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.
Related News Articles
Headline
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory…
Headline
The Occupational Safety and Health Administration today announced a 60-day extension of the comment period on its proposed rule to remove the remaining…
Headline
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…
Headline
The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one underlying condition that…