Boxes of the Johnson & Johnson coronavirus vaccine, which is manufactured by subsidiary Janssen, are seen at a warehouse in Budapest, Hungary, on April 13. Photo by Szilard Koszticsak/EPA-EFE
April 21 (UPI) -- Federal regulators said in a report Wednesday that a contractor that Johnson & Johnson paid to produce tens of millions of doses of its COVID-19 vaccine failed to ensure safe conditions at its Baltimore plant.
The contractor, Emergent BioSolutions, ruined about 15 million doses of the Johnson & Johnson vaccine by mixing up the formulation with that of another vaccine.
The Food and Drug Administration said in a 13-page report Wednesday that conditions at the Emergent plant were unsanitary and unsuitable to produce the coronavirus vaccine developed by Johnson & Johnson subsidiary Janssen.
The doses were ruined when the Emergent plant conflated the ingredients of the Johnson & Johnson vaccine with those that went into AstraZeneca's COVID-19 vaccine, which was also being produced at the facility.
AstraZeneca has since removed its vaccine from Emergent's Baltimore plant. That vaccine has not yet been approved for use in the United States.
The FDA said Emergent failed to do a thorough investigation into the cross-contamination.
"The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense and engineering operations to prevent cross-contamination of bulk drug substances," the report states.
"We are working with the company to address the conditions identified," the FDA said in a statement. "Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues."
The FDA said additional testing will be done on the vaccines that have already been produced.
Johnson & Johnson's vaccine has been halted in the United States due to a possible link to a few cases of blood clotting in recipients. The clotting cases and nationwide pause are not related to the quality control issues at the Emergent plant, since none of the ruined doses were distributed.
"The quality and safety of our COVID-19 vaccine is paramount," Johnson & Johnson said in a statement after the FDA findings were published.
"Johnson & Johnson will exercise its oversight authority to ensure that all of FDA's observations are addressed promptly and comprehensively. The company will also redouble its efforts as it continues to work toward securing emergency use authorization in the United States for drug substance manufactured at Emergent as quickly as possible, so that the company can help bring an end to this global pandemic."
January 31, 2020
National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo