A new congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated.
Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in Emergent’s Bayview plant in Baltimore.
In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.
The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.
The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.
It also noted that the FDA, J&J and AstraZeneca employees identified problems at the Bayview site “which Emergent failed to remediate despite urgent warnings.”
The report said the plant was forced to discard 400 million doses of the J&J vaccine, but Emergent disputes that conclusion.
“It is very difficult to estimate dose equivalents for batches that do not complete the manufacturing process or leave the facility to be turned into vaccine,” the company said in a statement.
The company said only a single batch of J&J drug substance was out of specification in March 2021.
“To equate these quality control actions with a ‘discarded dose’ figure displays a lack of understanding regarding the biomanufacturing process,” Emergent said.
The company also claims that the House report contains fundamentally no new information.
“Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered, including providing thousands of documents and willingly participating in a congressional hearing,” Emergent said. “Despite this overwhelming level of cooperation, we are dismayed that the first time we learned of the report was through the media.”
In 2020, Emergent signed a $482 million deal to produce the J&J vaccine and a $174 million agreement to manufacture AstraZeneca’s COVID-19 vaccine candidate. The AstraZeneca vaccine is yet to be authorized in the U.S.
Following reports about cross-contamination at an Emergent facility, the Biden administration halted Emergent’s vaccine manufacturing contract in November 2021.
Earlier this month, Emergent installed Joseph Philipose as the company’s senior vice president and chief ethics and compliance officer.
Philipose had previously served as Alexion’s vice president of U.S. and enterprise compliance.
Philipose will report to Emergent’s executive vice president of global quality and ethics and compliance, Coleen Glessner, who assumed her role in March. Glessner also worked at Alexion before joining Emergent.