Tag: fda

FDA Asks Court for 55 Years to Fully Release Pfizer COVID-19 Vaccine Data

The Food and Drug Administration (FDA) asked a federal judge on Nov. 15 to give it until the year 2076 to fully release the documents in its possession tied to the approval of the Pfizer-BioNTech COVID-19 vaccine.

The FDA’s request was made in a filing as part of a Freedom of Information Act (FOIA) lawsuit by a medical transparency group. The government told the court it has 329,000 pages of documents responsive to the FOIA request and proposed releasing 500 pages per month to allow for redactions of exempt material. At that rate, the FDA would fully release the records in question in just under 55 years.

The plaintiff, Public Health and Medical Professionals for Transparency (PHMPT), is a group of doctors and scientists, including Harvey Risch, a professor of epidemiology at the Yale School of Public Health.

The group filed the lawsuit (pdf) after the FDA denied their request to expedite the release of the records. The plaintiff and the defendant, unable to reach an agreement on a disclosure schedule, are seeking a hearing to argue their cases before the judge, who may eventually make a decision in that regard.

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FDA’s Smoking Gun: Disinformation Campaign Targeting Ivermectin

It recently came to my attention that communication within the U.S. Food and Drug Administration (FDA) evidences the Gold Standard agency’s explicit involvement in the Ivermectin disinformation war. While the agency approves ivermectin as an anti-parasite medicine, physicians have increasingly embraced it as an off-label treatment for early-onset COVID-19. Over 60 studies around the world have, for the most part, found positive findings; however, the mainstream media embraced the handful that are neutral or had data problems, for example. Regardless of position, a disinformation campaign was initiated by the FDA and others to deter the use of the off-label treatment. See the email here.

In my investigative report: How ivermectin became a target for the ‘fraud detectives,’ published in TrialSite, I highlighted the relentless smear campaign against this life-saving generic drug by a certain group of scientists/bloggers, which has been amplified in the mainstream media. My report included the overtly biased and controversial ‘You’re not a horse’ tweeted by the FDA. However, the revelatory email communication within the FDA exposes the insidious nature of this government agency’s deep involvement as one of the major planners of this disinformation war against ivermectin. 

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FDA Knew About Numerous Adverse Events For Children ‘Related’ To Pfizer Vaccine, Approved It Anyway

Here is the “Vaccines and Related Biological Products Advisory Committee Meeting October 26, 2021 Briefing Document” published by the FDA. Page 15 lists an “OVERVIEW OF CLINICAL STUDIES.” Two clinical studies are listed. The first clinical study listed is “Phase 1/2/3 Registrational Study C4591001,” which was sponsored by BioNTech and conducted by Pfizer. The other clinical study listed is “Phase 1/2/3 Pediatric Study C4591007,” which is listed as being sponsored by BioNTech and supported by Pfizer. “Pediatric Study c4591007” is an ongoing study and it was used by the FDA for approval of the vaccine for ages 5 to 12. That’s right. The FDA meeting’s data was taken from an ongoing study conducted by the very makers of the vaccine. The information below comes from the FDA Briefing Packet’s review of Pfizer Pediatric Study C4591007.

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British Medical Journal Publishes Damning Report Claiming Pfizer Faked Vaccine Data in Trials

Leading medical journal The BMJ has published an incendiary report exposing faked data, blind trial failures, poorly trained vaccinators, and a slow follow-up on adverse reactions in the phase-three trial of Pfizer’s Covid jab.

Central to the exposé is Brook Jackson, who, for two weeks, served as regional director at Ventavia Research Group, the company contracted to assist with the pivotal trial. She provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails supporting her concerns.

Jackson reveals that Ventavia staff who conducted quality-control checks were overwhelmed by the volume of problems they were identifying. She repeatedly informed her superiors of poor laboratory management, and patient safety and data integrity issues.

In a cited internal document from August 2020, shortly after the Pfizer trial began, a Ventavia executive identified three site staff members with whom to “go over e-diary issue/falsifying data, etc.” One employee was said to have been subsequently “verbally counseled for changing data” and “not noting late entry.”

Jackson reported her concerns to the US Food and Drug Administration (FDA), but was fired later the same day on the basis that she was “not a good fit.”

