U.S. regulators have ordered the shutdown of Johnson & Johnson’s coronavirus vaccine at a factory where 15 million doses of the drug were previously damaged.
The pharmaceutical giant told AFP in late March that it had identified a batch of doses at a Baltimore plant run by Emergent BioSolutions “that did not meet quality standards,” but did not confirm the specific number affected.
According to The New York Times, the batch consisted of about 15 million doses.
Emergent BioSolutions said in a document Monday that the U.S. Food and Drug Administration (FDA) had asked on April 16 to stop production of the J&J single-dose vaccine at its Baltimore plant while conducting an on-site inspection.
“On April 16, 2021, at the request of the FDA, Emergent agreed not to begin manufacturing any new material at the Bayview unit and to quarantine the material produced at Bayview until the inspection is completed,” the document reads.
Johnson & Johnson said in March that it was sending several experts to the field to monitor vaccine production and that it expected to produce another 24 million doses in April.
Emerging company BioSolutions had not been authorized by authorities at the time to produce ingredients for the J&J vaccine, the pharmaceutical company said, but US media reported that it expects to produce tens of millions of doses in the near future.
The J&J vaccine has been praised for being a single dose and for not requiring storage at freezing temperatures, unlike Moderna and Pfizer, which greatly facilitates its distribution.
The break in production is the latest hurdle the vaccine faces in the United States, after regulators temporarily suspended its use due to the discovery of thrombosis in six women, one of whom died two weeks after inoculated dose of J&J.
European regulators are due to decide on the safety of the J&J vaccine on Tuesday, after its use was suspended in that region due to fears of blood clots.