Originally written September 25, 2021
mRNA GENE THERAPIES
These new interventions are often referred to as vaccines in the media and medical community, but they are certainly not your father's vaccine. Traditional vaccines typically utilize a weakened or attenuated virus delivered via injection, pills, or some other mechanism to help the immune system develop antibodies against a pathogen in anticipation of future exposure to prevent illness and transmission.
For the sake of this email, I will focus specifically on the Pfizer/BioNTech mRNA gene therapy candidate for use against SARS-COV-2 (COVID-19.) I'm not going to go deep into the science of RNA because college was a long time ago, and we only need a high-level understanding of what it is and how it works. You can also Google this stuff if you're curious. Suffice to say that RNA has some similarities to DNA, and plays an active role in biological processes in the cell including protein synthesis. mRNA, or messenger RNA, is basically a set of instructions that directs the synthesis of proteins. Think of mRNA as software that is being downloaded into your cells, the hardware, to run a program.
In the case of Pfizer's gene therapy (and Moderna's as well), instead of injecting actual viral material, your cells are being programmed with mRNA from the injections to produce the spike protein to elicit an immune response which is supposed to help develop antibodies that will recognize the COVID-19 spike protein and fight future potential infection. Supposedly the program degrades, and your cells stop producing the spike protein eventually. But hey, what could possibly go wrong?
95% EFFECTIVE?
Based on clinical trial data, Pfizer claims that its gene therapy is 95% effective although they are a bit opaque in defining effective. As best as can be determined, the claim is based on the prevention of symptomatic cases of COVID-19 which is different than preventing cases of COVID, at least the way the CDC counts cases anyway. In the trials, 9 cases occurred among 21,720 gene therapy recipients and 169 cases among 21,728 placebo recipients which is indeed 95% relative risk reduction (RRR). (178-9/178 = 94.4%)
However, RRR does not tell the whole story. The true effectiveness of a treatment is based on the Absolute Risk Reduction (ARR) which is the statistical calculation that shows the difference between the percentage of COVID-19 illness events in the control group minus the percentage of COVID-19 illness events in the experimental group. The treatment and the placebo groups both had less than a 1% risk of developing symptomatic COVID illness. Based on the following 2 studies, the ARR of Pfizer’s COVID-19 vaccine candidate, which Pfizer failed to report, is .7% to .9%. That is not a typo. The ARR for this treatment is between .7% - .9%, or stated another way, it takes between 119 and 142 vaccinations to prevent 1 symptomatic case of COVID-19. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996517/) (https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00069-0/fulltext#%20)
If the ARR is so important, then why didn't Pfizer disclose it, and why doesn't the FDA do something about it? Well for one, 95% sounds a lot better than .7%, and how many people will rush out for an experimental treatment that reduces risk by less than 1%? And according the FDA, providers are supposed to disclose the ARR for the very obvious reason of reporting bias. Per the first link above, the authors point out:
"The same publicly available data, without absolute risk reduction measures, were reviewed and approved by the roster of members serving on the U.S. Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) for emergency use authorization (EUA) of the mRNA vaccines [10]. Ironically, the omission of absolute risk reduction measures in data reviewed by the VRBPAC overlooks FDA guidelines for communicating evidence-based risks and benefits to the public [11]. The FDA’s advice for information providers includes:
“Provide absolute risks, not just relative risks. Patients are unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used.”
They also point out:
“…critical appraisal knowledge and skills are limited among physicians,” and “use of relative effect measures was associated with greater perceptions of medication effectiveness and intent to prescribe, compared with the use of absolute effect measures.”
BUT WAIT, THERE’S MORE
I took time to read Pfizer's clinical trial design protocol which you can read here: https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf. You would think that regular, scheduled testing for COVID during the trials to see how the vaccines perform vs placebo would be a no-brainer, right? Wrong! Check out pages 23 and 85-98.
Except for performing a COVID test prior to each injection, the only time someone was tested was if the trial volunteer was sick and thought they had COVID! They didn't do the one freaking thing that mattered most!
We know that many COVID infections are asymptomatic or mildly symptomatic where people don't know they have an infection. Many people can't even go to work without being tested once a week, but it's not important enough to perform tests during clinical trials for the vaccine that's supposed to prevent the disease? What about all of the hysteria surrounding asymptomatic cases and transmission?! Does this mean asymptomatic transmission is a bunch of BS?
Kind of hard to find something if you aren't looking for it, but maybe that's the point with these trials? They didn’t design the trials to see if the vaccine prevented people from contracting COVID, so they have no idea how many people actually contracted COVID during the trial. According to Pfizer's CEO, they also do not know if this gene therapy prevents transmission because the trials were not designed to test for transmission rates either.
BUT WAIT, THERE’S MORE!
I forgot to mention that I was married to a pharma rep for 6 years, and got an in-depth education of how the industry works. The design of Pfizer's clinical trials is not really all that shocking if you spend much time digging into how pharma companies design and conduct their studies.
