Two Congressional committees made this discovery via a report published on May 10, which scrutinized vaccine manufacturer Emergent BioSolutions. According to the document, inexperienced staff and high turnover rates contributed to the contamination of COVID-19 vaccines being produced at its Bayview factory in Baltimore in March 2021.
According to the report, Emergent employees removed quality assurance hold tags attached to batches of the Johnson & Johnson COVID-19 vaccine "to avoid drawing attention." The removal was done immediately before inspectors from the Food and Drug Administration (FDA) conducted an inspection of the Bayview plant in February 2021.
Aside from this, the report also cited new documents revealing that Emergent employees were concerned about the Department of Health and Human Services "getting too involved" in the company's operations at Bayview.
The quality control problems led to Emergent discarding tens of millions of COVID-19 vaccines due to a mix-up of ingredients. Two vaccines – AstraZeneca's two-dose shot and J&J's one-dose shot – are manufactured in the Bayview facility. About 15 million J&J vaccine doses were thrown away after being contaminated by an ingredient meant for the two-dose vaccine. (Related: Johnson & Johnson threw out 15 MILLION DOSES of its coronavirus vaccine after sloppy worker mixed in the WRONG ingredient.)
The FDA subsequently ordered the closure of Emergent's Bayview facility in April 2021, but permitted it to resume production in August of the same year.
Rep. Carolyn Maloney (D-NY), who heads the House Committee on Oversight and Reform, said: "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." According to the report from her committee, Emergent received $330 million from the federal government before the latter terminated the contract in November 2021.
Rep. James Clyburn (D-SC), chairman of the House Select Oversight Subcommittee on the Coronavirus Crisis, denounced Emergent's executives for "[prioritizing] profits over producing vaccines in a responsible manner that complied with FDA requirements." Clyburn's committee also helped Maloney pen the report.
"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."
An Emergent spokesman said on May 10 that the report contained "nothing new" and reiterated that the company had already provided information to the media and the FDA. "Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site," he said in a statement.
Prior to this, Emergent CEO Robert G. Kramer apologized for "the failure of our controls." But instead of committing to address quality control concerns, he pointed his finger at the complexity of scaling up production quickly on two different COVID-19 shots.
Back in April 2020, the FDA conducted an inspection of the Bayview facility and cited several issues. Marcelinus Dordunoo, the FDA lead investigator, cited Emergent for failing to train employees in "the particular operations they perform as part of their function" and in "current good manufacturing practices."
He also cited the Bayview plant's failure "to ensure that electronically held data generated during analytical testing … was protected from deletion or manipulation."
The lead investigator's findings during the April 2020 inspection supported earlier reports that criticized the factory conditions at Emergent's different facilities. A December 2017 report said the company had not addressed the presence of "continued low-level mold and yeast isolates" in its Canton, Massachusetts plant.
Almost a year later, the FDA questioned why its Camden plant – also located in Baltimore – followed "an unwritten policy of not conducting routine compliance audits." Emergent's Camden plant sees anthrax vaccines filled into vials before distribution.
Vaccines.news has more stories about the quality control issues at Emergent BioSolutions and other vaccine makers.
Watch the clip below that shows the different contaminants inside a vial of the single-dose J&J COVID-19 vaccine.
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