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What are the new COVID vaccine guidelines? Is the RSV vaccine safe? When should you get the pneumococcal vaccine? Is there a vaccine for meningococcal disease?
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, Advisory Committee on Immunization Practices (ACIP); board member, AMA Board of Trustees
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. CDC's Advisory Committee on Immunization Practices, or ACIP, recently met and voted in favor of new recommendations for several vaccines. Here with us today to share all those details is the AMA's liaison to ACIP, Dr. Sandra Fryhofer in Atlanta. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Fryhofer, thanks so much for joining us today.
Dr. Fryhofer: Well, thanks for having me, Todd.
Unger: Well, in its most recent meeting, ACIP talked about vaccines for more than nine hours across two days. Must be a lot to talk about. Tell us about which vaccines were discussed.
Dr. Fryhofer: Well, there are new recommendations for COVID and pneumococcal vaccines. We also heard updates on the safety of RSV vaccines and their potential use in younger adult patients. Dosing recommendations for MenB vaccines were harmonized. So a lot to talk about. Where do you want to start?
Unger: Well, why don't we start with the pneumococcal vaccines. What's new there?
Dr. Fryhofer: Well, this is very exciting and should be life saving. ACIP lowered the age for routine pneumococcal vaccination from 65 down to 50, and it applies to PCV, the pneumococcal conjugate vaccine. However, there is still a risk-based recommendation for younger adults age 19 through 49 with certain medical conditions like diabetes, as well as chronic heart, liver, lung, kidney disease, and also for those with immunocompromising conditions.
Unger: What's the background on lowering the age to 50?
Dr. Fryhofer: Well, the workgroup took a deeper dive into the data, and it turned out that more than half of those 50 to 64 already had a risk indication for pneumococcal vaccination. They also considered health equity. Rates of invasive pneumococcal disease peak at younger ages and Black patients as compared to white patients. In fact, the rate of IPD—and that's invasive pneumococcal disease—for Black adults age 50 and older exceeds the average rate of IPD for all adults age 65 and older. So lowering the age to 50 for routine pneumococcal vaccination has the potential to reduce disease in the demographic groups with the highest burden of disease.
Unger: That's really interesting. Why is this change from a risk-based recommendation to an age-based recommendation so important?
Dr. Fryhofer: Well, risk-based recommendations are harder to implement than the age-based recommendations, particularly since many of these vaccines are now administered in pharmacies. And let's face it, pharmacists don't know the patients like their physicians do. And so it's harder for them to know who to give the vaccine to if the recommendation's based on risk. But as I said before, there is still a risk-based recommendation for high-risk adults under age 50.
Unger: Now, you said this only applies to PCV?
Dr. Fryhofer: Yes. And that's because PCV, pneumococcal conjugate vaccines, trigger memory B cell production and therefore induce greater long-term immunity. And these include PCV15, PCV20 and PCV21. And I know we've talked about the difference between PCV20 and PCV21 in the past. PCV21 is not just PCV20 plus 1. It's 21 strains are different. And it also includes non-unique serotypes not in PCV20.
PCV20 covers up to 58% of invasive disease in adults. PCV21 provides even greater protection and covers up to 84% of invasive disease. But PCV21 does have an important omission. It does not cover serotype 4, which is a major cause of invasive disease in certain populations, including adults experiencing homelessness and adults in Alaska, especially Alaska natives.
The research focus is now on even higher valent PCV vaccines. There are already two 24-valent vaccines and one 31-valent pneumococcal vaccine in the advanced stages of development. So again, the new routine recommendation is for pneumococcal vaccination with PCV starting at age 50.
Unger: All right. Well, thank you for that update there. Let's move on to COVID at this point. What's new with the COVID vaccine?
Dr. Fryhofer: Everyone 6 months and older is recommended to receive a dose of the updated COVID vaccine. So that hasn't changed. But an additional COVID vaccine dose is now recommended for everyone 65 and older and also for people age 6 months and older with immunocompromising conditions. This second dose is recommended at 6 months, but it can be given as early as 2 months after the last dose. And if you've recently had COVID, you can wait 3 months before getting an additional vaccine dose.
And this is really helpful because this flexibility allows patients to time vaccination around travel, life events like weddings, family get-togethers, chemotherapy, et cetera. And patients with immunocompromising conditions can also receive even more additional doses if recommended by their physician, and this would be under shared clinical decision making, which means you and your patient have to discuss and decide.
Unger: Now, Dr. Fryhofer, what is the rationale behind this decision?
