The Baltimore Emergent BioSolutions plant, where 15 million Johnson & Johnson COVID-19 vaccine doses have been ruined, has a history of quality management failures, some of which have gone unaddressed, The New York Times reported April 6.
The 15 million doses have been ruined after workers combined up components for Johnson & Johnson’s and AstraZeneca’s COVID-19 vaccines. AstraZeneca had additionally contracted with Emergent to make its vaccines there, however HHS has ordered Emergent to cease making the AstraZeneca vaccine at that plant to keep away from additional errors.
HHS directed Johnson & Johnson to supervise COVID-19 vaccine manufacturing and stated it will assist AstraZeneca search for an alternate web site. The error has delayed future shipments of Johnson & Johnson’s vaccine within the U.S. whereas the FDA investigates how the error occurred.
Documents reviewed by the Times revealed that an AstraZeneca audit of the positioning uncovered a high likelihood of cross contamination. Current and former federal officers in addition to former Emergent workers informed the newspaper little was carried out to handle these considerations, regardless of Emergent receiving a $163 million federal contract to organize the positioning for high-volume manufacturing.
Mold contamination, insufficient worker training, failure to correctly clear tools and failure to check uncooked supplies have been amongst different considerations revealed by different audits, in response to the Times.
Matt Hartwig, Emergent’s media relations director, informed 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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