US regulatory authorities ordered production of Johnson & Johnson’s coronavirus vaccine to be halted at a facility where 15 million doses of the drug had previously been damaged.
The pharmaceutical giant told AFP in late March that it had identified a batch of doses at a facility in Baltimore run by Emergent BioSolutions “that failed to meet quality standards,” but did not confirm the specific number affected.
The batch consisted of approximately 15 million doses, according to The New York Times.
Emergent BioSolutions said in a document Monday that the U.S. Food and Drug Administration (FDA) requested on April 16 to halt production of J & J’s single-dose vaccine at its Baltimore facility while conducting an on-site inspection.
“On April 16, 2021, at the request of the FDA, Emergent agreed not to produce new material at its Bayview facility and to quarantine the material produced in Bayview until the inspection is completed,” the document said.
Johnson & Johnson had said in March that it would send more experts to the site to oversee vaccine production, and that it expected to produce an additional 24 million doses by April.
The Emergent BioSolutions plant was not licensed by the authorities at the time to produce ingredients for the J&J vaccine, the pharmaceutical company said, but US media reported it was expected 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 needing to be stored at freezing temperatures, unlike Moderna and Pfizer, which greatly facilitates its distribution.
The shutdown is the latest obstacle facing this vaccine in the United States, after regulators temporarily halted its use due to the discovery of thrombosis in six women, one of whom died two weeks after inoculating the dose of J&J.
European regulators are due to decide on the safety of J & J’s vaccine on Tuesday, after use in that region was also suspended for fear of blood clots.