FDA clears more vaccine drug substance from Emergent BioSolutions

July 7, 2021

The U.S. Food and Drug Administration (FDA) has cleared an additional batch of drug substance for the COVID-19 vaccine from Janssen Pharmaceuticals that was manufactured at an Emergent BioSolutions manufacturing facility.

The drug substance was released for use under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine. To date, a total of four batches of the drug substance that were manufactured at the Emergent facility have been authorized by the FDA.

In making the decision, the FDA said it did “a thorough review of facility records and the results of quality testing performed by the manufacturer.” 

Earlier this year, Johnson & Johnson, parent company of Janssen, said its manufacturing quality-control process identified one batch of drug substance for the COVID-19 vaccine produced at Emergent BioSolutions that did not meet Johnson & Johnson’s standards.

The FDA then conducted an inspection in which it also noted quality issues. 

In the most recent announcement, the FDA said it continues to “work through issues” with the management at Emergent BioSolutions and Janssen. 

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