FDA Approves Latest Johnson & Johnson Vaccine Batch From Troubled Factory - Forbes

Topline

A fourth batch of Johnson & Johnson’s Covid-19 vaccine made in a plant shut down by the FDA can now be used, the agency said Friday after checking the batch for safety, but the plant is still not allowed to make new vaccines.

Key Facts

The batch of the vaccine’s active ingredient could make “up to 15 million doses,” an unnamed source told Bloomberg.

The FDA ran a quality test and checked records to make sure the batch was safe, the agency said in a statement.

The Emergent BioSolutions plant in Baltimore, Maryland is still not cleared to begin making new doses of the vaccine, the FDA said.

Johnson & Johnson and the FDA did not respond to Forbes’ request for comment.

Key Background

Emergent ruined 15 million doses’ worth of vaccine in March by cross-contaminating ingredients for the Johnson & Johnson vaccine with those of the AstraZeneca vaccine. The FDA called for the plant to be shut down, and Emergent complied, after agency inspectors found in April that Emergent’s workers were poorly trained and that the vaccines were “not maintained in a clean and sanitary condition.” Since then, the FDA has been checking batches that were already made to see if they’re safe, forcing some batches—worth tens of millions of doses—to be thrown out, and approving three of the batches in June. Because of the contamination, Canada, the European Union and South Africa said they would not use some or all of the vaccines Johnson & Johnson sent them from the plant.