Federal regulators on Wednesday released extremely critical results from their inspection of a Baltimore plant that was forced to dispense up to 15 million doses of Johnson & Johnson’s coronavirus vaccine and ordered all production to be temporarily suspended.
The Food and Drug Administration cited a number of shortcomings in the huge facility operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent employees had contaminated a batch of Johnson & Johnson cans with the harmless virus used to dispense the AstraZeneca vaccine, which is also manufactured at the factory.
Violations included failure to properly disinfect the factory and its equipment, as well as failure to establish and follow appropriate procedures to prevent contamination of the cans and to ensure the strength and purity of the vaccine produced there. “There is no guarantee that other batches have not been contaminated,” wrote the inspectors.
Their 12-page report cited nine violations, ranging from the design of the building to improperly trained staff. The inspection ended on Tuesday.
In a statement, the FDA stated that it did not authorize Emergent to distribute doses of Johnson & Johnson vaccines and that no vaccine manufactured at its facility has been approved for use in the United States.
AstraZeneca’s vaccine is not yet approved for use in the United States, and all of the Johnson & Johnson doses administered in the country to date have been manufactured overseas. At the agency’s request, all production in the factory was discontinued.
“We will only allow a product to be released when we are sure that it meets our quality expectations,” said Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the agency’s lead vaccine regulator.
The agency said it was working with Emergent to fix the issues.
Emergent is a longtime government contractor who has spent much of his time over the past two decades building a lucrative market for federal biological defense spending. The Baltimore facility is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that should be ready in the event of a pandemic.
The New York Times reported earlier this month that the Trump administration placed the company on a $ 628 million contract about ten months ago, despite previous performance issues. The contract primarily allowed the government to reserve manufacturing space at the facility for vaccine production. On Tuesday, the House Select Coronavirus Crisis Subcommittee announced that it would investigate procurement and other issues related to Emergent. The company has demonstrably failed to meet the contractual requirements.
Inspectors criticized Emergent’s response to last month’s discovery that Johnson & Johnson’s doses were contaminated with the benign virus used to make AstraZeneca’s vaccine. The incident “has not been fully investigated,” they wrote.
They said Emergent had not thoroughly checked whether the cross-contamination was caused by one or more workers moving between AstraZeneca and Johnson & Johnson production zones, or whether it could be related to how the raw materials used to make both vaccines were handled becomes.
The inspectors found that workers frequently moved between manufacturing zones without documenting that they had showered and changed their clothes as needed. In a ten-day period in February, for example, 13 employees moved from one zone to another on the same day, but only one documented having showered. After the Johnson & Johnson cans were found to be contaminated, only routine cleaning was performed, according to the report.
Workers also failed to properly handle production waste, creating a risk of contamination in the warehouse where the raw materials were stored, the inspectors found. They also cited peeling paint, overcrowded equipment, and other problems with the building. Overall, “it is not being kept in a clean and hygienic condition,” they wrote.
Emergent said in a statement on Wednesday: “While we are never satisfied with defects in our manufacturing equipment or processes, they can be corrected and we will take swift action to correct them.”
In its own statement, Johnson & Johnson said it had already stepped up its oversight of Emergent, its subcontractor, and that it would “ensure that any FDA observations are promptly and comprehensively addressed”.
One major change has already been made: AstraZeneca is no longer manufactured at the factory, a move federal officials insisted earlier this month to limit the likelihood of cross-contamination between two vaccines.
Dr. Jose Romero, the Arkansas Secretary of Health and chair of the panel of experts advising the Centers for Disease Control and Prevention on the future of the Johnson & Johnson vaccine, said in an interview that he was dismayed by the FDA’s findings. The panel will meet on Friday on whether to lift, change, or maintain a vaccine hiatus from Johnson & Johnson, which was initiated last week over an entirely different issue: the discovery that eight U.S. citizens would make a rare one afterward but developed dangerous bleeding disorder. You were shot.
“I’m shocked,” said Dr. Romero. “I can’t put it any other way. Inappropriate disinfection, prevention of contamination – at least in my opinion these are serious and grave violations that must of course be remedied.
“I would not have expected this, given the rigor we have in this country on good manufacturing practices at these vaccine facilities,” he said.