AMA Replace covers a variety of well being care subjects affecting the lives of physicians, residents, medical college students and sufferers. From personal apply and well being system leaders to scientists and public well being officers, hear from the specialists in drugs on COVID-19, medical training, advocacy points, burnout, vaccines and extra.
Featured matter and audio system
Featured matter and audio system
What are the brand new COVID vaccine tips? Is the RSV vaccine protected? When must you get the pneumococcal vaccine? Is there a vaccine for meningococcal illness?
Our visitor 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 Expertise Officer Todd Unger hosts.
- The AMA is your highly effective ally, targeted on addressing the problems necessary to you, so you possibly can deal with what issues most—sufferers. We’ll meet this problem collectively. Be part of us.
- Study extra about our AMA advocacy priorities, together with:
- Reforming Medicare fee
- Preventing scope creep
- Fixing prior authorization
- Decreasing doctor burnout
- Making know-how work for physicians
Speaker
- Sandra Fryhofer, MD, AMA’s liaison, Advisory Committee on Immunization Practices (ACIP); board member, AMA Board of Trustees
Unger: Good day and welcome to the AMA Replace video and podcast. CDC’s Advisory Committee on Immunization Practices, or ACIP, just lately met and voted in favor of recent suggestions for a number of vaccines. Right here with us right this moment to share all these particulars is the AMA’s liaison to ACIP, Dr. Sandra Fryhofer in Atlanta. I am Todd Unger, AMA’s chief expertise officer in Chicago. Dr. Fryhofer, thanks a lot for becoming a member of us right this moment.
Dr. Fryhofer: Effectively, thanks for having me, Todd.
Unger: Effectively, in its most up-to-date assembly, ACIP talked about vaccines for greater than 9 hours throughout two days. Have to be so much to speak about. Inform us about which vaccines had been mentioned.
Dr. Fryhofer: Effectively, there are new suggestions for COVID and pneumococcal vaccines. We additionally heard updates on the security of RSV vaccines and their potential use in youthful grownup sufferers. Dosing suggestions for MenB vaccines had been harmonized. So so much to speak about. The place do you need to begin?
Unger: Effectively, why do not we begin with the pneumococcal vaccines. What’s new there?
Dr. Fryhofer: Effectively, that is very thrilling and must be life saving. ACIP lowered the age for routine pneumococcal vaccination from 65 right down to 50, and it applies to PCV, the pneumococcal conjugate vaccine. Nevertheless, there’s nonetheless a risk-based advice for youthful adults age 19 by 49 with sure medical circumstances like diabetes, in addition to continual coronary heart, liver, lung, kidney illness, and likewise for these with immunocompromising circumstances.
Unger: What is the background on decreasing the age to 50?
Dr. Fryhofer: Effectively, the workgroup took a deeper dive into the info, and it turned out that greater than half of these 50 to 64 already had a threat indication for pneumococcal vaccination. Additionally they thought of well being fairness. Charges of invasive pneumococcal illness peak at youthful ages and Black sufferers as in comparison with white sufferers. In reality, the speed of IPD—and that is invasive pneumococcal illness—for Black adults age 50 and older exceeds the typical charge of IPD for all adults age 65 and older. So decreasing the age to 50 for routine pneumococcal vaccination has the potential to scale back illness within the demographic teams with the best burden of illness.
Unger: That is actually fascinating. Why is this alteration from a risk-based advice to an age-based advice so necessary?
Dr. Fryhofer: Effectively, risk-based suggestions are tougher to implement than the age-based suggestions, notably since many of those vaccines at the moment are administered in pharmacies. And let’s face it, pharmacists do not know the sufferers like their physicians do. And so it is tougher for them to know who to present the vaccine to if the advice’s primarily based on threat. However as I mentioned earlier than, there’s nonetheless a risk-based advice for high-risk adults underneath age 50.
Unger: Now, you mentioned this solely applies to PCV?
