Tag: fda

Who Needs Vaccine Data When You Have Vaccine Mandates?

FDA Gene-Editing mRNA Vaccine Chief – Peter Marks – has always been a strong proponent of vaccine mandates. Marks also has as a history of overruling large expert panels for FDA approval of gene therapies at the agency.

STAT News reported that “Marks was one of the architects of Operation Warp Speed, the $18 billion U.S. effort to speed development of Covid-19 vaccines. He regularly embraced regulatory flexibility. And he spoke not infrequently about the importance of accelerated approval for next-generation treatments, including with those whose potential benefits weren’t always crystal-clear in clinical trial data.”

“Vaccine Mandates Are Not Going to Get Us THERE. It’s Got to Be Compelling Evidence.” – Vaccine Chief Peter Marks

During a 4-hour Public Health Workshop hosted by Duke University on March 20, 2025, Marks alluded to having contentious disputes with the higher-ups of the new Health & Human Services (HHS) administration (aka – Secretary Kennedy) over ‘the need for vaccine efficacy and vaccine safety data’ when FDA-approved vaccines can just be mandated.

“How We Generate Evidence Going Forward”

Throughout the 4-hour workshop, Marks and his colleagues strategically avoided discussing retrospective data analyses (i.e. analyzing the adverse events of vaccines in the US government databases) and the specifics on how to measure safety data going forward.

“By Definition, Vaccines Are Very Safe Medical Products”

“By definition, when we are developing vaccines for broad use, one of their direct benefits has to be that they are very safe medical products. That just goes without saying, because that goes to getting acceptance for the individual’s direct benefit.”

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Congressional Committee Invites Hemp Industry Expert To Testify At Hearing On How FDA ‘Failed’ To Regulate Products

A congressional committee has scheduled a hearing for next week focused on the Food and Drug Administration (FDA), inviting a hemp industry representative to testify on how the agency “failed” to approve certain products such as CBD.

The House Oversight Committee hearing—titled “Restoring Trust in FDA: Rooting Out Illicit Products”—is set to take place on Wednesday.

FDA “failed to approve products and take necessary enforcement actions resulting in a flood of illicit and counterfeit products entering the country,” a memo on the hearing says.

The meeting won’t exclusively focus on cannabis issues. But among the four listed witnesses selected to testify is Jonathan Miller of the U.S. Hemp Roundtable, an organization that has long criticized FDA’s inaction on CBD and other cannabinoid regulations since the crop was federally legalized under the 2018 Farm Bill.

Miller told Marijuana Moment on Friday that he expects the hearing to be “wide-ranging,” but his testimony will concentrate on “all the challenges the hemp industry has been having by the FDA’s failure to regulate our products.”

He said that his testimony will serve as an “update” on issues he outlined during a 2023 hearing before a subcommittee of the full panel, where lawmakers raised concerns about FDA’s refusal to establish rules allowing for the marketing of federally legal hemp as a food item or dietary supplement.

In the two years since that initial meeting, the hemp market has faced repeated regulatory challenges—with a growing number of states moving to enact bans on certain hemp products due to the lack of regulations around intoxicating cannabinoids such as delta-8 THC that have become widely available.

“Nothing has happened at the FDA” to resolve the issue, Miller said. “And we think these ban efforts have a lot to do with the fact that we’re not regulated. So if we can get regulated, hopefully people will drop the efforts to ban our products.”

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Marjorie Taylor Greene Demands FDA Pull Approval of Dodgy COVID Vaccines ‘Causing Permanent Harm and Death’

Congresswoman Marjorie Taylor Greene is demanding the Food and Drug Administration (FDA) pull approval of the dodgy coronavirus vaccines.

The conservative firebrand pointed out in a post on the X platform that the vaccines are causing “permanent harm and deaths.”

She wrote:

FDA approval for COVID-19 vaccines needs to be pulled and they need taken off the childhood vaccine schedule ASAP.

COVID-19 vaccines are causing permanent harm and deaths.

I’ve been saying this ever since they were created and my personal Twitter account was permanently banned for my outspoken stance against the vaccines until Elon Musk bought Twitter, changed it to X, and restored my account along with thousands of people who were censored and silenced.

The truth remains the same. COVID-19 vaccines should have never received approval and they’ve known the entire time how bad the side effects are and deaths caused by them. It’s time to do the right thing. Stop the COVID-19 vaccines.

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RFK Jr. Seeks To End Rule Allowing Food Companies To Bypass FDA Ingredient Approval

The U.S. Department of Health and Human Services (HHS) said on March 10 that it is seeking to terminate a rule allowing food manufacturers to use additives without formal regulatory approval.

