US authorities seek documents from struggling Covid vaccine manufacturer

This decision does not mean that the FDA has largely authorized Johnson & Johnson to distribute doses manufactured by Emergent on an ...

This decision does not mean that the FDA has largely authorized Johnson & Johnson to distribute doses manufactured by Emergent on an emergency basis. The FDA has approved previous batches of vaccines manufactured at the Baltimore plant, but with a warning that he could not guarantee that the company had followed good manufacturing practices. The agency has cleared the equivalent of 75 million doses, but tens of millions remain in limbo.

In a conference call with investors Thursday, executives at Emerg announced a severe blow of $ 41.5 million for being forced to throw away doses the FDA had deemed unusable, and said the company had spent an additional $ 12.4 million to resolve manufacturing issues in Baltimore.

New inquiries from federal and state agencies point to a dramatic setback for a company that has spent much of the past two decades effectively cornering the biodefense market, becoming the government’s go-to supplier of bio-defense products. protection against bioterrorism and infectious diseases. epidemics.

For most of the past decade, the government has spent nearly half of the annual budget of the country’s emergency medical reserve, the strategic national reserve, on Emerging’s only anthrax vaccine, crowding out investment. in products such as masks which were scarce during the pandemic, a New York Times investigation uncovered.

When the coronavirus pandemic hit, the government turned to Emergent to produce vaccines and treatments. Thanks to a lucrative deal concluded in May 2020, Emergent won record profits and awarded executives with record bonuses.

Out of public view, however, concerns about the company’s ability to deliver were mounting, as the Times reported. A series of audits by customers, federal officials and the company’s own assessors revealed repeated deficiencies in disinfection and contamination prevention efforts, and a senior federal official warned that the business should be “closely watched”.

After discovering at the end of March that a batch of the Johnson & Johnson vaccine had been cross-contaminated With material from the AstraZeneca vaccine, federal inspectors descended on the plant and members of Congress launched an investigation into the company’s Covid-19 manufacturing work and its contracts with the stock.

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Newsrust - US Top News: US authorities seek documents from struggling Covid vaccine manufacturer
US authorities seek documents from struggling Covid vaccine manufacturer
Newsrust - US Top News
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