On Wednesday, April 21, the federal health regulators published a report on the Johnson&Johnson COVID-19 vaccine contractor’s production plant in Baltimore, Maryland, indicating the facility has several poorly qualified standards.
When the J&J single-shot vaccine production was halted last Friday, the U.S. Food and Drug Administration (FDA) decided to examine J&J’s contractor—the Emergent BioSolutions—and discovered the substandard conditions at the plant, which makes materials for the J&J Covid-19 vaccine production.
Federal health regulators disclosed that the facility was unsanitized, with manufacturing procedures not followed thoroughly, and staff underskilled, which have resulted in contaminated material that would later be used in a set of shots.
The FDA inspectors reported that a handful of the material that was supposed to be used for the J&J vaccine was contaminated with substances for another COVID-19 vaccine production, the AstraZeneca, with no proper procedure to prevent the contamination “followed in the execution of production.” Consequently, the materials that could have appeared in approximately 15 million J&J vaccine doses have been discharged.
Additionally, the facility that houses the manufacturing process was discovered to be under-sanitized in a way that makes it unqualifiable to “facilitate cleaning, maintenance, and proper operations.”
The description included “peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredient,” according to AP News.
The agency dubbed the lack of adequate staff training as the reason for the poor handling of the samples at the factory.
“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,” conveyed the report.
AP News reports that surveillance footage showed staff moving unsealed bags of medical waste carelessly around the facility, which touched the materials that were supposed to be used later on. Proof of employees moving between the two vaccine manufacturing sites getting sanitized properly was also not available for clarification.
FDA officials said that none of the materials made by the Emergent BioSolutions facility has yet to be approved for distribution by the agency. The United States has not used any of the vaccine doses produced from the plant’s resources yet.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” said Janet Woodcock and Peter Marks, FDA Acting Commissioner.
The agency promised that they would conduct a further examination with all the batches at the Baltimore factory.
“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the agency said.
1. Widespread manufacturing issues including contamination found during FDA inspection of factory J&J contracted facility manufacturing their COVID vaccine. pic.twitter.com/QRsEBn4q9q
— Rising serpent 🇺🇸 (@rising_serpent) April 21, 2021