The U.S. Food and Drug Administration on Tuesday released a 10,000-page cache of documents pertaining to the Emergency Use Authorization of Pfizer’s COVID vaccine. An initial review shows the documents contain details about animal studies, adverse events experienced by trial participants, the makeup of Pfizer’s internal review committee … and more.
Michael Nevradakis, Ph.D.
Children’s Health Defense
March 4, 2022
The U.S. Food and Drug Administration on Tuesday released a 10,000-page cache of documents pertaining to the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine.
The documents provide more insights into the FDA’s process for approving the vaccine, and may also shed more light on the safety and efficacy of the vaccines and the number and nature of adverse effects that were observed during the clinical trials and the first months after the EUA was issued.
The documents were made public as part of a court-ordered release schedule stemming from an expedited Freedom of Information Act (FOIA) request by Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT, a group of medical and public health professionals and scientists from Harvard, Yale, UCLA and other institutions, submitted the request in August 2021.BUY TODAY: Robert F. Kennedy, Jr.’s New Book — ‘The Real Anthony Fauci’
The FOIA request asked for the approximately 400,000 pages of documents pertaining to the approval of the Pfizer COVID vaccine to be made public, including safety and effectiveness data, adverse reaction reports and a list of the vaccine’s active and inactive ingredients.
When the FDA ignored the request, PHMPT sued the agency in September 2021, taking the case to the U.S. District Court for the Northern District of Texas. On Feb. 2, federal judge Mark Pittman issued an order requiring the FDA to release redacted versions of the documents in question according to the following disclosure schedule:
- 10,000 pages apiece, due on or before March 1 and April 1, 2022.
- 80,000 pages apiece, to be produced on or before May 2, June 1 and July 1, 2022.
- 70,000 pages to be produced on or before Aug. 1, 2022.
- 55,000 pages per month, on or before the first business day of each month thereafter, until the release of the documents has been completed.