FDA Makes Public Wait 55YRS for Pfizer Vaccine Safety Data Release


A group of scientists who asked the federal government to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine have been told they will not get the information until 2076 according to Reuters.


That’s how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency can expect to see the full record in 2076.


The 1967 FOIA law requires federal agencies to respond to information requests within 20 business days. However, the time it takes to actually get the documents “will vary depending on the complexity of the request and any backlog of requests already pending at the agency,” according to the government’s central FOIA website. Justice Department lawyers representing the FDA note in court papers that the plaintiffs are seeking a huge amount of vaccine-related material – about 329,000 pages.


The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September in U.S. District Court for the Northern District of Texas, seeking expedited access to the records. They say that releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.”


DOJ lawyers in a joint status report filed Monday wrote: 'the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.'


Civil division trial lawyer Courtney Enlow referred my request for further comment to the DOJ public affairs office, which did not respond. Plaintiffs' lawyers argue that their request should be top priority, and that the FDA should release all the material no later than March 3, 2022.


“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.

“The entire purpose of the FOIA is to assure government transparency,” they continued. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”


They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine."