U.S. regulators ordered a halt to production of Johnson & Johnson’s vaccine vaccine at a factory, where 15 million doses of the drug had previously been damaged.
The pharmaceutical giant told AFP in late March that it had identified a dose batch at a plant in Baltimore belonging to Emergent Biosolutions “that did not meet quality standards,” but did not confirm the specific figure affected.
According to The New York Times, the batch consisted of about 15 million doses.
Emerging 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 single-dose J&J vaccine at the his 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 its Bayview facility and to quarantine the material produced at Bayview until the inspection, “the document said.
Johnson & Johnson had said in March that it was sending more experts to the site to monitor vaccine production, and that it hoped to produce an additional 24 million doses by April.
The Emergent Biosolutions plant had not then been authorized by authorities to produce ingredients for the J&J vaccine, the pharmaceutical company said, but U.S. media reported that it was expected to produce tens of millions of dollars. dose in the near future.
The J&J vaccine was praised for being a single dose and because it does not require storage at sub-zero temperatures, unlike those of Moderna and Pfizer, which greatly facilitates its distribution.
The pause in production is the latest hurdle facing this vaccine in the United States, after regulators temporarily suspended its use due to the finding of thrombosis in six women, one of whom died, two weeks after -inoculated at J&J doses.
European regulators are due to decide on Tuesday on the safety of the J&J vaccine, after its use was also suspended in the region due to fears about blood clots.