J&J COVID-19 vaccine manufacturing halted at U.S. plant that had contamination concern By Reuters
© Reuters. FILE PHOTO: Signage is outside of FDA headquarters in White Oak, Maryland
From Manas Mishra
(Reuters) – Johnson & Johnson (NYSE 🙂 COVID-19 vaccine production at a U.S. manufacturing facility has been suspended by the U.S. Food and Drug Administration while the agency is investigating a bug that resulted in Millions of cans have been ruined in the last month.
Emergent BioSolutions Inc, the company that owns and operates the Baltimore facility that made the J&J vaccine, announced in a regulatory filing that the FDA will take a break in manufacturing new drug compounds for the shot on April 16 requested until the inspection was completed.
Johnson & Johnson said it would work with Emergent and the FDA to clarify any findings at the end of the inspection.
J&J was hired to manufacture at the factory by the U.S. government in early April after announcing the bug where ingredients from AstraZeneca (NASDAQ :), which were also manufactured at the factory at the time, were added to a batch of J. & J vaccine contaminated.
The call to cease manufacturing is the latest setback for J & J’s vaccine, which was halted by U.S. regulators as they review reports of rare but serious blood clots in the brains of people who received the single dose.
The Baltimore facility had applied for FDA approval for the J&J vaccine when the error occurred. J & J is authorized to manufacture cans in the Netherlands and to use Catalent’s (NYSE 🙂 Inc.
“At this point, it is premature to speculate on the timing of our vaccine shipments,” said J&J. The company previously announced that it would ship 100 million doses of its vaccine to the US in the first half of 2021 and has approximately 18 million to date submitted.
J&J said in a statement that it was about obtaining emergency clearance for the emergent plant.
Emergent announced in a regulatory filing on Monday that the FDA began its review on April 12th. The company said it will quarantine existing material made at the Baltimore facility until the review is complete. (Https: //
“We recognize that we need to make improvements to meet the high standards we have set ourselves and to restore confidence in our quality systems and manufacturing processes,” said Emergent in a statement sent via email.
In March, J&J announced it had identified a problem with a batch of the drug for the COVID-19 vaccine manufactured by Emergent.
J&J didn’t say how many doses of vaccine the spoiled batch would have produced, but the New York Times reported, without naming a source, that approximately 15 million doses were ruined.
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