Another 60MM J&J Doses Produced At Troubled Baltimore Plant Are Tainted, FDA Says

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Since the incident, the FDA has been reviewing safety and production procedures at the facility. But despite the US government handing over control to J&J, attempts to re-start production have been in limbo, and according to the NYT, another 60MM doses produced at the facility didn't meet the agency's safety standards.

In a statement, the F.D.A. said that before making its decision, it "conducted a thorough review of facility records and the results of quality testing performed by the manufacturer." It also considered the ongoing public health emergency. The agency said it was continuing to “work through issues” at the Baltimore plant with Johnson & Johnson and Emergent.

Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said in the statement that the agency has been conducting an extensive review of batches of vaccine 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."

Representatives from Johnson & Johnson and Emergent declined to comment on the agency’s decision.