WASHINGTON: Production of Johnson & Johnson's COVID-19 vaccine at a US manufacturing plant was halted by the US Food and Drug Administration while the agency investigates an error that led to millions of doses being ruined last month.
Emergent BioSolutions, the company that owns and runs the Baltimore plant that had been making the Johnson & Johnson vaccine, said in a regulatory filing that the FDA requested a pause on Apr 16 in production of new drug substance for the shot pending completion of the inspection.
Johnson & Johnson said it would work with Emergent and the FDA to address any findings at the end of the inspection.
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Johnson & Johnson was put in charge of manufacturing at the plant in early April by the US government after it disclosed the error in which ingredients from AstraZeneca's shot also being produced at the plant at that time contaminated a batch of the Johnson & Johnson vaccine.
The request to pause manufacturing is the latest setback to Johnson & Johnson's vaccine, which has been paused for use by US regulators as they review reports of rare but serious brain blood clots in people who took the one-dose shot.
The Baltimore plant had been seeking authorisation from the FDA for the Johnson & Johnson vaccine when the error occurred. Johnson & Johnson has authorisation to make doses in the Netherlands and finish them in the US plant of Catalent.
"At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries," Johnson & Johnson said. The company has previously said it would deliver 100 million doses of its vaccine to the United States during the first half of 2021 and has so far delivered about 18 million.
Johnson & Johnson said in a statement it was focused on securing emergency use authorisation for the Emergent plant.
READ: How worried should we be about blood clots linked to AstraZeneca and Johnson & Johnson COVID-19 vaccines?
Emergent said on Monday in a regulatory filing that the FDA started its review on Apr 12. The company said it would quarantine existing material manufactured at the Baltimore facility until the review is complete.
"We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes," Emergent said in an emailed statement.
In March, Johnson & Johnson said it had found a problem with a batch of the drug substance for its COVID-19 vaccine being produced by Emergent.
Johnson & Johnson did not say how many vaccine doses the spoiled batch would have produced, but the New York Times, without citing a source, reported that about 15 million doses were ruined.