Details of the House Select Subcommittee’s investigation into the coronavirus crisis, released Tuesday, which include internal email trophies, underscore the degree to which emerging staff and consultants working with the company were aware of Bayview’s broad issues. before going ahead with US government and pharmaceutical contracts to produce the shots.
“The [Food and Drug Administration] identified concerns about the emerging plan in April 2021 “and” immediately took swift action, “a spokesperson told POLITICO.” We have not allowed distribution of any products without first conducting a thorough review of the facility’s records and the results of the quality tests performed by the manufacturer “.
Emergent remains committed to being a trusted partner of the federal government, said Matt Hartwig, a spokesperson for the company.
“We have not received the report and sadly we are learning about it for the first time in the media,” he said. “Emergent has been open and available to the FDA, Congress and our partners about working on our Bayview site and the challenges that have been encountered, including providing thousands of documents, voluntarily attending a Congressional hearing and l ‘invitation to visit our facilities “.
J&J and AstraZeneca did not immediately respond to requests for comment.
POLICY what first to report on early warnings from the people working on the Trump administration’s Operation Warp Speed about Emergent’s problems. But the Congressional investigation provides new details on emerging internal warnings about problems the company could face in scaling production for the Covid-19 strikes.
“Doses were wasted despite repeated warnings from FDA employees, outside consultants, pharmaceutical companies and regulators that the company’s manufacturing practices were unsafe,” the rep said. Jim Clyburn (DS.C.), chairman of the committee. “Emerging executives prioritized profits over producing vaccines responsibly and in compliance with FDA requirements.”
Even in the early days of the Trump administration’s $ 628 million contract with Emergent, administration officials voiced concerns about the company’s ability to scale production.
In April 2020, the Authority for Advanced Biomedical Research and Development found that the Bayview facility was not compliant with standard manufacturing codes and “failure of quality systems,” according to the committee’s documents. The FDA conducted its own inspection that same month and identified similar quality control problems.
Later that spring, Carlo de Notaristefani, one of the main production officials of Operation Warp Speed, written by internal letter warning other administration officials that Emergent did not have enough qualified personnel to carry out large-scale production of Covid-19 vaccines, according to two people familiar with the matter who were granted anonymity to speak candidly about the situation. That letter was largely ignored, one of the people said. The FDA also completed an inspection of the Bayview facility in April 2020 and identified multiple problems, noting that “separate or defined areas to prevent contamination or misunderstanding are lacking.”
However, the Trump administration pushed the contract forward, largely because there were few other manufacturing sites in the United States that could help make the vaccine, one of the people familiar with the matter said. AstraZeneca and Johnson & Johnson also became aware of Bayview’s problems after conducting audits in June 2020. Both pharmaceutical companies documented quality control issues and contamination deficiencies, according to the investigation.
The administration advised Emergent, AstraZeneca, and Johnson & Johnson to hire consultants who could ensure Emergent could maintain the highest standards when it began manufacturing the vaccine, said one of the people familiar with the matter.
“Both companies accepted Emergent’s plans to address the observations with the understanding that they would work closely with Emergent to mitigate and address ongoing issues,” according to documents released by the committee.
In June 2020, the FDA wrote to Emergent, saying the company’s responses to the April regulatory authorities’ inspection were not acceptable and that it was “not ready to support commercial operations,” the investigation documents show.
Sean Kirk, Emergent’s then executive vice president of manufacturing and technical operations, emailed another Emergent senior executive, John Ducote, senior vice president of global quality.
“After all the assurances from you that we were doing our best on this answer, this is deeply concerning. This concern is amplified exponentially as we approach the production of hundreds of millions of doses of the Covid vaccine. Solve this, ”Kirk wrote, according to the investigation.
Kirk also expressed dismay at the FDA letter to Robert Kramer, President and CEO of Emergent, on June 24, 2020, writing in an email: “Bob … of all the things we have to provide on OWS, the what keeps me awake at night is the overall perception of the state of the quality systems a [B]ayview.
Despite internal anxiety over the company’s quality systems, Emergent went ahead to finalize contracts with Johnson & Johnson and AstraZeneca to manufacture the vaccines in July 2020 for $ 482 million and $ 174 million, respectively. According to the committee, emerging executives, including Kirk, have assured drug companies that they have the systems and staff to scale production throughout the summer of 2020.
