Committees’ Report on Emergent BioSolutions Uncovers Extensive Vaccine Manufacturing Failures, Deliberate Efforts to Hide Deficiencies
Washington, D.C. (May 10, 2022)—Today, Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, released a staff report on their joint investigation into coronavirus vaccine manufacturing failures of Emergent BioSolutions, Inc. (Emergent) under a contract awarded by the Trump Administration despite the company’s history of serious deficiencies. Today’s release follows the Committees’ May 2021 staff report detailing the Trump Administration’s decision to pay Emergent millions of dollars despite warnings about the company’s readiness and manufacturing failures.
New evidence shows that nearly 400 million doses of coronavirus vaccines—significantly more than previously known—were destroyed because of Emergent’s failure to meet or maintain quality standards at its Bayview manufacturing facility. Internal communications reveal efforts by Emergent executives to hide evidence of contamination in an attempt to evade oversight from government regulators.
Chairwoman Maloney released the following statement about the report:
“Today’s report shows that Emergent profited from the pandemic while violating the public’s trust. Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars. Ultimately, our report shows that Emergent’s manufacturing failures and deceptive tactics led to the destruction of millions of doses of desperately needed vaccines. Emergent’s business practices are simply unacceptable, and I urge the federal government to carefully consider future contracts in light of Emergent’s failures.”
Chairman Clyburn released the following statement about the report:
“Today’s staff report demonstrates how Emergent BioSolutions and its executives failed the American people through the contamination of hundreds of millions of desperately-needed vaccines at a pivotal point in the pandemic. These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe and that it was unlikely to fulfill the contract recklessly awarded by the Trump Administration. Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements. I commend the Biden Administration for terminating their contract following these unacceptable actions.”
Today’s staff report, entitled “The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions,” is available in full here and reveals the following key findings:
Nearly 400 million doses of coronavirus vaccines have been destroyed as a result of Emergent’s failure to meet or maintain quality standards. This includes millions of vaccine doses that were destroyed after FDA ordered a three-month halt of manufacturing activities between April and August 2021.
Emergent hid evidence of contamination from government inspectors.
Immediately before an FDA site visit in February 2021, Emergent employees removed quality-assurance “hold tags” from Johnson & Johnson vaccine batches, which indicated that the containers had a potential quality issue. An email obtained by the Committees states that the tags were removed “to avoid drawing attention” from FDA inspectors.
New documents also show that Emergent personnel expressed concern that HHS was “getting too involved” following the company’s cross-contamination of the Johnson & Johnson and AstraZeneca vaccines in March 2021.
Emergent executives promoted the company’s manufacturing capabilities despite being warned of severe deficiencies.
Documents obtained by the Committees reveal that before Emergent finalized manufacturing agreements with Johnson & Johnson and AstraZeneca, Emergent’s then-Executive Vice President of Manufacturing and Technical Operations privately acknowledged that he had warned Emergent senior executives “for a few years” about the company’s deficient quality systems, saying that “room to improve is a huge understatement.”
Despite these internal warnings, Emergent entered into contracts with Johnson & Johnson and AstraZeneca to manufacture coronavirus vaccines for $482 million and $174 million, respectively. Internal Emergent communications reveal that after manufacturing began, the Senior Director of Quality at the facility warned, “Our risk is high!” and, “we lack commercial GMP [good manufacturing practices] compliance maturity.”
FDA, Johnson & Johnson, and AstraZeneca identified multiple deficiencies at Bayview, which Emergent failed to remediate despite urgent warnings.
In July 2020, AstraZeneca personnel noted that they were “concerned that the FDA observation was that Emergent isn’t prepared for commercial manufacturing as things stand currently, and yet we will start commercial manufacture [sic] there very soon.”
Internal Johnson & Johnson communications from October 2020 reveal that the Director of Regulatory Compliance warned it was “unclear” if the Emergent’s Bayview site was ready to begin manufacturing and “effectively manage all the remediation efforts.”
An outside consultant to Emergent provided a stark warning in November 2020: “I am stating very loudly that this work is NON-CGMP compliant. And a direct regulatory risk.”
Inexperienced staff and high staff turnover at Emergent contributed to the vaccine contamination.
Emergent acknowledged in July and August 2020 that its staff were insufficiently trained, noting that “most temporary employees [have] little or no pharmaceutical experience.”
AstraZeneca concluded after visits to Bayview in November and December 2020 that “poor cleaning was part of the root cause” of the persistent contamination, which was corroborated by an Emergent executive, who asked in an internal email, “When will all these trash going to be out of here? Trash are piling up.”
FDA acknowledged during a staff briefing, “Clearly, in retrospect, they hired a lot of individuals not as familiar with vaccine manufacturing, that did not have adequate training to do so.”
Under the Biden Administration, HHS terminated its contract with Emergent because the company failed to follow federal manufacturing standards.
According to HHS, Emergent received $330 million in taxpayer dollars before the Biden Administration terminated the company’s contract in November 2021. This action saved taxpayers $320 million that remained on the contract and came after the Committees launched an investigation and released preliminary findings about Emergent’s troubling conduct.
Today’s report highlights the need for HHS and other federal agencies to carefully monitor Emergent’s performance in other ongoing contracts and carefully consider the company’s conduct before entering into future contracts.
The report presents findings from the Committees’ year-long investigation of Emergent, which began in April 2021 following reports of quality control issues and poorly trained staff at the company’s Bayview facility in Baltimore, Maryland.
On May 19, 2021, the Select Subcommittee held a hearing with Emergent’s then-Chairman and CEO to address the company’s manufacturing failures.
During the course of the investigation, the Committees obtained documents from Emergent, Johnson & Johnson, AstraZeneca, FDA, and HHS, held bipartisan staff briefings with representatives from Johnson & Johnson, AstraZeneca, FDA, and HHS, and conducted a September 2021 staff site visit of Emergent’s Bayview facility.
Click here to read today’s report.
Click here to read the Committees’ May 2021 staff report.