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FDA advisers recommend strain update to Covid-19 boosters ahead of expected fall surge

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The FDA’s goal is to make a recommendation for strain composition—preferably matched to the variant for which current vaccines are least effective—by early July so that companies can produce the doses in time for a booster campaign in October to be serious. may begin, said Peter Marks, director of the agency’s Center for Biological Evaluation and Research.

“If we want these to be available in the early fall, that’s going to have to happen very quickly,” Marks said. The agency usually makes a recommendation based on the vote of the expert panel, although not always.

Dissent and issues to watch for: Still, two panelists opposed the recommendation, with Paul Offit of the Children’s Hospital of Philadelphia disputing the lack of data on the need for updated vaccine prescriptions, while the scientific community has yet to determine their correlation of protection — the level at which a vaccine’s immune response. body against antibodies and memory cells provides adequate protection against the virus.

“I still don’t feel comfortable enough that we have the information we need to essentially support this new product,” he said.

Vaccine manufacturers said the production of booster formulations targeting BA.4 and BA.5 would push their delivery deadlines later than if they were tasked with producing BA.1 strain-specific prescriptions.

Moderna said it could have a vaccine targeting subvariants ready by the end of October, compared to August for bivalent compounds targeting the original Omicron strain. Pfizer said it would have an updated vaccine ready by the first week of October.

Committee members expressed concern about implementation confusion among healthcare providers if a separate booster formulation became available alongside the original vaccine prescriptions used since December 2020 for both primary series and booster vaccinations.

What’s next: The FDA needs to decide whether and how to recommend a stock compound for the Covid-19 vaccines so that manufacturers can start making updated shots.

It’s also unclear which populations will be eligible for booster shots in the coming months. The data from Pfizer and Moderna so far covers adults, particularly those over 50, and the Biden administration has said it is running out of money to ensure it can continue to provide all Americans with free Covid vaccines.

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