Health Friday Open Thread 5.23.2025: The FDA’s EUA to Pfizer-BioNTech for BNT162b2 on 11 December 2020 Is Invalid

The above free vintage image of a vaccine vial and syringe is courtesy of iStock and Google Images.

Health Friday is a series devoted to information about Big Pharma, vaccines, general health, and associated topics. As today’s offering is related to the COVID-19 biological toxin injections, aka the COVID-19 “vaccines”, Yours Truly dedicates it to all persons, of whatever age or location, who have been injured, made ill, become disabled, or have passed away, from the negative effects of these “vaccines” that they had in their body.

There are Important Notifications from our host, Wolf Moon; the Rules of our late, good Wheatie; and, certain caveats from Yours Truly, of which readers should be aware. They can be found here. NOTE: Yours Truly has checked today’s post for any AI-generated content. To the best of her knowledge and belief, there is none. If readers wish to post any AI-generated content in today’s discussion thread, they must cite their source. Thank you.

Yours Truly began writing about the results of the huge C4591001 clinical trial of the Pfizer-BioNTech modRNA COVID-19 “vaccine”, BNT162b2, on the board here back in 2023. I was reading through document after document that the company generated related to this clinical trial, documents that were released to the general public only after Pfizer-BioNTech, in partnership with the FDA, lost their case in federal court to keep all of the data about C4591001 sealed for 75 years, and they were then sued by Attorney Aaron Siri’s group, Public Health and Medical Professionals for Transparency (PHMPT.) Please see: https://www.biospace.com/non-profit-group-wins-transparency-lawsuit-over-fda-records-of-pfizer-vaccine-authorization, 7 January 2022. Note: regarding the Pfizer-BioNTech and the Moderna COVID-19 “vaccines”, “mRNA” and “modRNA” are interchangeable descriptive words for these injectables.

The FDA press release of 11 December 2020, announcing the agency’s granting of the EUA for the Pfizer-BioNTech modRNA COVID-19 “vaccine” BNT162b2 is here: https://www.fda.gov/news-events/press-annoucenments/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19, “FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine.” A screenshot from this press release is below:

Note the phrase, “Follows Thorough Evaluation…”. It is now known that this manifestly was NOT performed before the EUA was granted.

Regarding the invalidity of the 11 December 2020 EUA that was granted to Pfizer-BioNTech for BNT162b2 to be used “to prevent COVID-19 infection” in the United States: Yours Truly begins here: https://www.thefocalpoints.com/p/fda-authorization-of-pfizer-covid. “FDA VRBPAC December 11, 2020 Decision on Pfizer mRNA Found Invalid”, Nicolas Hulscher, MPH, 17 May 2025. There are several screenshots from this article, below:

Regarding the delaying by the FDA and the CDC of important information regarding the incidence of myocarditis following COVID-19 “vaccination”, and these agencies (and, also, Pfizer-BioNTech and Moderna) failing to issue Black Box Warnings about this on the Package Inserts for their modRNA COVID-19 “vaccines” (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]), please see: https://www.thefocalpoints.com/p/us-fda-and-cdc-delayed-health-advisory, “US FDA and CDC Delayed Health Advisory on COVID-19 mRNA Vaccine Myocarditis for Months, Failed to Issue Black Box Warning for Years”, Peter A. McCullough, MD, MPH, 18 May 2025. A screenshot from this article is below:

The above slide image is from the FDA’s VRBPAC meeting of 22 October 2020. This meeting was held seven weeks prior to the 11 December 2020 granting of the EUA for BNT162b2. The FDA therefore KNEW before 11 December 2020 that BNT162b2 could cause myocarditis — but went ahead and issue the EUA anyway.

Yours Truly has written extensively on the manufacturing process for BNT162b2, and on associated topics. Please see: https://www.theqtree.com/2023/11/06/the-infamous-process-2-manufacturing-method-for-the-pfizer-biontech-modrna-covid-19-vaccines/

Also: https://www.theqtree.com/2024/02/01/an-open-letter-to-medical-professionals-who-took-the-covid-19-vaccines/

And: https://www.theqtree.com/2024/11/15/health-friday-11-15-2024-open-thread-hold-them-accountable-edition/

The FDA’s VRBPAC members will meet on Thursday 22 May 2025 to make “recommendations” regarding the “2025-2026 COVID-19 Vaccine Formulas.” Public comment is accepted until 11:59PM on Friday 23 May. To submit comments electronically, please see: https://www.federalregister.gov/2025/05/08/2025-080803/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a; scroll down this page to the section “Electronic Submissions.”