Dr. Fryhofer: Well, we know that protection from vaccination wanes with time, and new studies looking at vaccine effectiveness show protection against COVID-associated urgent care and emergency department visits and hospitalizations waned to 0 by 4 to 6 months. But protection against critical illness did remain above 40% at 5 months for those 65 and older. We also know that additional COVID vaccine doses provide additional protection.
Unger: Now, interesting that we're talking about, of course, second for certain folks with immunocompromised situations because the uptake of last year's updated vaccine was really disappointing. In fact, only 22 and a half percent of adults and only 14% of children received it. Are we looking at better numbers this year?
Dr. Fryhofer: Yes. Well, compared to last year, we're on a roll. Uptake so far is higher, especially for older adults age 75 and older. 30.6% of them have already received a dose of the updated vaccine, as compared to 17.7% at this time last year.
Unger: That is good news. All right, let's move on to the third topic, and that's RSV. Were there any new recommendations? I heard that the FDA lowered the age for one of those vaccines down to 18 for those at high risk. Is that right?
Dr. Fryhofer: You're right about that. And to review, we now have three RSV vaccines that are FDA approved for adults, two protein subunit RSV vaccines, one by Pfizer called ABRYSVO that does not contain an adjuvant, and one by GSK called AREXVY that does. And the third RSV vaccine is by Moderna. It's called mRESVIA, and it uses an mRNA vaccine platform.
All three of these RSV vaccines are licensed for those 60 and older. The age indication for GSK's RSV vaccine, AREXVY, had already been lowered by FDA to age 50. And FDA recently lowered the age approval for ABRYSVO down to 18, only for those at higher risk.
Unger: Dr. Fryhofer, just to clarify, what are the current RSV recommendations for adults?
Dr. Fryhofer: So this is what ACIP says. Everyone age 75 and older needs a dose of RSV vaccine. There's also a risk-based recommendation for adults 60 to 75 with risk factors for severe RSV, and these risk factors include lung disease, heart disease, immunocompromising conditions, diabetes, obesity, neurological conditions, neuromuscular conditions, chronic kidney disease, liver disorders, hematologic disorders, also frailty, as well as living in a nursing home or other long-term care facility, they're considered risk factors for severe RSV disease too, and those 60 to 75 that don't have these risk factors are not recommended to receive it.
Also, there have been a lot of questions about the durability of protection for RSV vaccines, and there was some good news presented at ACIP. Studies now suggest the RSV protein subunit vaccines confer 36 months of protection rather than just 24. And at least for now, only one RSV vaccine dose is recommended. So if you happen to receive a dose last year, you don't need another one.
Unger: Dr. Fryhofer, was lowering the age of age indication for RSV vaccination for adults discussed?
Dr. Fryhofer: The work we did address the age lowering in their deliberation. But the main hesitation goes back to vaccine safety concerns. You may recall—and we talked about this before—FDA's required post-marketing surveillance for GBS and atrial fibrillation from both of the RSV protein-based manufacturers, and those vaccine surveillance safety studies are still ongoing.
FDA gave an update about GBS risk at this meeting, and their findings still suggest an increased GBS risk with both protein-based RSV vaccines among those 65 and older. However, the risk seems to be rare, less than 10 cases per 1 million vaccinations. The RSV workgroup will continue to evaluate recommendations for the use of RSV vaccines in adults under age 60, but at this time, the workgroup affirmed the current recommendation just for older adults is appropriate.
Unger: All right. Is there anything new about the maternal RSV vaccination and protecting babies from RSV? We're really in RSV season right now, right?
Dr. Fryhofer: We are entering RSV season. RSV season starts in October and goes through March. So we are there now. And as a reminder, we now have two new ways to protect little babies, the maternal RSV vaccine, given at 32 to 36 weeks to moms whose babies will be born during RSV season, but only the one by Pfizer called ABRYSVO. That's the one that doesn't have the adjuvant.
And also, there's Nirsevimab, a long-acting monoclonal antibody given to baby. Nirsevimab is indicated for all babies under 8 months old entering their first RSV season. It's also recommended in their second RSV season for children aged 8 to 19 months that are at increased risk of severe RSV disease.
The maternal vaccine can be administered from September through January to pregnant people at 32 to 36 weeks of gestation. And a maternal vaccine safety update was presented to ACIP, and it was quite reassuring. It found maternal vaccination with ABRYSVO was not associated with an increased risk for preterm birth or small gestational age at birth. And Nirsevimab can be administered October through March for babies under 8 months old in their first RSV season. I'm a new grandmother, and my little granddaughter, baby Fern, was born in May, and so she's now 5 months old, and she got her dose of Nirsevimab just last week, and it just made my day.