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FDA Admits MORE Serious Adverse Effects From Pfizer Vaccine ‘May Become Apparent’ With Widespread Use

A Fact Sheet for Vaccine Providers published on the Food and Drug Administration (FDA) website admits that “Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.” The Fact Sheet was issued in response to the FDA granting an emergency use authorization for the Pfizer vaccine for people aged 12 and older. The Fact Sheet also notes that the Pfizer vaccine carries risk of the heart conditions myocarditis and pericarditis in addition to numerous other ailments that have been reported in clinical trials, and that “immunocompromised persons…may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.” Recent former FDA commissioner Scott Gottlieb (pictured above) is now on the board of directors of Pfizer. A contingent of recent Pfizer workers who serve on an FDA advisory committee are trying to get the FDA to authorize a Pfizer vaccine for children aged 5 to 11.

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FDA Committee Members Reviewing Pfizer Vaccine For Children Have Worked For Pfizer, Have Big Pfizer Connections

The FDA’s Vaccines and Related Biological Products Advisory Committee is holding a virtual meeting Tuesday October 26 to discuss authorizing a Pfizer-BioNTech Coronavirus vaccine for children between the ages of 5 to 11 years old.

This committee has a lot of sway with the FDA and their findings will be relevant, considering the Biden administration is getting ready to ship vaccines to elementary schools and California has already mandated the vaccine for schoolchildren pending federal authorization.

But the meeting roster shows that numerous members of the committee and temporary voting members have worked for Pfizer or have major connections to Pfizer.

Members include a former vice president of Pfizer Vaccines, a recent Pfizer consultant, a recent Pfizer research grant recipient, a man who mentored a current top Pfizer vaccine executive, a man who runs a center that gives out Pfizer vaccines, the chair of a Pfizer data group, a guy who was proudly photographed taking a Pfizer vaccine, and numerous people who are already on the record supporting Coronavirus vaccines for children. Meanwhile, recent FDA Commissioner Scott Gottlieb is on Pfizer’s board of directors.

HERE’S THE MEETING ROSTER: Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Draft Roster.

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REVOLVING DOOR: The Three Big Pharma Companies with COVID Vaccines Authorized for Emergency Use All Employ Former FDA Commissioners

How can it be?  The three FDA-authorized distributors of the highly controversial COVID vaccine all have under their employment former FDA Commissioners.

The Freedom First Network made the following observations about another revolving door, this time in the drug industry.

In today’s America, you can buy yourself a former FDA commissioner, and use the public-sector private-sector revolving door system of corruption to impose your will on the American public, and make a windfall for your executives and shareholders in the process.

That appears to be the exact strategy utilized by Johnson & Johnson, Pfizer, and the company that founded Moderna, which have rostered a series of former top ranking government officials into top positions in their respective organizations.

Former FDA Commissioner Scott Gottlieb, the ultimate personification of the revolving door mechanism, sits on the board of Pfizer. The frequent Pfizer-sponsored CNBC guest also maintains several thousand shares of Pfizer stock, and he is compensated well into the six figures on an annual basis. Gottlieb earns millions from his continually increasing board appointments to a plethora of pharmaceutical and healthcare companies.

The pandemic profiteer also sits on the boards of Illumina and Tempus Labs, which sell FDA-authorized COVID-19 test kits. Additionally, he sits on the board of Aetion, which has partnered with the FDA on researching COVID-19 policy.

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FDA Official Wants To Deploy COVID-19 Vaccine ‘Drones’ To ‘Blow Dart’ Black People, Vaccine Resisters, Start Nazi-Style Registry

Project Veritas released a shocking video of a Food and Drug Administration (FDA) official advocating for the government use of drones to “blow dart” COVID-19 vaccines into black people and vaccine resisters.

In a disturbing video by Project Veritas, an effeminate FDA official told an undercover journalist that the government should use drones to “blow darts” of the COVID-19 vaccine into black people and vaccine resisters, signaling his support for a Nazi-style registry for the unvaccinated.  “That’s where we’re going,” said the FDA’s Taylor Lee.“Census goes door-to-door if you don’t respond. So, we have the infrastructure to do it [forced COVID vaccinations]. I mean, it’ll cost a ton of money,” Taylor said. “But I think, at that point, I think there needs to be a registry of people who aren’t vaccinated. Although that’s sounding very [much like Nazi] Germany.”

“Nazi Germany…I mean, think about it like the Jewish Star [for unvaccinated Americans],” he said. “So, if you put every anti-vaxxer, like sheep, into like Texas and you closed off Texas from the rest of the world, and you go, ‘Okay, you be you in Texas until we deal with this [pandemic].’”

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