But wait, there’s more! The “new” leadership of the FDA and the CDC, Dr. Vinay Prasad and Dr. Martin Makary wrote an article which was just published in the New England Journal of Medicine: https://doi.org/10.1056/NEJMsb2506929, “An Evidence-Based Approach to COVID-19 Vaccination”, Vinay Prasad, MD, MPH, and Martin A. Makary, MD, MPH, 20 May 2025. This article is NOT an “opinion piece” — Drs. Prasad and Makary make it clear that they are going to implement this “new approach” to COVID-19 “vaccination” through the FDA and the CDC.

In Yours Truly’s opinion, this “new approach” has many items to question. For example: the granting of FDA authorization for “new formula” COVID-19 “vaccines”, authorization based on lab-performed experiments on the “new formula” ingredients that produce certain numbers of “antibody titers” that might “correspond” to “effectiveness.” There would be no clinical trials at all, performed either on lab rats or on humans. This “lab-experiments with Petri dishes results” authorization method is outlined in “Option 4” of the FDA vaccine authorization / full approval guidelines that the agency adopted in 2022. This “lab-experiments with Petri dishes results” method will now be used for “new formula” COVID-19 “vaccines” for persons age 65 and over; and for persons under age 65 with compromised immune systems or who are part of “vulnerable” or “at risk” populations — such as, for example, pregnant women. Please see, regarding the “Option 4”: https://www.fda.gov/media/159452/download, “VRBPAC Briefing Document”, 28 June 2022. A screenshot of “Option 4” is below:

For another example: COVID-19 “vaccination” will still be “recommended” for pregnant women and for women who have just given birth. This flies in the face of the mounting, and published, evidence that COVID-19 “vaccination” during pregnancy can, and does, result in miscarriages, stillbirths, live births but the infant has medical issues, and so on. In addition, COVID-19 “vaccine” antibodies show up in the breast milk that “vaccinated” new mothers nurse their infants with.

Why do the FDA / CDC continue to ignore the evidence-based facts that Ivermectin, Hydroxychloroquine, Zinc, and Vitamin D both prevent and treat COVID-19 infections?

Three screenshots from the Prasad and Makary article are below:

NOTE THE LAST SENTENCE OF THE ABOVE IMAGE: “Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based.”

Let’s take a look at the combined Figure 2 and Figure 3 image:

Which makes it plain, in Figure 2, that the COVID-19 “vaccines” will be “recommended” for people who “fit” the diagnosis parameters of multiple types of medical conditions, including pregnant women and women who have just given birth — in other words, these groups of people may well be subjected to multiple types of “convincing” strategies to get them to agree to take these “vaccines.” Who made the decisions on the types of “risk factors” for the “increased at-risk” groups?

And, there’s this tweet, from Dr. Martin Makary, of August 2023:

There is published, irrefutable evidence that the COVID-19 “vaccines” can cause death among the “vaccinated.” Please see: https://www.thefocalpoints.com/p/the-causal-link-between-covid-19, “The Causal Link Between COVID-19 Vaccination and Death”, Nicolas Hulscher, MPH, 21 May 2025. There is an embedded interview between Mr. Hulscher and Dr. Idriss J. Aberkane, PhD, on this subject. A screenshot from the Hulscher article is below:

It appears to be unclear, in Yours Truly’s opinion, about where this “new approach to COVID-19 vaccination” fits in as regards the “Generation Gold Standard” that was announced a few weeks ago. Does the federal government control “new” COVID-19 “vaccine” development processes? Where does Big Pharma (Pfizer-BioNTech, Moderna, Novavax) come in? Is that what “Sponsor-Driven” clinical trials means (see the above image)?

However, here’s the real situation: In Yours Truly’s opinion, given that the initial EUA granted by the FDA to the Pfizer-BioNTech BNT162b2 on 11 December 2020 was invalid — that means, by extension, that every other EUA (and “Full Approval”) of the modRNA COVID-19 “vaccines” is also invalid: which would include any “formula” that is “recommended” for the “2025-2026 COVID-19 Vaccine”. Which would also, in Yours Truly’s opinion, invalidate any “Full Approval” of the Novavax COVID-19 “vaccine”, since the foundation of that injectable is the same Wuhan Hu1 SARS-CoV-2 virus that was used as the foundation for BNT162b2.

FLASH! — Meanwhile, the FDA just granted “Full Approval” to the Novavax company’s injectable on 19 May 2025, under the name “NUVAXOVID”: https://ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavax-COVID-19-Vaccine.

