Washington- Emergent BioSolutionsA long-time government contractor hired to produce hundreds of millions of coronavirus vaccine doses hid evidence of quality control issues from Food and Drug Administration inspectors in February 2021 — federal authorities. 6 weeks before warning 15 million doses were contaminated..
This disclosure was made in a new report by the House Committee on Democracy-led Oversight and Reform. Based on internal emails, documents and interviews, this report sheds new light on the concerns of start-up executives themselves regarding flaws in the company’s quality management system at the problematic Bayview plant in Baltimore. ..
Approximately 400 million doses of coronavirus vaccine produced by Emergent are “due to inadequate quality control”, approximately 200 million, according to a report released Tuesday morning by the House of Representatives and the Selection Subcommittee on the Coronavirus Crisis. It had to be destroyed, including 40 million doses. From late 2020 to early 2021. Previous estimates of vaccine loss were much lower. The contaminated dose was never open to the public.
South Carolina Democratic Party Rep. James E. Cryburn and Chairman of the House Subcommittee on Pandemics have warned employees, external consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices are unsafe. Despite being repeated, these doses were wasted. ” In the statement.
New York Times Report last year In June 2020, the Trump administration’s Fast Track Vaccine Initiative, Operation Warp Speed’s Chief Pandemic Countermeasures, said that relying on the plant poses a “significant risk” and the site “needs to be closely monitored. There is. “
In the same month, emerging executive Sean Kirk acknowledged in an email that he had warned other senior executives about the factory’s problems “for years” and wrote that “the room for improvement is very conservative.”
In another email to the company’s CEO, Robert Kramer, Kirk mentioned Operation Warp Speed ”among all that OWS has to offer.” I did. Overall awareness of the state of the quality system in Bayview. After that, Mr. Kirk left Emergent.
The company’s spokesman, Matt Hartwig, said in an email Monday night that Emergent was “open and approaching” to the FDA and Congress, and the company provided thousands of documents to investigators. He said he invited him to visit the facility.Emerging executives too Testimony in public Before the House Subcommittee in May last year.
“Emergent remains committed to being a trusted partner of the US and allied governments,” Hartwig wrote. He added that the company hadn’t seen the house report yet.
The federal government scrambled to secure vaccine production capacity early in the pandemic, so it commissioned Emergent to produce both Johnson & Johnson and AstraZeneca vaccines at its Baltimore facility. bottom.The company’s share price is $ 628 million with the announcement of a federal contract. Additional deals With two people A pharmaceutical company worth a total of $ 656 million.
However, documents released by House investigators show that some of Emergent’s own managers were afraid that the company would not be able to fulfill its mission.
Before FDA authorities visited the plant in September 2020, senior quality officers warned executives that it was important to convince authorities that rapid improvements were underway. “We are not yet fully compliant-but-we are making batches now,” the director writes.
In November 2020, one of Emergent’s external consultants stated that the company’s manufacturing defects constitute “direct regulatory risk.”
During the September visit, authorities pointed out the flaw. House reports that when authorities returned in February 2021, emerging employees sought to hide potential problems.
Previously, Emergent tagged a container holding a portion of a batch of Johnson & Johnson vaccines suspected of having a quality problem with a yellow tag. However, employees removed the tag shortly before the FDA’s visit and replaced it after authorities left. Senior managers and the company’s vice president were aware of those behaviors, the House Report found.
In an email received by the Commission, Emergent’s external consultant wrote that the purpose of removing the tag seems to be to “distract attention” to the potentially problematic container. I am.
Residential investigators wrote that “despite this apparent attempt to disrupt surveillance,” the FDA still identified serious quality concerns, but admitted some generosity to Emergent. In late March 2021, Emergent notified the Department of Health and Human Services about the contaminated dose.It caused a series of events that culminated in the Biden administration Termination of Emergent’s vaccine manufacturing contract November 2021.