Does FDA Approval Really Mean “Safe and Effective”? Why Mandates Are Wrong No Matter What.

 Covid-19 shots are constantly touted as “safe and effective” by our government officials and their parrots in the media. They are also called “vaccines” by almost everyone. They will also tell you that they are “FDA approved” implying that they have full authorization. None of this is true. These shots are gene therapy. In the Federal Register vaccines are listed under ECCN 1C991: Vaccines, immunotoxins, medical products, diagnostic and food testing kits. Genetically modified material, on the other hand, is ECCN 1C353: Genetic Elements and Genetically-Modified Organisms. But as with so many things, vaccines now can be genetically modified organisms just like child care is “infrastructure.” The shots are only approved under Emergency Use Authorization which means they have not gone through the normal testing other drugs and therapies have. Obviously, no long term human tests have been done-everyone who has taken the shot is now part of the largest drug trial in history. Yes, YOU are the guinea pig. As such, mandating the shot for anyone for any reason is a violation of the Nuremberg codes and U.S. law.

President Biden recently stated that those who got the shot would not get Covid-19 and government and media tell us that getting the shot will reduce symptoms and practically eliminate the possibility of hospitalization and death. Lies. Britain's Chief Scientific Adviser Patrick Vallance said that 40% of those admitted to the hospital; i.e a “hospitalization,” were fully vaccinated. It is now admitted, based on the science from lead researchers in the Netherlands, that not only can fully vaccinated people get Covid-19 but that they can spread it to the unvaccinated and the vaccinated! Makes those vaccine passports rather useless, doesn't it.

The final and most important claim is that these new gene therapies are safe. Long term, we have no idea, all of you who got the shot will find out eventually. But in the short term we know that there are dangerous side effects and thousands of deaths have been reported just in the VAERS system. As of July 26 6,340 deaths were reported. That is not the total, however. From the VAERS HHS website; “"Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events.” Studies have shown that reporting varies from one percent to forty. Obviously there have not been 634,000 death from the shot in the U.S. but fifteen to fifty thousand wouldn't be out of line with the studies. That is a lot of dead Americans. Death isn't the only result however. Permanent injury can result from the shot. Myocarditis or pericarditis among people ages 30 and younger (who have almost no risk from Covid-19). Thrombosis with thrombocytopenia syndrome, Guillain-Barre Syndrome (GBS) and Anaphylaxis are also side effects reported to VAERS. Plenty of other side effects like spontaneous abortions (on over 80% of women in their first and second trimester according to one study) and blood clots have also been reported but we'll stick with the government data on the VAERS site.

If you go there and look for yourself, they will downplay the numbers and based on one hundred and fifty million shots, it may seem that way. But if you have a .03% chance of dying from something that for most people has a .01% or less chance of killing you, will you take it? How about a greater chance of causing irreparable injury? You may choose not to but in many places in the country and the world people are not being given that option. Making this mandatory is like being forced to play Russian Roulette. Of course the people pulling the trigger, the government and the pharmaceutical companies are immune from prosecution.

The companies making these shots have been given legal immunity from liability until at least 2024 if anything “unintentionally” goes wrong with the “vaccines”. This is far from typical. You know that just from watching commercials on television where slip and fall lawyers are promising compensation for injuries from everything from talcum powder to antacids (all FDA approved, I might add). But in February HHS secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act (2005) which provides legal protection for these companies. Not only can't you sue Pfizer or J&J, you can't sue the FDA for something approved under EUA nor can you sue your employer for requiring the shot as a condition of employment.

There is, of course, the National Vaccine Injury Compensation Program.... No, sorry, does not apply to Covid-19 shots. From the HRSA website; “COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program.” Good luck there. Over the last decade only 6% of claims have been paid under the program. Think about how good this is for everyone but us. The government steals our tax dollars to pay a drug company for a shot they make us take and no one's liable for anything that goes wrong.

Of course, full FDA approval is what everyone is waiting for. This will give all the pro shot fanatics the last piece of their puzzle to enforce all their mandates. It is supposed to take all the wind out of any objections. Does FDA approval really mean “safe and effective” is a reality? Well, it won't change the lack of effectiveness but can we at least trust the FDA to make sure things are safe? Perhaps we should look at their track record.

In 1955 some batches of polio vaccine were contaminated with a live virus giving over 250 people polio it what became known as the “Cutter Incident.” This supposedly led to a better system of regulating vaccines. Yet from 1955 to 1963 up to 30% of polio vaccines were contaminated with simian virus 40. In 1976 the swine flu vaccine killed some 25 people and showed an increased risk of GBS (also associated with the Covid-19 shot). It was immediately discontinued unlike the current shot. In 1998 the FDA approved RotaShield vaccine to prevent rotavirus gastroenteritis and a number of infants developed bowel obstructions.

How about other notable drugs approved by the FDA. Quaaludes were an approved sedative and sleeping aid used between 1962 and 1985 until they were re-classed due to their dangerous and addictive qualities. Darvon/Darvocet was on the market for fifty-five years as an opiod pain reliever until it was found to create serious heart abnormalities. It was responsible for over 2000 deaths between 1981 and 1999. The FDA was petitioned for removal back in 1976 but did not do so until 2010. Then there was DES, a synthetic estrogen. It was supposed to prevent miscarriage, premature labor and keep mom and baby healthy. Instead it created problems that affected multiple generations including cervical and breast cancer, birth defects, early menopause and testicular cancer. Posicor, for high blood pressure and chest pain, interacted negatively with a number of other drugs, many of which were also recalled. Then there was Vioxx, subject to the largest recall in history. While the original tests showed no risk of heart attack, over the longer term, it was associated with over 27,000 heart attacks and deaths.

FDA approval is far from a guarantee of safety and effectiveness. When it comes to drugs there is no way to ensure there are no negative effects when you are introducing a foreign substance into the body. Some drugs, after a long history of use, have been found to be wonderful and others, deadly. Only time will tell the difference. And that is exactly why we shouldn't be forced to take any substance or employ any medical device or undergo any procedure. What we put into or do with our bodies should always be up to us as individuals because we are all different. We should be able to compile all the necessary information, weigh the risks and benefits, and make a decision we believe is best for us. But we are not being allowed to do that. The government ridicules and destroys anyone who questions “safe and effective” and their cooperation with big tech and social media to bury any information that contradicts their line making coming to an informed decision very difficult.

So it doesn't matter whether the Cocid-19 gene therapy shots are approved under EUA or they become “officially” approved. These shots have only been around eight months and are based on a completely unproven technology. There is no way to know what their long term effects are and no one should be forced to be part of a drug trial to find out. “Safe and effective” should be up to us to decide, not the government.