WASHINGTON — Federal regulators have found serious flaws at the Baltimore plant that had to throw out up to 15 million possibly contaminated doses of Johnson & Johnson’s coronavirus vaccine — casting doubt on further production in the United States of a vaccine that the government once viewed as essential in fighting the pandemic.
The regulators for the Food and Drug Administration said that the company manufacturing the vaccine, Emergent BioSolutions, may have contaminated additional doses at the plant. They said the company failed to fully investigate the contamination, while also finding fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.
“There is no assurance that other batches have not been contaminated,” the F.D.A.’s 12-page report states.
The report amounted to a harsh rebuke of Emergent, which had long played down setbacks at the factory, and added to problems for Johnson & Johnson, whose vaccine had been seen as a game changer because it requires only one shot, can be produced in mass volume and is easily stored.
The F.D.A. findings, based on an inspection that ended on Tuesday, underscore questions raised in reports by The New York Times about why Emergent did not fix problems earlier and why federal officials who oversee its lucrative contracts did not demand better performance.
A series of confidential audits last year, obtained by The Times, warned about risks of viral and bacterial contamination and a lack of proper sanitation at the Baltimore plant. Separately, The Times reported, a top federal manufacturing expert cautioned last June that Emergent would have to be “monitored closely.”
Some health officials were taken aback by the F.D.A.’s conclusions.
“I’m shocked — I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel advising the Centers for Disease Control and Prevention that later this week will recommend how to handle the Johnson & Johnson vaccine. “Inappropriate disinfection, the prevention of contamination — those are significant and serious violations.”
In statements on Wednesday, the F.D.A., Emergent and Johnson & Johnson all said they were working to resolve the problems at the factory. There was no indication of how long that would take.
In a statement, Dr. Janet Woodcock, the F.D.A.’s acting commissioner, and Dr. Peter Marks, its top vaccine regulator, said: “We will not allow the release of any product until we feel confident that it meets our expectations for quality.”
Emergent is a longtime government contractor that has spent much of the last two decades cornering a market in federal biodefense spending.
Though the government gave Emergent a $163 million contract in 2012 to ready the Baltimore plant for mass production in a pandemic, the site remained largely untested, and the company did not meet a requirement for demonstrating its rapid-response capabilities, according to former health officials and contracting documents.
Nonetheless, the government went on to award Emergent a $628 million contract last June, most of it to reserve manufacturing space at the plant, and arranged for the company to produce the Johnson & Johnson shot and a separate vaccine developed by AstraZeneca.
Now, Emergent’s dealings with the government are under increasing scrutiny. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis and the House Committee on Oversight and Government Reform announced an investigation into the company’s Covid-19 vaccine contract, as well as its longstanding hold on an outsize portion of the budget for the nation’s emergency medical reserve, the Strategic National Stockpile.