Third Drug Substance Batch From Emergent Plant Approved for Release
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent Biosolutions plant in Bayview, Md. — but still hasn’t authorized the 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, allowing the drug substance to be used in vaccine production in either the U.S. or abroad.