By AFRO Staff
Emergent BioSolutions (Emergent), a vaccine manufacturer located in East Baltimore, has come under fire for intentionally misleading the FDA about the mishandling of COVID-19 vaccines.
Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and Rep. James E. Clyburn (SC), Chairman of the Select Subcommittee on the Coronavirus Crisis, recently released a staff report on their joint investigation into coronavirus vaccine manufacturing failures of the plant.
Despite the company’s history of serious deficiencies, the Trump administration awarded the company a contract to make COVID-19 vaccines as the country grappled with inoculation solutions during the pandemic.
The findings follow 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 in East Baltimore. This includes millions of vaccine doses that were destroyed after FDA ordered a three-month halt of manufacturing activities between April and August 2021.
Internal communications show that Emergent executives tried to hide evidence of contamination in an attempt to avoid 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.”
The report, titled “The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions,” revealed several of the following key findings:
Emergent employees purposely removed quality-assurance “hold tags” from Johnson & Johnson vaccine batches, which indicated that the containers had a potential quality issue just before the FDA conducted a site visit in February 2021. The information was disclosed after the an email was obtained, stating that the tags were removed “to avoid drawing attention” from FDA inspectors.
New information shows that personnel on the Emergent team expressed concern about HHS was “getting too involved” after the company’s workers cross-contaminated doses of the Johnson & Johnson and AstraZeneca vaccines in March 2021.
It was also revealed that Emergent executives continued to promote the company’s ability to manufacture the vaccine- even though they were warned of severe problems.
Documents obtained by the Committees disclose that before Emergent finalized manufacturing agreements with Johnson & Johnson and AstraZeneca, the then-Executive Vice President of Manufacturing and Technical Operations admitted in private 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.”
Emergent later entered into contracts with Johnson & Johnson and AstraZeneca to manufacture coronavirus vaccines for $482 million and $174 million, respectively. Internal Emergent communications revealed 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
] the Internal Johnson & Johnson communications from October 2020 revealed 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.”
Some other contributing factors to the vaccine contamination was Emergent’s high staff turnover, and the inexperience of their staff overall.
Emergent acknowledged in July and August 2020 that its staff was insufficiently trained, noting that “Most temporary employees
] 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 an Emergent executive agreed with, who asked in an internal email when trash that was piling up would be removed.
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.”
Due to it’s failure to follow federal manufacturing standards, HHS ended its contract with Emergent under the Biden Administration.
According to HHS, Emergent received $330 million in taxpayer dollars before the Biden Administration terminated the company’s contract in November 2021. The termination of the contract saved taxpayers the $320 million that remained on the contract and came after the Committees launched their investigation and released initial findings of Emergent’s concerning conduct.
The 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.
On May 19, 2021, the Select Subcommittee held a hearing with Emergent’s then-Chairman and CEO to address the company’s manufacturing failures.
Through the course of the investigation, the Committees acquired 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.
This article was written with contributions from the U.S. Congress’ Committee on Oversight and Reform.
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