Dr. Fryhofer: Sure. And that is as a result of PCV, pneumococcal conjugate vaccines, set off reminiscence B cell manufacturing and subsequently induce better long-term immunity. And these embody PCV15, PCV20 and PCV21. And I do know we have talked in regards to the distinction between PCV20 and PCV21 up to now. PCV21 is not only PCV20 plus 1. It is 21 strains are completely different. And it additionally consists of non-unique serotypes not in PCV20.
PCV20 covers as much as 58% of invasive illness in adults. PCV21 offers even better safety and covers as much as 84% of invasive illness. However PCV21 does have an necessary omission. It doesn’t cowl serotype 4, which is a serious explanation for invasive illness in sure populations, together with adults experiencing homelessness and adults in Alaska, particularly Alaska natives.
The analysis focus is now on even increased valent PCV vaccines. There are already two 24-valent vaccines and one 31-valent pneumococcal vaccine within the superior phases of improvement. So once more, the brand new routine advice is for pneumococcal vaccination with PCV beginning at age 50.
Unger: All proper. Effectively, thanks for that replace there. Let’s transfer on to COVID at this level. What’s new with the COVID vaccine?
Dr. Fryhofer: Everybody 6 months and older is advisable to obtain a dose of the up to date COVID vaccine. In order that hasn’t modified. However an extra COVID vaccine dose is now advisable for everybody 65 and older and likewise for folks age 6 months and older with immunocompromising circumstances. This second dose is advisable at 6 months, however it may be given as early as 2 months after the final dose. And in case you’ve just lately had COVID, you possibly can wait 3 months earlier than getting an extra vaccine dose.
And that is actually useful as a result of this flexibility permits sufferers to time vaccination round journey, life occasions like weddings, household get-togethers, chemotherapy, et cetera. And sufferers with immunocompromising circumstances also can obtain much more extra doses if advisable by their doctor, and this may be underneath shared scientific choice making, which implies you and your affected person have to debate and resolve.
Unger: Now, Dr. Fryhofer, what’s the rationale behind this choice?
Dr. Fryhofer: Effectively, we all know that safety from vaccination wanes with time, and new research vaccine effectiveness present safety in opposition to COVID-associated pressing care and emergency division visits and hospitalizations waned to 0 by 4 to six months. However safety in opposition to vital sickness did stay above 40% at 5 months for these 65 and older. We additionally know that extra COVID vaccine doses present extra safety.
Unger: Now, fascinating that we’re speaking about, after all, second for sure people with immunocompromised conditions as a result of the uptake of final 12 months’s up to date vaccine was actually disappointing. In reality, solely 22 and a half % of adults and solely 14% of youngsters obtained it. Are we higher numbers this 12 months?
Dr. Fryhofer: Sure. Effectively, in comparison with final 12 months, we’re on a roll. Uptake to date is increased, particularly for older adults age 75 and older. 30.6% of them have already obtained a dose of the up to date vaccine, as in comparison with 17.7% right now final 12 months.
Unger: That’s excellent news. All proper, let’s transfer on to the third matter, and that is RSV. Have been there any new suggestions? I heard that the FDA lowered the age for a type of vaccines right down to 18 for these at excessive threat. Is that proper?
Dr. Fryhofer: You are proper about that. And to evaluation, we now have three RSV vaccines which can be FDA accepted for adults, two protein subunit RSV vaccines, one by Pfizer known as ABRYSVO that doesn’t include an adjuvant, and one by GSK known as AREXVY that does. And the third RSV vaccine is by Moderna. It is known as mRESVIA, and it makes use of an mRNA vaccine platform.
All three of those RSV vaccines are licensed for these 60 and older. The age indication for GSK’s RSV vaccine, AREXVY, had already been lowered by FDA to age 50. And FDA just lately lowered the age approval for ABRYSVO right down to 18, just for these at increased threat.
Unger: Dr. Fryhofer, simply to make clear, what are the present RSV suggestions for adults?
Dr. Fryhofer: So that is what ACIP says. Everybody age 75 and older wants a dose of RSV vaccine. There’s additionally a risk-based advice for adults 60 to 75 with threat elements for extreme RSV, and these threat elements embody lung illness, coronary heart illness, immunocompromising circumstances, diabetes, weight problems, neurological circumstances, neuromuscular circumstances, continual kidney illness, liver problems, hematologic problems, additionally frailty, in addition to residing in a nursing house or different long-term care facility, they’re thought of threat elements for extreme RSV illness too, and people 60 to 75 that do not have these threat elements will not be advisable to obtain it.
