FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.
To date (July 2, 2021) a total of four batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use.
While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.