Emergent Pledges FDA Improvements at Troubled Vaccine Plant

Emergent BioSolutions is promising the FDA a series of fixes in response to an inspection that led to production stopping at the company's Bayview facility in Baltimore, which had been making Johnson & Johnson's COVID-19 vaccine, reported Bloomberg.

In a letter to the FDA dated April 30, the contract manufacturer vowed to 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.

According to Bloomberg, the document details efforts Emergent said it is taking to ensure the quality of the Johnson & Johnson vaccine after its staff accidentally mixed ingredients with those used in the AstraZeneca vaccine, prompting US regulators to investigate the cross-contamination at the site and seek a pause in vaccine production.

Johnson & Johnson is now providing 24/7 oversight at the facility, and third-party consultants have been brought in to aid with the remediation, Emergent said in the response to the FDA. The company also hired three employees focused on quality control, according to the document.

The FDA has not provided full clearance to the Bayview facility to release its doses or resume production.

Meanwhile, Johnson & Johnson spokesman Jake Sargent said Monday that the company is continuing to work with the FDA and Emergent to add the facility under its emergency-use authorization for the vaccine.