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CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says

 
• By Derrick Gingery

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

Pordee_Aomboon/Shutterstock.com
EUAs for the two pending COVID-19 vaccines could be granted within days of each other, based on CBER Director Peter Marks' prediction. • Source: Shutterstock

Assuming favorable advisory committee results, the US Food and Drug Administration could issue emergency use authorizations for the Pfizer Inc./BioNTech SE and Moderna, Inc. coronavirus vaccines before Christmas.

Center for Biologics Evaluation and Research Director Peter Marks said 3 December that the agency would need only a few...

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Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.