion that they do occur. And people like Rafe Hollister can survive a run-in with a rusty saw or an animal bite.

The life-saving benefits of vaccination often overshadow the vast economic and personal benefits it has helped provide. Jonas Salk’s cure for polio has spared generations from a life hindered by the devastating physical handicaps of that terrible affliction. Children no longer must miss vast stretches of school to overcome a debilitating battle with pertussis (although there is no doubt that some children lament this decline in excused absences from school). Parents no longer have to spend restless hours worrying as their children suffer the body’s natural response to disease. In economic terms, this translates directly into fewer missed hours of work and less administrative difficulty, leading to a generally more productive society.

For all the benefits of vaccines, of course, it is important not to ignore the costs. The National Vaccine Injury Compensation Program is one way of dealing with the economic costs of vaccination, but this may provide little solace to the parent of a child who has been injured by a vaccine for a disease that is seemingly in decline. Side effects with very low probability will sometimes occur; though from a community-wide view this possibility is acceptable, for the individual who experiences the adverse effect the vaccination may not have been the best medical decision. Many who view natural immunity as a rite of passage for children might not desire a means of bypassing the disease entirely.

Some may accuse public health officials of dreaming for an unreachable day when all diseases are controlled by vaccination. Zeal on the part of public health officials, however, should not overshadow the actual benefits of vaccination generally. Soon may come the day when diphtheria, like smallpox, will be eradicated globally. At that point, it can be removed from the vaccination schedule and future generations will reap the benefits of vaccination while undertaking none of the costs.

This prospect, I think, sheds light on the ultimate solution to vaccination issues that have been discussed in this paper. Highly communicable and especially terrible diseases should continue on the vaccination schedule until they are virtually eliminated. The eventual elimination of these scourges will someday make vaccination unnecessary, and the costs of vaccination will drop to zero. Until that time, officials should seek stricter enforcement of the mandatory vaccination laws and should tighten down on non-medical exemptions. At the same time, information campaigns should be considered in the interest of reminding the public of the continued importance and relevance of vaccine programs. Though risks are unavoidable when dealing with vaccines, parents should constantly be reminded that immunity depends on a high level of cooperation. This will hopefully keep immunization rates high, at least for the most harmful diseases.

Meanwhile, public health officials may be wise to consider an alternate stance toward somewhat less-important vaccines such as Hepatitis B and varicella (chickenpox). [203] With such diseases it may be worthwhile to wait longer before placing the vaccines on the recommended schedule. This will undoubtedly make herd immunity more difficult if not impossible to attain, while simultaneously announcing to parents that undertaking the vaccine in question is a personal medical decision. Most of those who choose to vaccinate (and accept the risk of adverse effects from these newer vaccines) will still acquire immunity. Without a mandatory program in place, however, one would still expect to see regular occurrences of the disease. Given the relatively high likelihood of outbreak under these circumstances, a percentage of those who vaccinate will probably get the disease. They will likely turn to those who did not vaccinate at all and see them as the cause of the outbreak. In time, social pressures may lead to greater vaccination rates, and the time may be ripe for greater acceptance of mandatory vaccination for the disease.

One significant benefit to this approach lies in its natural tendency to point out to parents the importance of receiving the more important vaccines. When some vaccines are mandatory and others are not, the distinction between the two types of vaccines is impossible to neglect. It would hopefully make parents think more carefully before attempting to gain an insincere exemption. This approach would fail to satisfy those who want parents to have the option to choose “one, ten, or no vaccines,” [204] but it would at least allow an element of choice for some vaccines while hopefully maintaining a sufficient level of immunization for the more important vaccines. It is also important to remember that parents with serious reservations about any vaccines will usually have the option of home schooling. Overall, this approach might have the advantage of winning over those who only partially object to the vaccination schedule, thus helping bring about a greater chance of herd immunity for diseases associated with less objectionable vaccines.

Vaccination certainly is unique among medical treatments, both for its incredible potential and its coercive nature. It is unfortunate that questionable evidence has led many concerned parents to question the wisdom of vaccination programs that still serve important goals. Given the importance of public support for the achievement of these goals, however, public health officials must account for sometimes questionable concerns in determining vaccination policy. Greater information dissemination, combined with more sharply drawn (and potentially vaccine-specific) guidelines, can hopefully further the important goals of vaccination policy.

