• More Smoke and Mirrors: First FDA Approval of a COVID-19 Vaccine or Was It?

    Posted August 25, 2021: by Bill Sardi

    August 23, 2021: The U.S.  Food & Drug Administration announces the Pfizer COVID-19 RNA vaccine has been approved and will be marketed under the trade name COMIRNATY for the prevention of Covid-19 disease in individuals 16-years of age and older.

    This announcement is said to provide needed safety data to many people who were waiting to get vaccinated.  Advocacy of vaccine hesitancy is now considered to be “misinformation” in the public square and is being censored in news reports.

    However, the data used to gain FDA approval does not prove this RNA vaccine prevents infection, transmission or reduces the risk of hospitalization or death, which is what the public needs to know.

    In order for a vaccine trial to measure prevention of transmission people have to be nasal swabbed twice a week for very long periods of time, which is impractical, and this obviously was not done.  So, the claim of prevention is entirely without substantiation.

    Risk of heart inflammation

    The product insert for the newly approved Covid-19 Pfizer vaccine does warn of the risk for inflammation around the heart (pericarditis, myocarditis) with the highest risk among 12-17-year-old males.  Of course, any serious side effect such as this among totally healthy young people, no matter how small the risk, would be of grave concern.

    According to the VAERS (Vaccine Adverse Event Reporting System), there were 2,122 cases of myocarditis/pericarditis associated with vaccination in the period Dec. 4, 2020 to August 13, 2021, ~75% among presumably healthy younger to middle-aged Americans.

    Immunity wanes

    Pfizer’s Covid-19 vaccine takes time to develop antibodies and immunity.  More precisely, the newly FDA-approved vaccine is reported to produce waning immunity, which declined from 96% to 84% four months after a second dose.

    Vaccine-related deaths versus all-cause mortality

    After six months, 15 vaccinated recipients and 14 placebo recipients died, with company evaluators deeming these deaths to be unrelated to the vaccine.

    However, when it was revealed which subjects got vaccine or placebo, more deaths were reported in the vaccine group, for a total of 20 deaths among the vaccinated versus 14 in the placebo group.  Vaccination did not reduce all-cause death.  This is the shell game of vaccination.  “The vaccine prevented your mother getting infected but died anyway.”

    Just the process of vaccination in the placebo group in this study induced 36 cases of an adverse event that led to withdrawal from the study (32 in the vaccinated group).  This is out of ~22,000 in each group (placebo and vaccine).  T

    The risk for an adverse event requiring withdrawal from the study was very small.  But it is vaccine-induced since they also occurred among the placebo group, though we don’t have a third unvaccinated group for comparison.  We also don’t know whether these deaths occurred in perfectly healthy young individuals, which would make them even more unacceptable.

    Very small adverse event levels still affect thousands

    Just 6 excess deaths out of 22,000 occurred in the vaccine group = 0.00027% or 2.7 per 100,000.  Vaccinate all 328 million Americans and you end up with 8856 needless deaths over and above those who acquired natural immunity.

    Even the lowest mortality rates associated with vaccination when calculated for the masses may end up in tragedy for thousands of unsuspecting people.  How many of these deaths occurred among individuals with no co-morbidities (other diseases)?  This is what needs to be known.  Does the vaccine produce co-morbidities?

    After the first shot immunity dropped so low over time that makers of this vaccine now recommend boosters.

    A question arises: Would you buy a set of new tires where 16% of its tread wore off in six months and required re-treading (a booster shot)?

    Product insert information is useless since individuals are being coerced or forced to vaccinate

    Simply mentioning the serious side effect of heart inflammation in the product insert is of worthless value because subjects are being coerced to vaccinate rather than make a decision to inoculate based upon informed consent prior to immunization.  Informed consent has been side-stepped because authorities say this is a life-and-death situation and informed consent is therefore waved.  So legally, the vaccines are presumed to save lives before that is proven.

    The Nuremberg Code regarding informed consent prior to medical experimentation is tossed to the wind.  Why inform any prospective patient of anything when they have little or no choice in the matter?

    Study not large enough

    The approval was largely based upon a study of 44,047 participants, 22,026 who received a placebo, which may be why many vaccinated subjects indicated they felt no side effects.

    When dealing with a viral infection that only has a low frequency in the population like Covid-19, a trial that is ten times larger is needed, maybe 400,000 subjects, to determine if the vaccine prevents death or hospitalization which occurs in a very small percentage of the population.  In a trial of ~40,000 participants you only have maybe ~400 who are infected at the time of immunization and even far less who would need hospitalization or die.  So, the decision to inoculate the world is being based upon a few hundred subjects.

    A deadly side effect that kills 1 in 10,000 might escape detection because of small study group size, which could end up killing 790 million people if the whole world were inoculated!

    Unethical to give placebo to infected patients with symptoms

    It would be unethical to give a placebo shot to patients reporting to hospital emergency rooms with symptoms of Covid-19 compared to patients with no symptoms who elected to be vaccinated against future infection (prevention).

    There is no indication such distinctions were made as this would have unblinded the study (revealed which vials were vaccine or inactive placebo).

    What is needed is data showing people who came for vaccination with symptoms, how did they fare?  That would be a very small group as only about 1% of the population or less would be infected at any given time.

    FDA approval is for show

    The vaccine trials that have taken place do not prove these shots are effective or even that they save lives.  FDA approval is only for show, to induce people to mindlessly vaccinate.  A study to prove vaccination saves lives would take more than 2 years and billions of dollars.

    Peter Doshi, editor at the British Journal of Medicine, reminds us that the current trials are only designed to determine if the vaccine quells mild infections.  The FDA gave the vaccine makers a low bar to jump over.

