FDA Can Withhold Key COVID Vaccine Safety Records for Now: Judge

Published on December 16, 2023

The U.S. Food and Drug Administration (FDA) is being allowed to withhold COVID-19 vaccine safety data for at least six months, under a recent order from a federal judge. Lawyers representing the FDA said that the agency is overburdened by court orders forcing it to produce a certain amount of records pertaining to the authorization of the Pfizer and Moderna COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is “dealing with an unprecedented workload” and “specific and unprecedented hardships,” the lawyers said in a motion for a stay. They asked for an 18-month pause in processing a Freedom of Information Act request that seeks the results of COVID-19 vaccine safety data mining....

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