The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021. Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals, submitted the FOIA request.