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Featured topic and speakers
Is a new COVID vaccine coming out? Which RSV vaccine is better? Are there new PCV vaccines? Which vaccines can be given together? When is the new flu shot available?
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
- Sandra Fryhofer, MD, AMA’s liaison to the Advisory Committee on Immunization Practices (ACIP), member of ACIP’s COVID-19 Vaccine Workgroup
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. New vaccines with new recommendations were just voted on last week by the ACIP, the CDC's Advisory Committee on Immunization Practices. And back with us today to share all those details is the 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 again today.
Dr. Fryhofer: Well, Todd, thanks for having me back.
Unger: Dr. Fryhofer, the ACIP met for three days in June. Why don't you take us through some of the highlights?
Dr. Fryhofer: Well, it was a packed few days. ACIP made new recommendations for RSV, flu, COVID and pneumococcal vaccines. There was also an update on where we stand on the H5N1 bird flu outbreak in dairy cows.
Unger: Well, let's get into some of that. Why don't we start by talking about the new vaccine recommendations? Dr. Fryhofer, you also serve on the ACIP's COVID vaccine workgroup. So let's start with COVID vaccines. What should we expect for the fall, and who should get the vaccine?
Dr. Fryhofer: ACIP recommends everyone six months and older get a dose of the updated 2024-2025 COVID vaccine. So again, this is a universal recommendation, just like for flu. But understand, even though COVID is waned, it remains deadlier than flu. And uptake of last year's updated COVID vaccine has been very disappointing. Only 22.5% of adults and 14% of children have received it. We certainly hope uptake will be better this fall. Most Americans now have at least some immunity against COVID, but immunity wanes with time. And as the virus keeps changing, these updated vaccines provide a way to incrementally boost our immunity and keep us protected.
Unger: Dr. Fryhofer, where did we land on the formula for the new fall COVID vaccine? I know there's been some debate on that.
Dr. Fryhofer: Well, finalizing the recipe for that new vaccine has been a little tricky because the virus keeps changing and mutating. And lately, as you know, the virus has been flipping and "FLiRT-ing." The FLiRT variants got this nickname from the location of their mutations. There's an F for L at one position, an R for T at another, and they include any variants starting with KP or JN that has the same set of mutations.
So when VRBPAC, FDA's independent advisory committee, met on June 5, JN.1 had been dominated. KP.2 was on the rise. VRBPAC recommended a monovalent JN.1 formula. And initially, FDA did too. But over the next week, FDA continued to monitor what was circulating and made a slight change. The preferred recipe for the new JN.1 lineage formula is a COVID vaccine based on the KP.2 strain.
Unger: All right, well, thank you for the update there on the vaccine. Can you remind us—we talk about risk, who is most at risk of adverse outcomes from COVID?
Dr. Fryhofer: Two-thirds of COVID hospitalizations are in those aged 65 and older. And hospitalization rates are highest in those 75 and older and also in infants under six months old. And these little babies are too young to be vaccinated themselves. But maternal vaccination during pregnancy can help protect them. So that's why that's so important. Hospitalization rates are also high in adults aged 65 to 75. And unfortunately, we're still seeing racial and ethnic disparities in hospitalizations. COVID-associated hospitalizations are highest in American Indian, Alaska Native and in Black populations.
Unger: How did the COVID hospitalizations and deaths in children compare with, let's say, other vaccine preventable childhood illnesses?
Dr. Fryhofer: More pediatric hospitalizations and deaths occur each year associated with COVID than with other vaccine preventable diseases at the time those recommendations were made for children in the United States. And this includes hepatitis A, chickenpox, invasive pneumococcal disease, rubella, rotavirus and meningitis.
Unger: Dr. Fryhofer, it's clear that these vaccines are lifesaving for so many people. Why do you think the uptake has been so low?
Dr. Fryhofer: Focus group studies say older patients, those 65 and older, are most concerned about getting COVID and having to be hospitalized. Younger adults in their 20s are most concerned that they may unknowingly spread COVID to others. For children, the main reason parents gave for not having their child get the vaccine is concern about vaccine side effects. Other reasons include thinking the vaccine is not effective, which is not true, and that their child is unlikely to get very sick from COVID and we know that's not true either. So we really need to dispel these myths.
