Johnson & Johnson’s single COVID-19 vaccine is expected to become an important part of the US immunization efforts, but Emergent’s manufacturing issues have greatly reduced the number of vaccines available.
Emergent BioSolutions Inc. promised the Food and Drug Administration that it would take a series of remedial measures in response to an inspection that resulted in the suspension of production at the factory of a company that produces the Johnson & Johnson Covid-19 vaccine.
The contract manufacturer stated in a letter to the FDA on April 30 that it will strengthen its biological waste treatment process, develop new requirements for wearing protective clothing, and provide training for facility personnel, as well as other steps to ensure vaccine quality Agency inspectors listed numerous problems in a report earlier that month.
Bloomberg News obtained Emergent’s response to FDA investigators through a request for information. The document details that Emergent is taking measures to ensure the quality of Johnson & Johnson’s vaccines because its employees accidentally mixed ingredients with ingredients used in AstraZeneca vaccines, prompting US regulators to investigate cross-contamination at the site and seek to suspend vaccine production.
The emergency declined to comment. At 3:21 pm New York time on Monday, its shares fell 3.6%, while Johnson & Johnson’s shares fell 0.2%.
Johnson & Johnson’s single Covid-19 vaccine is expected to become an important part of the US immunization efforts, but Emergent’s manufacturing issues have greatly reduced the number of available doses and the speed of delivery. According to the Centers for Disease Control and Prevention, of the 144 million fully vaccinated Americans, only 8% have been vaccinated by Johnson & Johnson.
On Friday, Bloomberg reported that US regulators had released 10 million doses of vaccine produced by Emergent’s factory near Bayview, Baltimore. Later in the day, the FDA stated that it has determined that some batches are not suitable for use, while others are still under review.
The FDA has not yet provided a full license to the Bayview facility to release its dose or resume production. Johnson & Johnson spokesperson Jake Sargent said on Monday that the company will continue to work with the FDA and Emergent to increase the facility based on its emergency use authorization for the vaccine.
Emergent’s problem also caused scrutiny by legislators. A Congressional investigation of the Gaithersburg, Maryland-based company found that despite warnings issued after a series of inspections in 2020, the company failed to address the deficiencies in vaccine production.
At the House hearing in May, the Democrats detailed other findings of the FDA inspection, and Emergent CEO Robert Kramer discussed some of the company’s remedial activities. Emergent’s formal response to the FDA is based on these comments.
By stopping the production of AstraZeneca vaccines at the Bayview plant and focusing on Johnson & Johnson’s APIs, “any theoretical risk of cross-contamination has been eliminated,” Emergent said in its response. The company said it has also implemented other temporary control measures to ensure the quality of the vaccine.
An FDA inspection found that the unsealed garbage bag was in contact with the materials of manufacture. In response to this discovery, Emergent plans to strengthen its biological waste treatment process by identifying a clear waste exit route, cleaning the route, and allowing personnel to witness and record activities. It means that a system has been established to transport materials on pallets or carts to avoid contact with the floor.
In addition, after the FDA discovered that Emergent workers were wearing protective clothing in multiple rooms of the facility, Emergent stated that it would develop a new protective clothing agreement.
In its response to the FDA, Johnson & Johnson stated that Johnson & Johnson is now monitoring the facility 24/7 and has hired a third-party consultant to assist in the repair work. The document shows that the company has also hired three employees who focus on quality control.
During the production suspension, Emergent stated that it has been providing instructor-led training for employees to learn how to better conduct investigations, prevent microbial contamination and ensure virus control.
The FDA has not publicly classified inspections, which will indicate whether the voluntary steps Emergent has committed to take are sufficient, or whether the FDA will recommend additional actions. Generally, when inspectors find multiple problems in a facility, the FDA will re-inspect to ensure that the company is implementing any changes before the restrictions are lifted.
It may take months or even years for a pharmaceutical factory to discover a large number of problems from FDA inspections. The FDA did not immediately respond to Emergent’s request for comment.