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FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

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Sriparna reports on pharmaceutical companies and healthcare in the United States. She has a master's degree in English literature and post graduate diploma in broadcast journalism.

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China's manufacturing slowed to a six-month low in August, an official factory survey showed on Saturday, raising expectations policymakers will unveil fresh plans to direct more stimulus to households and less to infrastructure projects.

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FDA approves updated COVID-19 vaccines, shots should be available in days

U.S. regulators have approved updated COVID-19 vaccines, shots designed to better target recent virus strains -- and hopefully whatever variants cause trouble this winter, too.

This photo provided by Pfizer in August 2024 shows a packaging for the company’s updated COVID vaccine for ages 12 and up, approved by the U.S. Food and Drug Administration on Thursday, Aug. 22, 2024. (Steven Decroos/Pfizer via AP)

This photo provided by Moderna in August 2024 shows packaging and syringes for the company’s updated COVID vaccine for ages 12 and older approved by the U.S. Food and Drug Administration on Thursday, Aug. 22, 2024. (Moderna via AP)

This photo provided by Pfizer in August 2024 shows a vial of the company’s updated COVID vaccine for ages 6 months-5 years old, approved by the U.S. Food and Drug Administration on Thursday, Aug. 22, 2024. (Steven Decroos/Pfizer via AP)

This photo provided by Pfizer in August 2024 shows a vial of the company’s updated COVID vaccine for ages 5-11, approved by the U.S. Food and Drug Administration on Thursday, Aug. 22, 2024. (Steven Decroos/Pfizer via AP)

This photo provided by Moderna in August 2024 shows packaging and a syringe for the company’s updated COVID vaccine for ages 12 and older approved by the U.S. Food and Drug Administration on Thursday, Aug. 22, 2024. (Moderna via AP)

FILE - Pre-loaded syringes of the COVID-19 vaccine are ready for use in New Orleans on Jan. 25, 2022. (AP Photo/Ted Jackson, File)

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WASHINGTON (AP) — U.S. regulators approved updated COVID-19 vaccines on Thursday, shots designed to more closely target recent virus strains -- and hopefully whatever variants cause trouble this winter, too.

With the Food and Drug Administration’s clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its modified vaccine version to be available a little later.

“We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said FDA vaccine chief Dr. Peter Marks.

The agency’s decision came a bit earlier than last year’s rollout of updated COVID-19 vaccines, as a summer wave of the virus continues in most of the country. The Centers for Disease Control and Prevention already has recommended this fall’s shot for everyone age 6 months and older. Vaccinations could be available within days.

While most Americans have some degree of immunity from prior infections or vaccinations or both, that protection wanes. Last fall’s shots targeted a different part of the coronavirus family tree, a strain that’s no longer circulating -- and CDC data shows only about 22.5% of adults and 14% of children received it.

Skipping the new shot is “a hazardous way to go,” because even if your last infection was mild, your next might be worse or leave you with long COVID symptoms, said Dr. Robert Hopkins Jr. of the National Foundation for Infectious Diseases.

This fall’s vaccine recipe is tailored to a newer branch of omicron descendants . The Pfizer and Moderna shots target a subtype called KP.2 that was common earlier this year. While additional offshoots, particularly KP.3.1.1, now are spreading, they’re closely enough related that the vaccines promise cross-protection. A Pfizer spokesman said the company submitted data to FDA showing its updated vaccine “generates a substantially improved response” against multiple virus subtypes compared to last fall’s vaccine.

The big question: How soon to get vaccinated? This summer’s wave of COVID-19 isn’t over but the inevitable winter surges tend to be worse. And while COVID-19 vaccines do a good job preventing severe disease, hospitalization and death, protection against mild infection lasts only a few months.

People who are at high risk from the virus shouldn’t wait but instead schedule vaccinations once shots are available in their area, Hopkins advised.

That includes older adults, people with weak immune systems or other serious medical problems, nursing home residents and pregnant women.

Healthy younger adults and children “can get vaccinated anytime. I don’t think there’s a real reason to wait,” Hopkins said – although it’s OK to seek the shots in the fall, when plenty of doses will have arrived at pharmacies and doctor’s offices.

The exception: The CDC says anyone who recently had COVID-19 can wait three months after they recover before getting vaccinated, until immunity from that infection begins to wane.

Hopkins, who sees patients at the University of Arkansas for Medical Sciences, calls it vital for more youngsters to get vaccinated this year – especially with schools starting as coronavirus levels are high around the country.

“COVID does not kill many children, thank goodness, but it kills far more children than influenza does,” Hopkins said, adding that teachers, too, should quickly get up to date with the vaccine.

Health authorities say it’s fine to get a COVID-19 and flu vaccination at the same time, a convenience so people don’t have to make two trips. But while many drugstores already are advertising flu shots, the prime time for that vaccination tends to be late September through October, just before flu typically starts its cold weather climb.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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An Obesity Drug Prevents Covid Deaths, Study Suggests

People taking Wegovy were not protected from infection. But in a large trial, their death rates were markedly lower, for reasons that are not clear.

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By Gina Kolata

Wegovy, the popular obesity drug, may have yet another surprising benefit. In a large clinical trial, people taking the drug during the pandemic were less likely to die of Covid-19 , researchers reported on Friday.

People on Wegovy still got Covid, and at the same rate as people randomly assigned to take a placebo. But their chances of dying from the infection plunged by 33 percent, the study found.

In addition, the death rate from all causes was lower among subjects taking Wegovy, a very rare finding in clinical trials of new treatments. The result suggests that lower life expectancy among people with obesity is actually caused by the disease itself, and that it can be improved by treating obesity.

“Stunning,” Dr. Jeremy Faust, an emergency room physician at Brigham and Women’s Hospital who wrote an editorial accompanying the study , said of the data. The study was published in The Journal of the American College of Cardiology.

The study was not originally designed to look at the effects of taking Wegovy on people with Covid. But the participants taking the drug were not healthier than the others, said Dr. Harlan Krumholz, a cardiologist at Yale and the editor in chief of the journal.

“It is a randomized trial and the infection rates were similar, so this represents top-notch evidence,” he said.

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Semaglutide reduces COVID-19 related deaths in patients with obesity and cardiovascular disease

by American College of Cardiology

Semaglutide, the popular anti-obesity drug, reduced the rates of COVID-19-related adverse events, including death, in those who had overweight or obesity and established cardiovascular disease (CVD) without diabetes, according to a new study published in JACC . The results will be published simultaneously with a presentation at the European Society of Cardiology (ESC) Conference 2024 in London.

Obesity is associated with an increased risk of death and can increase many cardiovascular risk factors. A higher BMI can also increase the risk of non-CV causes of death, including infection. In this new substudy of the SELECT Trial, researchers looked at whether once-weekly semaglutide (2.4mg) reduced rates of all-cause death, CV death, and non-CV death, including death from COVID-19.

"This groundbreaking study demonstrates that semaglutide, perhaps by improving cardiometabolic health , has far-reaching benefits beyond what we initially imagined," said Harlan M. Krumholz, MD, FACC, Editor-in-Chief of JACC and the Harold H. Hines, Jr Professor at the Yale School of Medicine.

"The ability of semaglutide to significantly lower cardiovascular and COVID-19-related adverse events underscores the transformative potential of targeting obesity and improving cardiometabolic health as a strategy to protect against a broad spectrum of health threats."

The SELECT trial enrolled 17,604 people who were 45 years old or older and were overweight or had obesity and established CV disease but not diabetes. They received one-weekly semaglutide (2.4 mg) or placebo and were followed for 3.3 years. Of the 833 deaths in trial participants, 58% were CV related, and 42% were non-CV related. Infection was the most common cause of non-CV death, but that occurred at a lower rate in the semaglutide group vs. the placebo group.

Semaglutide did not reduce rates of COVID-19, but among participants who developed COVID-19, those who were treated with semaglutide had fewer COVID-19-related adverse events or died from COVID-19 (2.6% on semaglutide vs. 3.1% on placebo).

"The robust reduction in non-CV death, and particularly infections deaths, was surprising and perhaps only detectable because of the COVID-19-related surge in non-CV deaths," said Benjamin Scirica, MD, MPH, lead author of the study, a professor of cardiovascular medicine at Harvard Medical School, and director of innovation in the Cardiovascular Division at Brigham and Women's Hospital in Boston.

"However, these findings reinforce that overweight and obesity increases the risk of death due to many etiologies, which can be modified with potent incretin-based therapies like semaglutide."

In a related editorial comment, Jeremy Samuel Faust, MD, MS, an emergency medicine physician at Brigham and Women's Hospital, commended the researchers for adapting their study to look at COVID-19 when the pandemic began and said the findings that semaglutide could reduce COVID-19 morality is "akin to a vaccine against the indirect effects of a pathogen."

"People with coronary artery disease who had fatal myocardial infarctions precipitated by the physiological stress/ inflammatory response induced by COVID-19 (or any infection) could have averted those outcomes, were their risk profiles lower when infected," Faust said. "By adding documentation of COVID-19 cases and mortality, the SELECT trial has yielded important insights regarding the epidemiology of COVID-19 and the very nature of infectious disease mortality."

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A new vaccine comes amid COVID-19 levels that are “higher than we’re used to seeing this time of year” as a result of a late summer surge, according to Dr. Sindhu Aderson, the central region medical director for Northwestern Medicine Immediate Care.

Pat Nabong/Sun-Times

New COVID-19 vaccines were just approved: Everything you need to know

The newest formula is targeted at what’s expected to be the dominant strain of the virus. the approach is much like that used for the flu each year, according to the fda..

The Food and Drug Administration approved a third, updated version of the COVID-19 vaccine from Pfizer and Moderna Thursday, and the vaccine could be released to the public in the coming days.

Here’s what you need to know.

What’s different about this vaccine? Why should I get it?

The newest formula is targeted at what’s expected to be the dominant strain of the virus, much like the approach used for the flu, according to the FDA.

While the newest strain is following the pattern of the virus becoming more infectious but less deadly, 600 people are still dying weekly of the virus in the U.S., according to Dr. Beverly Sha, an infectious disease physician at Rush University Medical Center.

Sha, who worked on earlier clinical trials for COVID-19 vaccines, said immunity is waning after six months despite early hopes it would last longer.

“When the vaccines first became available, we were very hopeful immunity would be robust and long-lasting, but that turned out not to be the case,” Sha told the Sun-Times Friday. “So much like the flu, each fall they’re coming out with a new version of the vaccine for what’s expected to be circulating in the winter months.”

Drugmakers need only change the COVID-19 variant targeted by the vaccine, meaning they can develop vaccines quicker because of how much carries over between versions of the vaccine.

“Everything else about the vaccines is the same, so the safety data we’ve collected still applies,” Sha said. “I’m not advocating for something I wouldn’t do for myself or my family.”

Who can get it?

Unvaccinated children from 6 months to 4 years old can get three doses of the new Pfizer vaccine or two doses of the new Moderna vaccine, according to the FDA . Children of the same age who were previously vaccinated against COVID-19 can get one or two doses of either, while children 5 to 11 can get a single dose.

Those who are at least 12 years old can get a single dose of the updated Comirnaty or Spikevax vaccine, according to the FDA.

For anyone 5-years or older, the new shot should come at least two months after the previous one.

Dr. Sindhu Aderson, the central region medical director for Northwestern Medicine Immediate Care, likened it to an annual flu shot and suggested people get both their flu and COVID-19 shots as a precaution. She noted it was important for those who are immunocompromised or have other complications, such as heart or lung diseases, to stay up to date on their vaccines.

“We want to make sure we keep the general population safe,” Aderson said. “[But] it’s really important for people who have a high risk for severe COVID infection, they really should be seeking out these updated boosters.”

Where and when can I get it?

CVS and Walgreens are accepting appointments before the vaccine’s release. CVS will offer shots in the next few days for walk-in or scheduled appointments. Walgreens has said the new vaccine would be available beginning Sept. 6.

Aderson said the new vaccines will be available at immediate care clinics sometime in the next month, though they have not received specific dates.

The Chicago Department of Public Health suggests individuals check with their providers about when vaccines will become available and said it will share information about how to access the vaccines without insurance “as it becomes available.”

Will I have to pay for it?

While the CDC’s Bridge Access Program — which provided free COVID-19 vaccines to uninsured and underinsured adults — has ended, preventive care is usually covered by insurance, according to Aderson. She said patients should call providers and insurance companies ahead of time to see what the cost will be for them.

• Free COVID-19 vaccines could be a thing of the past as federal program is set to expire early

Charlie Rice-Minoso, a CVS spokesperson, said some systems may not be updated right away, leading to an initial out-of-pocket cost of $201.99 before being reimbursed by insurance companies. Patients can opt to return later when things have been sorted out.

Where are we at right now with COVID-19?

Aderson said COVID-19 levels are “higher than we’re used to seeing this time of year” as a result of more gatherings and travel in the summer. So far, COVID-19 has outpaced the flu, though she noted it’s still early in the season.

While the city no longer reports COVID-19 data as it used to, the latest city data , from the week of Aug. 4-10, puts COVID-19 test positivity at 15.2%, or about 110 people testing positive out of 719 who tested. This is below the recently reported national average of about 18%.

The CDC has also reported an increase in cases and hospitalizations .

• COVID-19 rising again in Chicago, but experts urge precaution — not panic

However, these numbers are likely underreported.

“People may have very mild symptoms and may not even be testing,” Aderson said. “[And] those that do have symptoms may be doing at-home tests and just isolating at home.”

Covid cases are rising: When to rest and when to test, according to CDC and experts

Covid rates are still rising across most of the country, fueled by the highly contagious new variants of the virus —  KP.2 and KP.3 and LB.1. As of July 18, the highest levels of Covid are in the Western states, although there are no areas of the U.S. where rates are noticeably dropping, according to CDC wastewater data .

At least 21 states have very high levels of Covid , the data shows.

“You have a very, very transmissible variant, probably one of the most transmissible we’ve had,” said Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at the University of California, San Francisco. “We have a lot of population immunity, but it doesn’t mean that there isn’t a lot of chaos.”

But people who test positive for Covid don’t need to isolate for five days, according to recent guidance from the Centers for Disease Control and Prevention.

This is the first major wave since the CDC updated its Covid guidance , said Katelyn Jetelina, an epidemiologist who tracks illnesses on her website, Your Local Epidemiologist . She recommends isolating until an at-home Covid test turns negative, which could be anywhere from three to 15 days.

Yet, with fewer people testing for Covid, experts say it’s more important than ever to pay attention to symptoms. Since March, the CDC’s guidance has matched advice for flu and other respiratory illnesses: Stay home when you’re sick, but you can return to work or school once you’re feeling better and you’ve been without fever for 24 hours. 

“The guidelines reflect a number of things, including the fact that we generally are overall shedding for less time now,” Bill Hanage, an associate director at the Center for Communicable Disease Dynamics at Harvard University, said. “And there’s more of a link between symptoms” and being contagious.

Because most Americans have already either had a version of the virus or have had several vaccines or boosters — or have had Covid and are also vaccinated —  it’s hard to separate Covid symptoms from other respiratory illnesses without testing. Right now, chances are, if you have upper respiratory symptoms — sniffles or congestion — or a cough, it could be Covid. 

According to the CDC, someone with Covid can go back to normal activities when symptoms have been getting better for at least 24 hours and no fever even without taking fever-reducing medication like acetaminophen or ibuprofen. 

Then for the next five days, take precautions such as wearing a mask in crowded indoor situations. 

The majority of viral spread happens when people are the sickest. 

“As the days go on, less virus spreads,” CDC Director Dr. Mandy Cohen said in an interview this year.

The CDC guidance is for the general public only, and does not include isolation guidelines in hospital settings, which is generally 10 days.

Covid symptoms

For people who have been through at least one Covid infection, or are up to date with the vaccines, symptoms often resemble a common cold or other respiratory illness.

Common Covid symptoms include:

• Fatigue and muscle aches
• Sore throat
• Nausea or diarrhea

There's not really a major sign that indicates Covid, doctors say, so the only way to know for sure is to take a test.

When should I test for Covid? How often?

The original guidance from the CDC was to test approximately five days after exposure because it took that long before the virus became detectable in the body. Now, with high levels of prior exposure, some people could feel symptoms a day or two after exposure, not because the virus is growing more quickly but because the immune system recognizes the virus and responds symptomatically, Michael Mina, an epidemiologist and former professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, said.

While many people aren't bothering to test now — tests aren't free anymore — Mina advises taking an at-home test on the third day after symptoms begin. If it's negative, test again the next day.

"If I had only two tests, that's where I'd stop testing," Mina said. "If positive, you don't need more tests. My best educated guess is, assume you're infectious for five days after testing positive."

In a prior study, Mina said that up to 50% of people were still infectious a week or eight days after symptoms begin and up to 20% were still contagious up to nine days later.

While people's immunity is doing a better job than a year ago, Mina believes many people could still be contagious five days after symptoms begin.

The experts recognize that most people will be ready to get back to work or school quickly after they feel better. What's most important is to be careful around people who may be immunocompromised or elderly.

"You don’t want people to be locking themselves in their bedrooms for five days," said Hanage. That said, "there are some contexts where you really would want to be more careful, including giving it to somebody who’s vulnerable for whatever reason."

Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

Akshay Syal, M.D., is a medical fellow with the NBC News Health and Medical Unit. 

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• COVID-19 Treatments and Medications , Centers for Disease Control and Prevention (CDC)
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COVID-19, also called coronavirus disease 2019, is an illness caused by a virus. The virus is called severe acute respiratory syndrome coronavirus 2, or more commonly, SARS-CoV-2. It started spreading at the end of 2019 and became a pandemic disease in 2020.

• Coronavirus

Coronaviruses are a family of viruses. These viruses cause illnesses such as the common cold, severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS) and coronavirus disease 2019 (COVID-19).

The virus that causes COVID-19 spreads most commonly through the air in tiny droplets of fluid between people in close contact. Many people with COVID-19 have no symptoms or mild illness. But for older adults and people with certain medical conditions, COVID-19 can lead to the need for care in the hospital or death.

Staying up to date on your COVID-19 vaccine helps prevent serious illness, the need for hospital care due to COVID-19 and death from COVID-19 . Other ways that may help prevent the spread of this coronavirus includes good indoor air flow, physical distancing, wearing a mask in the right setting and good hygiene.

Medicine can limit the seriousness of the viral infection. Most people recover without long-term effects, but some people have symptoms that continue for months.

Typical COVID-19 symptoms often show up 2 to 14 days after contact with the virus.

Symptoms can include:

• Shortness of breath.
• Loss of taste or smell.
• Extreme tiredness, called fatigue.
• Digestive symptoms such as upset stomach, vomiting or loose stools, called diarrhea.
• Pain, such as headaches and body or muscle aches.
• Fever or chills.
• Cold-like symptoms such as congestion, runny nose or sore throat.

People may only have a few symptoms or none. People who have no symptoms but test positive for COVID-19 are called asymptomatic. For example, many children who test positive don't have symptoms of COVID-19 illness. People who go on to have symptoms are considered presymptomatic. Both groups can still spread COVID-19 to others.

Some people may have symptoms that get worse about 7 to 14 days after symptoms start.

Most people with COVID-19 have mild to moderate symptoms. But COVID-19 can cause serious medical complications and lead to death. Older adults or people who already have medical conditions are at greater risk of serious illness.

COVID-19 may be a mild, moderate, severe or critical illness.

• In broad terms, mild COVID-19 doesn't affect the ability of the lungs to get oxygen to the body.
• In moderate COVID-19 illness, the lungs also work properly but there are signs that the infection is deep in the lungs.
• Severe COVID-19 means that the lungs don't work correctly, and the person needs oxygen and other medical help in the hospital.
• Critical COVID-19 illness means the lung and breathing system, called the respiratory system, has failed and there is damage throughout the body.

Rarely, people who catch the coronavirus can develop a group of symptoms linked to inflamed organs or tissues. The illness is called multisystem inflammatory syndrome. When children have this illness, it is called multisystem inflammatory syndrome in children, shortened to MIS -C. In adults, the name is MIS -A.

When to see a doctor

Contact a healthcare professional if you test positive for COVID-19 . If you have symptoms and need to test for COVID-19 , or you've been exposed to someone with COVID-19 , a healthcare professional can help.

People who are at high risk of serious illness may get medicine to block the spread of the COVID-19 virus in the body. Or your healthcare team may plan regular checks to monitor your health.

Get emergency help right away for any of these symptoms:

• Can't catch your breath or have problems breathing.
• Skin, lips or nail beds that are pale, gray or blue.
• New confusion.
• Trouble staying awake or waking up.
• Chest pain or pressure that is constant.

This list doesn't include every emergency symptom. If you or a person you're taking care of has symptoms that worry you, get help. Let the healthcare team know about a positive test for COVID-19 or symptoms of the illness.

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COVID-19 is caused by infection with the severe acute respiratory syndrome coronavirus 2, also called SARS-CoV-2.

The coronavirus spreads mainly from person to person, even from someone who is infected but has no symptoms. When people with COVID-19 cough, sneeze, breathe, sing or talk, their breath may be infected with the COVID-19 virus.

The coronavirus carried by a person's breath can land directly on the face of a nearby person, after a sneeze or cough, for example. The droplets or particles the infected person breathes out could possibly be breathed in by other people if they are close together or in areas with low air flow. And a person may touch a surface that has respiratory droplets and then touch their face with hands that have the coronavirus on them.

It's possible to get COVID-19 more than once.

• Over time, the body's defense against the COVID-19 virus can fade.
• A person may be exposed to so much of the virus that it breaks through their immune defense.
• As a virus infects a group of people, the virus copies itself. During this process, the genetic code can randomly change in each copy. The changes are called mutations. If the coronavirus that causes COVID-19 changes in ways that make previous infections or vaccination less effective at preventing infection, people can get sick again.

The virus that causes COVID-19 can infect some pets. Cats, dogs, hamsters and ferrets have caught this coronavirus and had symptoms. It's rare for a person to get COVID-19 from a pet.

Risk factors

The main risk factors for COVID-19 are:

• If someone you live with has COVID-19 .
• If you spend time in places with poor air flow and a higher number of people when the virus is spreading.
• If you spend more than 30 minutes in close contact with someone who has COVID-19 .

Many factors affect your risk of catching the virus that causes COVID-19 . How long you are in contact, if the space has good air flow and your activities all affect the risk. Also, if you or others wear masks, if someone has COVID-19 symptoms and how close you are affects your risk. Close contact includes sitting and talking next to one another, for example, or sharing a car or bedroom.

It seems to be rare for people to catch the virus that causes COVID-19 from an infected surface. While the virus is shed in waste, called stool, COVID-19 infection from places such as a public bathroom is not common.

Serious COVID-19 illness risk factors

Some people are at a higher risk of serious COVID-19 illness than others. This includes people age 65 and older as well as babies younger than 6 months. Those age groups have the highest risk of needing hospital care for COVID-19 .

Not every risk factor for serious COVID-19 illness is known. People of all ages who have no other medical issues have needed hospital care for COVID-19 .

Known risk factors for serious illness include people who have not gotten a COVID-19 vaccine. Serious illness also is a higher risk for people who have:

• Sickle cell disease or thalassemia.
• Serious heart diseases and possibly high blood pressure.
• Chronic kidney, liver or lung diseases.

People with dementia or Alzheimer's also are at higher risk, as are people with brain and nervous system conditions such as stroke. Smoking increases the risk of serious COVID-19 illness. And people with a body mass index in the overweight category or obese category may have a higher risk as well.

Other medical conditions that may raise the risk of serious illness from COVID-19 include:

• Cancer or a history of cancer.
• Type 1 or type 2 diabetes.
• Weakened immune system from solid organ transplants or bone marrow transplants, some medicines, or HIV .

This list is not complete. Factors linked to a health issue may raise the risk of serious COVID-19 illness too. Examples are a medical condition where people live in a group home, or lack of access to medical care. Also, people with more than one health issue, or people of older age who also have health issues have a higher chance of severe illness.

Related information

• COVID-19: Who's at higher risk of serious symptoms? - Related information COVID-19: Who's at higher risk of serious symptoms?

Complications

Complications of COVID-19 include long-term loss of taste and smell, skin rashes, and sores. The illness can cause trouble breathing or pneumonia. Medical issues a person already manages may get worse.

Complications of severe COVID-19 illness can include:

• Acute respiratory distress syndrome, when the body's organs do not get enough oxygen.
• Shock caused by the infection or heart problems.
• Overreaction of the immune system, called the inflammatory response.
• Blood clots.
• Kidney injury.

Post-COVID-19 syndrome

After a COVID-19 infection, some people report that symptoms continue for months, or they develop new symptoms. This syndrome has often been called long COVID, or post- COVID-19 . You might hear it called long haul COVID-19 , post-COVID conditions or PASC. That's short for post-acute sequelae of SARS -CoV-2.

