FDA authorizes another batch of J&J vaccine

The Food and Drug Administration (FDA) has authorized another batch of Johnson & Johnson’s (J&J) coronavirus vaccine manufactured at a troubled Baltimore facility.

The agency said in a short statement on Tuesday that it authorized an additional batch from the Emergent BioSolutions facility, bringing the total number of authorized batches to three.

The agency did not specify how many doses were in the batch that it approved. 

However, a source familiar with the situation confirmed that roughly 14 million doses had been authorized. 

“We welcome the approval of an additional batch of J&J vaccine made at Emergent. We remain committed to addressing the FDA’s observations in order to resume production as soon as possible and look forward to continuing our work to end this pandemic,” Emergent said in a statement. 

The Hill has reached out to the FDA for comment.

Johnson & Johnson said, “As COVID-19 continues to impact countries and cause untold suffering worldwide, we remain committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere. We believe that a single-shot, easy to distribute COVID-19 vaccine is an essential tool to combat the pandemic globally.” 

The announcement comes after the FDA cleared two batches from the Emergent plant on Friday. The New York Times reported that 10 million doses will be allowed to be distributed, but another 60 million were deemed unusable.

The agency said at the time that additional batches were still under review and that it would keep the public informed as the reviews get completed.

Emergent has been under fire since it was discovered that batches of Johnson & Johnson’s vaccine had been cross-contaminated with ingredients from AstraZeneca’s COVID-19 vaccine. Both vaccines were being manufactured by Emergent at the time.

Production was halted in April after the FDA issued a report revealing several failures, including not following procedures to prevent cross-contamination.

The FDA said on Tuesday that it is not yet ready to include the facility as an “authorized manufacturing facility.” However, the agency is continuing to work through issues with both of the companies.

Reuters reported that the authorized doses are expected to be exported to other countries. President Biden has made commitments to share vaccine doses with countries in need.