In a major blow to the U.S. Food and Drug Administration (FDA), a federal judge on Thursday ordered the agency to produce all data it utilized in approving Pfizer’s COVID vaccine at a rate of 55,000 pages per month — which means all information should be available within eight months. In ordering the release of […]
FDA
FDA Clears New Formula of Pfizer’s COVID Vaccine for Kids and Adults Despite No Data on Safety or Efficacy
The U.S. Food and Drug Administration (FDA) on Oct. 29, 2021, approved emergency use authorization (EUA) of the Pfizer-BioNTech COVID vaccine for children aged 5 to 11, signing off on a new formula that contains tromethamine (Tris), without requiring animal or human data to assess safety or efficacy. Instead, the FDA conducted “analytical comparability assessments” […]