FDA issues withering report on problems at Emergent BioSolutions factory that ruined millions of J&J vaccines

The FDA released an inspection report Wednesday skewering operations at a drug manufacturing plant blamed for ruining millions of doses of Johnson & Johnson’s vaccine.

The inspection, completed Tuesday, “cited a number of observations concerning whether the facility’s processes met our requirements and standards,” acting FDA Commissioner Janet Woodcock said in a statement.

The 13-page report says the Emergent BioSolutions Bayview plant in Baltimore was too small, poorly designed and dirty. Unsealed bags of medical waste were observed, along with peeling paint and damaged floors and walls that could inhibit proper cleaning, the inspectors said. 

Employees were not properly trained and failed to properly handle ingredients, the report says.

“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 inspectors said in the report.

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The FDA asked the plant to halt manufacturing, pending completion of the inspection. The agency stressed that it has not authorized the facility to manufacture or distribute J&J coronavirus vaccine or components, and no vaccine manufactured at this plant has been distributed in the USA. More than 7 million doses of J&J vaccine came from European plants.

Vaccine materials made at Emergent are stored pending FDA authorization. The plant’s issues are not the only hurdle facing the J&J vaccine. Its use was “paused” in the USA as health officials investigate its connection to very rare blood clots.

The withering inspection report comes as public health officials labor to overcome vaccine hesitancy among millions of Americans concerned about the safety and effectiveness of the shots.

Eric Cioe-Peña, director of global health for Northwell Health in New Hyde Park, New York, said the pause in manufacturing and the inspection showed the system for providing safe and effective vaccines is working.

“A company that was not adhering to the standards for production was inspected, cited and is now no longer involved in vaccine production,” he said. “This should inspire confidence in the quality control systems regulating vaccine producers.”

Ogbonnaya Omenka, an associate professor and public health specialist at Butler University in Indianapolis, said one of the challenges in delivering public health interventions is managing the public’s reaction to emerging information.

“It’s understandable if some people become apprehensive about COVID-19 vaccines in general or J&J vaccines,” Omenka said. “However, as much as the public want only positive updates, transparency remains a key tool in gaining public trust.”

Emergent Solutions issued a statement saying the company is committed to working with the FDA and Johnson & Johnson to resolve the issues. 

“While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them,” the statement said.

Johnson & Johnson promised to “exercise oversight authority” to ensure the FDA’s observations are addressed promptly and to work toward securing Emergency Use Authorization for drug substances manufactured at the plant.

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Emergent is a contract manufacturer that had been making vaccines for J&J and AstraZeneca. Problems arose this year when workers accidentally mixed up ingredients for the two vaccines, causing the shots to be wasted.

Emergent explained that “rigorous quality checks” determined that a single batch of drug substance was identified that did not meet specifications.

“Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” the company said.

Use of the Johnson & Johnson COVID-19 vaccine has been halted in the USA while investigators look into cases of blood clots. (Photo: Mark Lennihan, AP)

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