Other infections, such as the flu and polio, can lead to long-term illness. But the virus that causes COVID-19 has only been studied since it began to spread in 2019. So, research into the specific effects of long-term COVID-19 symptoms continues.

Researchers do think that post- COVID-19 syndrome can happen after an illness of any severity.

Getting a COVID-19 vaccine may help prevent post- COVID-19 syndrome.

The Centers for Disease Control and Prevention (CDC) recommends a COVID-19 vaccine for everyone age 6 months and older. The COVID-19 vaccine can lower the risk of death or serious illness caused by COVID-19.

The COVID-19 vaccines available in the United States are:

2023-2024 Pfizer-BioNTech COVID-19 vaccine. This vaccine is available for people age 6 months and older.

Among people with a typical immune system:

• Children age 6 months up to age 4 years are up to date after three doses of a Pfizer-BioNTech COVID-19 vaccine.
• People age 5 and older are up to date after one Pfizer-BioNTech COVID-19 vaccine.
• For people who have not had a 2023-2024 COVID-19 vaccination, the CDC recommends getting an additional shot of that updated vaccine.

2023-2024 Moderna COVID-19 vaccine. This vaccine is available for people age 6 months and older.

• Children ages 6 months up to age 4 are up to date if they've had two doses of a Moderna COVID-19 vaccine.
• People age 5 and older are up to date with one Moderna COVID-19 vaccine.

2023-2024 Novavax COVID-19 vaccine. This vaccine is available for people age 12 years and older.

• People age 12 years and older are up to date if they've had two doses of a Novavax COVID-19 vaccine.

In general, people age 5 and older with typical immune systems can get any vaccine approved or authorized for their age. They usually don't need to get the same vaccine each time.

Some people should get all their vaccine doses from the same vaccine maker, including:

• Children ages 6 months to 4 years.
• People age 5 years and older with weakened immune systems.
• People age 12 and older who have had one shot of the Novavax vaccine should get the second Novavax shot in the two-dose series.

Talk to your healthcare professional if you have any questions about the vaccines for you or your child. Your healthcare team can help you if:

• The vaccine you or your child got earlier isn't available.
• You don't know which vaccine you or your child received.
• You or your child started a vaccine series but couldn't finish it due to side effects.

People with weakened immune systems

Your healthcare team may suggest added doses of COVID-19 vaccine if you have a moderately or seriously weakened immune system. The FDA has also authorized the monoclonal antibody pemivibart (Pemgarda) to prevent COVID-19 in some people with weakened immune systems.

Control the spread of infection

In addition to vaccination, there are other ways to stop the spread of the virus that causes COVID-19 .

If you are at a higher risk of serious illness, talk to your healthcare professional about how best to protect yourself. Know what to do if you get sick so you can quickly start treatment.

If you feel ill or have COVID-19 , stay home and away from others, including pets, if possible. Avoid sharing household items such as dishes or towels if you're sick.

In general, make it a habit to:

• Test for COVID-19 . If you have symptoms of COVID-19 test for the infection. Or test five days after you came in contact with the virus.
• Help from afar. Avoid close contact with anyone who is sick or has symptoms, if possible.
• Wash your hands. Wash your hands well and often with soap and water for at least 20 seconds. Or use an alcohol-based hand sanitizer with at least 60% alcohol.
• Cover your coughs and sneezes. Cough or sneeze into a tissue or your elbow. Then wash your hands.
• Clean and disinfect high-touch surfaces. For example, clean doorknobs, light switches, electronics and counters regularly.

Try to spread out in crowded public areas, especially in places with poor airflow. This is important if you have a higher risk of serious illness.

The CDC recommends that people wear a mask in indoor public spaces if you're in an area with a high number of people with COVID-19 in the hospital. They suggest wearing the most protective mask possible that you'll wear regularly, that fits well and is comfortable.

• COVID-19 vaccines: Get the facts - Related information COVID-19 vaccines: Get the facts
• Comparing the differences between COVID-19 vaccines - Related information Comparing the differences between COVID-19 vaccines
• Different types of COVID-19 vaccines: How they work - Related information Different types of COVID-19 vaccines: How they work
• Debunking COVID-19 myths - Related information Debunking COVID-19 myths

Travel and COVID-19

Travel brings people together from areas where illnesses may be at higher levels. Masks can help slow the spread of respiratory diseases in general, including COVID-19 . Masks help the most in places with low air flow and where you are in close contact with other people. Also, masks can help if the places you travel to or through have a high level of illness.

Masking is especially important if you or a companion have a high risk of serious illness from COVID-19 .

