Johnson & Johnson Covid vaccine shipments halted in US after factory blunder destroys 15 million doses
Future Johnson & Johnson vaccine shipments have been halted in the United States after a human error mix up in a new manufacturing plant destroyed 15 million doses and raised questions over quality control, according to <a rel="nofollow" href="https://www.nytimes.com/live/2021/03/31/world/The New York Times.
Regulators delayed authorization of a new vaccine production line in Baltimore after workers accidentally conflated the ingredients of two different vaccines several weeks ago, the outlet reported.
The plant is said to be a manufacturing partner for both the Johnson & Johnson vaccine and the AstraZeneca vaccine.
While current doses of the Johnson & Johnson vaccine produced in the Netherlands are not affected, tens of millions of future doses scheduled to be delivered within the next month were to have come from the plant in Maryland, according to the Times.
The Food and Drug Administration is investigating the mix-up, attributed to human error, causing a delay to the authorization of the plant’s production line. Johnson & Johnson, meanwhile, was reportedly taking steps to increase its control over the plant, run by Emergent BioSolutions, to avoid further lapses in quality.
A Johnson & Johnson spokeswoman said in a statement that the issue was identified by its representatives at the factory and addressed with both its manufacturing partner and the FDA.
This quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our Covid-19 vaccine,” the statement said.
“This batch was never advanced to the filling and finishing stages of our manufacturing process.”
The spokeswoman said they were sending additional manufacturing and technical operation experts to the site, while continuing to work with the FDA on seeking emergency use authorization for the facility.
The Independent has contacted the FDA and Emergent BioSolutions for comment.
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