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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Public confidence in the Johnson & Johnson vaccine may be shaken. But faith in the regulatory system is solid, according to a recent poll, an Administration official maintained.
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
Similarities to AstraZeneca blood clots are clear, but more research needed before any ‘class effect’ conclusions can be drawn.