Emergent plant where 15M J&J vaccine doses ruined has history of failed quality audits

The Baltimore Emergent BioSolutions plant, where 15 million Johnson & Johnson COVID-19 vaccine doses were ruined, has a history of quality control failures, some of which have gone unaddressed, The New York Times reported April 6.

The 15 million doses were ruined after employees mixed up ingredients for Johnson & Johnson's and AstraZeneca's COVID-19 vaccines. AstraZeneca had also contracted with Emergent to make its vaccines there, but HHS has ordered Emergent to stop making the AstraZeneca vaccine at that plant to avoid further mistakes. 

HHS directed Johnson & Johnson to oversee COVID-19 vaccine manufacturing and said it would help AstraZeneca look for an alternate site. The error has delayed future shipments of Johnson & Johnson's vaccine in the U.S. while the FDA investigates how the error occurred. 

Documents reviewed by the Times revealed that an AstraZeneca audit of the site uncovered a high probability of cross contamination. Current and former federal officials as well as former Emergent employees told the newspaper little was done to address these concerns, despite Emergent receiving a $163 million federal contract to prepare the site for high-volume manufacturing.

Mold contamination, inadequate employee training, failure to properly clean equipment and failure to test raw materials were among other concerns revealed by other audits, according to the Times.

Matt Hartwig, Emergent's media relations director, told the Times, "Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false."

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