AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.
Featured topic and speakers
What is the newest COVID vaccine called? When is the new COVID vaccine available? Which COVID-19 vaccine is best? What are the CDC COVID guidelines for vaccines?
Our guest is Sandra Fryhofer, MD, AMA’s liaison to the Advisory Committee on Immunization Practices (ACIP), and a member of ACIP’s COVID-19 Vaccine Workgroup. AMA Chief Experience Officer Todd Unger hosts.
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Speaker
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Sandra Fryhofer, MD, physician; immediate past chair, AMA Board of Trustees and AMA liaison to ACIP
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. Three updated versions of the COVID vaccine are now available. But who needs them? And when is the best time to get them?
Here with us today to share all the details is AMA's in-house vaccine expert and ACIP liaison, Dr. Sandra Fryhofer, in Atlanta. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Fryhofer, thanks for joining us today.
Dr. Fryhofer: Well, Todd, thanks for having me back.
Unger: Well, let's get right to it, a lot of people out there with COVID right now, a lot of interest in the vaccines. So tell us more about them. When were they approved? And who needs them?
Dr. Fryhofer: Well, a lot's been happening, and here's the timeline. On Thursday, August 22, FDA authorized and approved Pfizer and Moderna mRNA versions of the 2024-2025 updated COVID vaccine. Both of them target the KP.2 strain of the JN.1 lineage.
Now, at that time, the updated Novavax protein-based vaccine was still under FDA review. And then more than a week later, on August 30, the Friday before Labor Day, FDA authorized a third shot, the Novavax version. And it also targets JN.1.
ACIP, the CDC's Advisory Committee on Immunization Practices, had already voted to recommend them at its June meeting. A dose of the updated 2024-2025 COVID vaccine is recommended for everyone six months and older. This is a universal recommendation, just like the one we have for flu.
This updated vaccine is not a new vaccine. It's just a strain change. Just like we do for flu vaccine each season, we update the strains each year. Now, vaccine was ready to ship, so once FDA gave the green light, vaccine was on its way to clinics and pharmacies around the country.
Both of the mRNA vaccines are authorized or fully approved for those six months and older. The Novavax version is only authorized for those 12 and older. And again, a dose of the 2024-2025 COVID vaccine is recommended for everyone six months and older. This includes people who have never been vaccinated, people who have been vaccinated in the past, as well as those who've previously had COVID. So that's who can get them, but the big question is when.
Unger: Absolutely. There are a lot of questions about that. How soon can you get the updated dose after you've had COVID and after you've received, let's say, a previous vaccination?
Dr. Fryhofer: Well, there are some slight differences between the two vaccine platforms. For the updated mRNA vaccines, guidance from CDC and FDA says you can get a dose at least two months after your last dose of any COVID vaccine. But if you recently had COVID, you can wait a little longer. CDC suggests waiting at least three months after infection to get the shot to maximize immune response to vaccination.
The FDA authorized the interval for the updated Novavax protein-based vaccine is not as straightforward. It depends on the type of vaccine you received in the past and the number of doses. A dose of the updated Novavax vaccine can be given at least two months after your last mRNA COVID vaccine dose. A dose of the updated Novavax vaccine can be given at least two months after previous completion of a Novavax two-dose primary series.
So for those who go with Novavax for all their doses, FDA's updated authorization reiterates the importance of an initial two-dose primary Novavax series with those doses given at least three weeks apart. And this new vaccine can be used for that.
Unger: OK, so it sounds like there's some leeway in terms of when you can get the updated dose. But what should people consider in determining the best time for them?
Dr. Fryhofer: You have the most protection in the first few weeks to months after vaccination, and after that, antibodies tend to wane. So you might want to time vaccination so antibodies will be at their peak for big events like weddings and major meetings. But understand, while you wait, you still run the risk of getting infected with COVID, and it's much safer to build up antibodies with vaccination than with infection.
That's why those at highest risk should probably not wait. They should get the updated dose as soon as possible, at least two months from their last mRNA dose, or at least three months after previous COVID infection. Now, right now, there's lots of COVID circulating, so if you do decide to wait on vaccination, try to avoid crowded indoor settings. But if you can't avoid them, consider wearing a high-quality mask.
Most people have at least some antibodies against COVID from previous infection, previous vaccination, or both. But if you haven't recently been infected and you didn't get a dose of last year's shot, you don't have updated protection, which means you're sort of a sitting duck for getting sicker. This new shot can wake up your body's immune system and update your antibody protection against COVID threats.