• Goldman L, et al., eds. COVID-19: Epidemiology, clinical manifestations, diagnosis, community prevention, and prognosis. In: Goldman-Cecil Medicine. 27th ed. Elsevier; 2024. https://www.clinicalkey.com. Accessed Dec. 17, 2023.
• Coronavirus disease 2019 (COVID-19) treatment guidelines. National Institutes of Health. https://www.covid19treatmentguidelines.nih.gov/. Accessed Dec. 18, 2023.
• AskMayoExpert. COVID-19: Testing, symptoms. Mayo Clinic; Nov. 2, 2023.
• Symptoms of COVID-19. Centers for Disease Control and Preventions. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed Dec. 20, 2023.
• AskMayoExpert. COVID-19: Outpatient management. Mayo Clinic; Oct. 10, 2023.
• Morris SB, et al. Case series of multisystem inflammatory syndrome in adults associated with SARS-CoV-2 infection — United Kingdom and United States, March-August 2020. MMWR. Morbidity and Mortality Weekly Report 2020;69:1450. DOI: http://dx.doi.org/10.15585/mmwr.mm6940e1external icon.
• COVID-19 testing: What you need to know. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html. Accessed Dec. 20, 2023.
• SARS-CoV-2 in animals. American Veterinary Medical Association. https://www.avma.org/resources-tools/one-health/covid-19/sars-cov-2-animals-including-pets. Accessed Jan. 17, 2024.
• Understanding exposure risk. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-exposure.html. Accessed Jan. 10, 2024.
• People with certain medical conditions. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Accessed Jan. 10, 2024.
• Factors that affect your risk of getting very sick from COVID-19. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html. Accessed Jan. 10, 2024.
• Regan JJ, et al. Use of Updated COVID-19 Vaccines 2023-2024 Formula for Persons Aged ≥6 Months: Recommendations of the Advisory Committee on Immunization Practices—United States, September 2023. MMWR. Morbidity and Mortality Weekly Report 2023; 72:1140–1146. DOI: http://dx.doi.org/10.15585/mmwr.mm7242e1.
• Long COVID or post-COVID conditions. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html. Accessed Jan. 10, 2024.
• Stay up to date with your vaccines. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html. Accessed Jan. 10, 2024.
• Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination. Accessed Jan. 10, 2024.
• Use and care of masks. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/about-face-coverings.html. Accessed Jan. 10, 2024.
• How to protect yourself and others. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed Jan. 10, 2024.
• People who are immunocompromised. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-who-are-immunocompromised.html. Accessed Jan. 10, 2024.
• Masking during travel. Centers for Disease Control and Prevention. https://wwwnc.cdc.gov/travel/page/masks. Accessed Jan. 10, 2024.
• AskMayoExpert. COVID-19: Testing. Mayo Clinic. 2023.
• COVID-19 test basics. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics. Accessed Jan. 11, 2024.
• At-home COVID-19 antigen tests — Take steps to reduce your risk of false negative results: FDA safety communication. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety. Accessed Jan. 11, 2024.
• Interim clinical considerations for COVID-19 treatment in outpatients. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/outpatient-treatment-overview.html. Accessed Jan. 11, 2024.
• Know your treatment options for COVID-19. U.S. Food and Drug Administration. https://www.fda.gov/consumers/consumer-updates/know-your-treatment-options-covid-19. Accessed Jan. 11, 2024.
• AskMayoExpert. COVID:19 Drug regimens and other treatment options. Mayo Clinic. 2023.
• Preventing spread of respiratory viruses when you're sick. Centers for Disease Control and Prevention. https://www.cdc.gov/respiratory-viruses/prevention/precautions-when-sick.html. Accessed March 5, 2024.
• AskMayoExpert. COVID-19: Quarantine and isolation. Mayo Clinic. 2023.
• COVID-19 resource and information guide. National Alliance on Mental Illness. https://www.nami.org/Support-Education/NAMI-HelpLine/COVID-19-Information-and-Resources/COVID-19-Resource-and-Information-Guide. Accessed Jan. 11, 2024.
• COVID-19 overview and infection prevention and control priorities in non-U.S. healthcare settings. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/overview/index.html. Accessed Jan. 16, 2024.
• Kim AY, et al. COVID-19: Management in hospitalized adults. https://www.uptodate.com/contents/search. Accessed Jan. 17, 2024.
• O'Horo JC, et al. Outcomes of COVID-19 with the Mayo Clinic Model of Care and Research. Mayo Clinic Proceedings. 2021; doi:10.1016/j.mayocp.2020.12.006.
• At-home OTC COVID-19 diagnostic tests. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests. Accessed Jan. 22, 2024.
• Emergency use authorizations for drugs and non-vaccine biological products. U.S. Food and Drug Association. https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products. Accessed March 25, 2024.
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• News Releases

Semaglutide reduces COVID-19 related deaths in patients with obesity and CVD

New SELECT trial substudy finds anti-obesity drug has protective effects beyond weight loss

American College of Cardiology

Semaglutide, the popular anti-obesity drug, reduced the rates of COVID-19-related adverse events, including death, in those who had overweight or obesity and established cardiovascular disease without diabetes, according to a new study published in JACC , the flagship journal of the American College of Cardiology. The results will be published simultaneously with a presentation at the European Society of Cardiology (ESC) Conference 2024 in London.

Obesity is associated with an increased risk of death and can increase many cardiovascular risk factors. A higher BMI can also increase the risk of non-CV causes of death, including infection. In this new substudy of the SELECT Trial, researchers looked at whether once-weekly semaglutide (2.4mg) reduced rates of all-cause death, CV death, and non-CV death, including death from COVID-19.

