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U.S. authorizes additional batch of J&J COVID-19 vaccine produced by Emergent – Metro US

U.S. authorizes additional batch of J&J COVID-19 vaccine produced by Emergent

FILE PHOTO: A box of Johnson & Johnson’s COVID-19 vaccines
FILE PHOTO: A box of Johnson & Johnson’s COVID-19 vaccines is seen at the Forem vaccination centre in Pamplona

(Reuters) – The U.S. Food and Drug Administration said on Friday it had authorized the use of an additional batch of Johnson & Johnson’s one-dose COVID-19 vaccine manufactured at the problem-plagued Baltimore factory of Emergent BioSolutions Inc.

The batch of bulk drug substance – which has not yet been put into vials – can make up to 15 million doses of J&J’s vaccine, according to a source familiar with the matter.

The FDA has now authorized a total of four batches of the vaccine manufactured at the Emergent facility.

“While the FDA is not yet ready to include the Emergent BioSolutions plant … as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management,” the agency said in a statement, referring to J&J’s pharmaceuticals unit.

Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April following the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine.

An FDA inspection of the plant also turned up a long list of sanitary problems and bad manufacturing practices.

“As COVID-19 continues to impact countries and cause untold suffering worldwide, we remain committed to producing safe, high-quality vaccines,” J&J said in a statement.

J&J shares closed up about 2% at $168.98.

(Reporting by Dania Nadeem in Bengaluru and Michael Erman in New Jersey; Editing by Devika Syamnath and Bill Berkrot)

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