Unger: Well, congratulations, Dr. Fryhofer. That's amazing. And baby Fern is very lucky because she has probably one of the grandmothers with the most expertise in this field ever. So congratulations to you and your family. What exciting news. That protection, too, is really so important during the first RSV season. Staying on maternal vaccination for one more moment, I know that Tdap is recommended in every pregnancy. Is the same true for maternal RSV vaccine?
Dr. Fryhofer: No. And that's been previously clarified by ACIP. At this time, people who receive the maternal RSV vaccine dose during a previous pregnancy are not recommended to receive additional doses during future pregnancies. However, infants born to people who were vaccinated during a prior pregnancy should receive Nirsevimab in their first RSV season.
Unger: All right. Thank you for that clarification. Dr. Fryhofer, you said there was also a new ACIP vote on meningococcal vaccination. First of all, it's pretty serious, as I understand. Can you talk about the severity of meningococcal disease?
Dr. Fryhofer: Meningococcal disease is rare, but it's deadly. And if you get it, you can get real sick real fast. The disease progresses very rapidly. And as many as 10% to 15% of people with meningococcal infection die, even with appropriate antibiotic therapy. And for those who do survive, about 20% of them suffer long-term sequelae, including cognitive deficits, hearing loss, and limb amputations.
Since the introduction of the MenACWY and MenB vaccines, the incidence of meningococcal disease in the United States has dropped to literally 1 in 1,000,000. However, there has been a recent spike in the Men type Y infection. For MenB, the risk for persons exposed during a MenB outbreak is increased up to 1,400 fold. And the risk of MenB disease is increased as much as 100 to 10,000 fold for people with complement component deficiency, complement inhibitor use, and for those with anatomic or functional asplenia.
Unger: So Dr. Fryhofer, tell us more about the new ACIP vote and what it means.
Dr. Fryhofer: The new ACIP vote only applies to MenB vaccination. There are two MenB vaccines, one by GSK, brand name BEXSERO and the other by Wyeth, which is a Pfizer subsidiary, with brand name TRUMENBA. The two MenB vaccine types are not interchangeable. The same type of MenB vaccine has to be used to complete the series.
To add to the confusion, the MenB vaccines initially had different dosing intervals, and now they don't. ACIP voted to harmonize and align the dosing schedule for the two different MenB vaccines to mirror a recent FDA labeling update. So the dosing recommendations for both MenB vaccines are now the same—two doses given at six months apart, if you're giving it to healthy adolescents and young adults, and a three-dose series at 0, 1 to 2, and at 6 months for those at high risk. The three-dose series can also be given to those who want to optimize rapid MenB protection, for example, if you have a child or a young person who's starting the series within six months of going off to college.
Now, understand, the current recommendation for MenB vaccination for healthy adolescents and young adults, preferably at age 16 through 18, is based on shared clinical decision making. It's not a routine recommendation. But vaccination with MenACWY is. Two doses of MenACWY are routinely recommended, the first dose at age 11 to 12 and the second dose at age 16. And the MenACWY vaccines are interchangeable.
To add to this confusion, there's also a new pentavalent vaccine called PENBRAYA that combines MenACWY with the BEXSERO version of MenB vaccine. But since the same product, the same MenB product has to be used for both doses, it can't be given to people who received the other MenB vaccine, TRUMENBA. Another pentavalent combo version by GSK that contains the other type of MenB vaccine, TRUMENBA, is up for regulatory decision in February 2025.
So as you can see, it's really, really confusing. And once this new pentavalent vaccine becomes FDA approved—and we hope it will—the workgroup will then take a fresh look at the meningococcal vaccination schedule. Hopefully, it would become simpler. So much more to come on that.
Unger: So much to talk about. Nine hours is probably not enough time. Dr. Fryhofer, any final thoughts?
Dr. Fryhofer: So we've talked a lot today about respiratory virus vaccines. We've talked about COVID. We've talked about pneumococcal. We've talked about RSV. But remember, everyone 6 months and older also needs flu vaccination. And again, I want to emphasize the power of physician recommendation. Adults and children who receive a health care provider recommendation are more likely to get vaccinated. So physician recommendation is so, so important.
Unger: Absolutely. And Dr. Fryhofer, thank you so much for being here today and sharing what we need to know about vaccines right now. That wraps up today's episode. To support more important public health information like this, please consider becoming 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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