US FDA Expects COVID-19 Vaccines To Meet ‘EUA Plus’ Standards, Marks Says
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
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COVID vaccines saved the world and then became a liability. US FDA vaccine advisors cited COVID experience as they urge agency to slow down on approval of new RSV vaccines, due to worries of declining public vaccine confidence and coadministration complications.
Early conversations on clinical trial endpoints were particularly helpful in developing Comirnaty, a Pfizer executive said. Whether sponsors can continue to get such discussions may go a long way in determining whether a new generation of products is developed.
Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.