The latest release of Pfizer-BioNTech COVID-19 vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.
The 80,000-page document cache released May 2 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.
The documents also include the “third interim report” from BioNTech’s trials conducted in Germany (accompanied by a synopsis of this report and a database of adverse events from this particular set of trials).
The FDA 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, a group of doctors and public health professionals, submitted the FOIA request.