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The AMA update covers a diversity of physical care topics that affect the lives of physicians, residents, medical students, and patients. From the leader of personal and fitness systems to scientists and public fitness officials, hear from medical experts about Covid-19, medical education, advocacy issues, burnout, vaccinations, and more.
Do you need a second COVID bivalent booster? Get the latest on new COVID vaccine booster recommendations from the CDC and the recent changes to simplify COVID-19 vaccine guidelines from 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.
The AMA is your powerful ally, focused on addressing the issues important to you, so you can focus on what matters most—patients.
Unger: Hello and welcome to the video and podcast of Ama Update. Today, we are talking about the new recovery recommendations for the CDC COVvv vaccine. A spring withdrawal dose of the updated Bivalent Covid vaccine is now an option for some. But who understands and when?
Answering these questions is Dr. Sandra Fryhofer, WADA board chair and WADA’s liaison to ACIP, CDC’s Advisory Committee on Immunization Practices. Dr. Fryhofer is also a member of the ACIP’s COVID vaccine painting group. I’m Todd Unger, the AMA Lead Party Officer in Chicago. Welcome back, Dr. Fryhofer.
Dr. Fryhofer: Thanks for helping me, Todd.
Unger: So, Dr. Fryhofer, what do we need to know about these new booster recommendations from the CDC?
Dr. Fryhofer: Well, older adults and adults with immunocompromised situations now have the opportunity to get more covid coverage from an additional dose of the updated bivalent vaccine. The FDA has legal and the CDC now recommends an additional bivalent booster dose for those 65 and older and for those who are immunocompromised.
As for the schedule, other people over 65 can obtain it at least 4 months after their last dose. People who are immunocompromised would possibly get their load dose a little earlier, at least two months after their last dose. And for them, more additional doses may be administered founded on their clinical scenario and in periods they decided through their doctor. These flexibility load characteristics for this organization of other people in the high threat of serious headaches of COVID.
For young children with immunocompromising conditions, those age six months through four, eligibility for additional booster doses is more complicated and depends on the type and number of vaccines previously received. And although the overarching theme of these new recommendations is flexibility and simplification, dosing for young children remains a little complicated.
However, CDC is in the process of putting together some detailed and specific step-by-step flowcharts to help clinicians determine what dose and what formulation children need and when.
Unger: Dr. Fryhofer, you mentioned the word simplicity. How have the new recommendations been simplified?
Dr. Fryhofer: Well, this is really good news. For those age six years old and older, COVID vaccination recommendations have been greatly simplified. The same mRNA vaccine formulation will be used for all vaccine doses for everyone.
Original monovalent vaccines are no longer recommended. And at least for now, the formulation of bivalent vaccine, which is partly original and partly OMICRON BA. 4/BA. 5, will be used for all vaccine doses for all.
Unger: Well, Dr. Fryhofer, tell us more about the timeline of this recommendation and why the FDA and the CDC are offering an additional booster to those selected groups right now.
Dr. Fryhofer: Well, it all happened last week. On Tuesday, April 18, the FDA approved an updated booster time for other people over 65 years of age and for those who are immunocompromised the bivalent vaccine for all vaccine doses. Then, on Wednesday, April 19, the ACIP, which is the CDC’s Advisory Committee on Immunization, met and discussed the FDA’s modified authorizations and also reviewed updates on protection and vaccine effectiveness.
There is no formal ACIP vote. CDC Director Dr. Rochelle Walensky made the decision. And she sealed the deal with her signature later in the night.
Additional bivalent boosters are now an option for those express groups. Monovalent vaccines are no longer recommended. Bivalent Boosters will be available for the first time in September 2022, around Labor Day. And we know that the effectiveness of mRNA vaccines decreases over time.
An additional dose of vaccine restores immunity. Some other people are now at least six months into their last dose of the bivalent vaccine, but many others have not even received a dose of the bivalent covid vaccine.
Unger: And those people? Is this vaccine recommended for those who are not yet vaccinated?
Dr. Fryhofer: Yes. And that is a wonderful question. Once again, by simplicity, the new advice establishes that other unaccoured people of six years or more want a single dose of the updated vaccine, which is a bivalent vaccine, that multiple doses. ORIGINAL MONOVALENT HRNM VACCINES DOSE.
Nutrition for young children is that simple. Children between six and 4 years old need two to three doses of bivalent RNA. Five -year -old children need one or two bivalent doses. For smaller children, the dose number depends on the product.
So the regimen for children is still complicated. And this was brought up in the discussion by several ACIP members. CDC is putting together detailed flow sheets to help clear up any confusion, however.
Unger: So what led them to those changes?
Dr. Fryhofer: Well, Covid has gone from being a pandemic to being endemic. Vaccinated people obtain benefits from vaccine induced immunity. People who have had Covid extend the immunity induced by infection. People who have been vaccinated and who have contracted COVID have hybrid immunity.
There is still a small subset of people who have not been vaccinated or infected. But this organization is getting smaller and smaller. The fact is that almost everyone in the United States, ages five and older, already has limited antibodies, either from vaccination, past infection, or both.