Our computers need update for cybersecurity, so does our immune system. And a dose of the updated vaccine updates your immune system's protection against coronavirus threats. And if you're in a high-risk group, the best sure way to stay well is to go ahead and get a dose of the updated vaccine as soon as possible.
Unger: Well, that's a great way to think about it. Everything needs an update, including your vaccine. Dr. Fryhofer, you mentioned that there are those who are at higher risk, who should really consider getting it now. Who are those people that you're talking about?
Dr. Fryhofer: Hospitalization rates for COVID are highest for those aged 75 and older and in infants under six months old. These little babies are too young to be vaccinated themselves, but maternal vaccination during pregnancy and breastfeeding can help protect these little babies. Hospitalization rates are also high in adults aged 65 to 75.
And we're still seeing racial and ethnic disparities in hospitalizations. COVID-associated hospitalizations are highest in American Indians, Alaska Natives and in Black populations. Two-thirds of COVID hospitalizations are in those aged 65 and older. So people age 65 and older, as well as people living in long-term care facilities, are at high risk. People with immunocompromising conditions and chronic medical conditions are also at greater risk.
People with immunocompromising conditions don't always have a robust immune response after vaccination, and that's why FDA has also authorized the monoclonal antibody PEMGARDA for those with immunocompromising conditions. It can be given prophylactically to help protect these patients from getting COVID.
Now, it's not a treatment. It's prophylactic. Another added benefit of getting vaccinated is it decreases the chance of getting long COVID. And in a recent news conference, CDC director Dr. Mandy Cohen reminded that every age group is at risk for COVID, including young children. In fact, the highest numbers of emergency department visits for COVID over the summer were in children under five years old.
Unger: That's a really important point. I also heard someone say you can't get long COVID if you don't get COVID, so more impetus to get that updated vaccine. Dr. Fryhofer, are they recommending just one shot this year? Or should anyone receive more than one dose?
Dr. Fryhofer: A dose of the updated vaccine is recommended for everyone six months and older. And unlike last year, additional doses are not recommended for those 65 and older yet, but that could change. People with immunocompromising conditions not only need at least one updated dose. They may need more.
And of course, those under five years old may need more than one updated dose if they're still completing their primary mRNA series. But to clarify, only the mRNA Pfizer and Moderna versions are authorized for those under 12 years old. These mRNA vaccines have full approval for those age 12 and older. The updated Novavax vaccine is authorized only for those aged 12 and older. And again, for those who go with Novavax for all their doses, FDA authorization reiterates the importance of an initial two-dose primary Novavax series with those doses given at least three weeks apart.
Unger: And Dr. Fryhofer, you mentioned up front about the variant that this particular update is targeting. Can you talk a little bit more in detail about that and how this year's shot compares to last year's updated vaccine?
Dr. Fryhofer: The virus is constantly changing, and new variants continue to emerge. Last year's vaccine specifically targeted omicrons XBB.1.5, which is no longer circulating. Now JN.1 lineage variants are dominant. Both of the new mRNA COVID vaccines target the KP.2 strain of the JN.1 lineage. The updated Novavax protein-based vaccine targets the JN.1 strain.
And you can think of JN.1 as the tree and KP.2 as one of its branches. As of August 20, FLip, SLip, FLiRT, and de-FLiRT variants are currently circulating, and they got these nicknames from the location of their mutations. And they include any variants starting with KP or JN that has this same set of mutations. KP.3.1.1 accounts for 37% of new COVID illnesses. KP.2.3 is at 14.4%.
A new variant, LB.1, is now gaining steam at 14.1%. All of these are relatives of JN.1. Understand, these new COVID vaccines have been updated to give you the best protection from JN.1-based variants, and these are the ones that are circulating now.
Unger: All right. If you happen to be unfortunate and get COVID, what about treatments?
Dr. Fryhofer: Well, fortunately, Paxlovid continues to be effective against JN.1 and FLiRT variants. Paxlovid is a protease inhibitor, and its mechanism of action involves a part of the virus that's not related to the spike protein. Paxlovid is available for free for people on Medicare and Medicaid. There's also some government funding to cover it for people who are uninsured through the so-called PACS access program.
Unger: Now, Dr. Fryhofer, I realized that COVID might not be top of mind for everyone. So give us a little bit of perspective. How bad was COVID last year?
