Johnson & Johnson informed AFP in late March that a batch of cans "that did not meet quality standards" had been identified at a Baltimore facility operated by Emergent BioSolutions.
The U.S. Food and Drug Administration called for the production of the Johnson & Johnson coronavirus vaccine to be halted at a factory that reportedly ruined about 15 million doses of the shot.
The pharmaceutical company told AFP at the end of March that it had identified a batch of cans "that did not meet quality standards" at a facility operated by Emergent BioSolutions in Baltimore, but did not confirm the number concerned.
The New York Times later reported that the batch consisted of about 15 million cans.
Emergent BioSolutions said in a US Securities and Exchange Commission filed Monday that the FDA requested a break in manufacturing the single vaccine on April 16 pending an inspection at the Baltimore, Maryland facility.
"On April 16, 2021, at the request of the FDA, Emergent agreed not to begin manufacturing new material at its Bayview facility and to quarantine existing material manufactured at Bayview until inspection and correction of the resultant Results is complete, "said the submission.
Johnson & Johnson announced in March that it would send more experts to the site to oversee vaccine production and is expected to deliver 24 million additional shots by April.
The Emergent BioSolutions plant had not yet been approved by US regulators to manufacture a "drug substance" for the J&J vaccine, the pharmaceutical company said. However, the US media reported that tens of millions of cans are expected to be produced in the near future.
The J&J vaccine received praise for its single dose and because – unlike the recordings from Moderna and Pfizer – it does not need to be frozen, which greatly simplifies distribution.
The manufacturing hiatus is the most recent setback for the vaccine in the US, as regulators temporarily suspended its use after authorities reported six cases of women who had low platelet count clots within two weeks of receiving the J&J shot, including of a death.
The European Medicines Agency is expected to make a decision on the safety of the J&J vaccine on Tuesday after its European use was also put on hold over fear of blood clots.
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J&J Covid vaccine manufacturing has ceased at a facility that ruined the cans (2021 April 20).
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