U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

That decision does not mean the F.D.A. has broadly authorized Johnson & Johnson to distribute doses made by Emergent on an emergency basis. The F.D.A. signed off on previous batches of vaccine made at the Baltimore factory but with a warning that it could not guarantee the company had followed good manufacturing practices. The agency has cleared the equivalent of up to 75 million doses, but tens of millions remain in limbo.

In a conference call with investors on Thursday, Emergent executives announced a $41.5 million hit from being forced to discard doses the F.D.A. had deemed unusable, and said the company had spent another $12.4 million to address manufacturing issues in Baltimore.

The newly disclosed inquiries from federal and state agencies underscore a dramatic reversal of fortune for a company that has spent much of the last two decades effectively cornering the market for biodefense, becoming the government’s go-to contractor for products to protect against bioterrorism and infectious disease outbreaks.

For most of the last decade, the government has spent nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, on Emergent’s anthrax vaccine alone, crowding out investments in products such as masks that were in short supply during the pandemic, a New York Times investigation found.

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

Out of public view, however, concern about the company’s ability to deliver was mounting, as The Times has reported. A series of audits by customers, federal officials and the company’s own evaluators found repeated shortcomings in efforts to disinfect and prevent contamination, and a top federal official warned that the company would have to be “monitored closely.”

After it was discovered in late March that a batch of the Johnson & Johnson vaccine had been cross-contaminated with material from the AstraZeneca vaccine, federal inspectors descended on the factory, and members of Congress launched an investigation into both the company’s Covid-19 manufacturing work and its contracts with the stockpile.