FDA authorizes third Johnson & Johnson COVID-19 vaccine batch from troubled Baltimore plant

The Food and Drug Administration on Tuesday announced that it had authorized an additional batch of Johnson & Johnson COVID-19 vaccine that had been produced from a troubled Baltimore facility. The news, posted in a press release on FDA’s website, comes days after the agency had authorized two batches from the Emergent BioSolutions plant but found “several other batches” not suitable for use. 

A New York Times report citing people familiar with the situation said the company was directed to toss about 60 million doses that had been produced at the facility. Tuesday’s update again noted that the regulatory agency is “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility.” The FDA said it “continues to work through issues there” with both Johnson & Johnson and Emergent BioSolutions. 

The company has been told previously to discard doses from the plant, which has been repeatedly cited for problems pertaining to poorly trained employees, cracked vials and mold issues, according to the Associated Press. 

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In the update posted last week by the FDA regarding the first two batches authorized, the agency noted that additional batches remain under review. 

Uptake of the Johnson & Johnson vaccine got off to a shaky start in the U.S. largely due to a temporary pause in the rollout while officials investigated a potential link to rare, severe blood clots. Appointments canceled during the 11-day pause were rescheduled using available Moderna and Pfizer-BioNTech supply, creating a backlog of sorts. As such, states said thousands of Johnson & Johnson doses were approaching expiration, prompting the FDA to adjust the dates. 

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Officials had been hopeful that the one-shot jab would play a crucial role in vaccinating hard-to-reach populations and others hesitant about scheduling issues or convenience. On Tuesday, the Biden administration delivered about 1.3 million doses of the vaccine to Mexico.