WASHINGTON – About 15 million doses of the single-shot coronavirus vaccine made by Johnson & Johnson (J&J) were ruined in a factory error in the United States, reported The New York Times – a blow to the company’s efforts to quickly boost production.
Contacted by AFP, the pharmaceutical giant said it has identified a batch of doses at a facility in Baltimore run by Emergent BioSolutions “that did not meet quality standards”, but did not confirm the specific number affected.
It also said the batch “was never advanced to the filling and finishing stages of our manufacturing process”.
“Quality and safety continue to be our top priority.”
The NYT report, however, signals that issues with quality control could affect future output, with the Food and Drug Administration expected to investigate.
The authority told AFP that it is “aware of the situation”, but declined to comment further.
J&J said it is sending more experts to the site to “supervise, direct and support all manufacturing of the J&J Covid-19 vaccine”, which will allow it to deliver an additional 24 million shots “through April”.
The Emergent BioSolutions plant has not yet been authorised by US regulators to manufacture a “drug substance” for the vaccine, said the company, but US media reported that it is expected to produce tens of millions of doses in the near future.
The J&J jab has won praise for its single dosage and because it does not need to be frozen – unlike the shots from Moderna and Pfizer – making distribution much simpler.
“We continue to expect to deliver our Covid-19 vaccine at a rate of more than one billion doses by the end of 2021,” said the firm. – AFP, April 1, 2021
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