April 5, 2021 – Federal health officials put Johnson & Johnson on Saturday at the helm of a vaccine factory in Baltimore that contaminated 15 million doses of the COVID-19 vaccine and ordered the plant to stop producing doses of AstraZeneca.
The move came days after federal health officials discovered the plant was mixing ingredients from two vaccine companies. Emergent BioSolutions, a contract manufacturer, had made both Johnson & Johnson and AstraZeneca vaccines at the factory.
The Department of Health and Human Services directed Johnson & Johnson to deploy new leadership at the plant to oversee production and production, the newspaper reported.
Johnson & Johnson is taking full responsibility for the production of drug substances for its COVID-19 vaccine in the BioSolutions Inc. Emergency environment. Bayview, wrote the vaccine company in a statement on Saturday.
Specifically, [Johnson & Johnson] is adding dedicated leaders to operations and quality, and significantly increasing the number of production, quality and technical operations personnel, the company wrote.
The Johnson & Johnson vaccine has received FDA approval in the US, but the AstraZeneca vaccine does not. 15 million Johnson & Johnson contaminated doses were not released for distribution, New York Times reported, and officials are now assessing whether the other herds were contaminated. In addition, AstraZeneca will find a new site to produce its vaccine, the newspaper reported.
The emerging coronavirus vaccine line has not yet been FDA certified, so vaccines made there can not be distributed yet, according to in the Washington Post. Factory-made doses are set aside as the FDA reviews the plant.
The FDA takes its responsibility to help ensure the quality of production of vaccines and other medical products for use during this pandemic very seriously, Janet Woodcock, MD, FDA commissioner, told the newspaper Saturday.
At the same time, Woodcock said the ultimate responsibility falls on Johnson & Johnson to ensure quality control.
Importers It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company holding the emergency use authorization to ensure that FDA quality standards are met, she said.
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