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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Global Supply Chain Scrutiny And Investment In Domestic Alternatives For US Drug Shortages
Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?
Coronavirus Update: J&J Highlights Positive Booster Shot Data
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.
Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use
Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.