Following the FDA’s recent announcement that they were granting “full approval” of the Comirnaty Covid-19 “vaccine” there has been a groundswell of controversy emanating across many social media platforms.
What on earth is the “Cominarty vaccine” [“co-MER-na-tee”] – who had even heard of it? – COMIRNATY, represents a combination of the terms COVID-19, mRNA, community and immunity, to highlight the first authorisation of a messenger RNA (mRNA) vaccine…
The Nebraska Medicine website states:…
“Pfizer Comirnaty and Pfizer BioNTech COVID-19 vaccine are biologically and chemically the same thing. Pfizer and BioNTech simply formally “branded” their vaccine Comirnaty.
The confusion we are witnessing stems from a section of the FDA’s Comirnaty Vaccine Information for Recipients and Caregivers sheet:
“[1] The licensed vaccine has the same formulation as the EUA-authorised vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness”.
[So similar, but not the same in legal terms].The FDA desires to have a single, combined Vaccine Information Sheet. A single sheet keeps things simple for the people administering and receiving the vaccines.”
Two separate letters were issued by the FDA – 1 to BioNtech and 1 to Pfizer. [BioNTech is
the German biotechnology company that partnered with Pfizer in bringing this COVID-19 vaccine to market.]
BLA Approval – BioNTech
https://www.fda.gov/media/151710/download
https://www.fda.gov/media/150386/download
What is BLA Approval?
A Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2)
What is a biological product?
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Gene-based and cellular biologics, for example, are often at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. They tend to be heat sensitive and susceptible to microbial contamination.
What does this all mean?
For clarity the FDA has decreed that the original Pfizer-BioNTech vaccine continues under the EUA (unlicensed) but can be used “interchangeably” with the newly licensed Comirnaty product. Neither of the 2 products are licensed for the under 16 age group, nor any booster doses for anyone.
Full approval gives enormous weight to vaccine mandates which are now being pushed aggressively and at pace in the US.
I have previously reported on the leaked document calling upon the US military to prepare for mandatory COVID-19 vaccines as early as Sept.1. It would appear the FDA are a little behind the predetermined schedule, but not my much.
Are the FDA playing bait and switch with the American people?
Many people do not realize that the Pfizer vaccine that was just granted approval in the U.S. is not actually available there yet. The Pfizer vaccine currently circulating is the one that was given emergency use authorisation (EUA). However, the fully approved vaccine from Pfizer and BioNTech [aka Comirnaty] no one knows when it will be available to Americans.
Health officials from various states reported to The Epoch Times that they do not have any doses of Comirnaty nor are they expecting to receive any. A spokesman for Arizona’s Department of Health Services stated in an email: “Comirnaty-labelled doses are not yet in circulation in the U.S. yet,” while a Tennessee Department of Health spokeswoman said there was no timeline for when the product would be shipped.
The U.S. plans to continue to distribute the originally labelled vaccine before the branded and approved product is released, but it doesn’t look like the current supplies are close to being exhausted. There are believed to be hundreds of millions of doses remaining.
Some states are not planning to keep a separate count of who has received which version of the vaccine.
This has serious far reaching repercussions, for example, some workplace vaccine mandates stated that employees would have 1 month after full FDA approval to get vaccinated or face losing their job. However, with the approved vaccine unavailable in the country at the moment, these people will either have to get a vaccine that was not technically approved or find themselves without a way to support their family.
Europe and the UK
To add more confusion into the mix, the companies’ product has already been distributed in Europe for several months under the Comirnaty brand, appearing on the UK Government’s website….
There is a huge real-world difference between products approved under EUA compared with fully licensed. US laws permit employers and schools to require students and workers to take licensed vaccines.
Scrutiny from Decision-Making Process Removed
The FDA’s determination that Comirnaty is interchangeable with the experimental Pfizer-BioNTech COVID-19 Vaccine was all done on the same day and accomplished without convening the FDA’s federal advisory panel [VRBPAC] to evaluate the data.
The National Vaccine Information Centre (NVIC) requested that the FDA release data to the public that would have been released to the VRBPAC, disclose what was meant by stating that the two products were legally distinct, and the impact of the interchangeability of these vaccines.
As at 3rd September the FDA had NOT responded to the NVIC’s request.
Analysis
For once I am lost for words….
https://edition.cnn.com/2021/08/23/health/fda-approval-pfizer-covid-vaccine/index.html
https://apnews.com/article/business-health-coronavirus-pandemic-e08a6e68308b27ad7653ca9210d953dc
I wrote my first article for Unity News Network on 30th December 2019, and I have been writing ever since – my library is now well in excess of 200 articles.
Alternative media is essential in these times of unprecedented censorship and mainstream bias, which has ramped up exponentially during the past 2 years. The overton window of “acceptable opinion” is growing every narrower.
Having a citizen’s log, cataloguing the twists and turns of life during these turbulent times is essential.
Thank you Unity News Network for allowing me a voice on your platform.
