US Officials Ask for Documentation of Troubled Covid Vaccine


This decision does not mean that the FDA has broadly authorized Johnson & Johnson to dispense doses on an Emergency basis. The FDA has approved previous batches of vaccines made at the Baltimore factory, but with a warning He said he could not guarantee that the company was following good manufacturing practices. The agency cleared the equivalent of 75 million doses, but tens of millions remained in limbo.

In a conference call with investors on Thursday, Emergency executives announced a $41.5 million hit from being forced to discard doses the FDA deemed unusable, and said the company had spent another $12.4 million solving production issues in Baltimore.

Newly announced investigations from federal and state agencies underscore a dramatic wealth reversal for a company that has spent most of the past two decades effectively cornering the biodefense market and has become the government’s primary contractor for products that protect against bioterrorism and infectious diseases. epidemics.

For much of the past decade, the government has spent nearly half of the annual budget of the Strategic National Stockpile, the nation’s emergency medical reserve, on Emergency’s anthrax vaccine, excluding investments in products like masks. pandemic, a New York Times investigation found.

When the coronavirus pandemic hit, the government turned to the Emergency to produce vaccines and treatments. Thanks to a lucrative deal in May 2020, Emergent record profit and award-winning executives record bonuses.

However, concerns were mounting about the company’s delivery capability, which had escaped the public eye, The Times reported. reported. A series of inspections by customers, federal officials, and the company’s own evaluators found repeated shortcomings in disinfection and contamination prevention efforts, and A senior federal official warned He said the company needed to be “followed closely”.

After the discovery of a batch of the Johnson & Johnson vaccine in late March had been cross-contaminated With ingredients from the AstraZeneca vaccine, federal investigators raided the factory, and members of Congress launched an investigation into the company’s contracts with both its Covid-19 production efforts and stockpile.


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