J&J's large COVID-19 vaccine plant receives FDA authorization

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NEW YORK (Reuters) – The Indiana plant at which Catalent Inc is helping to manufacture COVID-19 vaccine for Johnson & Johnson has received U.S. regulatory authorization, the companies said on Tuesday, enabling J&J to ship out millions of doses.

The White House on Tuesday said 27 million COVID-19 vaccine doses will be allocated to U.S. states and other localities this week, including 4 million from J&J.

J&J tapped contract manufacturers Catalent and Emergent BioSolutions Inc to scale up production and meet global supply targets for its COVID-19 vaccine. Catalent provides the final stage – called fill and finish – while Emergent makes the drug substance.

The U.S. Food and Drug Administration authorized the one-shot J&J vaccine in February, but only for its production facility in the Netherlands and a small fill-and-finish plant in the United States.

Based on that authorization, the company shipped nearly 4 million doses in the beginning of March. Shipments dropped sharply since then as J&J awaited the additional authorizations.

The company had previously promised to deliver 20 million vaccine doses by the end of March.

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