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Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use

 
• By Bowman Cox

Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.

Janssen COVID vaccine
fda bares thinking on vaccine drug substance cross-contamination issue

An internal memorandum the US Food and Drug Administration publicly shared on the day it was written shows how the agency made a potentially controversial decision on COVID-19 vaccine quality and raises the bar on transparency around agency decision-making.

The unredacted memo shows that the agency’s Center for Biologics Evaluation and Research studied the sequence of events surrounding a COVID-19 vaccine drug substance batch failure at the troubled Emergent BioSolutions, Inc. Bayview plant in Baltimore to decide whether to allow release of other batches in the US

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More from Compliance

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