Another key point that really stood out is the power of physician recommendation. Adults and children who received a health care provider recommendation to get the COVID vaccine were more likely to get vaccinated. So physician recommendation is so important. We have to recommend these vaccines to our patients.
Unger: That is so important. Let's switch gears and talk about something different, which is RSV. I hear there is a new RSV vaccine. Tell us more about that.
Dr. Fryhofer: Yes, there is a new one. Now, until June 2024, there were just two RSV vaccines on the market, one by Pfizer called ABRYSVO that does not contain an adjuvant, and one by GSK called AREXVY that does. And CDC does use these brand names. But with FDA's recent approval of Moderna's new mRNA RSV vaccine, MRESVIA, we now have three RSV vaccines to prevent severe RSV in older adults. This is Moderna's second ever licensed product, and it uses the same messenger mRNA platform as their COVID vaccines. All three of these RSV vaccines are licensed for those 60 and older.
Unger: Well, Dr. Fryhofer, going into this meeting, RSV vaccines had been recommended, as you say, by ACIP, those 60 and older, but under shared clinical decision making. Can you talk a little bit about what this means and what does ACIP recommend now?
Dr. Fryhofer: Shared clinical decision making means you and your patient have to discuss and decide. And these conversations are pretty easy for primary care physicians because we know our patients. But not everyone who administers vaccines is comfortable having them. The new recommendation is more specific and has both age-based and risk-based components.
Unger: Is there still that element of shared clinical decision making that—has that gone away, or is that still in place?
Dr. Fryhofer: Shared clinical decision making no longer applies here. The age-based recommendation is for those 75 and older. And all adults age 75 and older should receive a single RSV vaccine dose. And if you already received a dose under the old recommendation, you don't need to get another one, at least for now. The risk-based recommendation applies to adults 60 up to 75. And for them, RSV vaccine is now recommended only for those with risk factors for severe RSV.
These risk factors include lung disease, heart disease, immune compromise, diabetes, obesity with a BMI of 40 or more, neurological conditions, neuromuscular conditions, chronic kidney disease, liver disorders and hematologic disorders. Also, frailty, as well as living in a nursing home or other long-term care facility are considered risk factors for severe RSV disease. So those 60 up to 75 without these risk factors are no longer recommended to receive it.
Unger: Thank you for that clarification. In terms of timing, what's the best time to get the RSV vaccine?
Dr. Fryhofer: The best time to get the RSV vaccine for the greatest benefit is late summer to early fall, so think August through October.
Unger: What about coadministration with other vaccines? We've talked about COVID. You mentioned flu, RSV. Is that still allowed?
Dr. Fryhofer: Yes. Coadministration of RSV vaccine with other adult vaccines, including flu, COVID, pneumococcal, Tdap and shingles vaccines is allowed and is acceptable.
Unger: I heard that the age indication for GSK's RSV vaccine, AREXVY, has been lowered to age 50. Did ACIP look at giving the vaccine to people in their 50s with risk factors for severe disease?
Dr. Fryhofer: Well, they did talk about it, but ACIP doesn't recommend it for people in their 50s, even for those at high risk for severe disease. Now, one of the main hesitations goes back to vaccine safety concerns. You may recall FDA's required post-marketing surveillance for GBS and atrial fibrillation from both manufacturers, and those vaccine surveillance studies are still ongoing. There's still many unanswered questions, and vaccine safety concerns were top of mind during ACIP deliberations. ACIP did clarify this is not a recommendation against use of RSV vaccines in adults in their 50s. It's because more information is needed to make a population-level policy recommendation.
Now, this may change as more is clarified about potential safety concerns. And there's still many other questions we have about RSV vaccines—durability of protection, will a booster be needed, and if so, when? And will a booster restore the initial boost in immunity we get from that first shot? So there's much more we need to know about RSV vaccines.
Unger: Now, we've talked about RSV vaccination for adults 60, 75, and older. What about on the other end of the age range for babies? Is there anything new there?
Dr. Fryhofer: Yes. And as a reminder, we now have two new ways to protect little babies, a maternal RSV vaccine given to mom, but only the one by Pfizer called ABRYSVO that doesn't have the adjuvant, and also a new long-acting monoclonal antibody, nirsevimab, given to baby. ACIP clarified that at this time, people who received a maternal RSV vaccine dose during a previous pregnancy are not recommended to receive additional doses during future pregnancies.
