I've been getting conflicting answers on these questions and would love a firsthand credible source if anyone knows the answers.
-Is the legally-distinct COMIRNATY jab available in the US (to be distinguished from the EAU version, identical or not)? I have a liberal friend who claims his grandfather received it last month in California and that doesn't compute with what I've read on this site. Made me feel like an idiot.
-Was there ever an official FDA approval for COMIRNATY for ANY age range? The waters have been super muddy regarding this issue but surely after several weeks to read through the paperwork SOMEONE must have an answer by now?
Would love to have these questions resolved once and for all, I think all of us would benefit to have the facts, whether we like them or not.
EDIT: Thank you all for your responses. Seems there is still some disagreement, but these seem to be the most sensible answers I've gained from this.
Question 1: Still not 100% certain but I'm leaning towards NO. I might follow up with my friend's grandfather's clinic to see if they had the actual COMIRNATY shot at the time of his injection. My guess is that they did not, and my friend was mistaken, but that will be hard to verify without a package insert to examine.
Question 2: From Jon Rappoport's letter, it seems that YES, the COMIRNATY shot DID receive full FDA approval for the older age group, while simultaneously receiving EUA for the younger age group.
I understand Comirnaty is FDA approved, but not available in the US. You'll have to find the time line for when it is expected to be released as a booster shot in the US.
Also, I don't know if Comirnaty is the Pfizer mRNA vaxxine rebranded overseas or is somehow different. The booster shots here are not boosters at all but a full 3rd jab of the Pfizer mRNA vaxxine. This was pointed out by Dr. Jane Ruby.
I love the passion here. So Pfizer has provided a brand name to something that doesn't exist? That's really interesting. My widget will sell millions of dollars and we'll all be rich. That's reality. Not.
Look, the FDA provided a very deceitful announcement on August 23rd.
From the FDA website:
So according to the FDA, my statement is correct. Other sources like Jon Rappoport puts my statement into context. The Pfizer-BioNTech COVID vaccine and Comirnaty are the same vaccine, medically speaking. The ingredients are the same.
And this vaccine “will now be marketed” as the Comirnaty vaccine.
Next, we move to a letter, also dated August 23, sent from the FDA to BioNTech Manufacturing GmbH, and Pfizer Inc. The letter is marked, “BLA Approval.” BLA stands for “Biologics License Application.” Here are key quotes:
“Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA.”
“We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany…Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA…You may label your product with the proprietary name, COMIRNATY…”
The FDA officially licensed this vaccine. This is approval. It is not merely a continuation of Emergency Use Authorization (EAU).
And now we come to another key FDA document, a letter sent to Pfizer Inc. on August 23, 2021 (addressed to Ms. Elisa Harkins). It also mentions the full licensure (approval) of the vaccine:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
This letter is further acknowledgement that the vaccine has been fully approved.
Now we enter the thick weeds of the letter, during a discussion of how Emergency Use Authorization will continue to be used. The language is very dense. It’s taken me a while to separate out the strands.
The “new vaccine”—which has full FDA approval—CONTINUES TO ALSO HAVE EUA STATUS—and therefore it too can be injected in people 12 and older, and used as a third dose for certain immunocompromised individuals.
Bottom line, and my conclusion: The FDA has fully approved the “new vaccine” AND it has also retained the Emergency Use Authorization (EUA) for the “new vaccine.” Both.
You stated:
The hubris and ignorance here has besieged you, It's laughable. You failed your own test.
I've heard it's the exact same, but my opinion is that the legal distinction makes a hell of a difference.
Read Jon Rappoport's article on this. It explains it very well.
Thanks I'll take a look.
Bro do you have anything helpful to add to the conversation? Your snark is unnecessary and not appreciated.
Why would the FDA need to approve a vaccine that was not going to be distributed in the US.
Comirnaty like all drugs must have application submitted to the FDA for approval only if the company intends to distribute said drug/ vaccine in the US which happens to be the only nation where the FDA is authorized to regulate drugs.
Comirnaty as a vaccine has no set formula that would lock down it's composition or contents. It's basically the equivalent of a marketing vaporware product.
I've provided MI-Vet the facts above. His narrative is rather bankrupt. Again, I recommend reading the FDA statement and author and vaxxine expert Jon Rappoport's excellent article to understand why he's failing to understand the trickery and corruption that the FDA announcement presents. With his stating:
His own hubris and ignorance has besieged him. He failed his own IQ test.
The FDA is deceitful and about as corrupt of an agency as it can get. Their sole purpose is NOT to serve the health interests of the American public, but the interests of BIg Pharma.
Now that I have stated this. Let's look at the inevitable results of such a reality. FDA has long been a revolving door for Big Pharma executives being seated at the 'wheel house' of the FDA and vice versa. In addition, the CDC is in reality a Pharmaceutical company owning over 25 patents for vaccines and drugs.
All of this allows for the unbelievable usurpation of medical power in the US that we are now witnessing.. Not only is the FDA not following their own rules (regulations) without Congressional oversight, they are making rules willy-nilly as this COVID-19 democide continues. It is without congressional oversight. We are now seeing for the very first time all safety and efficacy regulations ignored and nullified. The FDA has approved Pfizer's mRNA vaxxine and maintained its EAU authority when the three phases for approval have not been completed. One can easily deduce that the American people are the experiment. What is outrageous is the FDA and their accomplices aren't trying to hide how unsafe this grand experiment actually is. I've said this before, this COVID-19 vaxxine mandate is the Greater Tuskegee Experiment. It is this and far worse. Another example leading up to this abuse of power was that the National Childhood Vaccine Injury Act of 1986 has been completely ignored by the Vaccine Industry. The Act compels DHHS to take responsibility for improving efficacy and safety of vaccines; and charges them with continuous monitoring and improving of adverse event reporting. The DHHS is also tasked with providing a report on improvements by the Mandate for Safer Childhood Vaccine clause to the Congress at least every 2 years.
The DHHS has failed to meet even the most basic aspects of these important duties entrusted to them by failing to file a single report for the past three decades. It has been over 30 years since NVICA was put into place and entrusted to the DHHS to safeguard children, despite being the agency tasked with the responsibility of investigating and improving safety they have not done as much as to raise a finger towards vaccine safety.
It was in 1990 that autism started to dramatically climb to its unprecedented level of today. Coincidence?
This type of behavior, in which laws were not enforced has only led to our current tyranny we are now witnessing. There is only one conclusion that can be drawn from this. We are at WAR. If anyone is relying on a legal solution for this, the wheels that turn for justice are squeaky and very slow. Chances are we won't see results for years. Tyranny is unfolding. What needs to be done, and it needs to be done NOW is that people need to unite, organize, and walk out from their jobs showing support to the airline pilots, nurses, fireman, and others and shut down all those companies who have fired people refusing to be experimented on. We must have visual presence in front of the FDA and CDC and all those that are perpetrating this evil. We are now living in a world of Dr. Moreau and on living the island of Dr. Moreau.
I regret to inform you I have this right and it is you that is in error. Read my other response or read it at the FDA Website and then read Jon Rappoport's article.