Washington, D.C. - Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, sent letters to the top executives of AstraZeneca and Johnson & Johnson, expanding their investigation into manufacturing problems that plagued the Bayview facility of Emergent BioSolutions, Inc. (Emergent), which manufactured both AstraZeneca and Johnson & Johnson coronavirus vaccines. Emergent’s coronavirus vaccine manufacturing deals with AstraZeneca and Johnson & Johnson-which combined with federal contracts are reportedly worth up to $1.5 billion-went forward despite multiple audits and inspections citing deficient controls at Emergent’s Bayview facility that could lead to contamination.
For the last two months, manufacturing at Emergent’s Bayview facility has remained on hold following FDA’s issuance of a scathing inspection report on April 20, 2021. More than 85 million total doses have been destroyed and an additional 60 million doses are being held back to determine if they are safe.
“Emergent’s mistakes have reduced the number of vaccines available for global vaccination efforts," the Chairs wrote. “We are troubled by the impact Emergent’s manufacturing errors have had on the availability of coronavirus vaccine doses, as well as the potential effect on public perceptions regarding the safety and efficacy of these vaccines."
“We are also concerned about the circumstances that led AstraZeneca and Johnson & Johnson to sign contracts with Emergent to produce their respective vaccines. We need to understand what went wrong and what corrective steps are needed to ensure these mistakes are mitigated and not repeated."
On April 19, 2021, Chairwoman Maloney and Chairman Clyburn launched an investigation into Emergent’s profits and performance under federal vaccine contracts.
On May 19, 2021, Chairwoman Maloney and Chairman Clyburn released initial findings from their investigation into Emergent, indicating that the failure to address serious deficiencies at Emergent’s Bayview facility led to the destruction of millions of doses due to contamination. At a Select Subcommittee hearing that same day, top Emergent executives acknowledged prior awareness of risks, but sought to downplay the contamination that occurred.
