A U.S. Food and Drug Administration committee on Thursday recommended the updated Omicron formula be used for initial doses of the COVID vaccinethis amid discussion of a controversial dosing regimen that could shift to just one booster shot a year, for many Americans.
The committee voted unanimously to replace the original monovalent formula, protective against the initial Wuhan strain, with the bivalent formula, protective against both the Wuhan strain and Omicron BA.4 and BA.5, for those receiving their initial shots.
When bivalent boosters became available in the U.S. around Labor Day, Americans became ineligible to receive monovalent boosters. But the monovalent formula has continued to be used in so-called primary series shotstwo in the case of Moderna, and up to three in the case of Pfizer.
Simple is better, and frankly I think we saw today that closer is better, committee member Dr. Michael Nelson, chief of the Asthma, Allergy, and Immunology Division at the University of Virginia School of Medicine, said after the vote. It relieved my fears that wed be in this game of trying to chase the latest [variant]. Today we saw reassuring data today shows just getting [the vaccine] closer [to currently circulating variants] gives additional benefit.
The advisory committees recommendation must be approved by the U.S. Centers for Disease Control and Prevention before implementation.
The aim of Thursdays meeting was to determine if weve reached a point in the pandemic where we can simplify and take a more routine approach, said Dr. David Kaslow, director of the Office of Vaccines Research and Review at the FDA.
Such simplification starts with the use of the same formula for both initial and booster vaccines. But the committee could eventually recommend further steps, like the administration of one booster shot a year for most Americans, updated annually for distribution in the fall. Two annual doses may be recommended for those who are at higher risk of severe disease and death, like the elderly and immunocompromised.
The committee could meet at any time to discuss an additional booster for a highly pathogenic escape variant, should one occur, Kaslow added.
The federal agencys proposal is a controversial onenot for lack of a desire for a routine, predictable COVID vaccine scheduleakin to that for the flubut due to concerns that the shift may be premature.
Unlike the flu, global distribution of [COVID] variants is more variable, Jerry Weirdirector of the Division of Viral Products at the Office of Vaccines Research and Review at the FDAsaid at the meeting, referencing the continual, highly unpredictable rise and fall of various variants in different areas of the globe.
Going forward, its still very challenging. [COVID] variants dont sweep across the world like they seem to with influenza, he added. Strains of flu dominant in the Southern Hemispheres winter usually become dominant during the Northern Hemispheres winter. Not so with COVID variants, some of which cause massive waves in some countries but barely make a splash in others.
While 81% of Americans have received at least one dose of COVID vaccine, only 15% have received an updated Omicron booster. Its a statistic that worries public health officials, as antibody immunity from vaccination and infection is thought to wane after about three months.
A whopping 95% of Americans 50 and older are thought to be vaccinated, Dr. Heather Scobie, a CDC epidemiologist, told attendees. In contrast, the vast majority of U.S. children 4 and younger90%are unvaccinated.
This is a developing story and will be updated.
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