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US asks Johnson & Johnson to run struggling vaccine factory




WASHINGTON The Biden administration on Saturday handed Johnson & Johnson responsibility for a struggling manufacturing plant in Baltimore that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and decided to block the plant from manufacturing another vaccine by AstraZeneca, senior federal health officials said.

The extraordinary move from the Department of Health and Human Services came just days after officials learned that Emerging BioSolutions, a contract manufacturer that makes both the Johnson & Johnson and AstraZeneca vaccines, had mixed the ingredients of both, which has led regulators to delay the authorization of factory production lines.

By moving the AstraZeneca vaccine, two senior federal health officials said, the plant can be devoted solely to the Johnson & Johnson single-dose vaccine and avoid future accidents.

The Department of Health and Human Services has asked Johnson & Johnson to install a new management team to oversee all aspects of production and manufacturing at the Emergent plant in Baltimore, officials said. The company said in a statement that it takes full responsibility for the vaccine made at the Emergent plant.

As President Biden lobbies aggressively to have enough doses to cover every adult by the end of May, federal officials fear the confusion could erode public confidence in Covid-19 vaccines. The AstraZeneca vaccine in particular has created safety concerns; Germany, France and other European countries briefly suspended its use after reporting rare brain blood clots in some vaccinees.

The confusion of ingredients and the administration’s shift to Saturday is a major setback and public relations debacle for Emergent, a Maryland-based biotech company that has built a profitable business by partnering with the federal government, primarily by selling his anthrax. vaccines to the strategic national stock.

A spokesperson for Emerg declined to comment except to say the company would continue to manufacture doses of AstraZeneca until it receives a contract amendment from the federal government.

Unlike Johnson & Johnson, AstraZeneca does not yet have emergency clearance from the Food and Drug Administration for its vaccine. With three federally licensed vaccines (the other two are from Pfizer-BioNTech and Moderna), it’s not clear whether the AstraZeneca vaccine, which has had a troubled history with regulators, might even be cleared in time to respond. to American needs.

However, one of the federal officials said the Department of Health and Human Services is discussing working with AstraZeneca to tailor its vaccine to fight newer variants of the coronavirus. AstraZeneca said in a statement that it will work with the Biden administration to find a new site to manufacture its vaccine.

So far, none of the doses of Johnson & Johnson manufactured by Emergent have been released by the FDA for distribution. Officials said it could take weeks to determine if other batches of the vaccine were contaminated and for FDA inspectors to determine if the Emergent Factory can be allowed to release the doses it made.


April 3, 2021, 9:22 p.m. ET

Acting FDA Commissioner Dr Janet Woodcock said in a statement on Saturday that the agency takes its responsibility to help ensure the quality of manufacture of vaccines and other medical products for use during this pandemic very seriously. .

But she clarified that the ultimate responsibility would rest with Johnson & Johnson, saying: It’s important to note that even when companies use contract manufacturing organizations, it ultimately rests with the company that holds the authorization. emergency use to ensure that the FDA quality standards are met.

In another arrangement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck, one of the world’s largest vaccine makers. Officials said Merck would help run the Baltimore plant.

The Emergents Baltimore Plant is one of two factories designated by the federal government as centers of innovation in advanced development and manufacturing that were built with taxpayer support. Last June, the government paid Emergent $ 628 million to set aside space for Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.

Johnson & Johnson and AstraZeneca both signed a contract with Emergent to use the space. Both vaccines are live viral vector vaccines, which means that they use a modified, harmless version of a different virus as a vector, or vector, to deliver instructions to the body’s immune system. The Johnson & Johnson vaccine is given in a single dose, AstraZenecas in two doses.

Vaccine manufacturing experts have said that in the past, the FDA had a policy of preventing such accidents by not allowing a factory to make two live viral vector vaccines, due to the potential for confusion and contamination.

Last month, Biden canceled a visit to the Emergents Baltimore plant and his spokesperson announced that the administration would conduct an audit of the strategic national stockpile, the country’s emergency medical reserve. Both actions came after a New York Times investigation into how the company had gained inordinate influence over the repository.

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