Lawmakers expand investigation of troubled Baltimore vaccine plant

Lawmakers are expanding their probe of the troubled Emergent BioSolutions vaccine plant in Baltimore and are now focusing attention on manufacturing contracts with AstraZeneca and Johnson & Johnson.

Democratic leaders on two House panels in letters dated Tuesday asked the CEOs of AstraZeneca and Johnson & Johnson to produce all communications related to efforts to supervise manufacturing, quality or compliance of their vaccines at the Emergent plant. 

The lawmakers also asked the companies to produce all records related to their decisions to hire Emergent as a subcontractor, as well as the specific numbers of doses that have either been destroyed, delayed or shipped.

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.

The Baltimore plant has been forced to destroy the equivalent of tens of millions of doses of Johnson & Johnson’s coronavirus vaccine because of suspected contamination with an ingredient for the AstraZeneca vaccine. Both vaccines were being manufactured by Emergent at its Baltimore facility. 

The congressional investigation has already shown that the company received numerous warnings about its potential manufacturing problems but did not take action. 

“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 coronavirus vaccines,” wrote Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House Oversight and Reform Committee, and Rep. James Clyburn (D-S.C.), chairman of the House Select Subcommittee on the Coronavirus Crisis.

In a statement, Johnson & Johnson said it will respond. 

The plant has been shuttered since April, and the Food and Drug Administration has not yet determined whether it can reopen. The agency recently declared about 25 million doses from there safe for delivery. 

At a congressional hearing last month, Emergent’s founder and executive chairman, Fuad El-Hibri, testified that AstraZeneca, Johnson & Johnson and the federal government’s Biomedical Advanced Research and Development Authority all were aware of the facility’s shortcomings prior to entering into manufacturing partnerships. 

“Everyone went into this with their eyes wide open, that this was a facility that had never licensed a product before, it’s a facility that although not in perfect condition, far from it, it’s the facility that had the highest level of state of readiness,” El-Hibri said.