FDA Tells Johnson & Johnson to Throw Out 60 Million Vaccine Doses Due to Possible Contamination

The doses were from a manufacturing plant in Baltimore where regulators found there may have been cross-contamination with materials from the AstraZeneca vaccine

johnson & johnson covid vaccine
Johnson & Johnson's COVID-19 vaccine. Photo: Alex Gottschalk/DeFodi Images via Getty

The Food and Drug Administration has instructed Johnson & Johnson to throw out 60 million doses of the COVID-19 vaccine produced at a Baltimore plant out of concern that they may have been contaminated, according to multiple reports.

The FDA determined, after a review, that the doses were "not suitable for use," NBC News reported. They are allowing two batches of the vaccine, totaling 10 million doses, to be used but with a warning that they cannot guarantee that the plant, which is run by Emergent BioSolutions, had upheld manufacturing standards, according to The New York Times.

The Baltimore plant has been shut down for the last two months after the FDA identified possible cross-contamination in the manufacturing process. Along with producing the Johnson & Johnson vaccine, the plant also makes AstraZeneca's COVID-19 vaccine and Emergent had discovered in March that workers had swapped ingredients in one batch.

"These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a release, according to NBC News.

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Johnson & Johnson's single-dose vaccine has been vital in the U.S. for efficiently vaccinating vulnerable communities. The loss of 60 million doses will likely not have a significant impact on the U.S. vaccination effort, with a large supply of Pfizer and Moderna's two-shot vaccine and a slowing interest in vaccinations from the American public.

The number of daily vaccinations has dipped down to around 1.14 million a day as of June 11, well below the peak of 4.6 million two months earlier. The country will likely miss President Joe Biden's goal of getting 70% of Americans at least one dose of a vaccine by July 4, with Southern and Midwestern states lagging in vaccinations.

As of June 11, nearly 172.5 million Americans have received at least one dose of a COVID-19 vaccine, or just below 52% of the total population, and 141.5 million or 42.6% are fully vaccinated. Of the eligible population, those aged 12 and up, 61.5% have received at least one dose and 50.5% are fully vaccinated, according to the Centers for Disease Control.

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