[1] Center for Disease Control, “Smallpox Disease Overview,” at http://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp (last visited April 27, 2006).

[2] GlaxoSmithKline is currently developing an ear infection vaccine and plans to seek regulatory approval shortly. Jessica Said, “Vaccine Could End Children’s Ear Infections,” CNN online article, March 3, 2006 (on file with author).

[3] Institute of Medicine. CP Howson, et al. eds. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press; 1991, at 1.

[4] James G. Hodge, Jr. and Lawrence O. Gostin, School Vaccination Requirements: Historical, Social, and Legal Perspectives , 90 Ky. L. J. 831, 867 (2001).

[5] See, e.g., Jacobson v. Massachusetts , 197 U.S. 11 (1905).

[6] Hodge and Gostin, supra note 4, at 867.

[7] Id. at 868.

[8] “Rather than having health departments require immunization in emergency conditions, legislatures acted to prevent disease by mandatory immunization as a condition of enrollment or attendance in schools or licensed day care facilities.” Id.

[9] See id. ; see also infra Part I (chart describing the current recommended vaccination schedule).

[10] The Center for Disease Control has gone so far as to suggest that “to have a medical intervention as effective as vaccination in preventing disease not use it would be unconscionable.” Center for Disease Control, National Immunization Program publication, “Six Common Misconceptions About Vaccination and How to Respond to Them,” at http://www.cdc.gov/nip/publications/6mishome.htm (last visited April 27, 2006) (hereinafter “Six Common Misconceptions”).

[11] Center for Disease Control, National Immunization Program publication, “Ten Things You Need to Know about Immunizations,” at http://www.cdc.gov/nip/publications/fs/gen/shouldknow.htm (last visited April 27, 2006).

[12] This is not to imply that parents who vaccinate without carefully considering the pros and cons of vaccination are in the wrong. The health and safety of a child is of paramount importance to most parents, and every parent must make decisions that affect the welfare of the child. Most parents approach such decisions with a sincere desire to promote the child’s best interests, and this desire is no different in the context of vaccination.

[13] “Despite its utility, vaccination has provoked popular resistance from the beginning.” Hodge and Gostin, supra note 4, at 834.

[14] “Some opponents express valid scientific objections about effectiveness or need for mass vaccinations; some fear harmful effects arising from the introduction of foreign particles into the human body; and others worry that vaccination actually transmits, rather than prevents, disease, or weakens the immune system.” Id.

[15] See, e.g. , Jacobson v. Massachusetts , 197 U.S. 11 (1905) (constitutional challenge to government mandated smallpox vaccination); “Six Common Misconceptions,” supra note 10 (“[s]ome see mandatory vaccination as interference by the government into what they believe should be a personal choice”).

[16] “Six Common Misconceptions,” supra note 10.

[17] A more detailed explanation of this subject appears in Part I of this paper.

[21] See, e.g. , “Ten Things You Need to Know about Immunizations,” supra note 11.

[22] Angie A. Welborn, “Mandatory Vaccinations: Precedent and Current Laws,” CRS Report for Congress, at http://www.fas.org/sgp/crs/RS21414.pdf (last updated Jan. 18, 2005).

[23] For a typical scenario of public health response to outbreak, see the facts of Jacobson v. Massachusetts , 197 U.S. 11 (1905).

[24] Hodge and Gostin, supra note 4, at 833-34.

[25] Id. at 867-68.

[26] Id. at 833.

[29] This level of immunity is often referred to as “herd immunity,” the concept that not everyone in a population must be vaccinated in order for the entire population to be protected. Abi Berger, “How Does Herd Immunity Work?” 319 BMJ 1466 (1999). “As long as a sufficient number of children are immunised against each disease for which there is a vaccine, protection against that disease will be conferred on everybody.” Id. Also, the level of vaccination necessary to attain herd immunity increases as the infectivity of the disease increases. Id. Highly infectious diseases, therefore, require higher levels of immunity for herd immunity to occur. Id. The concept of herd immunity will arise throughout this paper, with particular emphasis in Part III.

