Inspection keeps J&J vaccine plant on hold

Production at an Emergent BioSolutions Inc. facility in Baltimore that’s expected to help make Johnson & Johnson’s coronavirus vaccine will remain on hold, U.S. regulators said, after an inspection turned up multiple problems.

The U.S. Food and Drug Administration said in a report posted on its website Wednesday that Emergent failed to thoroughly investigate unexplained discrepancies, including the cross-contamination of a vaccine substance batch with ingredients from another shot.

Emergent’s facility also lacked sufficient oversight and conditions were unsanitary, the agency said. Output at the plant has been on hold amid the inspection, which began last week and concluded on Tuesday.

Use of the J&J vaccine has been paused in the U.S. since last week as regulators probe reports that a small number of people suffered serious blood-clotting side effects after receiving the shot. The FDA said the Emergent report was unrelated to a safety review that the agency and the Centers and Disease Control and Prevention are conducting. An advisory panel is meeting Friday to weigh whether use of the vaccine should resume.

The FDA said in a statement that already-manufactured vaccines will undergo additional testing and evaluation to ensure their quality before they are distributed. The agency said that no vaccine manufactured at the plant has been distributed for use in the U.S.

In response to the findings, J&J said in a statement that it planned to set up a global supply network to produce its shots, and that it would ensure that the concerns raised by the FDA about the Emergent plant are addressed.