The Generally Recognized As Safe (GRAS) rule allows companies to self-approve the inclusion of additives in food items without requiring a review and the approval of the U.S. Food and Drug Administration (FDA). The rule enables manufacturers to add an ingredient even if the FDA has not determined its safety.

On Monday, HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner to explore the possibility of eliminating the “self-affirmed GRAS pathway” available to companies, the department said in a statement.

“This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers,” HHS said.

As of now, manufacturers submit notices through the FDA’s GRAS notification program, which is not a mandatory process. The agency assesses 75 such submitted notices on average each year.

By eliminating the self-affirm pathway, companies would be required to publicly notify the FDA before introducing new ingredients to food items. The notification must include details such as underlying safety data and the intended use of the ingredients

A 2022 analysis conducted by the activist organization Environmental Working Group found that “nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry” through the GRAS rule, without requiring FDA approval.

Out of the 766 new chemicals added to the food supply since 2000, only 10 involved companies petitioning the FDA to approve the ingredient.

Nine out of the 10 FDA petitions were filed before 2010. The only petition filed post-2010 was in 2018, EWG said.

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Pfizer hires ex-FDA drug chief as top doctor

The former head of the Food and Drug Administration’s (FDA) drug division is joining Pfizer as its chief medical officer, the company announced Monday. 

Patrizia Cavazzoni was formerly director of the FDA’s Center for Drug Evaluation and Research (CDER) from 2020 until January, when she resigned just ahead of President Trump’s return to office. 

Cavazzoni previously worked at Pfizer prior to joining the FDA in 2018.  

The announcement spurred renewed criticisms about the common “revolving door” between the FDA and industry. Critics worry the close relationship leads to a quid pro quo and favoritism toward industry.

Robert Califf, who served as FDA commissioner under President Obama, left the agency to advise Google Health and its spinoff, Verily Life Sciences. The move garnered criticism and opposition from some Senate Democrats like Sen. Elizabeth Warren (D-Mass.) when President Biden nominated him for the same job.

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FDA Misled The Judiciary About Pfizer’s Vaccine Documents

On December 6, 2024, a federal judge ordered the US Food and Drug Administration (FDA) to release documents related to the emergency use authorisation of Pfizer’s Covid-19 vaccine. These documents had been hidden from public view.

The legal battle traces back to September 2021, when attorney Aaron Siri filed a lawsuit under the Freedom of Information Act (FOIA) on behalf of the Public Health and Medical Professionals for Transparency. The plaintiffs sought access to the vast trove of documents the FDA relied on to approve Pfizer’s vaccine.

Initially, the FDA proposed a slow release schedule. In November 2021, the agency stated it would release just 500 pages per month—a pace that would have stretched the full disclosure process to 75 years. 

However, in January 2022, District Judge Mark Pittman of Texas rejected the FDA’s proposal, ordering the agency to expedite its release to 55,000 pages per month, aiming to complete the disclosure of all 450,000 pages by August 2022.

As the documents trickled out, researchers began uncovering glaring gaps that prevented a systematic review of the data. These gaps fueled suspicions about what else the FDA might be withholding. 

It became evident that the FDA had withheld records directly tied to its emergency use authorisation of Pfizer’s vaccine, estimated to be over one million pages. 

These documents, which the FDA had full knowledge of, were excluded from earlier disclosures, effectively misleading the judiciary and undermining public trust.

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Emails reveal FDA refused to monitor select COVID-19 vaccine injuries from select vaccine manufacturers

In the first 18 months following the rollout of COVID-19 vaccines, the U.S. Food and Drug Administration (FDA) detected consistent safety alerts for the Janssen vaccine but largely overlooked similar risks for Pfizer and Moderna shots, according to newly released emails. These records, obtained through a Freedom of Information Act (FOIA) lawsuit by Children’s Health Defense (CHD), reveal a troubling pattern of oversight gaps in the federal government’s monitoring of vaccine injuries. Despite over 1.4 million adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), the FDA’s data analysis failed to flag widely recognized risks like myocarditis and pericarditis for mRNA vaccines. The revelations raise critical questions about the adequacy of the government’s safety monitoring and its commitment to transparency during the pandemic.

The FDA emails, posted on the agency’s website, detail weekly data mining of VAERS reports from January 12, 2021, to July 5, 2022. The analysis, known as Empirical Bayesian (EB) data mining, showed consistent alerts for serious adverse events linked to the Janssen vaccine, including deep vein thrombosis and death. However, the same analysis yielded almost no alerts for Pfizer and Moderna vaccines, even for well-documented risks like myocarditis and pericarditis.