[30] This is evidenced by the fact that in time of outbreak, the vaccinated population can still be susceptible to the disease, although usually the vaccinated population is far less susceptible to the disease than the unvaccinated population. Vaccines typically produce the desired antibody in an individual around 90% of the time, with actual percentages varying from vaccine to vaccine. Some vaccines, moreover, lose their efficacy and require boosters. These concepts will be further developed throughout this paper.

[31] Hodge and Gostin, supra note 4, at 850-51.

[32] Id. at 851.

[33] Id. at 834.

[34] Id. at 834-35.

[35] See, e.g. , Duffield v. Sch. Dist. , 29 A. 742 (Penn. 1894).

[36] 197 U.S. 11 (1905).

[38] Id. at 26.

[39] Welborn, supra note 22.

[41] 260 U.S. 174 (1922).

[42] Id. at 175.

[43] Id. (“[t]he bill charges that there was then no occasion for requiring vaccination” and that the ordinances “in effect, mak[e] vaccination compulsory”).

[45] Id. at 176.

[48] Id. at 177.

[49] Hodge and Gostin, supra note 4, at 867-68.

[50] Id. at 868.

[51] The schedule of immunizations is published by the Center for Disease Control, and follows the recommendations of the Advisory Committee on Immunizations Practices, the American Academy of Pediatrics’ Committee on Infectious Diseases, and the American Academy of Family Physicians. Id.

[52] Id. at 869.

[54] Based on chart publicized by Center for Disease Control, approved by Advisory Committee on Immunization Practices, American Academy of Pediatrics, American Academy of Family Physicians, available at http://www.cispimmunize.org/IZSchedule_2006.pdf (last visited April 27, 2006).

[55] Indeed, the law in Jacobson was challenged for this reason.

[56] Statement of Barbara Fisher, founder of National Vaccine Information Center, quoted in Neenyah Ostrom, “First Do No Harm,” at http://www.chronicillnet.org/online/Fisher.html (last visited April 27, 2006).

[57] K.N.O.W. Vaccines, Vaccine Awareness of Florida fact sheet, at http://www.know-vaccines.org/vaccine_fact.html (last visited April 27, 2006).

[58] The most direct way in which this occurs surrounds the concept of herd immunity, as discussed elsewhere throughout this paper. If a sufficient number of persons in the community does not vaccinate, herd immunity may be unattainable and others may be put at risk.

[59] See, e.g. , the discussion in Part III involving The Andy Griffith Show.

[60] See Statement of Barbara Fisher, quoted in Ostrom, supra note 56. See also “Autism and Vaccines: Activists Wage a Nasty Campaign to Silence Scientists,” Wall Street Journal, February 16, 2004, at http://www.opinionjournal.com/forms/printThis.html?id=110004700 (last visited April 27, 2006) (citing vaccination critics who had accused the vaccination-defending writers of “having an ‘industry profit promoting agenda’”).

[61] See Statement of Barbara Fisher, quoted in Ostrom, supra note 56.

[64] See the discussion in Part II regarding vaccine safety.

[65] See, e.g. , “Six Common Misconceptions,” supra note 10.

[66] Mission Statement of Vaccination News website, at http://www.vaccinationnews.com (last visited April 27, 2006).

[67] As the discussion in Part II on vaccine safety demonstrates, pre-licensing testing for very rare adverse effects cannot take place if vaccines are ever to reach the market. Phase 4 post-licensing testing does exist, but may take years to discover extremely rare adverse effects.

[68] World Health Organization Immunization Safety page, “Adverse Events Following Immunization,” at http://www.who.int/immunization_safety/aefi/en/ (last visited April 27, 2006).

[69] As the recent mumps outbreak in Iowa demonstrates, not everyone who receives a vaccine develops immunity to the disease. For this reason, the success of vaccination depends on a sufficient level of vaccination in the community. When a significant percentage of the population has not received the vaccine, an outbreak can occur and even threaten some of those who have been vaccinated. See David Pitt, “Iowa Mumps Epidemic Continues to Broaden,” Associated Press, April 13, 2006, at http://www.breitbart.com/news/2006/04/13/D8GVGL600.html (last visited April 27, 2006). See also the above discussion of the history of vaccination.

[70] Mission Statement of Vaccination News website, supra note 66.

