COVID-19 Resource Center

COVID-19 Resource Center

April 01, 2021
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Johnson & Johnson discards batch of COVID-19 vaccine that failed quality check

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Johnson & Johnson confirmed that it discarded a batch of COVID-19 vaccine following a mishap at a manufacturing site.

According to the company, a quality check at an Emergent Biosolutions manufacturing facility in Baltimore “identified one batch of drug substance that did not meet quality standards.” The company said the site has not yet been authorized to manufacture drug substance for the vaccine.

Johnson and Johnson COVID vaccine
Johnson & Johnson confirmed a mishap with vaccine ingredients at a manufacturing facility.
Source: Adobe Stock

“This batch was never advanced to the filling and finishing stages of our manufacturing process,” it said in a press release.

The drug maker did not say how many doses of vaccine were impacted, but The New York Times reported that the ruined batch totaled 15 million doses.

Johnson & Johnson said it met its goal of delivering more than 20 million doses of its one-shot vaccine in the Unites States by the end of March. It has pledged to deliver 100 million doses by the end of June. Despite the mishap, the company said it plans to deliver an additional 24 million doses through April.

“Quality and safety continue to be our top priority,” Johnson & Johnson said. “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.”

The FDA did not immediately respond to Healio’s request for comment.

References:

LaFraniere S, Weiland N. Factory mix-up ruins up to 15 million vaccine doses from Johnson & Johnson. New York Times. March 31, 2021. Accessed April 1, 2021. https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html

Press Release.