    Doshi says it is entirely possible for a medicine or a vaccine to reduce the risk of a mild infection but not reduce hospitalizations or deaths, which is the current situation.  A false sense of security is being given.

    PCR test unreliable; known to produce pseudo-epidemics

    Up till recently, the public was being induced to vaccinate based upon the Polymerase Chain Reaction (PCR) test which has now been discredited.  It is still in use but at a lower sensitivity which would eliminate 97% of the cases reported to date.  It is upon this fraudulent testing data that drove fear-based inoculations.

    Patients with only a cough and a positive laboratory test (PCR test) help rush vaccine trials like this one to completion.  But most of the data involves a PCR test involved an overly sensitive setting (35 doublings, which has been lowered to 18 now, probably to make the vaccines look good).  Most of the data could involve false positives and only detect Covid-19 based on a single innocuous symptom.  This would represent prevention of phantom infections.

    Doshi goes on to say:

    “PCR tests do not detect the virus, they detect the presence of known genetic sequences from which inferences are drawn. And the common phrase ‘viral shedding’ does not measure how much virus (or even noninfectious RNA fragments) are being actively dispersed by a person. The phrase only indicates PCR positivity.

    We have allowed seemingly benign ‘shorthands’ like “detecting the virus” to obscure what is actually being measured, leading to potentially erroneous conclusions with serious consequences: quarantining noninfectious persons and its attendant aspects on other parts of people’s lives and health.”

    “None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus”
    – Peter Dosh, British Medical Journal

    Relative vs hard numbers

    Doshi reminds everyone that only ~1% of the population is infected and exhibits symptoms at any given point in time.  So, the often-quoted 90+ percent effectiveness of these new RNA/DNA vaccines is not a hard number (95 in 100) but a relative number within that one-percent (reduction from 0.009% to 0.001% for example).

    Petition to delay FDA approval ignored

    Doshi says the COVID-19 RNA vaccines are only 19% to 29% effective.  Doshi claims that is because false negative PCR tests would drag efficacy down, and because “cause” doesn’t matter.  Suspect cases of COVID are being used in the tabulations.

    “If you get a PCR test before the virus has proliferated in your system, it wouldn’t be able to detect that you were infected even if you were,” states Doshi.  That is why a group of physicians and researchers petitioned the FDA to delay “full approval” of Covid-19 vaccines this year.

    Earlier the FDA also said it would want a vaccine at least 50% effective against a primary endpoint (mild infection/symptoms) in prevention of Covid-19 infection or disease of any severity—parameters it had previously defined as necessary for approval.

    Lack of transparency

    Peter Doshi laments over the lack of transparency in the studies being used to gain FDA approval.  He says “many key trial documents remain inaccessible.”  Only 12% of 86 clinical trial protocols have been made available.  Blinded individual data on each participant is also not available for most trials.

    Difficult to define as a vaccine

    What has been learned about Covid-19 coronavirus is that it utilizes spike protein on its surface to facilitate entry via the ACE receptor (doorway) into a living cell.  Viruses cannot replicate on their own and require the machinery of a cell to produce infection.

    The Pfizer BNT162b2 experimental vaccine, now approved by FDA, utilizes a mutated RNA nanoparticle to encode living cells to produce spike protein.  The production of spike protein would then perpetually open the ACE entryway and would result in cells being vulnerable to infection by Covid-19 or other viruses.  Why would anybody design a vaccine to forever make spike protein?  Technically such a vaccine would not just provoke an immune response, it would be an engineered bioweapon.

    Advice

    Don’t base your decision to vaccinate on press releases from the FDA or vaccine makers.

    Don’t forget, more thoroughly studied vaccines have been recalled after they gained FDA approval.  These RNA/DNA Covid-19 vaccines are rushed-to-market “Operation Warp Speed” products.  The VAERS adverse event data is months behind in tabulating vaccine related morbidity and mortality and the public cannot get an accurate picture of possible risks.

    Mortal side effects associated (but not necessarily caused by) vaccination are of grave concern as there is a difference between inoculating old, fragile patients who die and completely healthy young people who die after vaccination.  According to the VAERS data, as of August 13, 2021, among 6,018 vaccine-related deaths that have been reported so far, 13% were within 24 hours of vaccination; 19% occurred within 48 hours of vaccination; 33% occurred in people who experienced onset of symptoms within 48 hours of vaccination.

    Censorship of anti-vax information

    Armitage of the University of Nottingham argues that censorship is not the solution to vaccine hesitancy.  A survey finds 400 anti-vax online accounts with 58 million followers in the US, Canada and Australia.  Armitage writes in the journal Public Health:

    Many people have legitimate concerns around the safety and efficacy of COVID-19 vaccines…  The public must feel freely able to voice these concerns, raise challenging questions and expect transparent replies from trusted institutions. An unintended effect of shutting down anti-vax groups may be to silence those with legitimate questions for fear of shame or ridicule and lead them to harbor greater suspicion of public health authorities and sympathize with anti-vax rhetoric… All ideas – even the bad ones – must be allowed a public airing, and their qualities debated in the marketplace of ideas. It is through this process that institutions foster influence, respect and public trust, by presenting empirical evidence, reasoned arguments and a scientific method based on critical thinking. Conversely, widespread de-platforming of anti-vax campaigners is unlikely to dissuade those sympathetic to these messages but rather reinforce their strongly held beliefs about vaccine conspiracies while deepening their mistrust of public health authorities.

    Oddity: the smoke and mirrors

    Pfizer has earned $33 billion on its unapproved RNA Covid-19 vaccine.  An oddity is that the wording in the FDA’s press release of August 23 grants approval for Pfizer’s biological license application (BLA), but not for the vaccine itself.  The BLA is approved and emergency use is extended.  So, was this really a timed publicity stunt to get governmental, military and private employers to push vaccination down the throat of Americans?

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