The Food and Drug Administration forced Johnson & Johnson to toss about 60 million potentially contaminated COVID-19 doses produced at a troubled Baltimore plant, reports The New York Times.
The FDA, according to the Times, will distribute 10 million doses in the U.S. or send them to other countries with the warning that Emergent BioSolutions may not have followed good manufacturing practices.
The loss doesn’t put a dent in the nation’s COVID-19 vaccine stock as the federal government has a large supply of the shots from Pfizer-BioTech and Moderna, though it inhibits the Biden administration’s plan to send vaccines to other countries in need of shots.
Pfizer-BioTech, Moderna and Johnson & Johnson are the only companies federally authorized to develop coronavirus vaccines.
The FDA in a statement said it ''conducted a thorough review of facility records and the results of quality testing performed by the manufacturer'' before making its decision and said it also considered the ongoing public health emergency.
The agency also said it was working through issues at the Baltimore plant with Johnson & Johnson and Emergent.
Dr. Peter Marks, who oversees vaccine regulation at the FDA, said in the statement that the agency has been conducting an extensive review of vaccine batches produced at the plant ''while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the F.D.A.’s current good manufacturing practice requirements.''
The Associated Press reported that security camera footage showed employees at the Baltimore plant carelessly handling vaccine materials. Inspectors also reported unsanitary conditions and poorly trained employees.
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