Judge Rejects FDA’s 75 Year Delay On Vax Data, Cuts To Just 8 Months
A federal judge has rejected a request by the FDA to produce just 500 pages per month of the data submitted by Pfizer to license its Covid-19 vaccine – and has ordered them to produce 55,000 pages per month. Assuming there are roughly 450,000 pages, that means it will take just over eight months for the world to see what’s under the hood.
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This is a great win for transparency and removes one of the strangleholds federal “health” authorities have had on the data needed for independent scientists 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.
No person should ever be coerced to engage in an unwanted medical procedure. And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.
In ordering the release of the documents in a timely manner, the Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities. He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that 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.”
The following is the full text of the Judge’s order, a copy of which is also available here.
The Pfizer documents: Dr. John Campbell has been red-pilled
A former advocate of the vaccine, trusted by millions of people, has now realized he’s been deceived and he’s not happy about it at all.
Dr. John Campbell has been a source of trusted medical information for millions of people throughout the pandemic. His videos have been viewed over 400 million times and he has over 2 million subscribers.
…the immediate question in my mind, is why wasn’t this data in the public domain already? Surely we want to know this information to make informed healthcare decisions.
On March 9, 2022, Campbell published a video entitled “The Pfizer documents” where he goes through one of the released documents in detail: the ADVERSE EVENTS OF SPECIAL INTEREST (AESI) document (aka the “5.3.6 document”).
As of March 11, that video now has 1.4M views.
In the video, Campbell clearly shows that he is not happy with the lack of transparency. He is not happy with the safety signals disclosed in this document. Not happy at all. He concludes “This has just destroyed trust in authority” (watch @21:55). Bingo!
This means that, in the minds of the mainstream media, Dr. Campbell has transitioned from being a “respected health expert” to a “misinformation spreader” that should be ignored.
Public Health and Medical Professionals for Transparency, Pfizer / FDA FOI https://phmpt.org
Request, Freedom of Information Act (FOIA) https://phmpt.org/wp-content/uploads/…
Against FDA https://phmpt.org/wp-content/uploads/…
The court order https://phmpt.org/wp-content/uploads/…
List of downloadable documents https://phmpt.org/pfizers-documents/
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 https://phmpt.org/wp-content/uploads/…
Also:
British Medical Journal Demands Immediate Release of All COVID-19 Vaccine, Treatment Data
The British Medical Journal (BMJ) has demanded the full and immediate release of all data related to COVID-19 vaccines and treatments, saying it is in the public’s interest to do so.
BMJ, a weekly peer-reviewed medical trade journal published by the trade union the British Medical Association, called for the release of the data in an editorial published on Wednesday.
“Today, despite the global rollout of COVID-19 vaccines and treatments, the anonymized participant-level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come,” BMJ said.
“This is morally indefensible for all trials, but especially for those involving major public health interventions.”
BMJ also accused pharmaceutical companies of “reaping vast profits without adequate independent scrutiny of their scientific claims,” pointing to Pfizer, whose COVID vaccine trial was “funded by the company and designed, run, analyzed, and authored by Pfizer employees.”
New York-headquartered Pfizer still holds that trial data and has indicated that it won’t begin considering requests for such data until May 2025—24 months after the primary study completion date of May 15, 2023, which is listed on ClinicalTrials.gov.
Meanwhile, The Food and Drug Administration (FDA) had asked a judge to give it 75 years to produce all the data concerning the Pfizer and BioNTech vaccine.
However, a judge earlier this month ordered that the FDA make public 12,000 pages of the data it used to make decisions regarding approvals for the Pfizer/BioNTech COVID-19 vaccine by the end of the month. The FDA must also release Pfizer’s vaccine data at a rate of 55,000 pages a month until all of the requested pages are public.
BMJ also noted that AstraZeneca has indicated that it may be ready to entertain requests for data from a number of its phase III trials. However, the Cambridge-headquartered company says that the timeline for such data can “vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymization, and sharing of the requested data or documents.”
The Epoch Times has contacted spokespersons for Pfizer and AstraZeneca for comment.
“We are left with publications but no access to the underlying data on reasonable request,” BMJ said.
“This is worrying for trial participants, researchers, clinicians, journal editors, policymakers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymized individual participant data from clinical trials must be made available for independent scrutiny.”
BMJ added that regulators are not there to “dance to the tune of rich global corporations and enrich them further” but to protect the general public’s health and for that reason, they said, we need “complete data transparency for all studies, we need it in the public interest, and we need it now.”
In December, the Centers for Disease Control and Prevention (CDC) was also sued by the Informed Consent Action Network (ICAN) over claims that it is improperly withholding COVID-19 vaccine safety data from the American public.
ICAN is asking the CDC to provide de-identified post-licensure safety data for the COVID-19 vaccines in the CDC’s v-safe system so as to assure transparency with the general public regarding claims by both the CDC and the Biden administration that COVID-19 vaccines are “safe and effective.”
The British Medical Journal is one of the world’s oldest general medical journals, having been founded in 1840, and has editorial freedom from the British Medical Association.
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