FLASH! 2 — The VRBPAC members voted unanimously today to “recommend” that the “2025-2026 COVID-19 Vaccine Formula” injectables contain the JN.1 Omicron variant of the original SARS-CoV-2 virus. This is the same strain that was “recommended” for the “2024-2025 COVID-19 Vaccine Formula” injectables. The decision today by VRBPAC will be implemented according to the Dr. Prasad and Dr. Makary “new approach” method, as outlined above in today’s post. This means that persons age 65 and older, and that persons under age 65 who fall into one of the “increased risk” categories (Figure 2, above in the post) will be “encouraged” to get “vaccinated.” The exact formulation of the “2025-2026 COVID-19 Vaccine Formula” for the Pfizer-BioNTech and the Moderna injectables will be based, as was their other COVID-19 “vaccines” on the modRNA (aka mRNA)-based platform. The Novavax (now called NUVAXOVID) “2025-2026 vaccine” product will be based on the company’s previous “inactivated protein”-based platform. It is unclear whether the NUVAXOVID “2025-2026 vaccine” product will be authorized for persons under age 65 and/or who have underlying “increased risk” conditions. Please see: https://www.cidrap.umn.edu/covid-19/fda-vaccine-advisers-recommend-sticking-jn1-strain-next-covid-vaccines, 22 May 2025; and, https://cen.acs.org/pharmaceuticals/vaccines/FDA39s-new-COVID-19-vaccine/103/web/2025/05?sc=230901_cenrssfeed_eng_latestnewsrss_cen, 22 May 2025. A screenshot from the C&EN / ACS article is below, highlighting items related to the Dr. Prasad and Dr. Makary “new approach” article:

THERE. MUST. BE. JUSTICE.

Peace, Good Energy, Respect: PAVACA

Health Friday 5.2.2025 Open Thread: The PREP Act Must be Repealed. Now.

The above vintage image of the United States Congress in session is courtesy of the Library of Congress and Google Images.

Health Friday is a series devoted to Big Pharma, vaccines, general health, and associated topics. As today’s post speaks of the disaster of the lab-created bioweapons called COVID-19 — the COVID-19 virus itself; and, the COVID-19 “vaccines” — Yours Truly dedicates it to the memory of all persons, of whatever age or location, who have passed away from the negative effects of these bioweapons.

There are Important Notifications from our host, Wolf Moon; the Rules of our late, good Wheatie; and, certain caveats from Yours Truly, of which readers should be aware. They are linked here. NOTE: Yours Truly has checked today’s offering for AI-generated content. To the best of her knowledge and belief, there is none. If anyone wishes to post AI-generated content to today’s discussion thread, they must cite their source. Thank you.

The PREP Act (also called PREPA) is a “License to Kill“, in the words of Sasha Latypova (https://sashalatypova.substack.com/.) The PREP Act removes accountability, liability, and transparency from the activities of the Health and Human Services Department of the United States Federal Government under the provisions of the Act. The PREP Act allows: unlimited research, development, and use of COVID-19 “countermeasures”, including, but not limited to, “vaccine” development and use; “respiratory devices” development and use (think ventilators); prescription drugs use (think Paxlovid and Remdesivir); “mandated” uses of masking, of “social distancing”, and even of “lockdowns”; the “mandated” administration of COVID-19 “vaccines”, including to newborn babies, to persons under the age of 18, to persons who wish to attend school or to work; and much more. The PREP Act allows the United States Federal government and its associated departments (including Health and Human Services and the United States Defense Department) to literally use American citizens as “human lab rats” in the administration and use of dangerous, deadly, COVID-19 “countermeasures” which are not “safe and effective”; but which, instead, damage and/or destroy the bodies and minds of the persons who take the COVID-19 “vaccines” and/or drugs such as Remdesivir. The PREP Act uses taxpayer monies, private research grants, collaboration with scientific labs all across the United States (think the Baric Lab at UNC, Chapel Hill), and with foreign labs (think the Wuhan Institute of Virology) to pursue the provisions of the PREP Act.

