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When Should COVID Vaccines Get Full Approval? US FDA Squeezed By ‘Too Fast’ And ‘Too Slow’ Camps

 
• By Derrick Gingery

Some experts argue full FDA approval will help boost vaccination rates that are waning, but others want the agency to mandate studies in special populations and gather other data before making a final decision.

Between a rock and a hard place
US FDA finds itself between a rock and hard place in the arguments for quick or slow approval of the mRNA COVID-19 vaccine BLAs. • Source: Alamy

US Food and Drug Administration officials once again find themselves in the middle of an application review speed versus thoroughness debate, this time over the final approval of the Pfizer Inc./BioNTech SE and Moderna, Inc. mRNA coronavirus vaccines.

The outcome of the reviews of both biologics license applications does not appear in doubt

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