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

The Food and Drug Administration July 2 authorized for emergency use one more batch of drug substance for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore. To date, the agency has authorized four batches for emergency use after reviewing facility records and results of quality testing performed by the manufacturer. Though the FDA is not ready to include Emergent as an authorized manufacturing facility for the J&J vaccine, the agency said it “continues to work through issues there with Janssen and Emergent BioSolutions management.”