According to the court order, the FDA was to immediately release about 12,000 pages of documents, then 55,000 pages per month until all documents — more than 300,000 pages in total — were released. Before the documents can be released, the agency must redact confidential business secrets from Pfizer and BioNTech, as well as private patient information from clinical trials. On January 6, a federal court in the Northern District of Texas ordered an expedited release. As of Jan. 12, the FDA has not indicated it intends to appeal. Wait for what? FDA to process 55 years of FOIA request over vaccine data However, U.S. District Judge Mark Pittman of the Northern District of Texas issued a court order in January ordering the FDA to significantly expedite the release of documents. You can make the judge`s decision here: www.fdanews.com/01-07-22-PittmanFOIAOrder.pdf. – Suz Redfearn The FDA handed over thousands of documents last week related to its review of Pfizer-BioNTech`s COVID-19 vaccine, marking the first of several approvals ordered by a Texas court earlier this year. As then-presidential candidate Joe Biden told the American people, “You need to make everything [vaccine data] available to other experts across the country so they can watch and see.” He reiterated the need to share data repeatedly. The same was true for senators and representatives on both sides of the chamber. The nonprofit that won the lawsuit, Public Health and Medical Professionals for Transparency, sued the FDA last September, claiming the agency had denied its request to expedite the release of COVID-19 vaccine review documents through the Freedom of Information Act (FOIA). In a joint status report in November, the FDA proposed releasing about 500 pages of documents each month — which would satisfy the organization`s FOIA request in about 55 to 75 years.

In a CDC study published in Lancet Infectious Diseases, researchers looked at self-reported data from the Vaccine Adverse Event Reporting System (VAERS) and v-safe follow-up. While the court acknowledged the “excessively onerous challenges” this request posed to the FDA, it concluded that the disclosure of these documents was of “utmost public importance” and said expediting the process was “not only practical, but necessary.” The FDA and the nonprofit will submit a joint status report by April 1, detailing the progress of the application. “There is a danger of choosing and taking things out of context,” Zalewski said. “Just because you have all the data in front of you doesn`t mean you`ll come to different conclusions.” In response to a Freedom of Information Act request, the Food and Drug Administration asked a federal judge for permission to make the public wait until 2096 to release all the data it relied on to approve Pfizer`s Covid-19 vaccine. The FDA`s attempt to close the door and exclude independent scientists from the data needed to solve these problems was irresponsible. At this rate, it would take 75 years to release all the data. According to Zach Zalewski, a regulatory strategy consultant at Avalere Health, the published documents “will literally include every piece of paper submitted to the FDA for the entire pandemic,” but are unlikely to be useful in determining the overall safety and efficacy of the vaccine. A federal judge in Texas on Thursday ordered the Food and Drug Administration to release the data it relied on to approve Pfizer`s COVID-19 vaccine, imposing a significantly accelerated timeline that is expected to result in the release of all information within about eight months. In response, the FDA produced nothing.

Therefore, in September 2021, the scientists, represented by their lawyers at Siri & Glimstad, sued the FDA, asking them to submit this data by March 2022. As Pittman acknowledged, America needs transparency and independent scientists to verify this data, not 75 years from now. Anti-vaccine advocates have already used the publication of these documents to further question COVID-19 vaccines. Children`s Health Defense, a non-profit organization that has spoken out against the use of COVID vaccines in children, highlighted a list of adverse events reported in the literature – a list that includes all adverse events that occurred in people who participated in the clinical trial, including those who received a placebo. and is misleading. said experts. Zach Zalewski, PhD, JD, regulatory strategy consultant at Avalere Health, said many of the documents that will be released have been submitted to the FDA through emergency use authorization and full approval of the vaccine and may not be essential to an overall analysis of the vaccine`s safety and efficacy. The FDA has already published a drug approval dossier for Pfizer-BioNTech`s COVID-19 vaccine, consisting of data summaries reviewed by the FDA.