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FDA advisers vote to simplify COVID vaccines, do away with original ‘monovalent’ shots

The Food and Drug Administration’s panel of outside vaccine advisers voted unanimously in favor on Thursday. “Harmony” The first shot given to unvaccinated Americans in the latest booster shots deployed last year to simplify the COVID-19 vaccine.

If the FDA and the Centers for Disease Control and Prevention adopt this change, it could effectively end the use of the original “monovalent” shots originally developed in the pandemic to target the original strain of the virus. I have.

Last year’s booster shot was “bivalent”, BA.4 and BA.5 variantsAt the time, authorities were cautious about switching “primary series” shots until more data on their effectiveness were collected.

Thursday’s vote means those who have not been vaccinated can immediately skip to the bivalent vaccine given as a booster dose over the winter.

“There are some unanswered questions and things to be solved, but I think this is absolutely the right thing for the program to do. It makes things easier. I think it’s a good thing,” said panel member Dr. Melinda Wharton of the CDC.

Voting took place in a day meeting We are working on the future of how and whether to update the COVID-19 vaccine for future seasons.

“This is the moment to implement a more routine approach to regularly updating strain composition, as well as whether we have reached a pandemic stage that will allow us to simplify the use of current COVID-19 vaccines. Dr. David Kaslow, director of the FDA’s Office of Vaccine Research and Review, told the panel.

under suggestion Most Americans will receive one dose per year if presented to the committee by an agency. Some Americans, including unvaccinated young children and at-risk older adults, are now eligible to receive two or more doses per year, as recommended. influenza vaccine.

The committee convenes each year by early June to determine changes to targeted variants, prior to the fall booster rollout through September. COVID-19 (new coronavirus infectious disease) vaccination.

“The goal is not to track variants. And that’s our goal, these meetings,” said FDA’s Jerry Weir.

Weir stressed that the proposal is a “starting point” and more data will likely be needed for a final decision. I need immediate guidance on how to submit

The pathway proposed by regulators largely mirrors the process used to update the COVID-19 vaccine last year, as the BA.4 and BA.5 waves began building in the summer.

The dominant variant in the US today is XBB.1.5 strainso far mainly in the Northeast, descendants of another Omicron lineage that grew proportionally.

data published on wednesday According to the CDC, the bivalent vaccine suggests that it also works to protect against XBB.1.5 infection, as it has previously done against the BA.5 variant originally designed to target. increase.

“What we’ve observed is that if a variant has any advantage, it’s generally hijacked and spread across the country, regardless of where it was first detected. I think there is reasonable suspicion that the same will happen with XBB.1.5,” CDC’s Heather Scobie told the panel.

Executives from Moderna and Pfizer-BioNTech told the committee they could manufacture new mRNA shots on the timeline set by the FDA.

But that may be too late for traditional vaccines like Novavax to revise in time for the fall. The strain for the annual flu vaccine is selected several months in advance in February to give companies enough time to vaccinate.

The timing may also be out of sync with the World Health Organization, which has yet to set a timeline for how the committee will attempt and issue its coordinated vaccine recommendations.

At a meeting, Moderna When Pfizer We called for a coordinated global effort to determine which vaccine strain to use. However, some of the meetings noted variability in where and when the subspecies surged around the world.

There was also some skepticism about the proposed annual frequency for considering potential boosts, rather than more-or-less frequent dosing.

Dr. Eric Rubin, a member of the committee, said: “I think it’s very reasonable to think one more thing for the fall. I think it’s a very good idea. And there’s a limit to how often you can change it. But for step one, I think it’s fine. It is difficult to say that it will become an annual event at this point. ”

Waves of the virus so far have peaked at levels typically twice a year, once in the summer and then worse in the winter.

FDA’s Dr. Peter Marks said: “Because when should you worry about hospital overwhelm at its worst? That’s when you have the flu, RSV, and potentially COVID all at the same time.”

https://www.cbsnews.com/news/covid-vaccine-fda-advisers-vote-to-simplify-retire-monovalent-shots/ FDA advisers vote to simplify COVID vaccines, do away with original ‘monovalent’ shots

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