Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times.
Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.
The company in a statement provided to Pharmaceutical Processing World said that any allegation that its safety, quality, and compliance systems are not working — or that the company does not take such responsibilities seriously — is false.
Emergent’s statement also said: “Unfortunately, a batch of drug substance can fail to meet rigorous quality standards especially during the early part of the manufacturing process. Importantly, our quality control systems are working as designed to detect and isolate any batch that fails to meet quality standards for any reason. Emergent has rigorous safety, quality, and compliance processes that allow early identification of issues and means to address them when they arise.”
Johnson & Johnson (NYSE:JNJ) this week announced that it will assume full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility — news that came days after the disclosure that a factory error resulted in up to 15 million discarded COVID-19 vaccines.
The New York Times — citing internal logs, a government official and a former company supervisor — claims that contamination or suspected contamination also caused Emergent between October and January to discard five lots of AstraZeneca vaccine — with each lot large enough to provide 2–3 million doses.
Federal officials found the pattern of lapsed quality controls at the plant troubling, according to the newspaper.
Emergent BioSolutions meanwhile announced on April 4 that it remains on track with respect to COVID-19 contractual commitments.