Johnson & Johnson said its manufacturing quality-control process identified one batch of drug substance for the COVID-19 vaccine produced at Emergent BioSolutions that did not meet Johnson & Johnson’s standards, according to a news release.
Johnson & Johnson said the batch was never advanced to the filling and finishing stages of the manufacturing process. In addition, “the issue was identified and addressed with Emergent and shared with the United States Food and Drug Administration (FDA)," the company said, adding that the manufacturing site was not yet authorized to manufacture drug substance for Johnson & Johnson’s COVID-19 vaccine.
As a result of the issue, Johnson & Johnson said it is “providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”
The company also reiterated its plan to deliver more than 1 billion doses of its COVID-19 vaccine by the end of 2021.
As a result of the issue, the Johnson & Johnson said it is “providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.” The company also reiterated its plan to deliver more than 1 billion doses of its COVID-19 vaccine by the end of 2021.
