FDA Authorizes Additional Batch of the J&J COVID-19 Vaccine

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.

FDA authorized an additional batch of Janssen’s COVID-19 vaccine manufactured at Emergent BioSolutions’ facility in Baltimore under Emergency Use Authorization (EUA), the agency announced on July 2, 2021.

Thus far, four batches have been authorized to be manufactured at the Emergent BioSolutions plant in the Janssen EUA, though the facility isn’t officially an authorized manufacturing facility. FDA reviewed facility records, including quality testing, and concluded the batches were suitable for use.

FDA said it will continue to work through issues that arise at the Emergent facility with Janssen and Emergent BioSolutions management.

Previously, FDA authorized the use of two batches of Janssen’s vaccine under EUA on June 11, 2021.

Source: FDA