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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Next-Gen Vaccine Makers Want Up-Front Discussions With US FDA To Expedite Development
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’s Expected 2020 COVID-19 Vaccine Production Fell By 50% After Scaleup Delays
Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.
For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.