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