Yours Truly begins here: https://www.federalregister.gov/documents/2024/12/11/2024-29108/12th-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical, “12th Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19”, signed by then-Health and Human Services Secretary Xavier Becerra, 11 December 2024. This 12th Amendment extends the PREP Act (also called PREPA) “emergency status” of COVID-19, along with all medical countermeasures used against COVID-19 (including development and use of “vaccines”, “respiratory devices”, and so on) — until 31 December 2029 (in other words, until after the 2028 General Election and into the Presidential administration that takes over on 20 January 2029.) It also means that, even though the “official” COVID-19 “state of emergency” ended in May 2023, the “virus emergency status” has not been ended. It also means that legal liability for any person, any medical professional, any drug manufacturer, any hospital / clinic / care facility, and supplier, and so on, that fall under the provisions of the 12th Amendment — are legally exempt from any and all liability. It also means that, while the current Health and Human Services Secretary can sign a document that rescinds and/or modifies the 12th Amendment, it must take an act of Congress to repeal the PREP Act.

Per Katherine Watt (paralegal and professional researcher), the two separate actions mentioned above are discussed here: https://bailiwicknews.substack.com/p/repealing-prep-act-and-terminating, “Repealing PREP Act and terminating HHS Secretary determinations and declarations issued under PREP Act are two different things.”, 4 April 2025. Please see the screenshots from her article, below:

For more information on the PREP Act (aka PREPA), please see: https://aspr.hhs.gov/legal/PREPact/pages/default.aspx. ASPR means the Administration for Strategic Preparedness & Response. The PREP Act was passed by Congress in 2005, under the administration of then-President George W. Bush. Please also see: https://aspr.hhs.gov/legal/PREPact/Pages/PREP-Act-Questions-and-Answers.aspx#COVID.

It appears that the various States of the United States have little room to challenge the provisions of the PREP Act. However, a recent case before the North Carolina Supreme Court, regarding a person under age 18 who was given a COVID-19 “vaccine” without consent, was decided in favor of the plaintiff: https://thefocalpoints.com/p/give-it-to-him-anyway-teen-given, “Give It to Him Anyway”: Teen Given COVID-19 mRNA Shot Without Consent — State Supreme Court Says Family Can Sue”, by Nicolas Hulscher, MPH, 24 March 2025. Please see the screenshot from the Hulscher article, below:

A lower court in North Carolina ruled that the family could not sue the school system, due to the “liability provisions” of the PREP Act. However, the North Carolina Supreme Court overruled the lower court, stating that the family can indeed sue:

Before turning to the final aspect of today’s offering, Yours Truly will expand the mention of Sasha Latypova above in the post. Ms. Latypova, a native of Ukraine, was trained in medical and pharmaceutical technology. She owned and ran several companies in this area. She worked with Pfizer-BioNTech and other drug manufacturers in medical technology. She is therefore a person with deep experience, in Yours Truly’s opinion, regarding the workings of these industries. After moving to the United States and subsequently retiring from these endeavors, Ms. Latypova began to research and write on how the medical technology and the pharmaceutical industries have now become entities that serve their shareholders and the government, not the patients they claim to serve. Regarding the PREP Act, here is one of her blog posts: https://sashalatypova.substack.com/p/prep-act-license-to-kill-must, “PREP Act Brief: “License to Kill” must be repealed.”, 21 April 2025. This article is densely-written and detailed. Below are a couple of screenshots from her post. Note: There are numerous hyperlinked information sources embedded in the article:

Please also see this post, an interview between Ms. Latypova and Ms. Watt (Bailiwick News) regarding the PREP Act: https://sashalatypova.substack.com/p/interview-with-the-former-feds-foundation, “Interview with the Former Feds Foundation: Katherine Watt and I discuss PREP Act as an act of treason.”, 25 April 2025.

Finally, there is this blog article from “Spartacus”: https://iceni.substack.com/cp/162062988, “Declaration of Sovereignty Pt. 1”, 24 April 2025 (this is a cross-post from the Mole substack website.) This post is long and intense; it traces the “Profane Myth of COVID-19.” A screenshot of part of this post is below:

It is the PREP Act which, in significant amounts, has placed the United States in the position where the country is today: just under 70% of the population has taken at least one injection of a dangerous, deadly COVID-19 “vaccine” (these injectables are NOT “safe and effective”, and mounting evidence proves this); the country is just beginning to emerge from the economic devastation and chaos of the “COVID lockdowns” period; and, the Medical Tsunami of COVID-19 “vaccine”-induced injuries, illnesses, disabilities, and deaths, which is starting to present among the “vaccinated.” There are many persons involved in the above who must now be held accountable; not the least of which are those who knew how dangerous and potentially deadly the COVID-19 “vaccines” are while working with “Operation Warp Speed”, and who withheld this information from then-President Donald Trump.

THERE. MUST. BE. JUSTICE.

Peace, Good Energy, Respect: PAVACA