[71] See, e.g. , Ross D. Silverman, “No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions to Ensure Public Health Protection,” 12 Annals Health L. 277, 278-79 (2003).

[A]s risks of contracting many deadly and crippling diseases continue to decline to near negligible levels, and rates of childhood immunization continue to reach record levels, the public today places greater attention on the relative weaknesses and dangers of immunizations, and the systems through which they are administered.

[72] Hodge and Gostin, supra note 4, at 874.

[73] Usually this requires physician certification. Id.

[74] Indeed, the CDC itself presupposes the existence of medical exemptors in any broad mandatory vaccination program. See “Six Common Misconceptions,” supra note 10 (noting that the mandatory vaccination program can work to protect even those few who cannot vaccinate because of the possibility of adverse medical reactions).

[76] Hodge and Gostin, supra note 4, at 874.

[77] Jacobson v. Massachusetts , 197 U.S. 11 (1905). See also Employment Division v. Smith , 494 U.S. 872 (1990) (permitting neutral laws of general applicability that incidentally affect religion); Boone v. Boozman , 217 F.Supp.2d 938 (E.D. Ark. 2002) (“constitutionally-protected free exercise of religion does not excuse an individual from compulsory immunization...the right to free exercise of religion and parental rights are subordinated to society’s interest in protecting against the spread of disease”).

[78] W. Va. Code Sec. 16-3-4 (2004).

[79] See, e.g. , Boone v. Boozman , 217 F.Supp.2d 938 (E.D. Ark. 2002). The challenged Arkansas immunization statute exempted “individuals for whom ‘immunization conflicts with the religious tenets and practices of a recognized church or religious denomination of which [they are] an adherent or member.’” The statute was struck down under the Establishment Clause using the test laid out in Lemon v. Kurtzman , 403 U.S. 602 (1971). 217 F.Supp.2d at 950. The Arkansas legislature subsequently amended the exemption generally to allow for religious or philosophical objections without regard to recognized churches. Ark. Code Sec. 6-18-702(d).

[80] See Silverman, supra note 71, at 290-93.

[81] See id.

[82] Hodge and Gostin, supra note 4, at 874.

[83] Cal. Health and Safety Code Sec. 120365 (2003).

[84] Silverman, supra note 71, at 284.

[85] Id. at 285.

[87] See id.

[88] Recall that for those unable to vaccinate for medical reasons, herd immunity provides the only protection from the disease. See “Six Common Misconceptions,” supra note 10.

[89] Silverman, supra note 71, at 285.

[90] Id. The recent mumps outbreak may directly demonstrate this. Officials have pointed out that vaccination only confers immunity on 95% of patients, and of those affected in the recent outbreak, 25% have been vaccinated. See Pitt, supra note 69. The strong implication is that the 75% of those inflicted who were not vaccinated have put the entire community at risk.

[91] Center for Disease Control, National Immunization Program publication, “What Would Happen If We Stopped Vaccinations?” at http://www.cdc.gov/nip/publications/fs/gen/WhatIfStop.htm (last visited April 27, 2006).

[92] Silverman, supra note 71, at 293.

[93] Silverman suggests that eliminating philosophical and religious exemptions would do more harm than good. This approach, he believes, “would exacerbate feelings of animosity and skepticism toward vaccination and the public health system in general.” Id. at 293. On this score he is probably correct, and I agree that wider knowledge, at the very least, is a better initial response to this problem.

[94] Incidentally, it is worth mentioning that of the more longstanding vaccines, the tetanus vaccine stands out as unique. Tetanus is a very harmful disease with about a 20% fatality rate. “What Would Happen If We Stopped Vaccinations?” supra note 91. What makes it unique in the vaccine schedule is that tetanus is not contagious. That is, herd immunity is not attainable and cannot be used to justify mandatory tetanus vaccination. The reason for the general acceptance of the tetanus vaccine seems to stem both from the high risk of the disease and the fact that tetanus can only be prevented by immunization. In addition, the tetanus vaccine for infants has been combined with the vaccines for diphtheria and pertussis. On strictly public health grounds, however, the status of the tetanus shot on the compulsory vaccination schedule comes closest to government fiat of individual health decisions.

