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Vaccine developer hid quality control problems from FDA, House report concludes

The Congressional report found the total number of doses that were discarded or destroyed was far more than what had been previously disclosed by the company.
Credit: AP
Oct. 7, 2021 - House Oversight and Government Reform Committee Chair Carolyn Maloney, D-N.Y., presides during a House Oversight and Government Reform Committee hearing on Capitol Hill in Washington. (Bill Clark/Pool via AP)

WASHINGTON — A Congressional investigation has concluded that a prominent vaccine development company misled federal oversight agencies on the capabilities of a Baltimore plant, ultimately destroying hundreds of millions of doses of COVID-19 vaccines as a result of the company's negligence. 

In a response, Emergent declared the report was "nothing new" and said the company had been "open and forthcoming" with both the FDA and Congress.

According to Tuesday's report from the Democrat-led House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis, executives at Emergent BioSolutions failed to address deficiencies at the Maryland manufacturing site raised by the FDA. They were also aware of potential contamination and manufacturing issues brought forward by third parties like Johnson and Johnson and AstraZeneca "for years," according to one former executive. 

By reviewing internal emails, documents and interviews, the report concluded that nearly 400 million doses of COVID-19 vaccines were destroyed as a result of "poor quality control." The congressional report found the total number of discarded or destroyed doses was more than five times what had been previously disclosed by the company. It included 90 million doses that were manufactured after the Biden administration ordered the company to halt production last year after it was discovered vaccines had been cross-contaminated.

“Emergent remains committed to being a trusted partner of the U.S. and allied governments,” Emergent's statement said, adding that the company was "dismayed" it first learned of the report through media reporting.

The company also said it disputes the claim that 400 million doses were "rendered unusable." 

"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," the company said in its response. "While unfortunate, a batch of drug substance may test out of specification for a variety of reasons whether during the manufacturing process or after the process is complete."

Emergent had been awarded nearly $700 million in separate contracts with both Johnson and Johnson and AstraZeneca shortly before the contamination. The contaminated vaccines were never released publicly. 

"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," said Rep. Carolyn Maloney (D-N.Y.), chairwoman of the Oversight Committee. "Ultimately, our report shows that Emergent’s manufacturing failures and deceptive tactics led to the destruction of millions of doses of desperately needed vaccines."

The Trump administration was also repeatedly aware of systematic problems with Emergent's plant but decided to still award them a multimillion dollar contract to produce vaccines in 2020, the report alleges. The Biden administration has terminated future contracts with Emergent. 

According to the report, Sean Kirk, a then-executive with Emergent, acknowledged that despite the Trump administration initiating its vaccine "Operation Warp-Speed" with Emergent in 2021, Kirk had been warning colleagues about risks at the plants "for years," ultimately concluding that "room to improve is a huge understatement." 

Both Johnson and Johnson and AstraZeneca had also previously raised concerns about the Baltimore manufacturing site, with inspectors from AstraZeneca noting that poor cleaning was "part of the root cause" for contaminations. Emergent acknowledged that many of the employees hired at the Maryland site had little training in pharmaceutical technology, according to the report. 

Despite knowing the risks, Emergent still signed the contracts with the two biomedical giants, and according to the report, hid potentially-spoiled batches of the vaccine during a Food and Drug Administrations visit to the plant in February 2021. 

The report alleges that during the visit, Emergent employees removed warning labels from potentially-faulty doses as "to avoid drawing attention" from the FDA inspectors, as stated by an outside consultant. 

Documents also show that Emergent personnel expressed concern that the Department of Health and Human Services was “getting too involved” following the company’s cross-contamination, and company executives strategized regarding how to evade questions from HHS.  

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