Concerns about quality control systems continued to circulate within Emergent, the US government, and pharmaceutical companies throughout the fall, before and after a second FDA inspection in September.
In November 2020, an external consultant from Emergent warned the company that it did not comply with 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 where it’s really best to listen to me and do exactly what I tell you … I’m stating very loudly that this job is NOT- Compliant to CGMP. It’s a direct regulatory risk, “the consultant wrote to the company, according to committee documents.
Despite the red flags, work at Emergent continued even though the company “did not resolve the problems and the problems persisted in the facility for months,” the investigation found.
Although the US government was unaware of the contaminated doses in Bayview until an FDA inspection in February 2021, Congressional documents show that between October and November 2020, Emergent “aborted or rejected” seven batches of the vaccine. of AstraZeneca “due to microbial contamination”. Six additional batches of AstraZeneca were discontinued or rejected between December 2020 and April 2021, just before the contamination of the 15 million doses in March 2021, the drug mix that led to the discontinuation of production.
In December 2020, “microbial contamination and equipment failure necessitated the suspension of approximately 30 million doses of Johnson & Johnson.” An additional 30 million doses were discarded between March and April 2021, according to the survey.
“[The] the investigation found that in late 2020 and early 2021, Emergent’s failure to follow current good manufacturing practices in Bayview led to the destruction of more than 240 million doses of the vaccine … significantly more than disclosed earlier, “the committee report said.” An additional 60 million doses of AstraZeneca’s vaccine will be destroyed, at significant expense to taxpayers, because the drug is past its expiration date.
Minimizing the problems
Emerging personnel withheld evidence of the company’s manufacturing problems from FDA inspectors during a visit to the Bayview plant in February 2021, according to the committee’s investigation.
Employees removed wait tags that highlighted potential quality problems from Johnson & Johnson vaccine batches “to avoid drawing attention” of inspectors, as a contractor said in an internal message shared in the Congressional report.
The “flashy yellow” labels were placed back on the two containers after FDA inspectors left, the contractor said. According to the Congressional Committee’s findings, the top emerging executives, including the Vice President of Manufacturing Operations, the Head of Quality Assurance, the Senior Quality Systems Manager, and the Senior Quality Director, were aware that this had happened. .
Despite efforts, the FDA still raised several concerns about the facility after the February visit, according to Peter Marks, the agency’s chief vaccine officer, who briefed the committee on its findings. Within weeks, the company would have identified more contaminated batches of the J&J vaccine.
Department of Health and Human Services officials sent questions about the contamination to emerging employees in late March, prompting Bayview facility quality chief Tammy Lucik to write in an internal email that government officials they were “too involved”, according to the commission’s report.
A senior executive responded by advising Lucik to say the company is “actively working on the investigation” and will share his findings with government authorities via J&J.
Meanwhile, both J&J and AstraZeneca have raised alerts on Emergent’s manufacturing and quality control processes throughout 2020 and early 2021. Even before the AstraZeneca substance was mixed with J&J doses, Emergent discarded millions of doses of each vaccine due to antimicrobial contamination and, in the case of J&J, Equipment Failure in late 2020.
In October 2020, J&J employees wrote in internal messages that Emergent was not yet prepared for mass production, citing issues from mold to floor damage and overcrowded equipment in an email to Emergent’s quality control staff. .
But J&J decided to “move forward” with manufacturing at Bayview on November 19, 2020. “This is not without known risks as previously disclosed,” J & J’s Director of Pharmaceutical Regulatory Compliance wrote in an internal message.
Ultimately, Emergent’s partnerships cost the government $ 330 million before the Biden administration ended the deal last November. BARDA director Gary Disbrow told the committee that he chose not to terminate due to default or lawsuit – that he may have collected some payments – due to concerns that they could become even more expensive in legal battles.
About 390 million doses of the vaccine have been or will be destroyed, 330 million for quality control reasons and 60 million because the substance has expired pending safety checks. Another 135 million are still being tested while FDA security controls have authorized 165 million doses of J&J and 15 million doses of AstraZeneca for use.
Under the terms of their agreement with AstraZeneca, the United States will still pay $ 176,000 for the 60 million overdue doses.
“Shame on you for thinking that their experience in manufacturing would mean that they would be able to go ahead and produce the vaccines in a high-quality way that we would expect from a skilled vaccine manufacturer,” Marks told committee members in a bipartisan briefing. “This was a clear learning experience for not guessing.”