FDA announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen #COVID19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. fda.gov/news-events/pr… 
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.
The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries.
Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8°C for 4.5 months instead of 3 months. fda.gov/media/150064/d…
Dr. Peter Marks, @FDACBER Director: “These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product.”
With the action to extend the shelf life for refrigerated Janssen vaccine, jurisdictions that have doses on hand now have more time to administer the vaccine, Dr. Marks said.
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