Transparency, accessibility, and advancement of medical research represent a driving force for TrialSite, and recently, the move for greater translucence scored a victory regarding accessing the Pfizer COVID-19 vaccine product data. TrialSite has followed the transparency case led by attorney Aaron Siri and his firm Siri Glimstad. A Freedom of Information Act (FOIA) matter, up until now the federal judge followed the calls for opaqueness, by ensuring comprehensive access to the Pfizer FDA application data at a snail’s pace—500 pages per month would make the entire trove available in 55 years. Then, after a back and forth in court, the FDA added insult to injury by proposing to extend the full download of the Pfizer data to 75 years. Representing the Public Health and Medical Professionals for Transparency (PHMPT), attorney Siri at first sought to secure the entire batch of data within 108 days, which just so happens to be the amount of time it took for the Gold Standard regulatory agency to review and approve Pfizer’s vaccine. As TrialSite’s Sonia Elijah has uncovered, numerous concerns were raised after review of just one currently available set of Pfizer vaccine safety documents. Now, the attorney reports the federal judge rejected the FDA’s latest aggressive moves for unacceptable opacity—the court has more closely aligned with Siri’s clients and compelled the regulatory agency to now accelerate the data transfer—from 500 pages per month to 55,000 pages per month! In making this proclamation, the judge referred to quotes from both James Madison and John F. Kennedy emphasizing important attributes of good government.
Make a Good Decision—Have the Proper Data
TrialSite suggests that this ruling represents a real opportunity for what can become an eventual improvement in the mission-critical risk-benefit analysis needed for determination of benefit, or risk of COVID vaccination with the Pfizer vaccine called BNT162b2, or “Comirnaty.”
The mass vaccination of very young children, for example, raises several important ethical questions that can only be properly addressed by a rigorous, independent, and unbiased risk-benefit analysis of the true benefits and costs of this vaccine. But without underlying comprehensive product data there can be no such independent analyses.
As Siri reports himself, the latest ruling will make data available enabling independent scientists the ability to “offer solutions and address serious issues with the current vaccine program—issues which include waning immunity, variants evading vaccine immunity, and as the CDC has confirmed, that the vaccines do not prevent transmission.”
Mandate Elements
Bioethicists can make a strong case that forced mandates presuppose a few critical prerequisite factors, such as quality, safety, and effectiveness. In this case, a growing number of scientists, physicians, and health policy analysts, as well as political representatives, share concerns that the COVID-19 vaccines have failings that must be uncovered, analyzed, and better understood. The stakes are too high.
But who could deny that with a mandated medical procedure on hundreds of millions of people, that it’s right and proper that the regulatory agency involved allow for the transparency of underlying product documentation? Why would the FDA keep back critical COVID-19 vaccine data from the public when a substantial portion of that consumer base is coerced to engage in an unwanted medical procedure?
Apparently, this judge came around to the significance and importance of this case. He “recognized the release of this data is of paramount public importance and should be one of the FDA’s highest priorities,” wrote Siri.
Interestingly, the federal judge quoted two former popular presidents in this latest hearing. Referring to James Madison, the judge for the United States District Court for the Northern District of Texas declared a “popular government, without popular information, or the means of acquiring it, is but a prologue to a farce or a tragedy.” This was followed by a quote from John F. Kennedy: “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
As the data becomes available, TrialSite will collaborate with scientists to interrogate the trove for important data, insights, and breakthroughs—translated and streamlined and delivered in understandable, concise prose. One true hope—that Pfizer isn’t afforded the opportunity to redact too much of the information.