More J&J Vaccines Made by Emergent Are Released by FDA

Another batch of the main ingredient for Johnson & Johnson’s coronavirus vaccine made at a troubled Emergent BioSolutions Inc. facility in Baltimore has been released by the Food and Drug Administration.

The FDA said in a letter Tuesday to J&J that it is waiving manufacturing standards since Emergent was in violation at the time the drug substance was produced. The agency also said the clearance doesn’t mean the Emergent plant has the green light to again make the vaccine ingredient.

The clearance will allow 10 million doses of the vaccine that have already been placed into vials to be released, according to a person familiar with the matter.

Spokesmen for J&J and Emergent said the companies are continuing to work with the FDA to get clearance for the facility to produce shots.

Shares of J&J fell 0.1% to $169.27 at 4 p.m. in New York, while Emergent shares declined 1.8% to $57.92.

Manufacturing problems at Emergent have been a major factor limiting the reach of J&J’s vaccine, which accounts for only a small portion of overall immunizations in the U.S. Competing shots made by Pfizer Inc.-BioNTech SE and Moderna Inc. make up the lion’s share of U.S. vaccinations, according to the Centers for Disease Control and Prevention.

FDA inspectors in April found sanitation problems at Emergent’s plant in the Bayview section of Baltimore after a mix-up involving two different vaccine substances caused the plant to be shut down.

The FDA said earlier it had authorized four batches of the vaccine substance. All together, enough vaccine substance for about 50 million doses has now been authorized. Other batches have been deemed unsuitable and discarded.

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