Judge Orders FDA to Accelerate Release of COVID-19 Vaccine Trial Data to Just 2 Years

Pfizer and Moderna bivalent COVID-19 vaccines at a clinic in Richmond, Va., in a Nov. 17, 2022, file image. Steve Helber/AP Photo

A federal judge in Texas ordered the Food and Drug Administration (FDA) to make public data it relied on to license COVID-19 vaccines at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of about 23.5 years.

In a May 9 decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the agency was ordered to produce the data on Moderna’s vaccine for adults and Pfizer’s for children about 10 times faster than the agency wanted.