A Baltimore factory that rendered useless 75 million doses of a coronavirus vaccine developed by Johnson & Johnson failed for weeks to seal off a preparation area for vaccine ingredients and allowed production waste to be hauled through the area, the Food and Drug Administration said in a memorandum analyzing the plant’s operations.
The memo, posted on the agency’s website on Saturday, offered the most extensive explanation to date of why regulators believe that tens of millions of doses of Johnson & Johnson’s vaccine produced at that factory must be discarded.
The F.D.A. advised Johnson & Johnson on Friday that it should throw out the equivalent of 60 million doses. That brought to 75 million the total number of doses that cannot be used because of concerns about contamination at a southeastern Baltimore plant, operated by Emergent BioSolutions, Johnson & Johnson’s subcontractor and a longtime government contractor.
The vaccine-making factory has been shut for the past two months while regulators determine the cause of contamination that ruined many doses, whether it is safe to reopen the facility, and what to do with the equivalent of at least 170 million doses of vaccine that Emergent produced for Johnson & Johnson and AstraZeneca, another vaccine developer.
The F.D.A.’s memo stated that Emergent failed to properly segregate zones in which workers manufactured vaccines developed by Johnson & Johnson and AstraZeneca in order to prevent cross-contamination that could render doses unsafe or ineffective. It was written by Dr. Peter Marks, the F.D.A.’s top vaccine regulator, and was addressed to Johnson & Johnson.
When Emergent first began producing the Johnson & Johnson vaccine in November, the memo
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