Two U.S. House Panels Widen Probe Into Emergent’s Vaccine Plant

Two U.S. House committees are broadening their investigation into Emergent BioSolutions’ troubled Bayview, Md., facility, calling on Johnson & Johnson (J&J) and AstraZeneca (AZ) to provide details of their COVID-19 vaccine contracts with the firm.

The June 22 letters, addressed to J&J’s CEO Alex Gorsky and AZ’s CEO Pascal Soriot, seek documents and correspondence by July 6 to help the lawmakers understand what went wrong at the plant near Baltimore, which had undergone several FDA inspections in recent years that found quality lapses.

The House Oversight and Reform Committee and the House Select Subcommittee on the Coronavirus Crisis want specifics about how the firms selected Emergent, how many contaminated J&J doses had to be discarded and when they were destroyed, and what corrective steps are needed “to ensure these mistakes are mitigated and not repeated.”

The two committees are also looking into Emergent’s $1.5 billion COVID-19 contracts awarded during the Trump administration, despite a history of quality control problems at the Bayview site. An estimated 75 million doses of J&J’s vaccine produced at the facility were ordered destroyed by the FDA, following the discovery that many had been cross-contaminated with AZ shots (DID, June 15).

The FDA has authorized three J&J COVID-19 vaccine drug substance batches for distribution either in the U.S. or abroad (DID, June 17) and is currently reviewing additional batches for possible clearance. But the agency has not yet fully cleared the facility to produce vaccines, although the company’s CEO said more than a month ago that plant hoped to resume production “within days” (DID, May 20).

J&J is now overseeing production at the Bayview facility and the FDA has instructed AZ to find another producer for its vaccine to avoid any possibility of future cross-contamination of products at the plant.

Emergent declined to comment on the letters while J&J pledged to work with the committees in their investigation. AZ could not be reached by press time.

Read the letters here: www.fdanews.com/06-24-21-Letters.pdf. ― Jason Scott