FDA Set to Release Analyses of the Pfizer-BioNTech Covid-19 Vaccine

The Food and Drug Administration is set to release detailed analyses of the first Covid-19 vaccine being considered for U.S. distribution, providing the foundation for Thursday’s pivotal meeting of a panel that will advise on its possible approval for emergency use.

The agency is expected Tuesday to release two separate analyses, one from its own staff scientists and one from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE .

Both are likely to number in the hundreds of pages, and will document findings that show the vaccine’s effectiveness. Pfizer reports its vaccine is 95% effective at protecting against symptomatic Covid-19, and the U.K. approved its use last week.

Among other issues, the data are expected to show how the vaccine works with different age, ethnic and other demographic groups. The FDA has advised vaccine companies that these subgroup analyses will help overcome any hesitancy among Americans to be vaccinated.

A positive recommendation from the advisory panel is likely to lead to the FDA’s formally granting an emergency-use authorization of the vaccine in a matter of days.

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Written by Chekmagazine


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