The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson ’s Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter.
The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., the person said.
The regulatory scrutiny follows J&J’s disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn’t meet standards. The batch didn’t reach the vial-filling and finishing stage, and no doses from it were distributed.
J&J says the quality lapse didn’t affect vaccine doses that have been distributed in the U.S. since the vaccine was authorized in late February, and the company still has enough supply to meet near-term commitments. J&J also makes the main ingredient for the vaccine at its own plant in the Netherlands.
Emergent BioSolutions, of Gaithersburg, Md., said in a statement Thursday that it isolated the batch of vaccine ingredients because it didn’t meet specifications and quality standards. Emergent said it would dispose of the batch properly.