Are you confident that these injections are safe and effective?
The FDA has brazenly rejected their own protocols and previous statements and not held any public hearing leading up to this full approval of a Biontech vaccine which has a new name Comirnaty but guess what? This injection is not yet available!
The Pfizer product is the currently available product and that is still under EUA and is not fully approved. With that it still has the blanket liability shield but the new BioNtech product which now has full approval but is not yet available (according to scrutiny by Robert Malone, inventor of mRNA technology) will NOT have the liability shield.
An important thing to understand about this approval (regardless of the monkey business with the two different products) is that the FDA only reviewed the original clinical study for ~40,000 participants which has been highly suspect from the beginning and the control was pierced when they gave the shot to their control group. This means they reviewed NO NEW DATA!
They didn't look at the over 10,000 deaths on VAERS and over a half million adverse events reported on that same system! Talk about blindfolds these executives clearly don't care about science.
Commentary from leading health journals such as BMJ (British Medical Journal) questions the ethics of the full approval without any sort of hearing to discuss that status of this product and it's failures in safety and efficacy. We've reported plenty on those failures already so we'll keep today's discussion focused on this approval.
According to an article published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”
But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.
An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.
According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.
Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” said Witczak. Wticzak was one of 27 experts who launched a citizen’s petition demanding the FDA “slow down and get the science right” before approving COVID vaccines.
“The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing,” Wticzak said. “These meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.”
Witczak said it’s concerning that full approval is based on only six months’ worth of data — despite clinical trials designed for two years — and there’s no control group after Pfizer offered the product to placebo participants before the trials were completed.
Clearly science has no bearing on these decisions and media fear campaigns drive the push to promote these toxic products to the masses. It's not a coincidence that this product was given full approval right before nationwide illegal mandates are set to go into effect pushing healthcare workers (even independent ones), teachers, etc. to get these shots despite over 10,000 reported deaths on the CDC's own VAERS database.
This happened while Staten Island NY hospital workers protested mandatory vaccination for healthcare workers as reported by the New York Times.
Also an interesting study out of Oxford which is in preprint stage (soon to be published) is showing that vaccinated healthcare workers carry 251 times the viral load in their nostrils than that of the unvaccinated. These vaccinated healtcare workers also had lower levels of neutralizing antibodies than the unvaccinated.
This study is a good expose that explains at least some of what is going on with vaccinated healthcare workers passing infection to other vaccinated people. literally posing a threat to the unvaccinated!
What appears to be happening is that the injections ("vaccines") are suppressing the symptoms of the infected vaccinated workers making them carriers with mild or non-existent symptoms. This is just like I've been saying all along - the only real "asymptomatic carriers" are among the vaccinated.
And another good doctor is speaking out against the medical tyranny up in British Columbia echoing what I've been reporting for weeks that there is no such thing as "mild" myocarditis.
“You have to look at what the actual risk of COVID-19 is. The chances of dying from COVID is about .003% for people under the age of 24 in Canada,” said Dr. Steven Pelech, Division of Neurology in the Department of Medicine at UBC, and Senate Representative for Faculty of Graduate and Post-doctoral Studies.
In addition to Pelech’s work at UBC, where he has been on faculty since 1988, he is the president and chief scientific officer at Kinexus Bioinformatics Corporation, and chair of the Scientific and Medical Advisory Committee at the Canadian Covid Care Alliance.
“If you’re under 19, your chances of having harm from the vaccine is about four to five times higher than getting infected with SARS-CoV-2 itself,” said Pelech in an interview with the Western Standard.
He goes on...
“For example, myocarditis. Inflammation in the heart. Contrary to what a number of people have said, there is no such thing as ‘mild myocarditis,'” said Pelech.
“It’s the destruction of the myocytes, the heart cells that contract. When those cells die, they are not replaced in your body and are instead replaced by scar-tissue, which is from fibroblasts – skin cells which don’t have contractile activity, so the remaining muscle cells have to get a little bigger in order to compensate.
“Every time you get an inflammatory response, you lose more of that contractility and have a greater chance of heart attack and other problems later in life.”
Initially, full authorization was expected to arrive in September, but the Biden Administration has ramped up the pressure in recent days. Full approval opens the door to several activities that were barred under the emergency authorization: Pfizer can now advertise the jab, and it can now continue to vaccinate people even after the COVID "emergency" is deemed over. Pfizer can also now raise the price of the vaccine. They have already raised the price of the jab in the EU.
Pfizer and BioNTech have both said they intend to generate billions of dollars in revenues (and likely profits) from sales of the jab.
As vaccine proponents celebrate the news, Alex Berenson, a prominent skeptic, has a question: how can a vaccine be fully approved when we don't even know the optimal number of doses?
Here's the full press release from FDA:
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. 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.
Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs
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Photo By DES Daughter