July 2 (EuroJournal) – The U.S. Food and Drug Administration said on Friday it had authorized the use of an additional batch of Johnson & Johnson’s (JNJ.N) one-dose COVID-19 vaccine manufactured at the problem-plagued Baltimore factory of Emergent BioSolutions Inc (EBS.N).
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 (AZN.L) 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. read more
“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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