The FDA Must Not Hastily Grant Final Approval for the Covid Vaxx

The FDA Must Not Hastily Grant Final Approval for the Covid-19 Vaccine

By: Steve McCann

The Biden Administration, elected Democrat politicians, government bureaucrats, the education establishment, and clueless corporate management are hellbent on imposing Covid-19 vaccine mandates. These mandates could potentially apply to everyone over the age of 12. The FDA, at the urging of Biden Administration, is on the cusp of granting final approval for the mRNA (Pfizer and Moderna) vaccines in an unprecedented and abbreviated period of time, thus, providing the legal basis for the mandates to be imposed and enforced.

Based on ongoing research and actual experience with these drugs, there should be a significant slow-down in the approval process and a suspension in the mass vaccination program until all data is fully investigated without undue political influence.

Israel, determined to defeat Covid-19, dramatically accelerated their vaccination program beginning in late December 2020. Within three and a half months 80+% of the eligible population (citizens over 16) were fully vaccinated. Israel, thus, became the bellwether as to the efficacy and potential side-effects of the mRNA vaccine.

They were also the first nation with a successful mass vaccination program to experience a large-scale resurgence of Covid-19. A majority of cases were among the vaccinated population, prompting the government to reimpose travel restrictions, lockdowns and various mandates.

Further, the Israeli government determined that the Pfizer vaccine, after three to four months, was only 39% effective in preventing the virus. Which would ultimately require recipients to receive continual booster shots.

Meanwhile the overall hospitalization rates in Israel continue to dramatically climb among the fully vaccinated while, for the moment, remaining below the death rates of the initial Covid outbreak. The question is: are the hospitalizations due entirely the Covid-19 variants or complications from the vaccine or both?

Many other countries that have initiated mass vaccinations have similar experiences. It has become abundantly clear that these vaccines do not prevent Covid-19 or its variants. They are at best a therapeutic that reduces and controls the symptoms and, thus, the mortality rate. But they are therapeutics with major potential risks and side effects.

It has been determined that the mRNA vaccines cause some young adults to develop myocarditis (inflammation of the muscle of the heart) and pericarditis (inflammation of the tissue that forms a sac around the heart). A recent analysis of post Pfizer vaccine myocarditis cases at Boston Children’s Hospital revealed that 80% of the patients had “late gadolinium enhancement,” a prognostic marker which is associated with a nearly fivefold increase in the chance of future severe cardiac events.

Yet, the CDC has downplayed these reports. Stating that the numbers to date have been so small as to not be a concern, they are still recommending the vaccine for young adults as they claim the “benefits outweigh the risk.” Keeping in mind that without any vaccinations the survival rate of Covid-19 (per the CDC) for young adults (20-49) is 99.98% and for those 0-19, 99.997%. (Additionally, age 50-69– 99.5%)

Meanwhile, researchers in Israel investigated an extraordinary surge in excess mortality among 20-49-year-olds which coincided with the rollout of the vaccination campaign. As the susceptibility to Covid-19 mortality is extremely low among adults under 50 years of age, the excess mortality could not be just a mere coincidence.

The study revealed that there has been a 30% increase in cardiac arrests and heart attacks among young adults in Israel since the beginning of the mass vaccination program. And a shocking increase of 83.6% in heart attacks among young women in the 20-29 age group. Further, the United Kingdom and Hungary, also with very high levels of vaccination, have experienced similar results.  The authors of the study concluded:

Thus, our observations should prompt to pause the campaign, while clarifying the underlying reasons for those excess deaths, especially in the context of a low mortality risk from Covid-19 within adults under 50 years of age.

The pharmaceutical companies settled on what is known as the “spike protein” as the antigen that would induce an immune response in the body. However, the spike protein is a uniquely dangerous transmembrane fusion protein that is an integral part of the SARS-CoV-2 virus. This protein plays the primary role of penetrating host cells and initiating infections.

The Covid vaccines instruct the cells in the immune system to produce this same protein in the hope that the antibodies developed against it will prevent the most damaging effects of the actual spike protein in the virus. This process does work in most cases, but this produced protein can also slip into the bloodstream and thus flow throughout the body potentially causing serious damage to other cells in various organs that can result in severe illnesses or death.

A recent peer review study found that the Covid vaccine poses multiple adverse side effect risks, such as blood disorders, neurodegenerative diseases and autoimmune diseases, due to the production of the spike protein, which tracks with actual reported side effects.

Another study done by MIT and Harvard indicated that is possible that the mRNA vaccines could make human cells permanent spike protein factories due to the alteration of our genome DNA leading to potentially serious autoimmune problems.

The bottom line: at present we know almost nothing about the long-term effects of the mRNA vaccines and how they affect the human body.

This was reinforced by Dr. Robert Malone, the inventor of mRNA vaccines while at the Salk Institute. In an op-ed in The Washington Times Dr. Malone laid out four issues of concern:

  1. Universal vaccination cannot eradicate the virus and it will continually circulate much like the common cold and influenza.

  2. These vaccines are not effective in preventing Covid-19. They can only reduce, not eliminate, the risk of infection, replication and transmission.

  3. There are potential serious risks that must be taken into account, which include cardiac and thrombotic conditions, menstrual cycle disruptions, Bell’s Palsy, Guillain Barre syndrome and anaphylaxis. And unknown side effects that could emerge such as existential reproductive risks, additional autoimmune conditions and various forms of disease enhancement.

  4. These vaccines are likely to offer a mere 3 months of protection requiring additional boosters, each with the risks outlined above. The more people vaccinated the greater the number of vaccine-resistant mutations will occur. Ever more powerful vaccines will have to be developed which will expose individuals to increasingly greater risk.

Dr. Malone concludes that only the most vulnerable, the elderly with serious illnesses and others in the population with significant comorbidities, should be vaccinated.  The rest of the population should rely on outpatient access to a growing number of proven prophylactics and therapeutics, such as ivermectin, famotidine/celecoxib, fluvoxamine and various anti-inflammatory steroids as well as Vitamin D and Zinc.

There is no plausible basis at present for the FDA to grant final approval for the Covid-19 vaccine as there are far too many probable risks and potential side effects that must be thoroughly investigated. At this point the Covid vaccines do not even meet the definition of a vaccine — a drug that prevents not just treats a specific disease.

The only thing the final approval accomplishes is allowing the ruling class to unleash their vaccine mandates. Mandates that are overtly political. As the ruling elites are determined to further subjugate the citizenry through fear and intimidation.

A disease that has an average 99.8% survivability rate for all age groups under 70 (70+ age group survival rate is 95%) has been exploited for political gain and now the ruling class is determined to force the American people into being a massive laboratory experiment before the unknowns become known.

The doctors and researchers in the FDA must be thorough in their science, unfailingly honest with the citizenry and not succumb to political pressure before considering final approval for the vaccine or they will permanently lose the trust of the populace and potentially have blood on their hands. The American people must forcefully question those in authority, refuse to be intimidated and decide for themselves whether to be vaccinated or not.


The above article (The FDA Must Not Hastily Grant Final Approval for the Covid-19 Vaccine) is republished here under “Fair Use” (see the TLB disclaimer below article) with attribution to the articles author Steve McCann  and website

TLB Project recommends that you visit the American Thinker website for more great articles and information.

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