Posted on 10/03/2021 2:06:01 AM PDT by Jan_Sobieski
Senator Ron Johnson, R-Wisc., claimed that the U.S. still doesn’t have an FDA-approved vaccine as he exposed what was really approved by the government agency on “Fox News Primetime.”
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. They even admit it. I sent them a letter three days later going 'What are you doing?'
"What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question. If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates so that people actually think, 'Oh, OK now these things are FDA approved.' They are not and again, maybe they should be, but the FDA isn’t telling me why..."
(Excerpt) Read more at wnd.com ...
Then why wasn’t BionTech approved? Please provide the exact chemical composition of both vaccines side by side to show they are exact.
Thank God someone prominent had the guts to finally say it publicly.
You are lying.
Whether EUA or fully approved, Pfizer is indemnified.
Same for all vaccine makers.
Solson wrote: “Then why wasn’t BionTech approved? Please provide the exact chemical composition of both vaccines side by side to show they are exact.”
A cursory search of credible websites will provide multiple statements that these are identical in formulation and are interchangeable.
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.
Lurkinanloomin wrote: “You are lying.”
The anti-vaxxers are lying when the claim the pfizer vaccines have not been fully approved for those over sixteen.
BionTech is the name of the company. Not the product.
So if a company gives a name to their product that changes how it is produced? How does that make sense...at all?
They lie about a lot of other things, too.
Not only the full ingredients, but full approval by FDA requires that and the continuing study trials updated in real time with the agent that is Brand Named. It is this requirement which then LEGALLY extends the all-important MAJOR difference in these two agents.
Comirnaty, when finally approved for release, will have LIABILITY for product placed on the MANUFACTURER— PFIZER.
The current “hey it’s the same thing” as administered NOW under Emergency Use Authorization- has NO liability whatsoever for Pfizer, and thus NO protection for the public from what is an experimental unapproved agent.
Big Difference. They are attempting to use the EUA as a live trial, and using the fedgov to FORCE injection to drive the trial “participants” (without their INFORMED CONSENT-— which is removed by a signed waiver prior to injection-which the current law and the Nuremburg Laws require in the US).
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.
Very nice. What is left out is that the EUA “version” (which is serial numbered, btw, by each single use dose) has NO legal liability for Pfizer— by US law that govern the regulation of the FDA’s authority. No liability whatsoever, which is doubly inscribed by a waiver statement required to get the EUA shot. A waiver. No liability for the producer of the vaccine nor the adminstration of the injection individuals or companies.
For Comirnaty Brand approval on December 11 (that is the approval for the Pfizer/ BioNTech GmbH version, which is not stipulated as to content of the agent and thus is different without full disclosure), the approval is commensurate with the extension to the US public of Product Liability placed on PFIZER. Public liability is Pfizer’s. For the first time. Should also note that in this approval process, many drugs have been immediately pulled from the market as a result of “ongoing trials”.
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.
“but the pro-vax crowd here derided them at every turn”
Everyone paying attention knew that the alleged FDA-approved vaccine was Clinton-speak razzle-dazzle. They said it existed, but through a lie of omission they tried to make us believe it was there for Americans when it wasn’t.
Yesterday our next-door neighbor advised us that we “should trust the government”. I laughed right in her face without even thinking. And she’s JEWISH. Why would a Jewess trust the government? Ever? Nothing makes sense.
Good post John Mosby. In addition, the formula of the current Pfizer bioNtech can be changed as often as the manufacturer wants, and disclosure is not required.
The Pfizer shot is still EUA, only Comirnaty has been approved and is still not available.
Under law, approved vaccines can no longer be covered by the shelter given for an EUA experimental drug. So why is the BionTech formulation still covered?
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