Emergent BioSolutions says it has agreed with FDA not to manufacture new material at Baltimore facility
Drug contract company Emergent BioSolutions Inc. said Monday it has made an agreement with the U.S. Food and Drug Administration not to manufacture any new material at its Bayview facility in Baltimore. The FDA started an inspection of the plant last week, after Johnson & Johnson found Emergent workers had confused ingredients for its COVID-19 vaccine with ones used in making the vaccine developed by AstraZeneca PLC and Oxford University. J&J made the discovery in a batch that had not been distributed and immediately took over the making of its vaccine and imposed its own experts and technicians to oversee it. Emergent agreed it would shift manufacturing of the AstraZeneca vaccine elsewhere. Emergent has also agreed to quarantine existing material at the plant pending completion of the FDA inspection. Emergent shares were down 0.9% premarket, and have fallen 13% in the year to date, while the S&P 500 has gained 11.4%.
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