FDA Allowed Release Of Moderna COVID Booster While Still Mulling Plant Inspection Findings

 
• By Bowman Cox
  
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Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.

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fda: batch investigations were inadequate, but these batches look good • Source: Shutterstock

The US Food and Drug Administration has again demonstrated remarkable flexibility, speed and transparency in the regulatory setting of emergency use authorizations for COVID-19 vaccines with its 20 September decision to release 10 batches of Moderna, Inc.’s bivalent booster even as the agency continued to mull concerns raised during a monthlong inspection of the contract facility where they were manufactured.

The episode shows the regulatory agility surrounding the pandemic response is continuing even as broader societal concern diminishes two and...

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