This decision does not mean that the FDA has largely authorized Johnson & Johnson to distribute emergent-made cans in an emergency. The FDA approved previous batches of vaccine made at the Baltimore factory, but with warnings that it could not guarantee that the company followed good manufacturing practices. The agency has released the equivalent of up to 75 million cans, but tens of millions remain pending.
In a conference call with investors Thursday, Emergent executives announced a $ 41.5 million hit for being forced to dump cans that the FDA deemed unusable, saying the company had another 12.4 million Millions of dollars spent solving manufacturing problems in Baltimore.
The newly published inquiries from federal and state agencies underscore a dramatic turnaround for a company that has spent much of the past two decades effectively cornering the bio-defense market and becoming the government’s premier contractor for bio-terrorism products and infectious diseases become outbreaks.
For most of the past decade, the government has spent nearly half the annual budget of the country’s emergency medical reserve, the Strategic National Stockpile, on Emergent’s anthrax vaccine alone, to crowd out investments in products like masks that resulted during the pandemic, a New York Times investigation.
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When the coronavirus pandemic broke out, the government turned to Emergent to manufacture vaccines and treatments. Thanks to a lucrative deal in May 2020, Emergent achieved record profits and awarded record bonuses to executives.
From a public perspective, however, concerns about the company’s ability to deliver grew, The Times reported. A series of audits by customers, federal officials and in-house appraisers repeatedly identified deficiencies in disinfection and contamination prevention efforts, and a senior federal official warned the company needed “close monitoring”.
After it was discovered in late March that a batch of the Johnson & Johnson vaccine was cross-contaminated with material from the AstraZeneca vaccine, federal inspectors came to the factory and members of Congress opened an investigation into the company’s Covid-19 manufacturing work and their contracts with the company Stock.