FDA advisors recommend strain update before expected fall of Covid-19 boosters

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

“If we want it to be available in the early fall, it has to happen very soon,” Marks said. The agency usually makes a recommendation based on the votes of a panel of experts, but not always.

Dissenting opinion and issues to watch: However, two members of the panel opposed the recommendation, Paul Offit from the Children’s Hospital of Philadelphia worried about the lack of data on the need for updated vaccine prescriptions, when the scientific community has not yet determined their correlation of protection – the level in which the body’s immune response from antibodies and memory cells provides adequate protection against the virus.

“I’m still not comfortable enough that we have the information we need to substantively support this new product,” he said.

Vaccine manufacturers have said that production of booster formulations of BA.4 and BA.5 will push back their delivery timelines later than when they were tasked with producing BA.1 strain-specific formulations.

Moderna said it could have a subvariant-focused vaccine ready by late October, compared to August for bivalent compounds focused on the original Omicron strain. Pfizer has indicated that it will have an updated vaccine by the first week of October.

Committee members noted concerns about implementation misunderstandings among healthcare providers if a different booster formulation is available alongside the original vaccine prescriptions to be used for both the primary series and booster vaccinations starting in December 2020.

What is the following: The FDA must decide whether and how to recommend strain composition for Covid-19 vaccines so manufacturers can begin making updated shots.

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

FDA advisors recommend strain update before expected fall of Covid-19 boosters

Source link FDA advisors recommend strain update before expected fall of Covid-19 boosters

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