Senior officials in the Trump and Biden administrations knew of oversight and quality assurance problems at Emergent BioSolutions’ Baltimore plant months before the company accidentally contaminated 15 million doses of Johnson & Johnson’s Covid-19 vaccine, according to two people with direct knowledge of the matter and an internal report.
Officials with the Trump administration’s vaccine program, Operation Warp Speed, and the Department of Health and Human Services were sent a report in June 2020 on Emergent’s inner workings. Written by a government official, the document concluded that the company’s plan for manufacturing urgently needed Covid-19 vaccines was inadequate. Emergent’s problems hiring and retaining skilled workers meant that it could not guarantee success in producing the shots, said the two people, who read the report and described it to POLITICO.
The report was shared with senior Trump officials, including Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, who still serves in that role for the Biden administration; Moncef Slaoui, then Warp Speed’s vaccine lead; and Robert Kadlec, HHS assistant secretary for preparedness and response under Trump. Officials from the Trump administration later gave the report, along with other key Operation Warp Speed documents, to the Biden team during the transition.
The analysis, which came on the heels of an April 2020 inspection by the Food and Drug Administration, said Emergent only had a fraction of the necessary experienced personnel to oversee quality control and technology transfer operations for Covid-19 vaccine production. The company had already agreed to manufacture J&J’s vaccine and was negotiating a similar deal with AstraZeneca.
The saga underscores the United States’ lack of contract manufacturing capacity to produce critical life-saving drugs and vaccines during a worldwide pandemic. It also raises questions about whether pharmaceutical companies or the federal government could have done more to prevent contamination at Emergent given its critical role fighting a global public-health emergency.
The White House and HHS have not yet responded to requests for comment, nor has J&J. Emergent declined to comment.
Despite the early and detailed warnings, former federal officials say there were few companies that had the capacity to help produce Covid-19 vaccines and Emergent was a natural pick for the job. The company also had long ties to Kadlec from his previous contracting work and had earlier picked up a profitable federal contract to produce smallpox vaccines, The Washington Post reported last year.
Trump administration officials met several times with representatives of Emergent and J&J after the June 2020 report came out to discuss its findings. The federal government suggested that J&J detail employees to the Emergent plant to help improve operations there.
J&J committed a handful of workers to help oversee Covid-19 vaccine operations at Emergent — far fewer than the administration wanted, in part because J&J wanted to reserve those additional workers for its drug and vaccine operations in the Netherlands. The personnel working on the Covid-19 vaccine quality control and technology transfer operations at Emergent consisted mostly of temporary workers and consultants brought on to help with coronavirus operations, a former federal official and another person familiar with Emergent’s hiring practices said.
The company slowly hired more people for its quality control and tech transfer teams over time, those sources said, but the level of knowledge and skill inside the plant was still lacking — leading to continued production problems first revealed by the New York Times.
The Trump administration also deployed a handful of Pentagon personnel to embed within Emergent’s quality control section of the plant. They are still there today.
At some point in February 2021, Emergent accidentally mixed active ingredients for J&J’s vaccine with those for AstraZeneca’s shot, two people familiar with Emergent’s operations said. One of those people said Emergent’s batch failed a test at the end of the month and the company sent the 15 million doses to J&J’s facility in the Netherlands for further testing. J&J ran a series of additional tests which confirmed the contamination. Biden officials said they did not learn of the contaminated doses until the last week of March.
The FDA has cited Emergent several times over the years for poorly trained staff and dealing with mold and contamination in its facilities. After its April 2020 inspection of Emergent’s Baltimore plant, the agency cited the company over problems with its training of employees handling an experimental anthrax vaccine. The FDA said the company “failed to train employees 'in the particular operations they perform as part of their function and current good manufacturing practices,’” according to The Associated Press. A person familiar with the FDA’s investigation said the agency’s citation was the lowest-level warning the FDA doles out.
Both Trump and Biden officials argue there is little the federal government could have done to help Emergent ramp up hiring and quality control around the production of Covid-19 vaccines. Although the government has helped fund the development and testing of J&J’s shot, it has no control over operations at Emergent’s plant or how the company runs its internal inspection units.
Since the batch contamination news broke, J&J has said it will dedicate additional personnel and resources to the Emergent plant that will work 24/7 on the issue. “Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” according to a recently published statement by J&J.
It’s unclear how many additional J&J personnel have been assigned to the Baltimore plant in recent days.
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April 07, 2021 at 07:13AM
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Senior Trump and Biden officials knew for months about problems at vaccine plant - POLITICO
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