FDA Greenlights Fourth Batch of J&J Vaccine From Troubled Emergent Plant

July 7, 2021

The FDA has authorized the use of a fourth additional batch of the Johnson & Johnson (J&J) COVID-19 vaccine manufactured at the troubled Emergent BioSolutions facility in Bayview, Md. The batch of bulk drug substance can make up to 15 million doses of the J&J vaccine.

An estimated 75 million doses of J&J’s vaccine produced at Emergent were ordered destroyed by the FDA following the discovery that many had been cross-contaminated with AstraZeneca vaccines, also made at the facility.

The agency has not yet fully cleared the facility to produce vaccines. J&J is now overseeing production at the Bayview facility and the FDA has instructed AZ to find another producer for its vaccine to avoid any possibility of future cross-contamination of products at the plant.

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