This decision does not mean that the F.D.A. has been rescinded. Johnson & Johnson has been granted broad authority to distribute Emergent doses on an emergency basis. The F.D.A. The F.D.A. approved previous batches of vaccine manufactured at Baltimore's factory, but warned that the company could not be trusted to follow good manufacturing practices. Although the agency has approved up to 75,000,000 doses, tens of thousands of people remain unaccounted for.Emergent executives revealed a $41.5 million loss due to having to throw out F.D.A. doses in a conference call on Thursday. Emergent executives announced that the company had spent $12.4 million more to address manufacturing problems in Baltimore, which they had previously deemed unusable.The company's recent disclosures to federal and state agencies highlight a dramatic turn of events. It has been a dominant player in the biodefense market for many decades and is now the government's preferred contractor for products that protect against infectious disease outbreaks.The government spent almost half of its annual budget for the nation's emergency medical reserve, known as the Strategic National Stockpile (the Annual Budget), on Emergents Anthrax vaccine. This has pushed out investments in masks, which were scarce during the pandemic. A New York Times investigation revealed this.Emergent was the company that produced vaccines and treatments for the coronavirus pandemic. Emergent made record profits in May 2020 and received record bonuses thanks to a lucrative agreement.The Times reported that there was growing concern about the company's ability to deliver despite it not being visible publicly. Customers, federal officials, and company evaluators conducted a series of audits. They found numerous flaws in the efforts to prevent and disinfect contamination. A top federal official warned that the company would need to be closely monitored.Federal inspectors arrived at the factory to inspect the manufacturing process and contracts for the stockpile.