Dr. Fryhofer: Todd, in 2023, nearly a million people were hospitalized from COVID. More than 75,000 died. And to put this into perspective, during the 2023-2024 flu season, nearly 45,000 died from flu complications. COVID vaccines and flu vaccines helped protect us from severe disease, hospitalization and death.
Unger: That's really good perspective, big numbers. Are these vaccines covered by insurance? You mentioned before about Paxlovid, but what about the vaccine? And likewise, is there a backup plan for people who are uninsured?
Dr. Fryhofer: COVID vaccines are covered by Medicare, Medicaid and many private insurances. CDC's Bridge Access Program, which provided 1.5 million free COVID shots for uninsured and underinsured people, ran out at the end of August, and unfortunately, it will not be renewed. A CVS spokesperson said that the out-of-pocket costs at CVS for COVID vaccines for uninsured people is over $200.
However, uninsured and underinsured children can get COVID vaccines for free under VFC, the Vaccines for Children program. VFC is celebrating 30 years of providing life-saving vaccines to children at no cost. It's a fabulous program, but there's not a similar program for uninsured adults, though many experts say there should be. And I agree.
However, at least for the time being, CDC has managed to repurpose 62 million unspent dollars to state and local health departments to help them cover the cost of vaccine for uninsured people. But there are 25 to 30 million uninsured adults, and this won't cover all of them. However, the government will make up to four free COVID tests per household available again this year. You can sign up to receive them at covidtest.gov, and I think that website is supposed to go active at the end of this month.
Unger: Excellent. Dr. Fryhofer, there are a lot of people out there that just simply have booster fatigue. How do we convince them to get this updated shot?
Dr. Fryhofer: It's clear COVID is not going away. It's now endemic. It's here to stay.
And as we all know, uptake of the 2023-2024 updated COVID vaccine was very disappointing. Only 22.5% of adults and only 14% of children received it, and we certainly hope uptake of this new vaccine will be better.
And even if you've missed the last few doses, you really need to consider getting this one, especially if you're in a high-risk group or around someone who is. And here's why—antibodies from previous infection and previous vaccination are starting to wane. The virus has changed a lot.
Also, antibodies we've built from previous infection and previous vaccination don't work as well against these new variants. Our antibody protection needs a refresh. So getting a dose of the 2024-2025 updated COVID vaccine is the best way to catch up and level set and update your immunity to help stay protected.
Unger: Well, Dr. Fryhofer, COVID vaccines aren't the only ones we need to think about right now. What are some of the other vaccines that should be on our radar at this time?
Dr. Fryhofer: We're about to end our respiratory virus season, which means there are three shots, COVID, flu and RSV, to think about, recommend and receive, if indicated. And you can get all of these at the same time at the same visit if you need them and if you choose.
A dose of the updated COVID vaccine is recommended for everyone six months and older. Everyone six months and older needs flu vaccination every year. And for those 65 and older, one of the higher dose flu shots is preferred.
Everyone 75 and older needs a single dose of the RSV vaccine. So do those aged 60 to 75 with certain risk factors. But if you received an RSV vaccine dose in a previous season, you don't need another one.
And remember, RSV is also the most common cause of hospitalization for infants in the U.S., and we now have two new ways to protect little babies, a maternal RSV vaccine given to mom and the new long-acting monoclonal antibody, nirsevimab, given to babies. RSV season typically runs from October through March, and pregnant people whose baby will be born during RSV season are eligible for the vaccine at 32 to 36 weeks of pregnancy.
But if they receive the RSV vaccine in a previous pregnancy, they do not need another RSV vaccine dose. Also, make sure those age 65 and older, as well as people with certain medical conditions are up to date on pneumococcal vaccination. So lots of things to think about at this time.
Unger: Well, exactly. You have shared quite a bit of information. Any final thoughts?
Dr. Fryhofer: Please don't understand—underestimate the power of physician recommendation. Adults and children who receive a health care provider recommendation are more likely to get vaccinated. Physician recommendation is so important.
Unger: As always, thank you so much, Dr. Fryhofer, for being here and sharing your expertise and letting us know what we need to do about updated COVID vaccines and other vaccines heading into the fall. That wraps up today's episode. To support more important public health information like this, we encourage you to become an AMA member at ama-assn.org/join.
We'll be back soon with another AMA Update. In the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this podcast are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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