For example, the FDA noted an alert for “death” associated with the Janssen vaccine on March 8, 2022, and in every subsequent email. In contrast, the agency flagged only a handful of administration-related issues for Pfizer and Moderna shots, such as “mechanical urticaria” and “exposure via breast milk.” This discrepancy is striking, given that VAERS received over 15,000 myocarditis reports and 10,000 pericarditis reports for mRNA vaccines during the same period.

Ray Flores, senior outside counsel to CHD, criticized the FDA’s approach, stating, “The emails are further evidence of the federal government’s failure to make good on its promises to use VAERS as an ‘early warning system’ to detect and act on risks associated with the new vaccines.”

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The Compromised FDA Knows Exactly What It’s Doing

The sneaky bastards at the FDA did this a year ago, right under our noses. In January 2024, the FDA finalized a rule permitting Institutional Review Boards (IRBs) to waive or even alter informed consent requirements for clinical investigations deemed “minimal risk.” TTR guest author Jon Fleetwood, as always, brings us this news in his excellent reporting. Read his entire article here.

IRBs. Informed Consent. What does it all mean? If you don’t do research, you likely won’t know.

What is an IRB?

An Institutional Review Board (IRB) is a panel of individuals who review and oversee research studies that involve human participants. The IRB ensures that the studies are ethical and that they comply with all regulations. The IRB’s primary function is to protect the rights and welfare of the human research participants, making sure they are treated fairly, ethically and safely.

Anyone doing research must have an IRB, and that not only applies to direct human research (meaning the human is actually being given a drug or using a device), but also for indirect studies where the patient isn’t “touched” so to speak or actively involved. A direct example would be a clinical trial where a new drug is being tested. The human participants actually enroll in the trial and are given test doses of the medication. Even if a human participant is given a placebo, that research must be covered by an IRB to ensure the patients’ physical and psychological well-being. An example of an indirect study is one in which a company or other research entity is just using data from patients, with no direct patient interaction. In some cases an IRB is still needed to use data that may potentially identify who the subjects are.

The bottom line is that an IRB is needed for any drug, device assessment, survey or other study. And this is what makes the FDA’s ruling so unbelievable. Fleetwood says the implications are staggering, and he is absolutely right:

“Under this waiver, any person’s health data, biospecimens (such as blood or tissue samples), or medical records can be accessed and used for FDA-regulated research if it meets vague and highly subjective criteria.”

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Thiel-Linked HHS Nominee Threatens MAHA Ambitions with Biotech Stance

Late last November, President Donald Trump announced Jim O’Neill as his nominee for deputy secretary of Health and Human Services (HHS), where he would work under Robert F. Kennedy Jr., Trump’s pick for HHS secretary upon confirmation. As deputy secretary, O’Neill would essentially function as the Chief Operating Officer of the department, overseeing “the day-to-day operations of all sub-agencies” as well as leading “public health emergency preparedness,” i.e. the government’s policy responses to bio-terror events, pandemics, etc. In addition, O’Neill would “oversee the development and clearance of HHS regulations” and ostensibly be the main implementer of the “Make America Healthy Again” (MAHA) policy agenda.

Built on a promise to eliminate industry capture of public health regulatory agencies and curb the influence of Big Pharma and Big Food, Robert F. Kennedy Jr.’s MAHA movement played a crucial role in funneling would-be Kennedy voters into the Trump camp. MAHA, in essence, granted the Trump campaign a tinge of populist legitimacy among Covid era dissidents, which grew out of the shuttering of RFK Jr.’s independent presidential run.

However, O’Neill’s business connections, both past and present, as well as his previous statements on public health policy, strongly suggest that he is not only unlikely to implement the policies that MAHA-centric voters are expecting, but that he may in fact pursue an agenda that stands in direct conflict with the main tenets of the MAHA movement. Specifically, he advocates reforming the FDA to deregulate and accelerate the pathway from drug development to legalization. This would notably aid the biotech industry, which has long struggled to get its products approved outside of an “emergency”-based deregulatory paradigm.

When considering the investments and board positions that O’Neill himself has made and held in biotechnology companies, this would likely include mRNA products that Kennedy and other MAHA influencers have spent years criticizing since the Covid-19 pandemic — a clear contradiction between O’Neill’s views on public health, and those which the MAGA base were sold on the campaign trail.

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ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines After Years of Litigation

ICAN just got a 153 page document detailing COVID vaccine safety surveillance info collected by the FDA. Here’s the press release.

In a nutshell, the documents show that the FDA and CDC’s safety monitoring is inept. It generated no signals of adverse events of any significance. Not death, not myocarditis, not anything.

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