August 23, 2021 (document links updated March 1, 2023)
UPDATE September 1, 2021 – FDA Director of Vaccine Research and Review, Dr. Marion Gruber, and her top deputy, Dr. Philip, are stepping down from their positions in October and November, respectively. Gee, I wonder why? In other news, The Biden Administration is sidestepping the FDA, announcing it will unilaterally make booster shots available on September 20.
SILVER SPRING, MARYLAND — The U.S. Food and Drug Administration (FDA) is an official subsidiary of Pfizer. The FDA granted full approval for the experimental Pfizer mRNA injections this morning. The agency also announced that the injections are being rebranded and called “Comirnaty” for marketing purposes.
Note that Pfizer has used the brand name Comirnaty for its mRNA injection in Europe since December 2020. The generic, non-proprietary name of the drug is tozinameran. But “Comirnary” branded injections are not available in the United States as of publishing. The World Health Organization (WHO) also listed Comirnaty on its list of emergency use injections on December 31, 2020. Thus the name isn’t new. It’s just never been disseminated much until now. It’s the same tactic AstraZeneca (“Vaxzevria”) uses to attempt hiding the deadly nature of its experimental viral vector DNA injections. AstraZeneca is called “Covishield” in India.
Here is part of the FDA statement from this morning regarding the Pfizer approval:
“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.”
What this all means
The FDA approved Pfizer’s Biologics License Application (BLA). A BLA is the procedural process for “full approval” via the FDA. Pfizer may now directly market the mRNA injections to the public instead of relying on the government and media to push its agendas.
The mRNA injections can also now be sold in interstate commerce instead of governments buying up all the shots. The approved BLA will also increase Pfizer mRNA demand as it’s unlikely any new COVID-19 injections will receive emergency use authorization (EUA) since one is now fully approved. More mandates are also likely now that Pfizer has an FDA-approved product,
Interestingly, the FDA granted Pfizer’s BLA but also extended its emergency use authorization (EUA) for “certain uses that are not included in the approved BLA.” That provision is specifically in reference to the EUA for children age 12 to 15. Further, Pfizer and the FDA conceded that “Comirnaty” and the EUA Pfizer injections are not the same product.
To be crystal clear, Comirnaty branded injections received the BLA (“full”) approval. The Pfizer-BioNTech branded injections are still under the EUA. They are “legally distinct” products, according to the FDA.
This news changes only two things. First, it provides vaxx zealots celebration material and new talking points for defending their holy sacrament. It’s also a sure sign that those who refuse to be poisoned must be ready and willing to protect their lives and well-being by any means necessary.
This “full approval” was essentially purchased by the federal government. Pfizer profits will exceed $33.5 billion in 2021 from the mRNA injections alone, mostly courtesy of the U.S. and European governments. The facts about mRNA injections, the FDA and the Centers for Disease Control (CDC), however, remain unchanged. Keep this article handy to share with your Fauci-worshiping friends and family.
mRNA is gene therapy
Let’s be clear – the Pfizer and Moderna mRNA injections are the same product. The Moderna June 30, 2020 Quarterly Report filed with the U.S. Securities and Exchanges Commission tells you exactly what the mRNA injections are on page 70:
Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain.
Despite their mitigation attempts with the foregoing word salad, mRNA injections are in fact gene therapy.
FDA official policy since 1984 prohibits casting doubts about “vaccine” safety
For this we look at the Federal Register, Vol. 49, No. 107, from June 1, 1984. Long story short, the FDA eliminated a federal testing provision (21 CFR § 630.11) to ensure oral polio vaccines remained a profitable endeavor. The agency said:
In tort litigation involving the Federal government and private parties, questions have been raised concerning whether some of the lots of vaccine used in the 1961 and 1962 clinical trials met the test standard for neurovirulence prescribed in §630.16(6)(1). The purpose of the neurovirulence tests, which is performed in monkeys, is to assure that the live virus used in the oral poliovirus vaccine is properly attenuated (non-virulent).
But wait, it gets better:
The FDA has reviewed the data and has concluded that, although there may be a question as to whether the results of all the neurovirulence tests met the standard in the regulations, there is no doubt that the oral poliovirus vaccine used in the clinical trials involving 195,000 subjects was acceptably low in neurovirulence.
21 CFR § 630.11 read (past tense) as follows:
To qualify for license, the antigenicity of the vaccine shall have been determined by clinical trials of adequate statistical design conducted in compliance with part 56 of this chapter, unless exempted under Sec. 56.104 or granted a waiver under Sec. 56.105, and with part 50 of this chapter. Such clinical trials shall be conducted with five lots of oral poliovirus vaccine that have been manufactured by the same methods. Type specific neutralizing antibody for each type of poliovirus in the vaccine shall be induced in 90 percent or more of susceptibles after a series of doses.
RELATED: CDC Foundation is not a government entity, has many conflicts of interest (March 23, 2021)
The FDA concluded its official declarations with the most infamous, totalitarian verbiage that is relevant in 2021:
However, although the availability of the vaccine may not be in immediate jeopardy, any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives.
In other words, it is official FDA policy to lie about “vaccine” safety to ensure maximum sales. Here is a screenshot of the foregoing quote.
The following linked file is nearly 70 MB so it may take a couple minutes to download. But click here to read the full 1984 Federal Register yourself (it skips right to the relevant pages).
1976 Swine Flu vaccine halted after only three deaths
We’ve already written about this. But the 1979 60 Minutes broadcast talking about it is well worth the watch again in these surreal times.
RELATED: 60 Minutes: 1979 Swine Flu investigation has uncanny resemblances to COVID 2020-21 (February 26, 2021)
One item we left out of our original article is the 1976 New York Times piece. Nine U.S. states halted the use of the swine flu vaccines after just three people died that year. All of them had heart disease, but back then, that did not matter. The vaccine were considered unsafe and pulled off the market in Alaska, Illinois, Louisiana, Maine, New Mexico, Texas, Vermont, Virginia and Wisconsin. Allegheny County, Pennsylvania (Pittsburgh) also halted the injections. The 1960s polio vaccines killed 11 children and paralyzed 200 more. But remained on the market because polio was actually truly deadly, unlike COVID-19.
Nowadays Fauci and vaxx zealots proclaim that the Vaccine Adverse Event Reporting System (VAERS) is inaccurate. There have been 9,027 deaths reported in VAERS as a result of Pfizer injections alone as of August 13.
Let’s say, for the sake of argument, that only 10% of those reported deaths are accurate – a very generous error margin for the pharmaceutical industry at-large. That’s still 902 deaths, or 3,000% more than what triggered the cancellation of swine flu vaccines in nine states back in 1976. Times sure have changed.
Clinical trials are still ongoing
Don’t quote this blogger on the following statement. But this experimental Pfizer mRNA injection may be the first drug ever fully approved by the FDA with clinical trials still active. You may look at the full list of 32 Pfizer mRNA clinical trials that are either active or recruiting people right now. But here are a few highlights:
- The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose. Estimated Completion Date: December 30, 2022
- Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment (LymphVAX). Estimate Completion Date: December 31, 2022
- Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. Estimated Completion Date: May 2, 2023.
- Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children <12 Years of Age. Estimated Completion Date: September 27, 2023.
You’d think this information would be vital and necessary for government regulators to fully approve a new drug that has killed hundreds of thousands, and perhaps, millions of people across the globe already. But not in this dystopian world.
We’ll be updating this article throughout the week.
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