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.
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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.
Emergent declined to comment. Its shares were down 3.6% at 3:21 p.m. in New York on Monday, while J&J fell 0.2%.
J&J’s single-shot Covid-19 vaccine was expected to be a crucial part of the U.S. immunization effort, but Emergent’s manufacturing problems have sharply curtailed the number of doses available and the speed at which they’ve been delivered. Just 8% of 144 million fully vaccinated Americans have been given J&J’s vaccine, according to data from the Centers for Disease Control and Prevention.
On Friday, Bloomberg reported that U.S. regulators released 10 million doses of the vaccine produced at Emergent’s facility in the Bayview neighborhood of Baltimore. Later that day, the FDA said it had determined several batches weren’t suitable for use, and other batches remained under review.
The FDA hasn’t provided a full clearance to the Bayview facility to release its doses or resume production. J&J 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.
Emergent’s problems also have drawn the scrutiny of lawmakers. A congressional probe into the Gaithersburg, Maryland-based company found it failed to address deficiencies in vaccine production despite warnings after a series of inspections in 2020.
In a House hearing in May, Democrats detailed additional findings from the FDA’s inspection, and Emergent CEO Robert Kramer discussed some of the company’s remediation activities. Emergent’s formal response to the FDA builds on those comments.
By halting production of the AstraZeneca vaccine at the Bayview facility and focusing exclusively on J&J’s bulk drug substance, “any theoretical risk of cross-contamination is eliminated,” Emergent said in its response. The company said it has also put in place other interim controls to ensure the vaccine’s quality.
The FDA inspection found unsealed waste bags came in contact with manufacturing materials. In response to that finding, Emergent plans to strengthen its biowaste-handling process by identifying a defined exit pathway for the waste, cleaning that pathway and having personnel witness and document the activity. It said it has instituted a system to transport material on pallets or dollies to avoid contact with floors.
Additionally, after the FDA found that an Emergent worker had worn protective gowning in multiple rooms at the facility, Emergent said it will put in place a new protocol for gowning.
J&J is now providing 24/7 oversight at the facility, and third-party consultants have been brought in to aid with the remediation, it said in the response to the FDA. The company also hired three employees focused on quality control, according to the document.
Throughout the pause in production, Emergent said it has been providing instructor-led training to employees on how to better conduct investigations, prevent microbial contamination and ensure viral containment.
The FDA has not publicly classified the inspection, which would indicate whether the voluntary steps Emergent has pledged to take will suffice or whether the FDA will recommend additional actions. Often, when inspectors find multiple problems at a facility, the FDA will reinspect to ensure the company is implementing any changes before lifting restrictions.
It can take months, and sometimes years, for drugmaking plants to emerge from an FDA inspection that found extensive issues. The FDA did not immediately respond to a request for comment on Emergent’s response.