The U.S. Food and Drug Administration (FDA) on Friday granted full approval to Pfizer’s COVID-19 vaccine known as COMIRNATY for adolescents 12 through 15 years of age.
The kicker? COMIRNATY isn’t even available in the U.S., so children will still be receiving the experimental Pfizer-BioNTech vaccine, which despite what you’ve been told, is not the same formula as COMIRNATY.
The FDA in a press release said full approval follows a “rigorous analysis” and evaluation of the safety and effectiveness data, which obviously didn’t include looking at the Vaccine Adverse Event Reporting System — as no reasonably prudent person would conclude this gene therapy product is safe for children if they had.
Of course, nobody actually knows what “data” the agency based its decision on because they would prefer not to disclose that to us for another 75 years, at which point most of us will be dead.
What we do know from Pfizer — the company that has every incentive to frame its data in the most positive light — is that approval is based on data from a Phase 3 clinical trial of only 2,260 participants 12 through 15 years of age.
“Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age,” Pfizer said in its press release. “A two-dose primary series of the vaccine (30-µg dose) elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose.”
Let’s think about this:
About half of the small fraction of children who were analyzed saw an increase in neutralizing antibody titers one month after the dose — one month — and this led the people behind the scenes pulling the strings to the conclusion this vaccine should be approved?
Do you know why they didn’t follow these children longer than five minutes? They would have had to report rapidly waning “protection.” Against what? We’re still not sure.
Did I mention that neutralizing antibodies aren’t even an accurate marker for determining whether one has “protection” against the disease or its severity? This was a point brought up by many “vaccine experts” at the FDA’s recent vaccine advisory meeting.
Clearly, the FDA ignored its advisory panel’s lengthy discussion about needing to develop a better way to measure effectiveness. These experts even mentioned how Moderna’s COVID-19 vaccine in studies had a two-fold increase in “neutralizing antibodies” over Pfizer, but it did not correlate to clinical protection in the real world.
To bolster claims its COVID-19 vaccine is effective in the 12 to 15 age group, Pfizer used an “earlier analysis” of 16 to 25-year-olds as a comparison. The problem? The analysis was in an older age group and was assessed before Delta and Omicron hit the scene.
Pfizer specifically states, “the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges,” and the “only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha.”
How many variants have we had since Alpha? What kind of real-world science is this?
Pfizer also said, “no cases of severe disease occurred in either the COMIRNATY or placebo group.”
Ah, here it is — the reason why Pfizer and the FDA need to continue to use “neutralizing antibodies” as the benchmark for effectiveness. If they used anything else their claims would dissipate into thin air — like the actual risk of someone in this age group getting severe COVID-19.
Of course, if you read the rest of Pfizer’s press release, you would think they actually did studies with COMIRNATY, although we know from looking at the actual clinical trials that they didn’t. COMIRNATY, as we know it, does not exist.
Their studies were done with the Pfizer BioNTech vaccine, which is not interchangeable with COMIRNATY despite the lies they’re feeding the public. The Pfizer-BioNTech vaccine contains an entirely different buffer that was not subjected to anything other than an “analytical comparability analysis,” according to FDA documents.
Anyone who knows anything about science understands the buffer used in vaccines can alter potency, storage and one’s risk of heart inflammation, among other things. We know from research Moderna is associated with a higher risk of myocarditis, and one of the key differences between Moderna and Pfizer was the potency and type of buffer used.
For those keeping notes, Pfizer, when it secretly modified the Pfizer-BioNTech formula, switched from a phosphate-buffered saline (phos) to the tromethamine buffer ingredient Moderna uses. The clinical trials use the previously modified formula.
No human or animal trials were conducted to determine the safety or efficacy of the new formula. Zero.
So what is this really about? Why “approve” a vaccine behind closed doors and force it on children who aren’t at risk of severe COVID-19?
One can only speculate, but COVID-19 vaccines are a billion-dollar industry and we know that it is essential for pharmaceutical companies to have liability protection from the mounting harms caused by their gene therapy products.
If COVID-19 vaccines are fully approved for children, they can be added to the National Vaccine Injury Compensation Program (NVICP).
The NVICP is a special, no-fault tribunal housed within the U.S. Court of Federal Claims that handles injury claims for 16 federally recommended vaccines. To date, the court has awarded more than $4 billion to thousands of people for vaccine injuries.
In the NVICP, America’s legal system is replaced by a “special master.” The special masters who review claims are government-appointed attorneys, many of whom are former U.S. Department of Justice (DOJ) attorneys.
Under the NVICP, the parents of vaccine-injured children are forced to sue the secretary of the U.S. Department of Health and Human Services (HHS) for compensation. HHS is represented by DOJ attorneys.
It is exceptionally difficult to obtain compensation within the NVICP and a single case can drag on for over a decade. Payouts, including attorneys’ fees, are funded by a 75-cent tax per vaccine, and there is a $250,000 cap on pain and suffering and death benefits.
It’s a “win” for Pfizer. Taxpayers pay for the research and development of the vaccine, pay for the vaccines obtained by the government as part of a multi-billion-dollar contract, and then pay for the harms caused by a product that will undoubtedly be mandated upon us and our children. (You must fully approve a vaccine in order to mandate it legally.)
Currently, the continued “emergency” COVID-19 classification allows pharmaceutical companies like Pfizer and Moderna to be covered by the Public Readiness and Emergency Preparedness Act (PREP). As a result, injuries caused by COVID-19 vaccines are processed by the Countermeasures Injury Compensation Program (CICP), which is an absolute joke.
In 2005, Congress passed the PREP Act which authorizes the U.S. Department of Health and Human Services (HHS) to issue a declaration providing immunity from tort liability for claims of loss caused by medical countermeasures (e.g., vaccines, drugs, products) against diseases or other threats of public health emergencies.
On Feb. 4, 2020, HHS invoked the PREP Act when it declared COVID-19 to be a public health emergency.
On Jan. 21, 2021, HHS amended the act, extending the liability shield to include additional categories of qualified persons authorized to prescribe, dispense and administer COVID vaccines authorized by the FDA.
In exchange for immunity for vaccine makers, under the PREP Act, the federal government pledged compensation for adverse reactions to COVID treatments and vaccines through a program called the Countermeasures Injury Compensation Program (CICP), run by HHS.
To date, almost 9,000 claims have been filed with the CICP — only 29 have been compensated and 2 are pending.
These pharmaceutical companies know the “emergency” will not last forever, so there’s a rush to fully approve COVID-19 vaccines for children so that when it does end, they’ll have liability protection for the mounting number of injuries, including deaths, caused by their products and they can mandate a product that does not even exist for millions of children.
The FDA knows this.
Now you do too.