WASHINGTON — Emergent BioSolutions, a longtime government contractor hired to supply tons of of hundreds of thousands of coronavirus vaccine doses, hid evidence of quality control problems from Food and Drug Administration inspectors in February 2021 — six weeks before it alerted federal officials that 15 million doses had been contaminated.
The disclosure got here in a latest report by the Democratic-led House Committee on Oversight and Reform. The report, based on internal company emails, documents and interviews, sheds latest light on Emergent executives’ own worries about deficiencies in the corporate’s quality control systems at its troubled Bayview plant in Baltimore.
The report, released Tuesday morning by the House and the Select Subcommittee on the Coronavirus Crisis, said that each one told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent needed to be destroyed “because of poor quality control,” including about 240 million doses in late 2020 and early 2021. Previous estimates of lost vaccine were far lower; no contaminated doses were ever released to the general public.
“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical corporations and F.D.A. regulators that the corporate’s manufacturing practices were unsafe,” Representative James E. Clyburn, Democrat of South Carolina and the chairman of the House subcommittee on the pandemic, said in a press release.
The Recent York Times reported last yr that a top pandemic preparedness official with Operation Warp Speed, the Trump administration’s fast-track vaccine initiative, warned in June 2020 that counting on the plant would present “key risks” and that the positioning would “need to be monitored closely.”
The identical month, an Emergent executive, Sean Kirk, acknowledged in an email that he had alerted other senior executives “for just a few years” about problems on the plant, writing that “room to enhance is a big understatement.”
In one other email, which he wrote to Robert Kramer, the corporate’s chief executive officer, Mr. Kirk said, “Of all of the things we now have to deliver on OWS,” referring to Operation Warp Speed, “the thing that keeps me up at night is overall perception of state of quality systems at bayview.” Mr. Kirk has since left Emergent.
A spokesman for the corporate, Matt Hartwig, said in an email on Monday night that Emergent had been “open and forthcoming” with the F.D.A. and Congress, noting that the corporate had provided investigators with 1000’s of documents and invited them to tour its facilities. Emergent executives also testified in public before the House subcommittee last May.
“Emergent stays committed to being a trusted partner of the U.S. and allied governments,” Mr. Hartwig wrote, adding that the corporate had not yet seen the House report.
Because the federal government scrambled to secure vaccine manufacturing capability in the course of the early days of the pandemic, it entrusted Emergent with a mammoth task — producing each Johnson & Johnson’s and AstraZeneca’s vaccines at its Baltimore facility. The corporate’s stock price soared on the announcement of a $628 million federal contract and on additional deals with the 2 drugmakers price a combined $656 million.
However the documents released by the House investigators show that a few of Emergent’s own managers feared the corporate was less than the duty.
Upfront of a visit to the plant by F.D.A. officials in September 2020, a senior quality director warned executives that it will be critical to persuade the agency that rapid improvements were underway. “We should not in full compliance yet- BUT- we’re making batches NOW,” the director wrote.
In November 2020, one outside consultant to Emergent wrote that the firm’s manufacturing deficiencies constituted “a direct regulatory risk.”
Throughout the September visit, the agency noted deficiencies. When officials returned in February 2021, Emergent employees sought to cover potential problems, in line with the House report.
Previously, Emergent had placed yellow tags on containers holding a part of a batch of Johnson & Johnson’s vaccine that was suspected to have quality problems. But employees removed the tags shortly before the F.D.A. visit and put them back on after the agency officials had left. Senior managers and an executive vice chairman of the corporate were aware of those actions, the House report found.
In an email obtained by the committee, an outdoor consultant to Emergent wrote that the aim of removing the tags appeared to have been to “avoid drawing attention” to the doubtless problematic containers.
House investigators wrote that “despite this apparent try to impede oversight,” the F.D.A. still identified serious quality concerns, but granted Emergent some leniency. In late March 2021, Emergent notified the Department of Health and Human Services in regards to the contaminated doses. That set off a series of events that culminated with the Biden administration terminating Emergent’s vaccine production contract in November 2021.