[95] Because medical risks may vary from vaccine to vaccine, and thus the justification for such exemptions remains even if the risk is to some but not all vaccines, medical exemptions are somewhat outside the scope of this discussion.

[96] Sean Coletti, Taking Account of Partial Exemptors in Vaccination Law, Policy, and Practice , 36 Conn. L. Rev. 1341, 1344 (2004).

[98] This follows directly from the all-or-nothing nature of the vaccination decision in this world.

[99] Again, this follows directly from the nature of the decision.

[100] See, e.g. , National Vaccine Information Center, at http://www.nvic.org (last visited April 27, 2006) (urging parents to consider eight questions before vaccinating, none of which inform parents of the effect their decision may have on others).

[101] See “Six Common Misconceptions,” supra note 10.

[102] 42 U.S.C. §§ 300aa-1 to 300aa-34.

[103] U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, “Vaccine Product Approval Process,” updated July 27, 2002, at http://www.fda.gov/cber/vaccine/vacappr.htm (last visited April 27, 2006) (hereinafter “Vaccine Product Approval Process”).

[104] See id.

[105] See, e.g. , Isadora Stehlin, “How FDA Works to Ensure Vaccine Safety,” FDA Consumer magazine (December 1995), at http://www.fda.gov/fdac/features/095_vacc.html (last visited April 27, 2006).

[106] “Licensing of a vaccine is only the beginning of FDA’s oversight.” Id.

[109] “Vaccine Product Approval Process,” supra note 103.

[112] Stehlin, supra note 105.

[115] Id. ; “Vaccine Product Approval Process,” supra note 103.

[116] Stehlin, supra note 105.

[118] “Vaccine Product Approval Process,” supra note 103.

[121] Id. ; Stehlin, supra note 105.

[123] Indeed, the National Immunization Program has confidently pointed to the FDA’s role in continued oversight of vaccines:

FDA would recall a lot of vaccine at the first sign of problems. There is no benefit to either the FDA or the manufacturer in allowing unsafe vaccine to remain on the market. The American public would not tolerate vaccines if they did not have to conform to the most rigorous safety standards. The mere fact that a vaccine lot [is] still in distribution says that the FDA considers it safe.

“Six Common Misconceptions,” supra note 10.

[124] “Vaccine Product Approval Process,” supra note 103.

[127] Stehlin, supra note 105.

[128] So states Susan Ellenberg, Ph.D., director of CBER’s division of biostatistics and epidemiology. Id.

[129] “Vaccine Product Approval Process,” supra note 103.

[130] Stehlin, supra note 105.

[136] See, e.g. , “Six Common Misconceptions,” supra note 10 (“[o]nly some of the reported health conditions are side effects related to vaccines. A certain number of VAERS reports of serious illnesses or death do occur by chance alone among persons who have been recently vaccinated”).

[137] “VAERS reports have many limitations since they often lack important information, such as laboratory results, used to establish a true association with the vaccine.” Id.

[138] “In summary, scientists are not able to identify a problem...based on VAERS reports alone without scientific analysis of other factors and data.” Id.

[139] U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, “Thimerosal in Vaccines,” at http://www.fda.gov/Cber/vaccine/thimerosal.htm (last updated Sept. 6, 2005).

[141] See, e.g. , Gardiner Harris and Anahad O’Connor, “On Autism’s Cause, It’s Parents vs. Research,” New York Times, June 25, 2005, at http://www.nytimes.com/2005/06/25/science/25autism.html (last visited April 27, 2006) (reporting the ongoing tension between parents of autistic children and the medical community over the use of thimerosal in vaccines).

[142] See, e.g. , Center for Disease Control, National Immunization Program publication, “Mercury and Vaccines (Thimerosal),” at http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/default.htm (last visited April 27, 2006) (studies have failed to find any association between exposure to thimerosal in vaccines and autism); “On Autism’s Cause, It’s Parents vs. Research,” supra (noting that the amount of ethyl mercury in each childhood vaccine was once about the same as the amount of methyl mercury, a more toxic compound, found in an average tuna sandwich).

[143] “Thimerosal in Vaccines,” supra note 139.

[146] Stehlin, supra note 105.

[149] “On Autism’s Cause, It’s Parents vs. Research,” supra note 141.

