The decision came after a lawsuit was filed by the group Public Health and Medical Professionals for Transparency which had requested detailed data on the vaccine under the Freedom of Information Act.
The court sided with PHMPT, directing the FDA to provide documents from the EUA file, which includes clinical trial data, safety information and manufacturing details.
Although the FDA had argued that the EUA and the Biologics License Application for the vaccine were separate and that the EUA data did not need to be released, the court found that the EUA data was incorporated into the vaccine’s BLA and must be disclosed.
The ruling mandates that the FDA release the requested documents by June 30, 2025.
