I have seen the claim that the FDA pulled the bait and switch for a combination of reasons.
1> placate the hesitant that were saying there is no full approval.
2> Keep Pfizer out of court, they cannot be sued for EUA treatments or Childhood vaccines, but can be sued for adult only vaccinations.
3> Many of the laws about requiring vaccinations require full authorization.
What happens if the FDA doesn’t approve any of them? Do the vaxxers get their money back? Save your receipts!
So many FReepers have been saying this since the announcement, but the pro-vax crowd here derided them at every turn. Now we have a sitting senator saying the same thing. Is that still insufficient?
If there is an approved FDA drug on the market, then you can’t have EUA on Moderna. Yet Moderna is still available.
The only drug approved comirnaty is in foreign countries and not available.
Oh and for those that want to say oh it’s the same as the Phizer. Legally speaking the FDA cannot do that. They have to say the drug on the market. So it was a switch and bait.
Surprise, surprise the media lied to the public again. There are lawsuits challenging this now, because they know the public is being misled.
Perhaps we should ask the administrators of the vaccine reporting office of FDA that resigned.
“We know they are lying, they know they are lying, they know we know they are lying, we know they know we know they are lying, but they are still lying.” – Attributed to Aleksandr Isayevich Solzhenitsyn
Less ads to scroll past on the Fox website:
https://www.google.com/amp/s/www.foxnews.com/media/ron-johnson-no-fda-approved-covid-vaccine.amp
The most hopeful thing about this, is that people at the FDA still feel the need to play games, they are afraid to flat-out violate their own policies. They are afraid to fully approve experimental and ineffective treatments that in no way deserve approval.
It means they don’t have complete control of their membership, and it means they fear the repercussions of their actions, should the political winds change direction.
“SEN. RON JOHNSON: We do not have an FDA–approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S.”
Comirnaty is identical to the Pfizer vaccine and they can be used interchangeably.
Full approval also requires publishing the ingredients. They say comirnaty is “legally similar” to Pfizer BioNTech. Doesn’t mean squat. Obvious they are hiding something.
Thank God someone prominent had the guts to finally say it publicly.
FDA News Release
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."
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.
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.
All I’ve heard about this of a technical nature is that the “approved” variant is of the same formulation.
Umm, “same formulation” does not mean the same. Pancakes and pound cake are the same formulation, but no one would accuse them of being the same.
Semantic games. Like “gay”. A word is stolen, redefined, and then spewed out like you should recognize and accept it without question.
Even if the FDA approves a vaccine, would anyone in his right mind trust the FDA’s seal of approval?
They are a bunch of Faucists.
Bttt
At this point, would FDA “approval” actually mean anything?
We already know that this “vaccine” is the most dangerous ever released by a country mile. It’s not even close.