Johnson & Johnson COVID-19 vaccine batch fails quality check

Apr 2, 2021

BALTIMORE, MD (WEAA) — Johnson and Johnson says a batch of its COVID-19 vaccine that was created at a production plant in Baltimore City, failed quality standards and cannot be used. 

The drug company said the mix-up happened at Emergent BioSolutions.

Johnson & Johnson released a statement saying, “…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. 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. This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.

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