US regulators are allowing the release of nearly 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory
US regulators are allowing the release of nearly 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but many more doses cannot be used and must be thrown out.
The Food and Drug Administration announced Friday that it has determined that two batches can be released from the plant, which is owned by Emergent Biosolutions, and closed for eight weeks. But it said several other batches are not suitable for use and additional batches are still under review.
The agency would not specify the size of those batches or why they could not be used, but a person familiar with the decision told the Associated Press that they could have received tens of millions of doses and were likely contaminated. Another person familiar with the situation said the dose to be discarded was made as a vaccine batch equal to about 15 million doses that was contaminated earlier this year and was thrown out.
No individual was authorized to release details about the decision and spoke to the AP on condition of anonymity.
J&J and Emergent will not provide any details about the size of the usable batches, nor will those being discarded.
Two batches from a factory called Bayview can be used in the US or exported to other countries. They are the first J&J vaccine approved for use from Bayview.
The FDA said that if a vaccine is exported, J&J and Emergent must allow the agency to confidentially share information about manufacturing those batches with regulators in other countries.
The FDA’s statement implied that not all batches meet the agency’s manufacturing quality standards. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement, “This review is taking place as Emergent BioSolutions is revisiting manufacturing operations with corrective actions to ensure compliance with the FDA’s manufacturing requirements. Preparing to start.”
The agency said the vaccines are “severely necessary” given the current public health emergency, and it made the decisions after reviewing records and quality test results.
However, the FDA stopped short of allowing the plant to resume production of the vaccine. The agency said it was working with Jammu and Kashmir and Emergent Biosolutions management through the issues there.
Emergent is one of several J&J contractors that produce their one-shot vaccines in bulk. Concentrated vaccines are shipped to other factories for final stages, which include diluting them to the right strength, pouring into vials, and packaging them.
About 100 million doses made from the bulk vaccine produced at Emergent’s factory, including those currently approved for use, were set aside for additional review by FDA staff after factory workers accidentally contaminated the first batch.
That contamination prompted the FDA to close the factory in mid-April and dispatch a team of inspectors. He visited the factory for a week and reviewed security camera footage that showed workers recklessly handling vaccine material. Inspectors reported unhygienic conditions, poorly trained staff and other problems.
Shortcomings have hindered J&K’s efforts to become a major player in immunizing people, especially in remote areas and poor countries, given that it is the only drug manufacturer with an authorized vaccine that only needs a single dose and standard refrigeration. Is required. It is also cheaper than some other vaccines.
Production problems have forced J&J to import millions of doses from its factory in the Netherlands into the US and miss supply commitments.
Emergent’s factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained staff and an inadequate strategy to prevent contamination, yet it was given a major role in COVID-19 vaccine production by the Trump administration was. Emergent was assigned a lucrative contract to manufacture millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.
Emergent’s chief executive has blamed contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.
The Biden administration is working to find a separate US manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the US.
Associated Press writer Matthew Perrone contributed. Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma.
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