The regulators for the Food and Drug Administration said that the company manufacturing the vaccine, Emergent BioSolutions, may have contaminated additional doses at the plant. They said the company failed to fully investigate the contamination, while also finding fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.
“There is no assurance that other batches have not been subject to cross-contamination,” the F.D.A.’s 12-page report states...
“I’m shocked — I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel advising the Centers for Disease Control and Prevention that later this week will recommend how to handle the Johnson & Johnson vaccine. “Inappropriate disinfection, the prevention of contamination — those are significant and serious violations.”...
The F.D.A. has not yet certified the plant, located in Baltimore’s Bayview neighborhood, and no doses made there have gone to the public. All the Johnson & Johnson shots that have been administered in the United States have come from overseas.
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