03/11/2022 / By Mary Villareal
Information that the Food and Drug Administration (FDA) and pharmaceutical giant Pfizer was hoping wouldn’t be released for another 75 years has now been released. In the March 7 episode of “Live with Dr. Jane Ruby” on Brighteon.TV, the host talked about the controversial documents and what was lacking so far.
Ruby, who has spent two decades in the pharmaceutical industry, said much of the information in the files contain study setup materials, but not necessarily data or information. The initial documents include contracts for research organizations, source documentation and instructions.
The Brighteon.TV host also noted there are still some redactions in the material. It appears that the company doesn’t want the data dump to happen, as there was still information that is blacked out.
All in all, the agency released 55,000 pages of COVID-19 vaccine review documents on March 1, following the loss in court months earlier that forced the company to expedite its process in making the vaccine information available to the public.
The Public Health and Medical Professionals for Transparency, the nonprofit that sued the FDA last September 2021, claimed that the agency denied their request to expedite the release of the documents via the Freedom of Information Act (FOIA).
Although the court recognized the “unduly burdensome challenges” of the request imposed on the FDA, it concluded that the release of the documents is of “paramount public importance” – thus stating that expediting the process is necessary.
Once the FDA distributed the first batch of documents, the group posted the files on its own website instead. The content ranges widely with no real explanation of what was in them.
Zach Zalewski, a regulatory strategy consultant at Avalere Health, said many of the documents that will be released were submitted to the FDA through the vaccine’s emergency use authorization and full approval, and may not be important to the overall analysis of the vaccine’s safety and efficacy.
“This will literally include every scrap of paper that was submitted to FDA for the entirety of the pandemic. If transparency is what they want, transparency is what they’ll get,” he said. (Related: There is no debate: Vaccine data is largely based on research fraud and intimidation of scientists.)
Ruby, however, found that a lot of relevant information is still missing. “There is the entire group of studies that should have been done of humans prior to this going public, like pharmacokinetics and pharmacodynamics, which are completely missing,” she said.
There were also safety commitments that many may find interesting in the documentation, like information that the FDA would give to parents of children in the pediatric plan. The Vaccine Information Statement, which is the checklist for parents, does not discuss informed consent, which is an extensive document around 20 to 30 pages long, as it is supposed to be very detailed.
Another thing that Ruby noticed is that there is no institutional human subjects review board approval in any of the released data so far.
As for the appendix that got everyone talking, the company is not saying that the document – which listed around 1,600 potential adverse events of interest – does not list all adverse events that will happen. Instead, they listed all the possible adverse events that may or may not happen. (Related: Pfizer vaccine data shows far more damaging side effects than initially expected.)
“There’s a risk of cherry-picking and taking things out of context. Just because you will have all the data in front of you, that doesn’t mean you’ll reach any different conclusions,” Zalewski said.
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