It’s common to design studies that give them the best chance of obtaining the results they are looking for which goes squarely against the idea of the scientific process. The statistical shenanigans of disclosing RRR only and avoiding ARR is also not shocking, and many approved medications work slightly better than placebos. One of the best quotes I've heard is, "Statistics are like a police confession. Beat the numbers around long enough, and they'll give you the answer you want to hear."
What is shocking is that Pfizer, and Moderna, eliminated their control groups upon the approval of their EUAs in December. Interestingly, this same article from the NPR contains the following information we know to be untrue (misinformation) based on the clinical trial document referenced above: "Participants provide periodic nose swabs and saliva samples, to see if they've been infected."
Despite all of our wonderful technology, the one thing that can't be done is speed up time which is why trials take years. These trials are still ongoing to collect long term efficacy and safety data, but if you have no control group then you have nothing with which to compare the treatment. I guess we're just supposed to assume that it's working and safe because they said so even though they don't know and will never know. Again, maybe that's the point?
To summarize according to Pfizer’s own clinical trial design:
- ZERO evidence that Pfizer’s vaccine prevents COVID-19 infection.
- ZERO evidence that Pfizer’s vaccine prevents transmission of COVID-19.
- Limited evidence that Pfizer’s vaccine reduces risk of symptomatic cases by .7-.9% based on a few months of observation.
- ZERO reliable long-term safety and efficacy data due to elimination of the control group.
While there are many people with good intentions in the pharmaceutical industry and the FDA, it's profits above all else. This is just one more example of what a sham the process is for approving medications, vaccines, and food ingredients. Hell, dig into the history of Donald Rumsfeld and the aspartame approval, but you might have to go past page 1 on Google. It's well known that a revolving door exists between big pharma and the FDA (Scott Gottlieb, the former commissioner of the FDA, is on Pfizer's board of directors) so it's essentially the fox guarding the hen house otherwise known as Crony Capitalism.
I guess the upshot to all of this is that we know the risk of developing a symptomatic case of COVID is less than 1% with or without the Pfizer vaccine.
THE NARRATIVE
The media, Fauci, the CDC, and the White House (both admins) told us these "vaccines" were safe, effective, and would protect the vaccinated from getting COVID while also preventing them from spreading it to the unvaccinated. To be fair, Pfizer never made that claim to my knowledge, but they also never tried to set the record straight.
When it became obvious that "breakthrough cases", which is just a euphemism for vaccine failure, were increasing the narrative began to change and so did the way the CDC counts cases. In May, the CDC began counting a case as a breakthrough case only if the person tests positive for COVID and has serious enough symptoms resulting in hospitalization or death (https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html.) Doesn't matter if you're sick and on your deathbed at home, you're not a breakthrough case. But if you're unvaccinated and receive a positive test, you're counted as a case even if you have no symptoms.
Now, we hear Fauci and Walensky telling us, "Our vaccines are doing exactly what they are supposed to do, prevent severe disease, hospitalization, and death." Apparently, Walensky hasn't read her CDC’s own report on the breakthrough cases in Massachusetts where 4 of the 5 people hospitalized were vaccinated, or that Israel, one of the most highly vaccinated countries in the world using the Pfizer/BioNTech vaccine exclusively, has exploding rates of cases and hospitalizations amongst the vaccinated and that immunity from prior infection, is far superior to the vaccine.
Or check out this interview from CNN where Walensky confirms that vaccines don't prevent you from contracting or transmitting COVID anymore because of Delta. That’s a lie because there was never any proof the vaccine could prevent transmission of the original strain.
And according to Biden in his infamous mandate speech, vaccinated people have great protection and this is a pandemic of the unvaccinated. But "The bottom line: We’re going to protect vaccinated workers from unvaccinated co-workers. We’re going to reduce the spread of COVID-19 by increasing the share of the workforce that is vaccinated in businesses all across America."
Huh? If you're vaccinated and have great protection, then why do you need to be protected from the unvaccinated? And because Pfizer did not test the vaccine for its ability to prevent transmission and therefore has no evidence it can prevent transmission, it’s a flat out lie to say they’re going to reduce the spread of COVID by vaccinating more people.
This is like some bad Jedi mind trick which I would normally call baffling with bullshit, but it's something much worse. It is a glaring example of the Big Lie. When the media is aligned with government in one direction and any opposing voice is crushed without objectively considering the viewpoint and giving equal time on the platform, it's propaganda. Hilariously, Wikipedia points to Trump's election fraud charges as the Big Lie example for the 21st century. God knows Trump would have loved that power, but he never had most of the media on his side on any issue. But how about George W’s weapons of mass destruction in Iraq whopper?
When you hear these people referring to "The Science" you know it's propaganda. Science is supposed to be an objective process that you adhere to throughout the entire experiment to discover the truth. But to the powers that be it's an ideology or a religion, and they are the high priests worshiping and wielding "The Science" to dictate to the masses from on high. "Here is what "The Science" is telling us now," they proclaim.
From parts 1 and 2 we’ve seen the holes in the narrative about PCR tests, cases, hospitalizations, and deaths, and the part they played in the Big Lie. Obviously, some real science was employed with the Pfizer clinical trials regarding the technology they were using. But then they invoked "The Science" to get the results they desired, and the media and government fired up the propaganda machine to sell it to the masses.