FDA report: Major problems at plant that ruined vaccine
BALITMORE — An inspection by the U.S. Food and Drug Administration found significant sanitation and procedural problems at the East Baltimore plant that ruined 15 million doses of the Johnson & Johnson COVID-19 vaccine.
Released Wednesday, the new documents shed light into Emergent BioSolutions’ continued lack of federal authorization to distribute the vaccine it’s produced. Inspectors found cleaning and sterilization failures; lack of adherence to protocols; and potential cross-contamination in multiple areas.
The FDA has instructed Emergent to pause new production while it works with the agency to correct the documented problems. But the federal regulators did not offer a timeline as to when the corrections should be implemented.
Emergent spokesperson Matt Hartwig said Wednesday that the company would work to get the facility up to par.
“While we are never satisfied to see shortcomings in our manufacturing facilities or process,” Hartwig said, “they are correctable and we will take swift action to remedy them.”
The company, based in Gaithersburg, has received hundreds of millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at the East Baltimore factory near Johns Hopkins Bayview Medical Center. That plant, built with federal money to respond to pandemics and other bio-threats, has a history of violations dating back at least a year, including insufficient employee training, a lack of standardization of quality-control measures, and a non-adherence to test procedures and laboratory control mechanisms.
Johnson & Johnson has since assumed control over the plant at the request of federal officials. Federal regulators paused the use of the company’s singleshot vaccine to review reports of an extremely rare blood clotting reaction found in six women.
Emergent confirmed earlier this week that it had stopped production of vaccine as the FDA did its inspection of the Bayview facility. None of the bulk Johnson & Johnson vaccine from the plant had been in use, as the production line had not yet been approved by federal regulators.
All Johnson & Johnson vaccine distributed in the United States had come from the Netherlands before the move by the FDA to pause its use.
The FDA’s plant inspection was completed Tuesday, a day after an institutional shareholder filed a lawsuit in the U.S. District Court for Maryland that seeks class action status for what it alleges were false statements made by Emergent and its top officials about the company’s ability to mass produce vaccine.
The suit alleges the comments pushed up the share price, which dropped significantly after problems with the plant came to light in media reports, including both the mistake that led to disposal of an estimated 15 million doses of the Johnson & Johnson vaccine and ongoing quality problems.