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).
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.
The error does not affect any J&J doses currently being distributed and administered in the U.S., as those were produced in the Netherlands where operations have been fully approved by federal regulators.
“As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards,” J&J said in a statement Wednesday. “This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.” Read Full Article >