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# FDA Releases 15 Million Doses of Janssen Vaccine
- URL: https://www.fdaweb.com/fda-releases-15-million-doses-of-janssen-vaccine/
- Published: 2021-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:03:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149551

FDA has authorized another vaccine drug substance batch (15 million doses) that was manufactured at troubled Emergent BioSolutions’ Baltimore facility for use in Janssen’s Covid-19 vaccine. The authorization follows last week’s sign-off on two other batches (10 million doses) from the same plant ([see earlier story](https://www.fdaweb.com/fda-oks-2-covid-19-batches-made-at-troubled-facility/)).

FDA says it conducted a “thorough review” of facility records and the results of quality testing performed by the manufacturer. “Based on this review and considering the current Covid-19 public health emergency, the FDA has concluded that these batches are suitable for use,” it says. “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.”