In a statement, Johnson & Johnson said a batch of drug substance failed its quality test.
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 people familiar with the matter, though the company downplayed the situation and said it met its most recent vaccine delivery target.
The issue, which occurred recently at an Emergent BioSolutions Inc. facility in Baltimore, isn't expected to change President Joe Biden's expectation that the U.S. will have enough vaccine for all adults in May, the people said.
None of the doses produced and shipped so far in the U.S. have come from that plant, which isn't authorized yet, two administration officials said, speaking on condition of anonymity.