Now, this is different from what we do with Tdap. Tdap is recommended in each and every pregnancy to prevent pertussis in little babies. However, infants born to people who are vaccinated with RSV during a prior pregnancy should receive nirsevimab. These recommendations can be updated as additional data become available.
Unger: Is there anything new with the long-acting monoclonal antibody that's given to babies to prevent RSV?
Dr. Fryhofer: Yes. Nirsevimab really works well. A study published in March in MMWR showed nirsevimab is 90% effective at preventing RSV-associated hospitalization for infants in their first RSV season. And this is great news for families with little babies. Nirsevimab's recommended for infants up to eight months old during their first RSV season and for high-risk toddlers aged 8 to 19 months in their second RSV season. And you might remember last RSV season, nirsevimab supplies were limited and we had to prioritize doses. Fortunately, no supply shortages are expected for the upcoming season.
Unger: Dr. Fryhofer, there's also a new pneumococcal vaccine with a new ACIP recommendation. Can you tell us how this vaccine is different from other pneumococcal vaccines?
Dr. Fryhofer: A new PCV 21 pneumococcal vaccine has been FDA licensed for those aged 18 and older under an accelerated approval pathway. ACIP voted to recommend PCV 21 as an option for adults 19 and older, who currently have an indication to receive a dose of PCV. Now, there are two basic types of pneumococcal vaccines, polysaccharide vaccines, like PPSV 23, which do not produce memory B cells, and conjugate vaccines, which do trigger memory B cell production, and therefore induce long-term immunity. And these include PCV 15, PCV 20, and now PCV 21.
Unger: What's so special about this new PCV 21 vaccine? Or is it just PCV 20 plus one?
Dr. Fryhofer: No, it's not just PCV 20 plus one. What's unique about PCV 21 is it just didn't add additional coverage. It's 21 strains are different and include 11 unique serotypes not in PCV 20. Now, this is important because many of the cases we see in adult disease are caused by subtypes not covered in other FDA-approved pneumococcal vaccines. ACIP reviewed the evidence and says PCV 21 has greater coverage of the serotypes that cause invasive pneumococcal disease in adults as compared to PCV 20. IPD, invasive pneumococcal disease, includes bacteremic pneumonia, pneumococcal bacteremia and meningitis.
PCV 20 covers up to 58% of invasive disease in adults. PCV 21 provides much greater protection and covers up to 84% of the serotypes that cause invasive disease. PCV 21's additional protection from strains that cause invasive disease is very impressive, and it's licensed for both prevention of invasive pneumococcal disease and pneumococcal pneumonia.
Unger: Is there any downside to using PCV 21 compared to the older versions of PCV since it covers more strains?
Dr. Fryhofer: Well, PCV 21 does not cover serotype 4, which is a major cause of invasive disease in certain populations. Adults experiencing homelessness are 100 to 300 times more likely to report invasive disease due to serotype 4. And adults in Alaska, especially Alaskan Natives, have an 88-fold increase in serotype 4 invasive disease.
Fortunately, serotype 4 is covered by other pneumococcal vaccines, including PCV 15, PCV 20 and PPSV 23. So we haven't heard the end of this story. And even higher valency pneumococcal vaccines, including a 25 valent and a 31 valent version, are under development, so much more to come. I'm sure I'll be back talking to you more about pneumococcal vaccines.
Unger: Thank you for the update on that. Let's talk about the other thing that we're aware of for the fall, and of course, that's the seasonal flu vaccine. What's new there?
Dr. Fryhofer: Well, this coming fall, the seasonal flu vaccine's going trivalent. FDA's removed the Yamagata flu B strain because it no longer appears to be circulating. And new CPT codes are ready to go, thanks to AMA's CPT editorial team. ACIP also made a special off-label recommendation for people aged 18 through 64 who've had a solid organ transplant and are on immunosuppressive medications. These high-risk patients can now be given one of the higher dose flu vaccines, including fluzone high-dose and also the adjuvanted flu vaccine, which are FDA approved only for those 65 and older.
Unger: Well, Dr. Fryhofer, that is a lot of great information. I just want to say, thank you so much for being here and for that quick run through of the highlights from ACIP's June meeting. That wraps up today's episode. To support important public health information like this, I encourage you to become an AMA member. You can join at ama-assn.org/join. We'll be back soon with another AMA Update. And 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 video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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