Some doses of J&J vaccine can be used, but many need to be released


by Linda A. Johnson and Zeke Miller

Credit: Unsplash / CC0 Public Domain

U.S. regulators allow 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 discarded.

The Food and Drug Administration announced Friday that it had determined that two batches of the plant, owned by Emerging BioSolutions, could be released and that it had been closed for eight weeks. But he said several other lots are not suitable for use and are still under review.

The agency would not specify the size of these batches or why they cannot be used, but a person familiar with the decision told The Associated Press that they could have produced tens of millions of doses and were possibly contaminated. Another person familiar with the situation said the doses that should be ruled out were done almost at the same time as a batch of vaccines equal to about 15 million doses that were contaminated earlier this year and were throw away.

None of the people were allowed to disclose details about the decision and spoke to the AP on condition of anonymity.

J&J and Emergent would not provide any details on the size of the batches that could be used or discarded.

The two batches from the factory known as Bayview can be used in the US or exported to other countries. They are the first Bayview J&J vaccines approved for use.

The FDA said that if any of the vaccines are exported, J&J and Emergent should allow the agency to share information about the manufacture of these batches in confidence with regulators in other countries.

The FDA statement implied that the batches did not meet all of the agency’s manufacturing quality standards. “This review has been conducted as Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s“ manufacturing requirements, ”said Dr. Peter Marks, director of the Assessment Center. and FDA Biological Research, in a statement.

The agency said vaccines are “critically necessary,” given the current public health emergency, and that it made the decisions after reviewing records and quality test results.

The FDA, however, stopped allowing the plant to restart vaccine production. The agency said it was working on issues with the management of J&J and Emergent BioSolutions.

Emergent is one of J&J’s contractors producing its unique bulk vaccine. The concentrated vaccine is sent to another for the final steps, including diluting them to the correct strength, putting them in vials and packing them.

Approximately 100 million doses made from mass-produced vaccines produced at the Emergent factory, including those just approved for use, had been set aside for further review by FDA staff after employees of the factory accidentally contaminated a previous batch.

This contamination led the FDA to close the factory in mid-April and send a team of inspectors. They spent a week walking through the factory and reviewing security camera footage showing employees carelessly handling vaccine materials. Inspectors reported unhealthy conditions, poorly trained employees and other problems.

Deficiencies have hampered J&J’s efforts to be a major player in vaccinating people, especially in remote areas and poor countries, as it is the only drug maker with an authorized vaccine that only requires a standard dose and refrigeration. 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 to lose supply commitments.

The Emergent factory had a history of FDA citations for problems such as mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, although COVID-19 was given a huge role. production of the Trump administration. Emergent received a lucrative contract to manufacture many millions of COVID-19 vaccines for J&J and AstraZeneca at the Bayview factory.

The chief executive of Emergent has blamed pollution and other problems of the complexity of increasing the factory in a few months to make two different vaccines.

The Biden administration is working to find a different US manufacturer partner for the British drug manufacturer, which has not yet applied for permission to distribute it in the US.

The FDA inspection found problems at the factory for making the J&J vaccine

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