Almost 400M COVID vaccine doses destroyed at Emergent BioSolutions facility: congressional report

Nearly 400 million COVID-19 vaccine doses were destroyed at Emergent BioSolutions’s facility in Baltimore due to the company’s “failure to meet or maintain quality standards,” a congressional report released on Tuesday said.

According to the report, around 240 million doses were destroyed at the facility in late 2020 and early 2021 because of “poor quality control,” more than had initially been believed. Another 90 million newly manufactured doses have since had to be destroyed for quality control reasons, and about 60 million will have to be destroyed due to expiring while in quarantine.

The report was compiled by the House’s Oversight and Reform Committee and Select Subcommittee on the Coronavirus Crisis.

It alleged that Emergent tried to hide evidence of these ruined vaccine doses from the federal government and drug companies, saying employees hid “hold tags” that indicated potential quality issues when the Food and Drug Administration made a site visit in February 2021. They also allegedly declined to allow Johnson & Johnson’s quality staff members to access the facility.

Additionally, according to the congressional report, Emergent executives boasted of their company’s manufacturing capabilities to vaccine makers such as Johnson & Johnson and AstraZeneca despite being aware of its “deficient” quality systems.

Audits performed by Johnson & Johnson and AstraZeneca both identified issues at the Baltimore facility, including “documentation control issues; contamination control deficiencies; an inadequate quality management system; inadequate computerized systems; and certain other faulty manufacturing and cleaning practices.”

The report further alleged that the Trump administration, which awarded Emergent a $628 million contract to make the COVID-19 vaccines, was aware of these deficiencies beforehand and knew that they could impact manufacturing.

Vaccine production at Emergent’s Baltimore facility was halted in April 2021 and a congressional investigation was launched. In November, the Biden administration and Emergent canceled their contract, with both the company and the Department of Health and Human Services agreeing to end the deal.

“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.), the chairwoman of the Oversight and Reform Committee, said in a statement.

Rep. James Clyburn (D-S.C.), the chairman of the Select Subcommittee on the Coronavirus Crisis, said the millions of doses destroyed at the facility had been “squandered” and accused Emergent of prioritizing profits of vaccine manufacturing.

In a response, Emergent dismissed the congressional report as offering no more than what the company had already disclosed to regulators. However, it disputed the number of vaccines that had been destroyed.

Emergent said it was “difficult” to estimate how many doses were in fact destroyed, but said equating the quality control actions to number of doses showed a “lack of understanding regarding the biomanufacturing process.”

The company also claimed that it had “sought to be overly transparent” with the government

“Emergent has publicly and privately acknowledged its challenges in manufacturing Covid-19 vaccine drug substance, including transitioning Bayview from a clinical to a commercial site and hiring sufficient staff to operate the facility,” said the company. 

“Emergent has also highlighted the failures of the public-private partnership model due to the government’s lack of adequate investment and engagement with partners in the program prior to the start of the pandemic.”

–Updated at 1:24 p.m.