According to a congressional report published Tuesday, Emergent BioSolutions was forced to discard or destroy up to 400 million coronavirus vaccine doses between March 2020 and February 2022 due to quality-control issues, a figure that is more than five times what the beleaguered firm previously disclosed.
According to the report, problems included contamination of vaccine ingredients, as well as equipment failures and employee errors.
Congressional investigators investigating the Maryland-based biotech firm discovered that Emergent executives privately raised urgent quality-control concerns even before the company began manufacturing the vaccines’ key ingredient, despite publicly expressing confidence in their ability to deliver on their multimillion-dollar government contract.
Meanwhile, Emergent lab workers, according to the report, purposefully misled government inspectors about issues at its Bayview, Maryland, plant, and repeatedly “rebuffed” efforts by AstraZeneca and Johnson & Johnson to inspect their facilities.
According to the committees, none of the tainted batches of the ingredient in question made it into finished vaccine doses released from Emergent’s plant.
The House Oversight Committee and the House Subcommittee on the Coronavirus Crisis issued a joint report on Tuesday that summarized the findings of their yearlong investigation into Emergent’s quality control issues. As part of their efforts, committee investigators obtained internal Emergent emails and interviewed several key witnesses, including senior FDA officials.
In May 2020, the Biomedical Advanced Research and Development Authority awarded Emergent a $628 million contract to help develop Johnson & Johnson and AstraZeneca vaccines at its Bayview facility as part of Operation Warp Speed, the Trump administration’s rapid vaccine development program.
However, according to the committees’ report, problems at Bayview began even before the company received its vaccine-development contract. During the spring of 2020, executives and managers expressed growing concern about the firm’s response to an April 2020 FDA audit that revealed troubling safety deficiencies in a flurry of internal emails.
Sean Kirk, an Emergent executive at the time, told a quality-control manager in a June 2020 email that the situation was “deeply concerning” and demanded that he “fix this.” Kirk wrote in an email to another colleague the same day that “room for improvement” in the Bayview plant’s quality control systems was “a huge understatement.”
Outwardly, the company claimed that its longstanding relationship with US government agencies, which included multiple contracts to develop anthrax vaccines, demonstrated its competence. However, alarm bells continued to ring internally, according to the report, and concern about Bayview’s readiness grew.
According to the congressional report, the drumbeat of concern about quality control at Bayview reached a fever pitch in the fall of 2020, when internal memos ahead of a September 2020 FDA inspection revealed that executives were fully aware of gaps in quality control measures for months after vaccine development began.
According to an email obtained by the committees, in November 2020, an outside consultant warned the company that “ultimately Emergent will have to decide what level of risk they are willing to accept, but this is one of those where you really need to listen to me and do exactly what I tell you to.”
According to the report, Emergent executives admitted in internal emails that in their rush to ramp up production, they hired temporary employees with “little or no pharmaceutical experience” and described trash “piling up” in their facilities. Emergent “hired a lot of individuals who were not as familiar with vaccine manufacturing and did not have adequate training to do so” — a message it conveyed directly to Emergent as early as April 2020.
The committee found that despite these red flags, Emergent “did not remediate the issues, and problems persisted at the [Bayview] facility for months.” And from late 2020 to early 2021, the committee wrote, a series of contaminations at Bayview led to the disposal of enough vaccine drug ingredients to produce 240 million doses.