Emergent is also making the AstraZeneca vaccine, which has yet to be authorized for use in this country.
Johnson & Johnson said in a statement to CNN Wednesday that the quality control process at the plant identified “one batch” of drug substance that did not meet quality standards. The batch in question was part of a test run and quality check. The site is not yet authorized by the FDA to make the drug substance used in the vaccine.
“This batch was never advanced to the filling and finishing stages of our manufacturing process,” the emailed statement from the company said.
None of the lost doses impact the company’s goal of delivering 20 million Covid-19 vaccine doses in March. For that, the company said Wednesday, it is on track. Those doses come from J&J’s Janssen vaccine plant in the Netherlands.
“This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA),” the statement said.
“Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson 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. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.”
The FDA told CNN it is “aware of the situation, but we are unable to comment further” and referred CNN back to J&J. The manufacturer, Emergent, also referred CNN back to J&J.
Emergent manufactures the vaccines at its plant, then ships the material to other plants for what’s known as fill and finish — the process of putting the vaccine into vials and completing the packaging.
In February, J&J also said it had been working to expand its own manufacturing capacity and was expanding the number of third-party vaccine manufacturers with which it was working.
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