And FDA said that for those with prior infection, their immune response after one dose of vaccine was comparable to the immune response after two vaccine doses. However, younger children, those age six months through five years old who have not been previously vaccinated, do need more than one vaccine dose. They need a prime-boost, which means two or three mRNA vaccine doses depending on the vaccine product use, including at least one bivalent vaccine dose.
Unger: Then, Dr. Fryhofer, discussed hybrid immunity and the fact that he already had a Covid infection. Is this the period of time advised to obtain a spice if it recently had a Covid infection?
Dr. Fryhofer: Well, a lot of other people who have Covid don’t even know they’ve had it. That’s a wonderful question, Todd.
UNER: So this new recommendation only applies to other people 65 and older and other immunocompromised people. What about other people under 65? When are other younger people making plans to develop the vaccine?
Dr. Fryhofer: FDA says it intends to address additional boosters for those younger than 65 when their advisory committee VRBPAC meets in June. And at that time, FDA will also address any needed changes and the strains included in the vaccine. Changing the strains for a vaccine that’s already been studied isn’t new. We do this for flu vaccine every year.
The WHO technical advisory body on the composition of COVVI-19 vaccines, which is also called Tag-Co-Vac, meets in May to talk about the composition of the codified vaccination antigen. And I am sure that the FDA will take into account these recommendations when it meets in June. And this gives time to vaccine brands to make changes to recipes. Therefore, in autumn, if necessary, updated vaccines may be available.
UNGER: And one of those recipe changes, so to speak, the transition from monovalent to bivalent. Just for those who want a little refreshment on this topic, can you review the difference between those two?
Dr. Fryhofer: Sure. Bivalent means it’s half original strain and half Omicron BA.4/BA.5. Now remember, mRNA COVID vaccines trigger antibodies to spike protein. And although BA.4 and BA.5 are different subvariants and have different mutations, their spike protein just happens to be the same. So that’s why this new bivalent vaccine targets both.
It is possible that Omicron BA. 1 bivalent studies have found that adding a second covid virus to the original vaccine expands the antibody reaction and also affects superior antibody titers for omicron variants and superior antibody titers compared to other covid variants. And the resulting antibody titers were as high as or higher than those of vaccines that contained only the original vaccine strain.
Unger: Dr. Fryhofer, are we out front on this in the U.S.? Are other countries already doing this?
Dr. Fryhofer: No, we are not the first ones to do this. Both Canada and the United Kingdom are already offering second-bivalent booster doses to older patients. But their definition of who’s considered older is older.
The CDC Council begins at age 65. In the United Kingdom, the additional council of Spice Up begins at age 75. In Canada, other older people begin at 80.
The Council of Canada, like ours, is permissive and flexible. Canada states that these older patients can be contacted. The United Kingdom Council is more definitive. The British CDC equivalent says that other people over 75 and more obtain advantages of an additional vaccine.
UNGER: Going back to the trajectory of many vaccines we’ve discussed, how does this new advice make the Janssen single-dose vaccine and the protein-based Novavax vaccine?
Dr. Fryhofer: This new recommendation only applies to mRNA vaccines. And there are no changes, at least for now, in the authorization of Janssen’s viral vector vaccine or Novavax’s protein-based anti-Covid vaccine. And note that available Janssen doses expire until the end of May 2023.
Unger: Well, taking a step back, how can I get Covid that causes severe illness? And how do we vaccinate other people?
Dr. Fryhofer: In the United States, Covid still kills about 1,300 people every week. There are still more than 100,000 new cases and more than 1,600 hospitalizations per Covid every week. Older adults have higher hospitalization rates than younger adults.
Unger: So there are still high numbers. Any updates on the variants circulating lately?
Dr. Fryhofer: Well, the Omicron subvariants are dominant. XBB. 1. 5 represents more than 78% of circulating strains. Omicron Ba. 4 and Ba. 5 are ancient history at this point. XBB. 1. 16 is now in full swing. And this represents 7. 2% of new infections nationwide. But what variant is there in the following menu?
Unger: That’s the question, I guess. In that sense, any definitive ideas to share?There are many new developments this week.
Dr. Fryhofer: Covvid is still a very genuine threat to many other people, so FDA and CDC inspire everyone to keep up with their vaccines. Adults and young elders are considered six and more as updated if they have won a single dose of the bivalent vaccine opposed to COVVID. But, in general, only 16. 7 % of the American population earned an updated dose of retirement. And only about 43 % of other people over 65 years and more won the bivalent retirement.
The Covvid vaccine shield opposes serious diseases. Covid vaccines can hospitalize and save your life. And I hope that this transition to a single formulation, an easier schedule, a single dose for the maximum component, and a more flexible dose for others at higher risk inspires more others to get vaccinated and stay protected.
Unger: I hope so too. Thank you so much, Dr. Fryhofer, for being with us today and providing these important updates on the booster. That’s it for today’s update. We’ll be back soon with another episode. 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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