Additionally, there have been a number of questions in regards to the sturdiness of safety for RSV vaccines, and there was some excellent news offered at ACIP. Research now recommend the RSV protein subunit vaccines confer 36 months of safety moderately than simply 24. And no less than for now, just one RSV vaccine dose is advisable. So in case you occur to obtain a dose final 12 months, you do not want one other one.
Unger: Dr. Fryhofer, was decreasing the age of age indication for RSV vaccination for adults mentioned?
Dr. Fryhofer: The work we did tackle the age decreasing of their deliberation. However the primary hesitation goes again to vaccine security considerations. Chances are you’ll recall—and we talked about this earlier than—FDA’s required post-marketing surveillance for GBS and atrial fibrillation from each of the RSV protein-based producers, and people vaccine surveillance security research are nonetheless ongoing.
FDA gave an replace about GBS threat at this assembly, and their findings nonetheless recommend an elevated GBS threat with each protein-based RSV vaccines amongst these 65 and older. Nevertheless, the danger appears to be uncommon, lower than 10 instances per 1 million vaccinations. The RSV workgroup will proceed to guage suggestions for the usage of RSV vaccines in adults underneath age 60, however right now, the workgroup affirmed the present advice only for older adults is acceptable.
Unger: All proper. Is there something new in regards to the maternal RSV vaccination and defending infants from RSV? We’re actually in RSV season proper now, proper?
Dr. Fryhofer: We’re getting into RSV season. RSV season begins in October and goes by March. So we’re there now. And as a reminder, we now have two new methods to guard little infants, the maternal RSV vaccine, given at 32 to 36 weeks to mothers whose infants can be born throughout RSV season, however solely the one by Pfizer known as ABRYSVO. That is the one that does not have the adjuvant.
And in addition, there’s Nirsevimab, a long-acting monoclonal antibody given to child. Nirsevimab is indicated for all infants underneath 8 months outdated getting into their first RSV season. It is also advisable of their second RSV season for kids aged 8 to 19 months which can be at elevated threat of extreme RSV illness.
The maternal vaccine will be administered from September by January to pregnant folks at 32 to 36 weeks of gestation. And a maternal vaccine security replace was offered to ACIP, and it was fairly reassuring. It discovered maternal vaccination with ABRYSVO was not related to an elevated threat for preterm start or small gestational age at start. And Nirsevimab will be administered October by March for infants underneath 8 months outdated of their first RSV season. I am a brand new grandmother, and my little granddaughter, child Fern, was born in Might, and so she’s now 5 months outdated, and she or he obtained her dose of Nirsevimab simply final week, and it simply made my day.
Unger: Effectively, congratulations, Dr. Fryhofer. That is wonderful. And child Fern could be very fortunate as a result of she has most likely one of many grandmothers with probably the most experience on this subject ever. So congratulations to you and your loved ones. What thrilling information. That safety, too, is absolutely so necessary in the course of the first RSV season. Staying on maternal vaccination for yet one more second, I do know that Tdap is advisable in each being pregnant. Is similar true for maternal RSV vaccine?
Dr. Fryhofer: No. And that is been beforehand clarified by ACIP. Presently, individuals who obtain the maternal RSV vaccine dose throughout a earlier being pregnant will not be advisable to obtain extra doses throughout future pregnancies. Nevertheless, infants born to individuals who had been vaccinated throughout a previous being pregnant ought to obtain Nirsevimab of their first RSV season.
Unger: All proper. Thanks for that clarification. Dr. Fryhofer, you mentioned there was additionally a brand new ACIP vote on meningococcal vaccination. To begin with, it is fairly critical, as I perceive. Are you able to discuss in regards to the severity of meningococcal illness?
