Details of the investigation by the selected subcommittee of the Coronavirus Crisis Chamber and the Committee of Oversight and Reform, published on Tuesday, including internal emails, underscore the extent to which the ambulance staff and consultants working with the company were aware of extensive issues. At Bayview, before continuing to produce staff with the U.S. government and pharmaceutical contracts.
„ [Food and Drug Administration] “We’re not allowing any product to be distributed without a thorough review by the manufacturer ‘s records and quality test results,” a POLITICO spokesman told POLITICO.
Emergent remains committed to being a trusted partner of the federal government, said Matt Hartwig, the company’s spokesman.
“Emergent is open and ready to work with the FDA, Congress, and our partners on our Bayview site and the challenges, including delivering thousands of documents, volunteering for congressional hearings, and inviting them to our facilities. Said.
Hartwig, in a statement issued Tuesday, said the company had deliberately never misled the FDA, but did not specifically deny that the company was hiding potentially troubled parties from the federal government. He also denied reports that about 400 million doses should be discarded because “it is very difficult to estimate dose equivalents for parties who do not complete the production process or leave the facility to be vaccinated.”
A J&J spokesman said the company was cooperating with the committee.
“Since the beginning of the pandemic, [J&J subsidiary] “Jansen was working on a safe, high-quality COVID-19 vaccine,” the spokesman said. AstraZeneca did not immediately respond to a request for comment.
It was POLITICO The first report The Trump administration’s operation on Warp Speed early warnings about emergent problems. But the congressional inquiry provides new details about internal emergency warnings about problems the company may face in producing scalable Covid-19 shots.
“The doses were squandered, despite repeated warnings from employees, outside consultants, pharmaceutical companies and FDA regulators that the company’s manufacturing practices were dangerous,” he said. Jim Cliburn (DS.C.), Chairman of the Coronavirus Committee. “American executives preferred to make a profit by being responsible for producing vaccines that met FDA requirements.”
Even in the early days of the Trump administration’s $ 628 million contract with the administration, administration officials expressed concern about the scale of the company’s capacity.
In April 2020, the Advanced Biomedical Research and Development Authority determined that the Bayview facility did not comply with standard production codes and “quality system malfunctions,” according to committee documents. The FDA conducted its own inspection the same month and identified similar quality control problems.
Later that spring, Carlo de Notaristefan, one of the leading production representatives in Operation Warp Speed, Wrote an internal letter Warned other administration officials that Emergent did not have sufficiently trained staff for the large-scale production of the Covid-19 vaccine, according to two people familiar with the matter who were given anonymity to speak candidly about the situation. This letter was largely ignored, said one person. The FDA also completed its Bayview facility inspection in April 2020 and identified a number of problems, noting that “isolated or designated areas are deficient to prevent contamination or mixing.”
Still, the Trump administration has pushed the contract forward, largely because there were several other manufacturing sites in the United States that could have helped produce the vaccine, said one person familiar with the matter. AstraZeneca and Johnson & Johnson were also aware of any problems with Bayview following an audit in June 2020. Both pharmaceutical companies fixed quality control issues and contamination deficiencies, the investigation found.
The administration has advised Emergent, AstraZeneca and Johnson & Johnson to hire consultants who can ensure Emergent could maintain the highest standards when starting vaccine production, said one person on the issue.
“Both companies have adopted Emergent monitoring plans in the sense that they will work closely with Emergent to address and resolve ongoing issues,” the committees said in a statement.
In June 2020, the FDA wrote Emergent, stating that the company’s responses to the regulators’ April inspection were unacceptable and that it was “not ready to support commercial operations,” according to the investigation documents.
Sean Kirk, the then Executive Vice President of Emergent for Manufacturing and Technical Operations, emailed another emergent CEO, John Ducot, the Senior Vice President for Global Quality.
“After all the assurances from you that we were doing our best to answer this, it is deeply troubling. This concern is growing exponentially as we accelerate the production of hundreds of millions of doses of Covid vaccine. “Correct it,” Kirk wrote, according to the investigation.
Kirk also expressed concern about a letter from the FDA to Emergent President and CEO Robert Kramer on June 24, 2020, in which he wrote an e-mail: At night is a general perception of the state of quality systems [B]ayview. ”
Despite internal concerns about the company’s quality systems, Emergent has pushed to complete contracts with Johnson & Johnson and AstraZeneca to produce vaccines in July 2020 for $ 482 million and $ 174 million, respectively. According to committees, emergency executives, including Kirk, convinced pharmaceutical companies that it had the systems and personnel to increase production by the summer of 2020.
