FDA investigates cause of failure of Johnson & Johnson Covid-19 vaccine batch

The Food and Drug Administration is investigating the cause of a batch of Johnson & Johnson’s Covid-19 vaccine active ingredient being discarded for failing to meet quality standards at a contract manufacturing facility, according to someone familiar with the subject.

The FDA may send an inspection team to assess the situation at the Baltimore plant operated by emerging entrepreneur BioSolutions Inc., the person said.

The regulatory review follows J&J’s disclosure on Wednesday that a batch of the main ingredient in its Covid-19 vaccine made at the Emergent plant did not meet standards. The batch did not reach the filling and finishing stage of the vial and no dose was dispensed.

J&J says the lack of quality has not affected vaccine doses distributed in the United States since the vaccine was authorized in late February, and that the company still has enough supply to meet its short-term commitments. J&J also manufactures the main ingredient of the vaccine in its own factory in the Netherlands.

Emergent BioSolutions, of Gaithersburg, Md., Said in a statement Thursday that it isolated the batch of vaccine ingredients because it did not meet specifications and quality standards. Emergent said he would dispose of the lot properly.