BioCentury
ARTICLE | Product Development

COVID roundup: FDA inspecting Emergent facility as manufacturing halted; plus J&J, WHO, Sputnik V and NIH

April 20, 2021 1:27 AM UTC

FDA will weigh in on when Emergent BioSolutions Inc. (NYSE:EBS) can resume manufacturing of COVID-19 vaccines, including one from Johnson & Johnson (NYSE:JNJ), at the company’s Bayview facility in Baltimore, after it concludes an inspection it began on April 12. The company disclosed the halt, which follows errors that led to contamination of millions of J&J vaccine doses last month, in an SEC filing Monday; it did not say when it expects FDA to conclude the investigation. 

Meanwhile, circle Friday on the calendar as the likely day by which FDA’s non-binding decision to recommend pausing use of the J&J vaccine could lift. Presidential adviser and NIAID Director Anthony Fauci made the call Sunday on ABC’s This Week as questions continue to swirl around whether rare blood clotting events seen with the vaccine are related to the product’s modality. ...