Concerns about quality control systems continued to erupt in Emergent, the U.S. government, and pharmaceutical companies throughout the fall – before and after the second FDA review in September.
In November 2020, an emerging consultant for Emergent warned the company that it was not in line with current good manufacturing practices or the CGMP. “Ultimately, Emergent will have to decide what level of risk it wants to take, but this is one of them where you really’s better to listen to me and do exactly what I tell you… I say very loudly that this work is not CGMP compatible. And direct regulatory risk, ”the consultant wrote to the company, according to committee documents.
Despite the red flags, work at Emergent continued, despite the fact that the company “did not fix the problems and the problems existed at the facility for months,” the investigation found.
Although the U.S. government did not find out about contaminated doses at Bayview before the FDA inspection in February 2021, congressional documents show that from October to November 2020, Emergent “stopped or denied” seven batches of AstraZeneca vaccine “for microbial contamination. Due to “. Six additional batches of AstraZeneca were discontinued or rejected from December 2020 to April 2021, with 15 million doses of contamination in March 2021 – mixing of the drug substance, which led to the cessation of production.
In December 2020, “microbial contamination and equipment shortages required the discontinuation of approximately 30 million doses of Johnson & Johnson.” The investigation found that an additional 30 million doses were canceled between March and April 2021.
“[The] “The investigation found that emergent failures in late 2020 and early 2021 led to the ongoing good manufacturing practice at Bayview leading to the destruction of more than 240 million doses of the vaccine, significantly more than previously identified,” the committee said in a statement. “An additional 60 million doses of AstraZeneca vaccine will be destroyed – at the expense of a significant taxpayer – because the drug has an expiration date.
According to a committee investigation, emergency staff hid evidence from FDA inspectors about the company’s production issues during a February 2021 visit to the Bayview facility.
Employees removed arrest tags highlighting Johnson and Johnson’s vaccine parties “so as not to attract attention,” one contractor said in an internal message shared in a congressional report.
According to the contractor, the “yellow and visible” tags were again placed on the two containers after the departure of FDA inspectors. According to congressional committee findings, top ambulance executives, including the vice president of manufacturing operations, the quality assurance manager, the senior quality systems manager, and the senior quality director, knew this had happened.
Despite the efforts, the FDA still raised some concerns about the facility after a February visit to the agency, said Peter Marks, the agency’s chief vaccine official, who briefed the committees on his findings. In a few weeks, the company will identify more contaminated batches of J&J vaccine.
Health and Human Services Department officials sent questions of contamination to Emergent staff in late March, prompting Bayview’s quality director, Tammy Lukick, to write in an internal email that government officials were “overly involved.” Report of the committees.
The chief executive wrote to Lukik that the company was “actively working on the investigation” and would share its findings with government officials through J&J.
Meanwhile, J&J and AstraZeneca have issued emergent production and quality control processes for 2020 and early 2021. Even before AstraZeneca was mixed in J&J doses, Emergent canceled millions of doses of each vaccine due to antimicrobial cases. Equipment shortage by the end of 2020.
In October 2020, J&J employees wrote in internal messages that Emergent was not yet ready for mass production, citing problems ranging from form to floor damage and overloaded equipment in a letter from Emergent quality control personnel.
But J&J chose to “go ahead” in production at Bayview on November 19, 2020. “It’s not known to be risk-free, as stated earlier,” J & J’s director of pharmaceutical compliance said in an internal statement.
Eventually, the Emergent Partnership cost the government $ 330 million before the Biden administration terminated the deal last November. BARDA Director Gary Disbrow told the committees that they chose not to stop for a default or reason – which might have led to some back payouts – because it might become more expensive in legal battles.
Approximately 390 million doses of the vaccine have been or will be destroyed, 330 million due to quality control reasons and 60 million due to the substance expiring pending safety inspection. Another 135 million are still being tested, and an FDA safety check has approved 165 million J&J doses and 15 million AstraZeneca doses for use.
Under the terms of the contract with AstraZeneca, the US will still pay $ 176,000 for 60 million overdue doses.
“It is a shame for us to think that their experience in manufacturing means that they will be able to go ahead and make vaccines of the highest quality that we expect from an experienced vaccine manufacturer,” Marx told committee members at a bipartisan briefing. “It was an obvious learning experience not to make assumptions.”
Emergent’s Covid vaccine problems are more widespread than previously known
Source link Emergent’s Covid vaccine problems are more widespread than previously known