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 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.