June 29, 2022

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Emergent BioSolutions hid evidence of COVID vaccine problems from FDA

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Emergent BioSolutions hid evidence of COVID vaccine problems from FDA

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, NYT reports.

The disclosure came in a report released by House Democrats, who said that all told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent had to be destroyed “due to poor quality control.” Previous estimates of lost vaccine were far lower; no contaminated doses were ever released to the public.

The report, issued jointly by the House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis, is the product of an investigation that began last year, after The New York Times documented months of problems at Emergent’s troubled Bayview plant in Baltimore. Based on internal company emails, documents and interviews, it sheds fresh light on Emergent executives’ own concerns about quality control deficiencies.

“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies and FDA regulators that the company’s manufacturing practices were unsafe,” Rep. James E. Clyburn, D-S.C., the chairman of the House subcommittee on the pandemic, said in a statement.

Emergent “disputes the claim that 400 million doses of vaccine were rendered unusable” and “refutes the allegation that it knowingly misled the FDA or any of our public and private partners,” a company spokesperson, Matt Hartwig, said in an email.

Hartwig said it was hard to know how many doses were wasted because, when discarding batches of drug ingredients, it is difficult to estimate dose equivalents. He said the company “sought to be overly transparent” with regulators and lawmakers, by sharing documents, having its executives testify in Congress and inviting House investigators to its facilities for a tour.

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 two drugmakers worth a combined $656 million.

Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. In March of last year, before news of the contamination problem became public, the Times reported that purchases of Emergent’s anthrax vaccines for the Strategic National Stockpile accounted for nearly half of the stockpile’s half-billion-dollar annual budget throughout most of the last decade, leaving the federal government with less money to buy the kind of supplies needed in a pandemic.

In 2012, the company was designated a Center for Innovation in Advanced Development and Manufacturing under a program that aimed to create a manufacturing base that the government could rely on in the event of an infectious disease emergency. In May 2020, the Trump administration turned to Emergent to produce coronavirus vaccines through Operation Warp Speed.

But both the company and the government knew it was a dicey proposition.

In April 2020, a month before the Warp Speed agreement was finalized, FDA inspectors identified problems with quality control at the Baltimore plant, including that “separate or defined areas to prevent contamination or mix-ups are deficient,” according to the House report.

Confidential audits obtained by the Times last year showed that Johnson & Johnson and AstraZeneca — as well as the division of the Department of Health and Human Services that oversaw Emergent’s contract — all found deficiencies in the summer of 2020. That June, the month after the agreement with Warp Speed was signed, a top pandemic-preparedness official warned that relying on the Baltimore plant would present “key risks” and that the site would “have to be monitored closely,” the Times reported.

Internal emails obtained by the House investigators show that Emergent executives were deeply concerned about those findings. Sean Kirk, who ran the company’s manufacturing operations, wrote in a June 2020 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, 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.” Kirk has since left Emergent.

Outwardly, though, the company maintained it was ready. But by the fall, the House report shows, Emergent’s own concerns about quality were mounting in advance of a visit to the plant by FDA officials.

Before the inspectors arrived that September, a senior quality director warned executives that it would be critical to convince the agency that rapid improvements were underway. “We are not in full compliance yet- BUT- we are making batches NOW,” the director wrote.

In November 2020, one outside consultant to Emergent laid out the stakes in stark terms, noting that the firm was deviating from Current Good Manufacturing Practices, or CGMP.

“Ultimately Emergent will have to decide what level of risk they are willing to accept, but this is one of those where you really better listen to me and do exactly what I tell you to,” the consultant wrote. “I am stating very loudly that this work is NON-CGMP compliant. And a direct regulatory risk.”

During the September visit, the agency noted deficiencies. When officials returned in February 2021, Emergent employees sought to hide potential problems, according to the House report.

Previously, Emergent had placed yellow tags on containers holding part of a batch of Johnson & Johnson’s vaccine that was suspected to have quality problems. But employees removed the tags shortly before the FDA visit and put them back on after the agency officials had left. Senior managers and an executive vice president of the company were aware of those 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 have been to “avoid drawing attention” to the potentially problematic containers.

House investigators wrote that “despite this apparent attempt to impede oversight,” the FDA still identified serious quality concerns, but granted Emergent some leniency.

In late March 2021, Emergent notified the Department of Health and Human Services about the contaminated doses. That set off a series of events that led to the House investigation, and culminated with the Biden administration terminating Emergent’s vaccine production contract in November 2021.

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