Emergent Suspends COVID-19 Vaccine API Manufacturing As US FDA Inspects Bayview Plant
After discovery of viral vector cross-contamination, AstraZeneca quit, J&J took control and the FDA launched inspection.
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Also, Moderna completed the submission of the BLA for mRNA-1273’s FDA approval, Pfizer starts a rolling submission for a booster shot and Brii Biosciences announced data for its two-antibody antiviral cocktail, and Japan withdraws selected lots of Moderna's vaccine over contamination worries.
Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.
US congressional ‘coronavirus crisis’ panel explores Emergent BioSolutions COVID-19 vaccine launch failures while scoring points about private sector support.