US plant for J&J vaccine still on hold after probe

The US Food and Drug Administration said Emergent BioSolutions failed to thoroughly investigate unexplained discrepancies

Use of the J&J vaccine has been paused in the US since last week as regulators probe reports that a small number of people suffered serious blood-clotting side effects after receiving the shot. Picture: AP Photo/Mary Altaffer

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

The US Food and Drug Administration (FDA) said 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. 

Use of the J&J vaccine has been paused in the US since last week as regulators probe reports that a small number of people suffered serious blood-clotting side effects after receiving the shot. 

Last month, Emergent staff conflated materials for the J&J vaccine with another from drugmaker AstraZeneca that was also being made on the premises. The error led the site to discard 15m doses worth of an ingredient used in the J&J vaccine. 

Not handled properly

FDA inspectors found that containers where the drug substance was stored were not handled properly, including instances caught on security cameras where employees dragged unsealed bags of special medical waste from manufacturing areas to the warehouse.

In response to the findings, J&J said it planned to set up a global supply network to produce its shots.

“There is no assurance that other batches have not been subject to cross-contamination,” wrote the FDA inspectors in their report.

Cameras caught employees who removed outer protective garments and put them in open garbage containers in the warehouse where raw materials sat awaiting manufacturing. 

Inspectors observed peeling paint, paint flecks on the floor and walls, and brown residue on the wall. 

• Bloomberg