Johnson & Johnson’s single-shot COVID-19 vaccine was supposed to be a crucial part of vaccination efforts in the United States, but Emergent’s manufacturing issues sharply reduced the number of available doses.
Emergent BioSolutions Inc. is promising the Food and Drug Administration a series of fixes in response to an inspection that resulted in production stopping at a facility of the company that made 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 management processes, put in place new requirements for wearing protective gowns, and provide training to facility staff. , among other measures to ensure vaccine quality, after agency inspectors cited a myriad of problems in a report earlier this month.
Bloomberg News obtained Emergent’s response to FDA investigators via a request for information. The document details Emergent’s efforts to ensure the quality of the J&J vaccine after its staff accidentally mixed ingredients with those used in the AstraZeneca Plc vaccine, prompting US regulators to investigate cross-contamination at the site and request a break in the vaccine. production.
Emergent declined to comment. Its shares were down 3.6% as of 3:21 p.m. in New York on Monday, while J&J fell 0.2%.
J & J’s single-injection Covid-19 vaccine was to be a crucial part of the U.S. vaccination effort, but Emergent’s manufacturing issues sharply reduced the number of doses available and the speed at which they were delivered. According to data from the Centers for Disease Control and Prevention, only 8% of the 144 million fully vaccinated Americans received J&J’s vaccine.
Bloomberg reported on Friday that U.S. regulators released 10 million doses of the vaccine produced at Emerg’s facility in the Bayview neighborhood of Baltimore. Later today, the FDA said it had determined that several lots were unsuitable for use, and that other lots were still under study.
The FDA has not provided full clearance for the Bayview facility to release its doses or resume production. J&J spokesman Jake Sargent said Monday the company continues to work with the FDA and Emergent to add the facility to its emergency use authorization for the vaccine.
Emerging’s issues have also caught the attention of lawmakers. A Congressional investigation into the Gaithersburg, Md. Based company found that it had failed to close gaps in vaccine production despite warnings after a series of inspections in 2020.
At a House hearing in May, Democrats detailed additional findings from the FDA inspection and Emerg CEO Robert Kramer discussed some of the company’s remediation activities. Emerging’s official response to the FDA is based on these comments.
Response from the Emerging
By stopping production of the AstraZeneca vaccine at the Bayview plant 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 also put in place other interim controls to ensure the quality of the vaccine.
The FDA inspection found that unsealed garbage bags had come in contact with manufacturing materials. In response to this discovery, Emergent plans to strengthen its bio-waste management process by identifying a defined exit route for waste, cleaning up that route, and having staff assist and document the activity. He said he had set up a system for transporting equipment on pallets or carts to avoid contact with the floors.
Additionally, after the FDA discovered that an Emergent worker had worn protective clothing in several rooms of the facility, Emergent said it would implement a new dressing protocol.
J&J now provides 24/7 monitoring on the facility, and third-party consultants have been recruited to help with remediation, it said in the FDA response. The company also hired three employees focused on quality control, according to the document.
Throughout the production hiatus, Emergent said it has provided instructor-led training to employees on how to better conduct investigations, prevent microbial contamination and ensure virus containment.
The FDA has not publicly filed the inspection, which would indicate whether the voluntary actions Emerging has pledged to take will suffice or whether the FDA will recommend further action. Often, when inspectors discover multiple issues at a facility, the FDA will re-inspect to make sure the company implements any changes before lifting the restrictions.
It can take months, or even years, for drug factories to emerge from an FDA inspection that has revealed many problems. The FDA did not immediately respond to a request for comment on Emerging’s response.