The mix-up at a Baltimore manufacturing plant forced regulators to delay authorization of the plant’s production lines and prompted an FDA investigation.
Fifteen million doses of Johnson & Johnson (J&J’s) vaccine failed quality control after workers at a Baltimore manufacturing plant negligently combined ingredients from AstraZeneca and J&J’s COVID vaccine.
The mix-up forced regulators to delay authorization of the plant’s production lines and prompted an investigation by the U.S. Food and Drug Administration (FDA).
According to The New York Times, the plant is run by Emergent BioSolutions, a manufacturing partner with J&J and AstraZeneca, whose vaccine has yet to be authorized for use in the U.S.
Emergent has been cited repeatedly by the FDA for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by the Associated Press through the Freedom of Information Act.
AstraZeneca and J&J’s COVID vaccines employ the same technology which uses a version of a virus — known as a vector — that is transmitted into cells to make a protein that then stimulates the immune system to produce antibodies.
However, J&J’s and AstraZeneca’s vectors are biologically different and not interchangeable.
Federal officials said Emergent’s mistake was human error that went undiscovered for days until J&J’s quality control checks uncovered it, according to people familiar with the situation. By then, up to 15 million doses had been contaminated, reported The Indian Express.