15 million J&J vaccine doses lost due to factory error, report says

Coronavirus

This picture taken on November 17, 2020 shows a syringe and a bottle reading “Vaccine Covid-19. (Photo by JOEL SAGET/AFP via Getty Images)

(NEXSTAR) – Human error led to a mistake at a Baltimore manufacturing plant that ruined roughly 15 million future doses of the Johnson & Johnson COVID-19 vaccine, the New York Times reports.

Workers at Emergent BioSolutions, the manufacturer for AstraZeneca and J&J, conflated the main ingredients for coronavirus vaccines, according to the paper. The J&J doses that are being distributed across the U.S. now were all created in the Netherlands under federal approval, so the error won’t effect the current flow of vaccines.

The mistake will, however, affect the planned scaling of vaccine delivery from the Baltimore plant, according to the Times, which was projected to produce tens of millions of doses in April.

In a statement to Nexstar, Johnson & Johnson said they have been performing “test runs and quality checks” at the plant, which they said is still awaiting authorization to “manufacture drug substance for our COVID-19 vaccine.” The company said the spoiled batch “was never advanced to the filling and finishing stages of our manufacturing process.”

J&J did not say how many doses would have been created by that batch and did not immediately respond to a question about whether or not the batch that failed quality control would have ultimately been delivered to Americans if it wasn’t compromised.

“This is an example of the rigorous quality control applied to each batch of drug substance,” the statement read. “The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).”

The company says it is pleased to have delivered “enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States” and plans to deliver 100 million single-shot doses by the end of May.

Emergent Biosolutions did not respond to requests for comment.

See the full statement from Johnson & Johnson below:

Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.

We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.

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).

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.

Copyright 2021 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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