The FDA came into conflict with a Texas judge over the release of data the agency used to license Pfizer’s Wuhan coronavirus (COVID-19) vaccine. The FDA wanted the Big Pharma company to only produce 500 pages of data per month.
But District Judge Mark T. Pittman of Northern Texas ruled that the FDA had to turn over 55,000 pages of data a month starting on March 1. According to the court’s order: “The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”
This means all of Pfizer’s COVID-19 vaccine trial data should be made public within eight months. (Related: Congress refuses to investigate FDA’s failure to look into claims that Pfizer falsified COVID vaccine trial data.)
The FDA originally requested that Pfizer’s data be made public over the course of 75 years. When this was taken to court, the agency lowered its request to 55 years. What this means is that if the FDA had gotten its way, the public would not have full access to Pfizer’s COVID-19 vaccine data until 2077 at the earliest and 2097 at the latest.
Some Pfizer documents are already available, but nothing groundbreaking released yet
Public Health and Medical Professionals for Transparency is the non-profit organization that successfully sued the FDA into releasing the Pfizer COVID-19 vaccine data faster.
PHMPT released all of the currently available Pfizer data on the organization’s website but did not offer any sort of proper context or any other explanation of what the data shows.
Speaking to Endpoints News, Siri & Glimstad managing partner Aaron Siri, who represented PHMPT in its lawsuit, said: “Our job was to get the documents. We leave it to the scientists and others to analyze.”
The documents the FDA and Pfizer have already released are mostly technical documents, including one that shows the Big Pharma company paying the standard $2.9 million user fee to the FDA for its application.
Other documents released include the FDA granting Pfizer and BioNTech’s request to get its experimental vaccine fast track designation.
Some of the documents currently available include one labeled as a priority review request. It includes more than 100 pages worth of anonymous safety data tables. Another document includes tables listing the genders, ages and body mass indexes of COVID-19 vaccine trial participants.
Other information from the document release includes a confidential nonclinical overview of the vaccine, a request from Pfizer to waive the requirement to add a suffix to the end of the vaccine’s name and a long list of anonymized trial subjects who did not receive the vaccine.
Journalist Zachary Brennan, senior editor for Endpoints News, noted that some of the documents that Pfizer and the FDA released were unnecessary documents that did not need to be released. These include Pfizer’s fast track designation approval and its request for a waiver regarding the name of the vaccine.
“The sheer volume of pages and document types will give readers a good overall sense of the required documentation necessary to apply for a drug or vaccine approval at the FDA,” wrote Brennan. “But it’s still unclear if the documents will offer any new insight into the vaccine’s safety or efficacy, especially given the real-world data on the vaccine that’s already been published in major medical journals.”
What this shows is that the FDA and Pfizer may be colluding to release documents that they are not required to release in order to delay the publication of documents that may have more important information regarding Pfizer’s vaccine.
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Listen to this episode of the “Health Ranger Report” as Mike Adams, the Health Ranger, talks about a smoking gun document from Pfizer that shows it covered up COVID-19 vaccine deaths with the help of the FDA.
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