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article imageJohnson & Johnson subcontractor ruins 15 million vaccine doses

By Karen Graham     Mar 31, 2021 in Health
Future shipments of the Johnson & Johnson COVID-19 vaccine have been halted while the Food and Drug Administration investigates after a human error at a manufacturing plant ruined 15 million doses, it was reported Wednesday.
Baltimore, Maryland-based Emergent BioSolutions was hired to manufacture the active ingredient, or drug substance, of the vaccine at its plant. Workers at the facility mistakenly mixed ingredients for the J&J vaccine with those of another manufacturer’s coronavirus shot, according to two officials.
The error does not affect doses of the Johnson & Johnson vaccine that have already been distributed, as they were made in the Netherlands, but it impacts future shipments of the vaccine, reports The Hill.
Emergent BioSolutions is also making the AstraZeneca vaccine which has yet to be authorized for use in this country. The mistake that ruined as many as 15 million vaccine doses will also delay the US Food and Drug Administration's authorization of the plant. The AstraZeneca vaccine has yet to be authorized for use in this country, according to CNN.
A senior administration official says the Biden administration has asked Johnson & Johnson to directly supervise Emergent’s vaccine production going forward, reports Politico. It could take days or weeks to get the facility back on track and up to regulatory standards, according to plant officials.
To further added an issue to the mix-up, Emergent was supposed to send its drug substance to Catalent, a New Jersey drug manufacturer, to bottle the vaccine. The FDA approved Catalent’s production role last week.l
Emergent had already begun shipping millions of doses to the other firm, people familiar with J&J’s authorization told POLITICO last week. But Catalent cannot release the Emergent doses without the Maryland company’s emergency clearance, and that FDA clearance is now being delayed.
“FDA is aware of the situation, but we are unable to comment further. Questions about a firm’s manufacturing facilities should be directed to that firm,” the FDA said in a statement.
Emergent's problems are the latest blow to Johnson & Johnson’s efforts to accelerate production of its vaccine, which — as the only one-dose coronavirus shot cleared for use in the U.S. — is a critical component of President Joe Biden’s vaccination push.
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