Coronavirus: manufacturing error at plant affects 15 million doses of Johnson & Johnson’s vaccine

The company said a batch of drug substance failed its quality test at a Baltimore Emergent BioSolutions facility

Johnson & Johnson said it reported the issue to the Food and Drug Administration

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A health worker prepares a dose of the Johnson & Johnson Covid-19 jab at a vaccination site in Philadelphia, US. File photo: AP

Published: 9:22am, 1 Apr 2021Updated: 9:22am, 1 Apr 2021

A manufacturing error at a plant involved in Covid-19 vaccine production affected 15 million doses worth of an ingredient for Johnson & Johnson’s vaccine, according to two sources familiar with the matter, but the company downplayed the situation and said it met its most recent vaccine delivery target.

The issue, which occurred recently at a Baltimore Emergent BioSolutions facility, was first reported by The New York Times on Wednesday. It isn’t expected to change President Joe Biden’s expectation that the US will have enough vaccine for all adults in May.

In a statement, J&J said a batch of drug substance failed its quality test.

“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorised to manufacture drug substance for our Covid-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process,” J&J said.

The company said it addressed the issue with Emergent and reported it to the Food and Drug Administration.

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