Johnson & Johnson’s single-injection COVID-19 vaccine was expected to be a crucial part of U.S. vaccination efforts, but Emergent’s manufacturing problems have drastically reduced the number of doses available.
Emergent BioSolutions Inc. promises the Food and Drug Administration a series of solutions in response to an inspection that led to production shutdown at a facility of the company that had been manufacturing the Johnson & Johnson Covid-19 vaccine .
The contract manufacturer said in a letter to the FDA dated April 30 that it would strengthen bio-waste handling processes, establish new requirements for wearing protective gowns and provide training to facility personnel, among other steps to ensure vaccine quality, then agency inspectors cited countless issues in a report earlier this month.
Bloomberg News got Emergent’s response to FDA investigators through 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 U.S. regulators to investigate the contamination. crossed into the spot and look for a break in the vaccine. production.
Emergent declined to comment. Its shares fell 3.6% at 3:21 p.m. on Monday in New York, while J&J fell 0.2%.
The single-shot Covid-19 vaccine was expected to be a crucial part of the U.S. vaccination effort, but Emergent’s manufacturing problems have drastically reduced the number of doses available and the speed with which what have been administered. Only 8% of the 144 million fully vaccinated Americans have received the J&J 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 the Emergent facility in the Bayview neighborhood of Baltimore. Later that day, the FDA said it had determined that several batches were not suitable for use and that other batches were still being reviewed.
The FDA has not provided full authorization to Bayview facilities to release their 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 issues have also attracted scrutiny from lawmakers. A Congressional investigation into the Gaithersburg, Maryland-based company found it failed to address deficiencies in vaccine production despite warnings after a series of inspections in 2020.
At a hearing in the House in May, Democrats detailed additional findings from the FDA inspection and emerging CEO Robert Kramer discussed some of the company’s remediation activities. Emergent’s formal response to the FDA is based on these comments.
By stopping production of the AstraZeneca vaccine at Bayview’s facilities and focusing exclusively on J&J’s massive pharmacological substance, “any theoretical risk of cross-contamination is eliminated,” Emergent said in its response. The company said it has also established other interim controls to ensure the quality of the vaccine.
The FDA inspection found that the unsealed waste bags came into contact with manufacturing materials. In response to this finding, Emergent plans to strengthen its bio-waste handling process by identifying a defined exit route for waste, cleaning it up and having staff witness and document the activity. He said he has instituted a system to transport material on pallets or dolls to prevent contact with the ground.
In addition, after the FDA found that an emerging worker was wearing a protective gown in several rooms of the facility, Emergent said it would implement a new protocol for the gown.
J&J now provides oversight 24 hours a day, 7 days a week at the facility and third-party consultants have been conducted to assist them in the repair, he said in response to the FDA. The company also hired three employees focused on quality control, according to the document.
Throughout the break in production, Emergent said it has been providing instructor-led training to employees on how to conduct better research, prevent microbial contamination and ensure viral containment.
The FDA has not publicly classified the inspection, which would indicate whether the voluntary steps that Emergent has committed to take will be sufficient or whether the FDA will recommend additional actions. Often, when inspectors encounter multiple problems in a facility, the FDA will review to make sure the company is implementing any changes before lifting restrictions.
Pharmaceutical plants can take months, and sometimes years, to come out of an FDA inspection that has found major problems. The FDA did not immediately respond to a request for comment on Emergent’s response.