FDA authorizes additional drug substance batch for use in J&J vaccine

The Food and Drug Administration yesterday authorized for emergency use one more batch of drug substance manufactured for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore. To date, the agency has authorized three batches for emergency use after reviewing facility records and results of quality testing performed by the manufacturer. 

“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,” FDA said.