Execs from troubled vaccine maker to face House grilling over ruined doses

Execs from troubled vaccine maker to face House grilling over ruined doses
© Greg Nash

Emergent BioSolutions, the troubled vaccine maker whose Baltimore factory ruined millions of COVID-19 vaccine doses, has been paid more than $200 million in taxpayer money despite failing to address serious manufacturing control issues, according to documents released Wednesday by House Democrats.

Democrats on the Oversight and Reform Select Subcommittee on the Coronavirus Crisis found that under a May 2020 contract issued by the Trump administration, taxpayers have already paid Emergent more than $271 million.

Emergent has charged the federal government $27 million per month in reservation fees to maintain its “readiness” to manufacture vaccines, but has not been able to distribute any doses.

ADVERTISEMENT

Two of Emergent’s top executives, founder and Executive Chairman Fuad El-Hibri, along with president and CEO Robert Kramer are set to appear Wednesday morning before the Select Subcommittee on the Coronavirus Crisis.

Lawmakers are expected to home in on the company’s failure to address manufacturing problems that led to the destruction of millions of desperately needed coronavirus vaccine doses and the large bonuses paid to top executives despite these failures.

The documents show the company was warned multiple times about serious deficiencies at its facility in Bayview that could lead to contamination but failed to take action. Those deficiencies eventually resulted in up to 15 million destroyed doses of the Johnson & Johnson coronavirus vaccine.

The company is facing scrutiny from Congress after it was awarded a $628 million contract last year to establish the primary U.S. facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca.

A Food and Drug Administration (FDA) inspection in April found serious problems, operations have been suspended and the remaining doses are being inspected for quality issues. The facility still lacks FDA manufacturing certification that would allow production to resume.

The documents raise new questions about Emergent's oversight from the Trump administration, and the outsize role it played in Johnson & Johnson's manufacturing plan. 

ADVERTISEMENT

According to the committees, Emergent was aware of serious control issues at its Bayview facility but failed to act. Numerous inspections from federal regulators, Johnson & Johnson and AstraZeneca found that Emergent’s Bayview facility had persistent problems with mold, poor disinfection of plant equipment and inadequate training of employees.

In June 2020, an adviser to Operation Warp Speed identified “risks” in relying on Emergent to handle the production of two coronavirus vaccines.

During a separate audit, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, found that the Bayview facility had a “deficient” contamination control strategy.

Johnson & Johnson relied on Emergent as its only domestic manufacturer of coronavirus vaccine. 

An ingredient mix-up in March ruined 15 million doses of the J&J vaccine after they were contaminated by ingredients from AstraZeneca's vaccine. Since manufacturing has yet to resume, the U.S. has virtually no more supply of the single-dose Johnson & Johnson vaccine.

"We recognize that our role in helping the nation respond to, and hopefully end, the COVID-19 pandemic is a profound and unique responsibility, unlike any we have confronted before," company spokesman Matt Hartwig said in a statement.

"We look forward to clarifying misconceptions and addressing the Committee’s concerns. At this time, our focus is on the path forward to release drug substance currently under evaluation, to resume production, and to do our part to help strengthen the global supply chain for Johnson & Johnson’s COVID-19 vaccine."