In a stunning move, the Food and Drug Administration (FDA) on Monday granted full approval to Pfizer and BioNTech COVID-19 vaccine making it the first COVID vaccine in the US to win the approved designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates.
I say “stunning move” because the mRNA vaccines over time have shown low efficacy rates and multiple side-effects including palsy, permanent nerve damage, blood clots, heart inflammation, and death among others. Recent studies show the vaccines are causing protein spikes to attack vital organs.
All of that begs the question: how could the FDA give approval for a vaccine that doesn’t work correctly and is causing tens of thousands of Americans serious disabilities?
We reported that the Pfizer and Moderna clinical trials intentionally lost their control group forthe efficacy and safety study by telling them they did not get the vaccine as soon as the FDA gave Emergency Use Authorization. All but two went and got vaccinated. So they don’t have any clinical trial studies for efficacy and safety, yet they approved it, anyway.
The approval comes as studies show the efficacy of vaccines in preventing the COVID virus is waning. That got a bunch of officials, including the FDA’s Woodcock, to announce last week that starting next month, they will begin recommending booster shots, pending FDA authorization.
So the FDA just gave full approval on a vaccine that works so poorly that they have to provide a booster shot. Makes sense for this administration.
This came from a political decision and not science. Too many people were pointing out laws saying that you can’t force Americans to get a vaccine if it is under Emergency User Authorization (EUA), so the Biden administration forced the FDA to approve it. That’s the conclusion we have to make considering the circumstances.
The Pfizer mRNA vaccine was used under the EUA that the FDA granted back in December 2020. Now that the FDA has approved it, the vaccine will be marketed under the name Comirnaty.
Since EUA was granted, over 204 million of the Pfizer shots were administered, according to Centers for Disease Control and Prevention (CDC) data.
Federal health officials have been getting flack from the scientific community (corrupted as they have become) and advocacy groups to have the FDA fully approve Pfizer and BioNTech’s vaccine since the time they submitted their applications for approval in early May.
Peter Doshi, a senior editor at the British Medical Journal, said on Monday that the FDA should have demanded “controlled studies with long term follow up” before granting approval to the Pfizer vaccine.
I believe the Biden White House forced the FDA to give approval because they want to mandate vaccinations. They want 100 percent vaccinated so that they can get rid of the control group of unvaccinated Americans who are not getting sick the way vaccinated people will be in about 3 to 5 years. That’s what many doctors are surmising.
The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.
The administration wants you to believe that once the FDA gives approval for a vaccine that there are no problems whatsoever with the vaccine. According to a 2017 piece done by NPR, one-third of new drugs approved by the FDA have safety problems after approval.
Despite full FDA approval, regulators said they determined that there are “increased risks” of myocarditis and pericarditis, or heart inflammation, after getting the shot, notably within the 7 days following the 2nd dose of the two-dose regimen.
“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks,” the agency said.
FDA scientists evaluated “hundreds of thousands of pages” of vaccine data, according to the US agency. Woopdy flippin ding! They read a lot. What about the VAERS system data? Did they read that? What about the fact that vaccines normally have to be tested for years for long-term side effects?
Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
High standards? The CDC’s VAERS system is showing 13,000 Americans so far have died as a result of taking the vaccine. 17,000 people have been disabled by the vaccine. What high standards for safety, effectiveness are they talking about?
Even though about 60 percent of the US population has gotten at least one dose of the COVID vaccine, there are still millions of Americans who say they are still hesitant about getting the jab. They are against it even as the delta variant is spreading. Some doctors and epidemiologists are saying that full approval might convince some Americans that the shots are safe. Those would be the stupid Americans who pretty much fall for anything.
A Kaiser Family Foundation survey found 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval. But what would they say now that the Pfizer vaccine was approved in far less than the normal amount of time it takes to safely test a vaccine? When those people were surveyed, I’m sure they didn’t mean if the FDA approved a vaccine on Monday.
Another frightening thing is now that the Pfizer vaccine has been approved, corporations will start enforcing vaccine mandates on their employees even if they are afraid of getting sick or dying from the vaccine.
With full FDA approval, Pfizer and BioNTech are now able to market the shots directly to US consumers. EUA prohibits companies from marketing their products. Approval also allows the vaccine to remain on the market once the pandemic is over and the US is no longer considered in an “emergency.” But that will never happen so long as Democrats are in charge of everything and so long as there’s another election every two years.
Millions of Americans are still not going to trust the vaccines because of how the government has been handling it. The CDC changes its COVID policies all the time to fit whatever political narrative is running at the time. Politics is how the so-called science “experts” are making decisions. How are people supposed to believe FDA approval of the Pfizer vaccine is based on science and not on the politics of the Biden administration because they want to get Afghanistan out of the headlines or for some other sinister motive?
The one thing that no one is talking about is the freedom to decline getting vaccinated. Freedom and liberty aren’t even part of the equation with the officials involved in the COVID vaccines.