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

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. 

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