Johnson & Johnson COVID- 19 Vaccine Manufacturing Error Affects 15 Million Doses

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 Inc. facility, was first reported by the New York Times on Wednesday. It isn’t expected to change President Joe Biden’s expectation that the U.S. 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 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,” J&J said.

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

Johnson & Johnson said it beat its March delivery target, providing the U.S. government more than 20 million doses, and that it expects to deliver another 24 million by the end of April. Biden has set a goal for almost 100 million doses by the end of May. J&J said it still plans to deliver 100 million by the end of June, “aiming to deliver those doses by the end of May.”

J&J is now expanding its presence in the Emergent facility, according to the statement. “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,” it said.

Representatives for Emergent declined to comment, deferring to J&J’s statement.

Johnson & Johnson has committed to delivering 20 million doses by the end of March, and 100 million by the end of June, though Biden had said that he expected nearly all of those to arrive by the end of May. He relied on that in moving up his timeline on when the U.S. would have enough vaccine to cover all adults.

The White House said last week that it expected a surge of 11 million doses this week from Johnson & Johnson. It’s not clear if those are among the affected doses.

The two other authorized vaccine producers, Pfizer Inc. and Moderna Inc., are on schedule for their deliveries.