Approved First. Studied Later

On August 27, 2026, as documented on the FDA’s website, the agency approved the Pfizer and Moderna mRNA jabs for this season’s COVID-19 variant. Strangely, four days later, on August 31, the human-based study for the formulation of Pfizer’s jab was set to begin. And the human study for Moderna’s same jab doesn’t begin until November 16, some three months after it was approved for injection in the arms of Americans. How is this even real?

With no human trials conducted beforehand, what did regulators actually review before signing off on these injections? Well, let’s see. In order to approve the new components of the mRNA jabs designed to target this year’s XFG variant, the FDA considered “evidence” from the 8 to 10 mice that Pfizer and Moderna used to test the new parts of their shots. In Pfizer’s studies, for the new components approved for use in millions of Americans, ten mice were used for each group in the main study for the new parts approved for use in the largest number of people, meaning everyone 65 and older and all of the high-risk children from 5 years old and up. And for the high-risk infants as young as six months, Moderna’s data rested on experiments involving just 8 rodents. Again, how is this real?

Not surprisingly, Pfizer and Moderna defend themselves by arguing that this is how the annual flu vaccine is approved. Those formulas are updated annually in an effort to match, often rather unsuccessfully, the influenza strains expected to be prevalent during the upcoming flu season. No new, full human clinical trials are conducted each year to prove the safety and efficacy of the flu vaccines. The FDA has apparently treated the COVID-19 mRNA jabs in essentially the same manner. Dr. William Schaffner, a Vanderbilt University School of Medicine professor, spoke about this approval process with ABC News, sharing, “Like the influenza virus, the COVID virus mutates; it changes notably over time, and so we have to update the vaccine in our best attempt to match the strain that we anticipate will be most active during the coming winter.” He added, “The better the match we have with what’s in the vaccine and the circulating strain, the more effective the vaccine will be.” Hmm. Same license, with a new recipe.

But comparing the flu shot to the mRNA variant shot carries weight only so far and really makes no sense. The seasonal flu vaccine does not carry a label warning about the potential for heart inflammation in young men, yet the mRNA COVID vaccines do carry such a serious warning. We have known from very early on that the rushed COVID-19 vaccines have long been associated with a known, documented signal for cardiac-related adverse events, specifically for cases of myocarditis and pericarditis (inflammation of the heart and surrounding lining). Most of the reported cases of these serious adverse events, which are a known and labeled risk on both jabs, have been in males approximately 12-24 years of age. Given the circumstances, the comparison seems careless.

On top of that, hidden behind the rodent studies, late human trials, and speedy authorizations, the approval letters quietly erased the need for further critical studies. Put another way, the FDA abruptly dropped already-established safety studies it had required of both Pfizer and Moderna. What? For both Pfizer and Moderna, these studies would have compared vaccinated individuals with unvaccinated individuals over time to determine whether any adverse events occurred. Given the devastation of the mRNA COVID jabs, it is surreal to understand this type of study has not occurred yet. Again, in the recent approval letters, the FDA released both companies from conducting those important studies, citing “operational and feasibility challenges.”

For Pfizer, these now-canceled studies—which should have occurred before the shots were on the market—would have included placebo-controlled safety studies (vaccinated vs. unvaccinated, which is the only way to actually prove whether a shot causes a given harm) measuring the amount of spike protein circulating in the blood and the symptoms it caused in study participants over time, including at 1 month, 3 months, 6 months, and 12 months after receiving the jab. Instead of conducting these appropriate studies to determine whether vaccinated individuals suffered any adverse events, the FDA agreed to several lax “commitments,” with no control group at all. One study will simply track where the spike protein travels in the body and how long it lingers there. Good to know, but it is not being compared to anything, and we already know the spike protein travels throughout the body and remains there, wreaking havoc for at least weeks or months. After years of distributing an unknown mRNA gene-therapy jab that promised to protect people from COVID, the FDA swapped the study that could have proven cause and effect for one that will only describe, quietly giving up the tool best suited to find answers.

It’s worth noting that the government official who is overseeing these approval decisions is Health and Human Services Secretary Robert F. Kennedy Jr., who in the past called the mRNA gene-altering COVID jabs instruments of “mass murder.” Yet his agency is waving through a second annual round of them. Meanwhile, back in June of this year, the CDC committed up to $1.55 billion in this season’s mRNA shots from Pfizer and Moderna. The administration committed those dollars months before the FDA approved the specific formulation of shots. And, thanks to the PREP Act liability shield protecting these vaccine manufacturers through the end of 2029, these Big Pharma billionaires are immunized far better than those getting the shots.

Again, shockingly, the new COVID shots were approved before the end of the human study in Pfizer’s case, and before the human study even began in Moderna’s case. The new COVID shots were approved based on eight to ten mice. The placebo-controlled safety studies that the FDA required manufacturers to do have been dropped. The warning about heart inflammation in young men remains on the label for these shots. Over a billion in taxpayer dollars have already been committed to purchasing these shots before they have even been proven safe and effective. The PREP Act liability shield has granted total legal immunity to all manufacturers of these shots, and it remains in place through the end of 2029. Whether you believe these are poisonous jabs or not, this sequence of events is alarming. We deserve to believe that “safe and effective” means something, and that evidence should prove it before the product is released on the market for use, especially in very young children.