Dr. Fryhofer: Meningococcal illness is uncommon, but it surely’s lethal. And in case you get it, you will get actual sick actual quick. The illness progresses very quickly. And as many as 10% to fifteen% of individuals with meningococcal an infection die, even with applicable antibiotic remedy. And for individuals who do survive, about 20% of them endure long-term sequelae, together with cognitive deficits, listening to loss, and limb amputations.
For the reason that introduction of the MenACWY and MenB vaccines, the incidence of meningococcal illness in the US has dropped to actually 1 in 1,000,000. Nevertheless, there was a current spike within the Males sort Y an infection. For MenB, the danger for individuals uncovered throughout a MenB outbreak is elevated as much as 1,400 fold. And the danger of MenB illness is elevated as a lot as 100 to 10,000 fold for folks with complement part deficiency, complement inhibitor use, and for these with anatomic or practical asplenia.
Unger: So Dr. Fryhofer, inform us extra in regards to the new ACIP vote and what it means.
Dr. Fryhofer: The brand new ACIP vote solely applies to MenB vaccination. There are two MenB vaccines, one by GSK, model title BEXSERO and the opposite by Wyeth, which is a Pfizer subsidiary, with model title TRUMENBA. The 2 MenB vaccine varieties will not be interchangeable. The identical sort of MenB vaccine must be used to finish the collection.
So as to add to the confusion, the MenB vaccines initially had completely different dosing intervals, and now they do not. ACIP voted to harmonize and align the dosing schedule for the 2 completely different MenB vaccines to reflect a current FDA labeling replace. So the dosing suggestions for each MenB vaccines at the moment are the identical—two doses given at six months aside, in case you’re giving it to wholesome adolescents and younger adults, and a three-dose collection at 0, 1 to 2, and at 6 months for these at excessive threat. The three-dose collection may also be given to those that need to optimize speedy MenB safety, for instance, in case you have a toddler or an adolescent who’s beginning the collection inside six months of going off to varsity.
Now, perceive, the present advice for MenB vaccination for wholesome adolescents and younger adults, ideally at age 16 by 18, relies on shared scientific choice making. It isn’t a routine advice. However vaccination with MenACWY is. Two doses of MenACWY are routinely advisable, the primary dose at age 11 to 12 and the second dose at age 16. And the MenACWY vaccines are interchangeable.
So as to add to this confusion, there’s additionally a brand new pentavalent vaccine known as PENBRAYA that mixes MenACWY with the BEXSERO model of MenB vaccine. However because the identical product, the identical MenB product must be used for each doses, it could’t be given to individuals who obtained the opposite MenB vaccine, TRUMENBA. One other pentavalent combo model by GSK that comprises the opposite sort of MenB vaccine, TRUMENBA, is up for regulatory choice in February 2025.
In order you possibly can see, it is actually, actually complicated. And as soon as this new pentavalent vaccine turns into FDA accepted—and we hope it’ll—the workgroup will then take a contemporary take a look at the meningococcal vaccination schedule. Hopefully, it could change into less complicated. A lot extra to come back on that.
Unger: A lot to speak about. 9 hours might be not sufficient time. Dr. Fryhofer, any last ideas?
Dr. Fryhofer: So we have talked so much right this moment about respiratory virus vaccines. We have talked about COVID. We have talked about pneumococcal. We have talked about RSV. However keep in mind, everybody 6 months and older additionally wants flu vaccination. And once more, I need to emphasize the ability of doctor advice. Adults and kids who obtain a well being care supplier advice usually tend to get vaccinated. So doctor advice is so, so necessary.
Unger: Completely. And Dr. Fryhofer, thanks a lot for being right here right this moment and sharing what we have to find out about vaccines proper now. That wraps up right this moment’s episode. To assist extra necessary public well being info like this, please think about changing into an AMA member at ama-assn.org/be a part of. We’ll be again quickly with one other AMA Replace. Within the meantime, you will discover all our movies and podcasts at ama-assn.org/podcasts. Thanks for becoming a member of us right this moment. Please take care.
Disclaimer: The viewpoints expressed on this video are these of the individuals and/or don’t essentially mirror the views and insurance policies of the AMA.
