Executives at a company that produced millions of COVID-19 vaccine doses attempted to hide evidence that some of the doses were contaminated, according to a congressional report released on May 10.
Emergent BioSolutions “took repeated steps to conceal its quality failures from the federal government and other third parties by limiting access to Bayview, tampering with drug-substance labels to impede FDA oversight, and strategizing to withhold information from HHS following the cross-contamination event in March 2021,” a report from the House Oversight Committee and the Subcommittee on the Coronavirus Crisis concluded.
The Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS), identified deficiencies in the manufacturing process at Emergent’s Baltimore, Maryland facility—known as Bayview—in 2020.
In early 2021, Johnson & Johnson announced that up to 15 million doses of its COVID-19 vaccine at the facility became contaminated.
Documents obtained by the committees showed that Emergent rejected requests from Johnson & Johnson to visit the site around that time ahead of a follow-up FDA inspection.
One email from a consultant hired by Emergent indicated that employees removed quality-assurance tags from containers of Johnson & Johnson’s vaccine drug substance just before inspectors began their tour and put them back into place after inspectors left. The tags alerted employees that portions of the batches were potentially unable to be used.
Several days later, the consultant said that the tags were removed to “avoid drawing attention” to the potential quality issue.
Internal communications obtained by lawmakers show top executives at Emergent were aware of what happened.
Despite the tag removal, the FDA identified problems during the inspection.
In March 2021, another cross-contamination issue was identified by Johnson & Johnson, but Emergent did not alert AstraZeneca—whose vaccines Emergent was also manufacturing—and HHS for three weeks, according to the new report.
When an HHS agency asked for details, an executive said that no details should be shared with the government until its investigation was over.
“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,” Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House oversight panel, said in a statement.
Approximately 400 million doses of COVID-19 vaccines were destroyed because of the contamination issues.
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