Johnson & Johnson (J&J) has confirmed it is “assuming full responsibility” of a US manufacturing plant after a batch of its Covid-19 vaccine doses were reportedly ruined due to human error.
Up to 15m doses of J&J’s vaccine are reported to have been ruined at a plant in Baltimore which was also developing vaccines for AstraZeneca (AZ), according to the New York Times.
The reports said employees at the Bayview facility, which is owned by Emergent BioSolutions, had accidentally conflated ingredients for the J&J vaccine with those used in the AZ formula.
In a statement, J&J said its quality control process had identified one batch of vaccines that “did not meet quality standards”.
“This batch was never advanced to the filling and finishing stages of our manufacturing process… The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA)”, J&J said.
As a result of the mix-up, J&J is sending additional experts in manufacturing, technical operations and quality to be present on-site at Bayview to “supervise, direct and support all manufacturing” of its Covid vaccine.
J&J said it still expects to deliver nearly 100m doses of its vaccine to the US government by the end of May.
Robert Kramer, president and chief executive officer said Emergent welcomed the additional support at Bayview, including “increased and final sign-off of manufacturing of its bulk drug substance and supervision and direction of all Johnson & Johnson critical manufacturing operations.”
Eric Stoop, CEO of technology firm EASE, Inc said it is “unfathomable” that such vital quality processes in vaccine production had failed.
“Creating safe vaccinations is a matter of life and death,” he said. "Fundamentally, human error simply mustn’t happen when the stakes are so high, and it is so easily avoidable. I implore the pharma industry to review its processes, and quickly.”