[150] “Thimerosal in Vaccines,” supra note 139; see also “On Autism’s Cause, It’s Parents vs. Research,” supra note 141 (“[b]y 2001, no vaccine routinely administered to children in the United States had more than half a microgram of mercury – about what is found in an infant’s daily supply of breast milk”).

[151] “Autism and Vaccines: Activists Wage a Nasty Campaign to Silence Scientists,” Wall Street Journal editorial, February 16, 2004, at http://www.opinionjournal.com/forms/printThis.html?id=110004700 (last visited April 27, 2006).

[152] “On Autism’s Cause, It’s Parents vs. Research,” supra note 141.

[153] Indeed, one recent study has suggested that neurological disorders have decreased with the removal of thimerosal from most vaccines. See David A. Geier and Mark R. Geier, “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines,” 11 J. Am. Physicians and Surgeons 8 (2006). This study should be taken with a grain of salt, however, as the Geiers are widely known thimerosal critics. Years before this study, Dr. Mark Geier called thimerosal use in vaccines the world’s “greatest catastrophe that’s ever happened, regardless of cause.” “On Autism’s Cause, It’s Parents vs. Research,” supra note 141. A witness in many vaccine cases, a judge once ruled that he was “a professional witness in areas for which he has no training, expertise and experience.” Id. Scientists have criticized his prior studies and even called his methods “voodoo science.” Id.

[155] See id.

[156] See “The Politics of Autism: Lawsuits and Emotion vs. Science and Childhood Vaccines,” Wall Street Journal editorial, Dec. 29, 2003, at http://www.opinionjournal.com/forms/printThis.html?id=110004487 (last visited April 27, 2006) (characterizing the position of thimerosal critics as “scientifically untenable”).

[157] See generally “On Autism’s Cause, It’s Parents vs. Research,” supra note 141.

[161] “The Politics of Autism,” supra note 156.

[162] Id. ; “Study: Autism Rise from Labeling, Not Epidemic,” April 3, 2006, at http://www.cnn.com/2006/EDUCATION/04/03/health.autism.reut/index.html (last visited April 27, 2006) (noting rise in diagnosed cases of autism since 1994 is correlated with fall in diagnosed cases of mental retardation and learning disabilities).

[163] The Politics of Autism,” supra note 156.

[164] See, e.g. , “Six Common Misconceptions,” supra note 10 (noting that many anti-vaccine publications claim vaccines are unsafe on the basis of sheer numbers of reports to VAERS without noting that many of them may not represent actual vaccine side-effects).

[165] National Vaccine Information Center, “The Vaccine Injury Compensation Program,” at http://www.909shot.com/Issues/Comp_Summary.htm (last visited April 27, 2006).

[166] Center for Disease Control, National Vaccine Program Office, Vaccine Fact Sheets, “National Vaccine Injury Compensation Program,” at http://www.hhs.gov/nvpo/factsheets/fs_tableIV_doc1.htm (last visited April 27, 2006).

[167] See National Vaccine Injury Compensation Program, at http://www.hrsa.gov/vaccinecompensation/ (last visited April 27, 2006).

[169] The Andy Griffith Show: The County Nurse (CBS television broadcast, March 19, 1962).

[177] Id. That is, there will be a high probability of death.

[179] See the discussion above in Part I of this paper.

[180] For example, she begs Rafe to consider his family and what his decision could mean to them. She literally appears to be on the verge of tears as he refuses.

[181] In utilizing the theoretical framework of economic analysis, it is useful to keep in mind a few foundational concepts. First, a policy or program (in this case mandatory vaccination) is desirable if the overall benefit to society as a whole outweighs the cost of the program, where benefits and costs include both monetary and non-monetary factors. Second, individuals making rational choices regarding vaccination will vaccinate when the benefits of vaccination outweigh the risks or costs of non-vaccination to the individual. This decision-making process can be skewed by externalities, such as an unforeseeable decrease in the effectiveness of a vaccine due to a reduction in vaccination by others unknown to the individual at the time of the decision.

[182] 197 U.S. 11 (1905).

[183] Id. at 12.

[185] Id. at 13, 22.

[186] Id. at 36.

[187] Id. at 12.

