A “human error” at Emergent BioSolutions’ vaccine facility in Baltimore ruined 15 million doses of the Johnson & Johnson vaccine. That’s according to the New York Times.
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“Workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines’ ingredients several weeks ago, ruining about 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines,” the Times reported on Wednesday.
Emergent BioSolutions also makes the AstraZeneca vaccine as well.
No Johnson & Johnson vaccine doses administered to the public have been tainted.
Johnson & Johnson issued a statement that reads in part:
“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.
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).”
Source: CBS Baltimore
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