WASHINGTON — Emergent BioSolutions, a longtime government contractor hired to manufacture hundreds of millions of doses of coronavirus vaccine, hid evidence of quality control issues from Food and Drug Administration inspectors in February 2021 — six weeks before warning federal officials that 15 million doses were contaminated .
The revelation came in a new report from the Democrat-led House Committee on Oversight and Reform. The report, based on internal company emails, documents and interviews, sheds new light on Emergent executives’ own concerns about deficiencies in the company’s quality control systems at its troubled Bayview facility in Baltimore.
The report, released Tuesday morning by the House and Select Subcommittee on the Coronavirus Crisis, said all together nearly 400 million doses of the Emergent-manufactured coronavirus vaccine had to be destroyed “because of poor quality control,” including about 240 million doses by the end of 2020 and early 2021. Previous estimates of lost vaccine were much lower; no contaminated doses were ever released to the public.
“These doses were wasted despite repeated warnings from employees, outside consultants, drug companies and FDA regulators that the company’s manufacturing practices were unsafe,” said South Carolina Democrat Representative James E. Clyburn and the chairman of the House Subcommittee. before the pandemic. in a statement.
DailyExpertNews reported last year that a top pandemic preparedness official with Operation Warp Speed, the Trump administration’s rapid vaccine initiative, warned in June 2020 that relying on the plant would pose “significant risks” and that the site “would need to monitor closely.” being watched.”
That same month, Sean Kirk, an Emergent executive, admitted in an email that he had warned other senior executives “for a few years” about problems at the plant, writing that “room for improvement is a huge understatement.”
In another email he wrote to Robert Kramer, the company’s CEO, Mr. Kirk: “Of all the things we have to deliver on OWS,” referring to Operation Warp Speed, “the thing that keeps me up at night is general perception of the state of quality systems at Bayview.” Mr. Kirk has left Emergent ever since.
A company spokesperson, Matt Hartwig, said in an email Monday evening that Emergent had been “open and willing” with the FDA and Congress, noting that the company had provided investigators with thousands of documents and invited them to explore the facilities. to visit. Emerging executives also testified publicly before the House subcommittee last May.
“Emergent remains committed to being a trusted partner of the US and allied governments,” wrote Mr Hartwig, adding that the company had not yet seen the House report.
As the federal government scrambled to secure vaccine production capacity during the early days of the pandemic, it entrusted Emergent with a mammoth task: to produce both Johnson & Johnson and AstraZeneca vaccines at its Baltimore facility. The company’s stock price skyrocketed after the announcement of a $628 million federal contract and additional deals with the two drug companies worth $656 million together.
But documents released by the House investigators show that some of Emergent’s own executives feared the company was not up to the task.
Prior to a visit to the factory by FDA officials in September 2020, a senior director of quality warned executives that convincing the agency that rapid improvements were underway would be critical. “We are not yet fully compliant – BUT – we are making batches NOW,” the director wrote.
In November 2020, an outside consultant from Emergent wrote that the company’s manufacturing deficiencies posed “a direct regulatory risk.”
During the visit in September, the agency identified shortcomings. When officials returned in February 2021, Emergent employees tried to hide potential problems, according to the House report.
Earlier, Emergent had placed yellow labels on containers containing some of a batch of Johnson & Johnson’s vaccine suspected of having quality issues. But employees removed the tags shortly before the FDA’s visit and put them back on after agency officials left. Senior executives and an executive vice president of the company were aware of these actions, the House report found.
In an email obtained by the committee, an outside consultant to Emergent wrote that the purpose of removing the tags appeared to be “to avoid drawing attention” to the potentially problematic containers.
Home investigators wrote that “despite this apparent attempt to hinder oversight,” the FDA still identified serious quality issues, but granted some leniency to Emergent. In late March 2021, Emergent notified the Department of Health and Human Services of the contaminated doses. That sparked a series of events that culminated in the termination of Emergent’s vaccine manufacturing contract in November 2021 by the Biden administration.
