Johnson & Johnson said one batch of its new Covid-19 vaccine didn’t meet quality standards at a contract manufacturer, and the doses weren’t distributed.
J&J said Wednesday the batch never advanced to the filling and finish stages of its manufacturing process, and that the quality lapse wouldn’t affect its ability to supply the U.S. with 100 million doses by the end of May.
J&J didn’t disclose the nature of the quality lapse or how many doses were affected, but said it arose from quality checks during the start-up phase of manufacturing. The company said it shared information about the issue with the U.S. Food and Drug Administration.
The FDA is investigating, according to a person familiar with the matter.
The New York Times reported Wednesday that the J&J doses were ruined due to an accidental mix-up of ingredients at Emergent BioSolutions Inc., the contract manufacturer working with J&J. The Times reported that about 15 million doses were ruined.