[188] As the CDC itself explains, “[e]ven one serious adverse effect in a million doses of vaccine cannot be justified if there is no benefit from the vaccination.” “Six Common Misconceptions,” supra note 10.

[189] In Japan in the 1970s, for instance, pertussis vaccination coverage fell from 80% to 20%, leading to an outbreak in 1979 resulting in 13,000 cases and 41 deaths. “What Would Happen If We Stopped Vaccinations?” supra note 91.

[190] Judge Richard Posner has suggested that this difference between sexually transmitted diseases and air- and water-borne diseases may imply a lesser imperative to eliminate sexually transmitted diseases:

[T]he externality created by sexually transmitted diseases is smaller than in the case of other contagious diseases. Sexually transmitted disease is spread primarily by voluntary contact, implying (to the economist) that a person is compensated...for assuming the risk of contracting the disease. Hence the number of cases of sexually transmitted diseases may be closer to the optimum than in the usual air-borne or water-borne or insect-borne epidemics.

Posner, Economic Analysis of Law 162. (6th Ed. 2003).

[191] Additionally, if vaccination rates are high, these individuals may assume that those in society who have already made the choice to vaccinate have performed a similar cost-benefit analysis. These individuals choose to vaccinate based simply on vaccination rates in the community. See John C. Hershey et al., The Roles of Altruism, Free Riding, and Bandwagoning in Vaccination Decisions , 59 Organizational Behavior and Human Processes 177, 178 (1994).

[192] See, e.g. , id. (behavioral survey studying various factors individuals use to make vaccination decisions).

[194] See id. at 178 (“[i]f a patient believes vaccination is in his own best interests, then he has two reasons to vaccinate. One is selfish, in that he will improve his own well being. The other is altruistic, in that he can improve the health prospects of those around him who might otherwise become infected if he is not vaccinated himself”).

[195] The concept of herd immunity is discussed in Part I. Note that “[i]n economic terms, herd immunity is a positive externality of vaccination. Altruistic individuals who recognize and value this externality may undergo vaccination partly to help others in addition to themselves.” Id. See also Berger, supra note 29 (“‘[h]erd immunity’...is the concept that not everybody in a population has to be immunised to protect everyone in that population. As long as a sufficient number of children are immunised against each disease for which there is a vaccine, protection against that disease will be conferred on everybody”).

[196] The CDC has pointed to this as one of the two most important reasons to vaccinate:

There is a small number of people who cannot be vaccinated (because of severe allergies to vaccine components, for example), and a small percentage of people don’t respond to vaccines. These people are susceptible to disease, and their only hope of protection is that people around them are immune and cannot pass disease along to them. A successful vaccination program, like a successful society, depends on the cooperation of every individual to ensure the good of all.

[197] In economic terms, “[w]idening vaccine use decreases each individual’s benefit from being vaccinated, but leaves unchanged each individual’s risk from the vaccination itself.” Hershey, supra note 191, at 178.

[198] “Six Common Misconceptions, supra note 10.

[199] Hershey, supra note 191, at 178.

[200] Suppose, for sake of example, that a vaccination program, if implemented, would save ten lives out of a thousand that would otherwise have perished without the program. Unfortunately, the vaccine will randomly cause death to five persons out of a thousand. From an ex ante perspective, the vaccination program should be implemented as it will save five lives overall. Concerns or complaints from those five persons who die (or their estates) represent ex post objections, and, though unfortunate, should not affect evaluations of the soundness of the program.

[201] This mathematical explanation is a slight variation of that found at CDC, “Six Common Misconceptions,” supra note __.

[202] Note that no vaccine is 100% effective, and vaccination efficacy rates for most childhood vaccinations range from 85 to 95%. Id. As stated in an earlier section, herd immunity is relied upon to protect those who do not develop full immunity from the vaccine.

[203] Given that these particular vaccines are already on the schedule, I think it would be unwise to remove them now. My analysis applies to comparable vaccines that may arise in the future – vaccines for those communicable diseases that do not pose relatively significant health risks. The definition of such diseases, of course, would be a matter of debate. Vaccines for noncommunicable diseases like ear infections would also fall within this rubric.

[204] Statement of Barbara Fisher, quoted in Ostrom, supra note 56.