FDA Authorizes Third Drug Substance Batch From Emergent Facility

The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production.

The agency said it wasn’t ready to include Emergent’s plant in J&J vaccine’s Emergency Use Authorization as a cleared manufacturing facility, but that it was continuing to “work through issues” with J&J and Emergent management.

The third batch joins two others cleared last week (DID, Jan. 14), allowing the drug substance to be used in vaccine production in either the U.S. or abroad.

The agency said it would share confidential information about the batches’ manufacturing process with international regulators. — Jason Scott