Company Hid Problems With COVID Vaccines From FDA

TUESDAY, May 10, 2022 (HealthDay News) — Evidence of quality control problems was concealed by a company contracted by the US government to produce hundreds of millions of COVID vaccine doses, a new House committee report suggests.

It noted that Emergent Biosolutions did not disclose issues at its Bayview plant in Baltimore to US Food and Drug Administration inspectors in February 2021, after the company told federal officials six weeks earlier that 15 million doses had been done. contaminatedThe new York Times informed of.

Nearly 400 million doses of the COVID-19 vaccine made by Emergent had to be destroyed “due to poor quality control,” according to a House Committee on Oversight and Reform report, which was based on internal company emails, documents and interviews.

This is much higher than the previous estimates. No contaminated doses were issued to the public, Times informed of.

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James Clyburn (DS.C.), chairman of the House subcommittee on the pandemic, said, “These supplements were doomed despite repeated warnings from employees, outside consultants, drug companies and FDA regulators that the company’s manufacturing practices are unsafe. was.” a statement.

Company spokesman Matt Hartwig said Emergent has been “open and forthcoming” with the FDA and Congress by providing thousands of documents and inviting them to tour its facilities. Statement,

Last May, rising officials testified publicly before a House subcommittee.

“Emergent is committed to being a trusted partner of the US and allied governments,” Hartwig said.

Documents released by House investigators show that some of Emergent’s managers weren’t sure the company could handle the government’s order.

Before FDA officials visited the Baltimore plant in September 2020, a senior quality director at Emergent advised officials that it would be important to convince the agency that the company was rapidly improving, Times informed of.

“We are not yet in full compliance – but – we are batch making now,” the director wrote.

Last year, Times reported that in June 2020, a top official with the Trump administration’s fast-track vaccine initiative, called Operation Warp Speed, cautioned that relying on Emergent’s Baltimore plant would pose “major risks” and could harm the site. Will have to be closely monitored.”

In November 2021, the Biden administration terminated Emergent’s COVID-19 vaccine production contract.

For more information visit the US Centers for Disease Control and Prevention covid vaccine,

originally published on consumer.healthday.comPart of townnews content exchange,

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