Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says

WASHINGTON — Emergent BioSolutions, a longtime government contractor hired to produce hundreds of millions 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 came in a new report by the Democratic-led House Committee on Oversight and Reform. The report, based on internal company emails, documents and interviews, sheds new light on Emergent executives’ own worries about deficiencies in the company’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 all told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent had to be destroyed “due to 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 public.

“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies and F.D.A. regulators that the company’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 statement.

The New York Times reported last year that a top pandemic preparedness official with Operation Warp Speed, the Trump administration’s fast-track vaccine initiative, warned in June 2020 that relying on the plant would present “key risks” and that the site would “have to be monitored closely.”

The same month, an Emergent executive, Sean Kirk, acknowledged in an email that he had alerted other senior executives “for a few years” about problems at the plant, writing that “room to improve is a huge understatement.”

In another email, which he wrote to Robert Kramer, the company’s chief executive, Mr. Kirk said, “Of all the things we 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 company, 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 company had provided investigators with thousands of documents and invited them to tour its facilities. Emergent executives also testified in public before the House subcommittee last May.

“Emergent remains committed to being a trusted partner of the U.S. and allied governments,” Mr. Hartwig wrote, adding that the company had not yet seen the House report.

As the federal government scrambled to secure vaccine manufacturing capacity during the early days of the pandemic, it entrusted Emergent with a mammoth task — producing both Johnson & Johnson’s and AstraZeneca’s vaccines at its Baltimore facility. The company’s stock price soared on the announcement of a $628 million federal contract and on additional deals with the…