Troubled J&J vaccine manufacturer Emergent promises to fix plant

Johnson & Johnson’s single-shot COVID-19 vaccine was expected to be a crucial part of United States immunisation efforts, but Emergent’s manufacturing problems have sharply curtailed the number of doses available.

Emergent BioSolutions Inc. is promising the Food and Drug Administration a series of fixes in response to an inspection that led to a halt in production at a company facility that had been making Johnson & Johnson’s Covid-19 vaccine. The contract manufacturer said in a letter to the FDA dated April 30 that it would strengthen its biowaste handling processes, put in place new requirements for wearing protective gowns and deliver training to facility personnel, among other steps to ensure the quality of the vaccine, after agency inspectors cited myriad problems in a report earlier that month. Bloomberg News obtained Emergent’s response to FDA investigators via an information request. The document details efforts Emergent said it is taking to ensure the quality of the J&J vaccine after its staff accidentally mixed ingredients with those used in the AstraZeneca Plc vaccine, prompting U.S. regulators to investigate the cross-contamination at the site and seek a pause in vaccine production.