The details of the investigation by the House Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform, released Tuesday, which include troves of internal emails, underscore the degree to which Emergent staff and consultants working with the company knew of the extensive issues at Bayview before moving forward with U.S. government and pharmaceutical contracts to produce the shots.
“The [Food and Drug Administration] identified concerns at the Emergent plant in April 2021” and “immediately took swift action,” a spokesperson told POLITICO. “We have not allowed the distribution of any product without first conducting a thorough review of facility records and the results of quality testing performed by the manufacturer.”
Emergent remains committed to being a trusted partner of the federal government, said Matt Hartwig, a company spokesperson.
“Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities,” he said.
Hartwig, in a statement released later Tuesday, said the company never knowingly misled the FDA, but would not specifically deny that the company hid potentially problematic batches from federal authorities. He also disputed the report’s assertion that nearly 400 million doses had to be discarded because “It is very difficult to estimate dose equivalents for batches that do not complete the manufacturing process or leave the facility to be turned into vaccine.”
A spokesperson for J&J said the company cooperated with the committee.
“Since the start of the pandemic, [J&J subsidiary] Janssen has worked to produce a safe, high-quality COVID-19 vaccine,” the spokesperson said in a statement. AstraZeneca did not immediately respond to requests for comment.
POLITICO was first to report about the early warnings from individuals working on the Trump administration’s Operation Warp Speed about Emergent’s problems. But the congressional investigation provides new details on the internal Emergent warnings about the problems the company could face scaling production for the Covid-19 shots.
“Doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe,” said Rep. Jim Clyburn (D-S.C.), chair of the coronavirus committee. “Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements.”
Even in the early days of the Trump administration’s $628 million contract with Emergent, officials from the administration raised concerns about the company’s ability to scale manufacturing.
In April 2020, the Biomedical Advanced Research and Development Authority found that the Bayview facility was not in compliance with standard manufacturing codes and “failure of quality systems,” according to committee 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 lead manufacturing officials on Operation Warp Speed, wrote an internal letter warning other administration officials that Emergent lacked enough trained staff to carry out large-scale Covid-19 vaccine manufacturing, according to two individuals 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 mix-ups are deficient.”
Still, the Trump administration moved forward with the contract, in large part because there were few other manufacturing sites in the U.S. that could help produce the vaccine, one of the people familiar with the matter said. AstraZeneca and Johnson & Johnson also became aware of the problems at Bayview after conducting audits in June 2020. Both pharmaceutical companies documented quality control issues and contamination deficiencies, the investigation found.
The administration advised Emergent, AstraZeneca and Johnson & Johnson to hire consultants with the ability to ensure Emergent could maintain the highest standards as it began to produce the vaccine, one of the people familiar with the matter said.
“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 committees.
In June of 2020, the FDA wrote Emergent, saying the company’s responses to the regulators’ April 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 senior Emergent executive, John Ducote, the senior vice president of global quality.
“After all the assurances from you that we were putting our best foot forward on this response, this is deeply concerning. That concern is exponentially amplified as we ramp up to produce hundreds of millions of doses of Covid vaccine. Fix this,” Kirk wrote, according to the investigation.
Kirk also expressed dismay at the FDA’s letter to Robert Kramer, Emergent’s president and chief executive officer, on Jun 24, 2020, writing in an email: “Bob … of all the things we have to deliver on OWS, the thing that keeps me up at night is overall perception of state of quality systems at [B]ayview.”
Despite the internal anxiety about the company’s quality systems, Emergent moved forward to finalize contracts with Johnson & Johnson and AstraZeneca to manufacture the vaccines in July 2020 for $482 million and $174 million, respectively. Emergent executives, including Kirk, assured the pharmaceutical companies that it had the systems and staff in place to scale production throughout the summer of 2020, according to the committees.
Concerns about quality-control systems continued to circulate inside Emergent, in the U.S. government and among the pharmaceutical companies, throughout the fall — before and after a second FDA inspection in September.
In November 2020, an outside consultant to Emergent warned the company that it was not compliant 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 of those where you really better listen to me and do exactly what I tell you to … I am stating very loudly that this work is NON-CGMP compliant. And a direct regulatory risk,” the consultant wrote to the company, according to the committee documents.
Despite the red flags, the work at Emergent continued even though the company “did not remediate the issues, and problems persisted at the facility for months,” the investigation found.
Although the U.S. government did not learn about contaminated doses at Bayview until an FDA inspection in February 2021, congressional documents show that between October and November 2020, Emergent “aborted or rejected” seven batches of AstraZeneca’s vaccine “due to microbial contamination.” Six additional batches of AstraZeneca were aborted or rejected between December 2020 and April 2021, right before the contamination of the 15 million doses in March 2021 — the drug substance mixup that led to a halt in production.
In December 2020, “microbial contamination and equipment failure necessitated the termination of roughly 30 million Johnson & Johnson doses.” An additional 30 million doses were discarded between March and April 2021, the investigation found.
“[The] investigation found that in late 2020 and early 2021, Emergent’s failure to follow current good manufacturing practices at Bayview led to the destruction of more than 240 million vaccine doses … significantly more than revealed previously,” the committees’ report said. “An additional 60 million doses of AstraZeneca’s vaccine will be destroyed — at significant taxpayer expense — because the drug substance has passed its expiration date.”
Emergent staff hid evidence about the company’s manufacturing issues from FDA inspectors during a visit to the Bayview facility in February 2021, according to the committees’ probe.
Employees removed hold tags highlighting potential quality issues from batches of the Johnson & Johnson vaccines “to avoid drawing attention” from inspectors, as one contractor said in an internal message shared in the congressional report.
The “yellow and conspicuous” tags were placed back on the two containers after FDA inspectors left, the contractor said. Top Emergent executives including the vice president of manufacturing operations, the quality assurance manager, the senior manager in quality systems, and the senior director of quality were aware this happened, according to the congressional committees’ findings.
Despite the efforts, the FDA still raised several concerns about the facility after the February visit, according to Peter Marks, the agency’s top vaccine official, who briefed the committees on its findings. Within weeks, the company would identify more contaminated batches of the J&J vaccine.
Officials with the Department of Health and Human Services sent questions about the contamination to Emergent employees in late March, prompting the Bayview facility’s Head of Quality, Tammy Lucik, to write in an internal email that government officials were getting “too involved,” according to the committees’ report.
A senior executive wrote back advising Lucik to say the company is “actively working on the investigation” and would share its conclusions with government authorities through J&J.
Meanwhile, both J&J and AstraZeneca raised alarms about Emergent’s manufacturing and quality-control processes throughout 2020 and early 2021. Even before the AstraZeneca substance was mixed up with J&J doses, Emergent scrapped millions of doses of each vaccine over antimicrobial contamination and in J&J’s case, equipment failure in late 2020.
In October 2020, J&J employees wrote in internal messages that Emergent still was not prepared for mass manufacturing, citing issues from mold to floor damage and overcrowded equipment in an email to Emergent quality-control staff.
But J&J elected to “move forward” with manufacturing at Bayview on Nov. 19, 2020. “This is not without known risks as have been previously communicated,” J&J’s director of pharmaceutical regulatory compliance wrote in an internal message.
Ultimately, the Emergent partnerships cost the government $330 million before the Biden administration terminated the deal last November. BARDA Director Gary Disbrow told the committees they chose not to terminate for default or cause — which may have reaped back some payments — because of concerns it could become even costlier in legal battles.
Approximately 390 million vaccine doses have been or will be destroyed, 330 million for quality-control reasons and 60 million because the substance expired while waiting for safety checks. Another 135 million are still undergoing testing while FDA safety checks authorized 165 million J&J doses and 15 million AstraZeneca doses for use.
Under the terms of their agreement with AstraZeneca, the U.S. will still pay $176,000 for the 60 million expired doses.
“Shame on us for thinking that their experience in manufacturing would mean they would be able to move ahead and make the vaccines in a high-quality manner that we would expect for an experienced vaccine manufacturer,” Marks told committee members in a bipartisan briefing. “This has been a clear learning experience not to make assumptions.”
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