FDA panel votes to greenlight COVID vaccine update for omicron

A vaccine expert advisory panel for the Food and Drug Administration (FDA) voted on Tuesday to recommend updated COVID-19 vaccines specifically designed to fight the omicron variant.

Of the voting members of the FDA’s Vaccines and Related Biologicals Advisory Committee, 19 voted in favor of recommending an omicron-specific booster, while two voted against approval.

The FDA is not required to follow the committee’s recommendations, although the agency generally does.

Several members of the vaccine panel felt that the likely benefits of an omicron-specific vaccine – possibly a bivalent vaccine – outweighed the possible risks.

During the meeting, however, members raised several possible points of contention regarding the recommendation.

Some members argued that approaching the COVID-19 pandemic like it was the flu with seasonal reminders was the wrong way, pointing out that the SARS-CoV-2 virus has been shown to mutate. faster than the flu virus.

Other members noted at the meeting that an entirely different variant of the COVID-19 virus could emerge by the fall, as some health authorities anticipate a possible new surge in cases.

Stanley Perlman, a committee member and professor of immunology at the University of Iowa, questioned whether it would be globally appropriate for the United States to begin administering bivalent doses – believed to offer a stronger protection – as the world still lacks access to standard coronavirus vaccines.

Perlman noted that there was already a widespread feeling that the United States and other wealthy countries put themselves first and said that could be “ultimately a bad thing” for the United States of America. deliver improved vaccines that the rest of the world cannot access.

However, several other members argued that time was running out and it was better to have an updated booster dose available in time, than to wait. Moderna and Pfizer have shared data on candidates for possible booster doses effective against the omicron variant.

Earlier this month, Moderna announced it was submitting preliminary data on a bivalent COVID-19 booster containing omicron. According to the company, its booster candidate was found to increase neutralizing activity against the omicron variant by eight times above baseline levels.

Bivalent vaccines stimulate immune responses against two different antigens. In the case of COVID-19, a bivalent shot would theoretically target two different variants or sub-variants.

Pfizer announced last week that its omicron-matched candidates — a monovalent dose and a bivalent dose — caused multiple increases in neutralizing activity against omicron.

Pfizer said it shared its data with the FDA.

Updated at 5:52 p.m.

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