“This groundbreaking study demonstrates that semaglutide, perhaps by improving cardiometabolic health, has far-reaching benefits beyond what we initially imagined,” said Harlan M. Krumholz, MD, FACC, Editor-in-Chief of JACC and the Harold H. Hines, Jr Professor at the Yale School of Medicine. “The ability of semaglutide to significantly lower cardiovascular and COVID-19-related adverse events underscores the transformative potential of targeting obesity and improving cardiometabolic health as a strategy to protect against a broad spectrum of health threats.”

The SELECT trial enrolled 17,604 people who were 45 years old or older and were overweight or had obesity and established CV disease but not diabetes. They received one-weekly semaglutide (2.4 mg) or placebo and were followed for 3.3 years. Of the 833 deaths in trial participants, 58% were CV related, and 42% were non-CV related. Infection was the most common cause of non-CV death, but that occurred at a lower rate in the semaglutide group vs. the placebo group.

Semaglutide did not reduce rates of COVID-19, but among participants who developed COVID-19, those who were treated with semaglutide had fewer COVID-19-related adverse events or died from COVID-19 (2.6% on semaglutide vs. 3.1% on placebo).

“The robust reduction in non-CV death, and particularly infections deaths, was surprising and perhaps only detectable because of the COVID-19-related surge in non-CV deaths,” said Benjamin Scirica, MD, MPH, lead author of the study, a professor of cardiovascular medicine at Harvard Medical School, and director of innovation in the Cardiovascular Division at Brigham and Women’s Hospital in Boston. “However, these findings reinforce that overweight and obesity increases the risk of death due to many etiologies, which can be modified with potent incretin-based therapies like semaglutide.”

In a related editorial comment, Jeremy Samuel Faust, MD, MS, an emergency medicine physician at Brigham and Women's Hospital, commended the researchers for adapting their study to look at COVID-19 when the pandemic began and said the findings that semaglutide could reduce COVID-19 morality is “akin to a vaccine against the indirect effects of a pathogen.”

“People with coronary artery disease who had fatal myocardial infarctions precipitated by the physiological stress/inflammatory response induced by COVID-19 (or any infection) could have averted those outcomes, were their risk profiles lower when infected,” Faust said. “By adding documentation of COVID-19 cases and mortality, the SELECT trial has yielded important insights regarding the epidemiology of COVID-19 and the very nature of infectious disease mortality.”

The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, ACC credentials cardiovascular professionals in over 140 countries who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family of JACC Journals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart patient resources and more, the College is committed to ensuring a world where science, knowledge and innovation optimize patient care and outcomes. Learn more at www.ACC.org or follow @ACCinTouch.

The ACC’s JACC Journals rank among the top cardiovascular journals in the world for scientific impact. The flagship journal, the Journal of the American College of Cardiology ( JACC) — and specialty journals consisting of JACC: Advances, JACC: Asia, JACC: Basic to Translational Science, JACC: CardioOncology, JACC: Cardiovascular Imaging , JACC: Cardiovascular Interventions , JACC: Case Reports, JACC: Clinical Electrophysiology and JACC: Heart Failure — pride themselves on publishing the top peer-reviewed research on all aspects of cardiovascular disease. Learn more at JACC .org .

Journal of the American College of Cardiology

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Employee, Student Health outline new COVID-19 guidance

• Written by Karen Burbach, UNMC strategic communications
• Published Aug 27, 2024

Employee Health and Student Health have adjusted their policies and protocols related to COVID-19 testing and isolation for faculty, staff and students at UNMC and Nebraska Medicine.

Now, COVID-19 isolation, return-to-school and return-to-work guidance align with other respiratory illnesses. Individuals experiencing symptoms of COVID are encouraged to refrain from coming to campus, test for COVID-19 and follow the COVID-19 isolation guidelines below:

COVID-19 testing

• Employees wanting COVID-19 testing can use a home test, pursue testing through their primary care provider or be evaluated by the  Virtual Care Clinic.
• Students in Omaha can contact the Nebraska Medicine UNMC Student Health Clinic at 402-559-7204 for testing.  Students in Kearney, Lincoln, Norfolk and Scottsbluff can contact Student Health at their campus to request a telehealth appointment or testing.

COVID-19 isolation guidance

• Temperature less than 100°F for at least 24 hours without the use of fever-reducing medications, and
• Symptom improvement for at least 24 hours.
• Individuals returning from a COVID-19 infection should mask at work or in educational environments for 10 days. (Day 0 is day of symptom onset or date of test, whichever occurred first.)
• Absences due to COVID-19 will follow typical call-in/illness procedures and attendance policies.
• Employees with questions about returning to work after illness should call the Employee Health Nurse Line for guidance: 402-552-3563, option 2.

During the pandemic, the med center analyzed its building air handling systems and either increased filtration or added UV light treatment within the air handlers consistent with the general recommendations of Nebraska Medicine’s Infection Control group for non-patient care spaces.

The U.S. Centers for Disease Control and Prevention expects 2024-25 vaccines to be available this fall. UNMC and U.S. public health experts encourage individuals to get their flu, COVID-19 and RSV vaccines when available. Watch for updates on the CDC webpage .

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