Health Friday 8.1.2025 Open Thread: The FDA and the CDC — Rebuild Them From Top To Bottom

The free vintage public health poster from World War II about washing the hands is courtesy of Open Culture and Google Images.

Health Friday is a series of information regarding Big Pharma, vaccines, general health, and associated topics.

There are Important Notifications from our host, Wolf Moon; the Rules of our late, good Wheatie; and, certain caveats by Yours Truly, of which readers should be aware. They are linked here. Note One: Yours Truly has checked today’s offering for any AI-generated content. Other than AI-generated images that may be embedded in URL links, 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. Note Two: Nothing in today’s offering is intended to be, nor shall it be construed as, what might be termed “character assassination” regarding HHS Sec. Kennedy, Jr., or any employee (current or former) of the FDA or of the CDC. Thank you.

Today’s offering is about one topic: It is past time to: first, to shut down the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) divisions of the United States Department of Health and Human Services (HHS); then, second, to rebuild these agencies from top to bottom so that they truly serve the public health of Americans.

Yours Truly begins here: https://sashalatypova.substack.com/p/another-day-another-episode-of-the, “Another day, another episode of the new FDA lying just like the old FDA…plus self dealing by MAHA Action”, by Sasha Latypova, 28 July 2025. This article regards certain statements by Dr. Martin Makary, the current Commissioner of the FDA. Ms. Latypova worked in Big Pharma for her professional career, designing and helping to implement clinical studies for drugs. She retired from her career when she realized that, in Yours Truly’s opinion, she concluded that it was all part of a “shell game” that was played by Big Pharma. Since retiring, Ms. Latypova has begun a new endeavor: to expose this “shell game.” There are those who may differ with certain of Ms. Latypova’s opinions; however, Yours Truly believes that she is right on the mark on multiple issues. Please see the screenshot from her article, below:

The Latypova 28 July article discusses several aspects of what appears to Yours Truly to be two things: first, an internecine war going on within the FDA; and, second, deep and potentially catastrophic conflicts of interest within certain key employees of the FDA regarding their personal prejudices versus the line of their duties within the FDA. The transcript portion above is from an interview with Dr. Martin Makary (current FDA Commissioner) by Jan Jekielek of American Thought Leaders (ATL) of 16 July 2025; the second screenshot is Ms. Latypova’s considered opinion as to what is going on “behind the scenes.” The Jekielek tweet about this interview, with an embed of the interview itself, is here: https://x.com/JanJekielek/status/1945560472909906288.

Yours Truly now turns to the case of Dr. Vinay Prasad, the now-former head of the CBER division of the FDA (Center for Biologics Evaluation and Research.) The CBER division of the FDA is responsible, among other duties, to make sure that “biological products” (drugs, vaccines, and so on) are “safe and effective” and are available “to those who need them” (https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber). Dr. Prasad joined CBER as the new Director in May 2025, and he resigned abruptly on 29 July 2025. Sasha Latypova wrote the following article about the situation: https://sashalatypova.substack.com/p/breaking-vinay-prasad-is-out-from, “Breaking: Vinay Prasad is out from the FDA!”, 29 July 2025. Please see the screenshot from this article, below:

About the Sarepta decision: please see https://sashalatypova.substack.com/p/sarepta-plot-thickens, 25 July 2025, and the screenshot from this article, below:

Dr. Prasad was an opponent of the FDA re-instating the use of Elevidys for young people with Duchenne Muscular Dystrophy who can still walk (as opposed to the 18 July 2025 FDA request that the drug be stopped for all Duchenne Muscular Dystrophy patients.) He was overruled by Dr. Martin Makary.

The Latypova article above presents an argument that the FDA re-instatement of Elevidys is profound on several levels — among them, funding for the drug’s manufacturing company, Sarepta. And there are other “ripple effects” from this re-instatement: please see the screenshot of the stock value of Sarepta related to the FDA withdrawal of the drug; then, to the FDA re-instatement:

Yahoo Finance has this article regarding Sarepa, funding, and the Elevidys situation: https://finance.yahoo.com/news/fda-ask-sarepta-halt-elevidys-193245811.html. Please see the screenshot from this article, below:

Elevidys, by the way, has a list of adverse effects and other complications; among them is acute liver injury (this is what killed the patients who passed away after being treated with Elevidys.) Please see the Package Insert for this drug, available here: https://www.drugs.com/pro/elevidys.html, “Sarepta Refused FDA’s Request to Halt Elevidys Shipments”, 18 July 2025.

Regarding the departure of Dr. Prasad from the FDA’s CBER division, there are several “pieces to the puzzle” (and some of these “pieces” are still unknown.) However, Yours Truly has been able to trace the following:

ONE: Please see the items above in today’s offering related to the Sarepta / Elevidys situation and the involvement of Dr. Prasad.

TWO: It was Dr. Vinay Prasad who signed off on the Moderna modRNA COVID-19 “vaccine” SPIKEVAX being used on babies and young children ages 6 months to 11 years old. This “FDA full approval” was signed on 9 July 2025. Dr. Prasad did this signing off on his own authority as Director of the FDA’s CBER division, and without informing HHS Sec. Kennedy, Jr., who was on vacation. However, there is another aspect of the issue: Did Dr. Prasad confer with, and/or communicate with, Dr. Martin Makary, either in advance of, or after, this signing off? Please see: https://www.thegatewaypundit.com/2025/07/now-we-know-who-approved-spikevax-vaccine-children/, “Now We Know the Official Who Approved the Spikevax Vaccine for Children While Robert Kennedy Jr. Was Allegedly on Vacation”, by Jim Hoft, 31 July 2025. Please see a screenshot from this article, below:

THREE: The investigative reporter, Laura Loomer, posted multiple items regarding Dr. Prasad that, in his own words, paint him as a believer in left-wing political positions; as a person who actually despises President Donald Trump 47; and more. The 2nd Smartest Guy in the World Substack article on the Laura Loomer investigation is here: https://www.2ndsmartestguyintheworld.com/p/breaking-vinay-prasad-is-out-at-the, “BREAKING: Vinay Prasad is Out at the FDA”, 30 July 2025. Please see the screenshots from this article, portions of Ms. Loomer’s X posts of her investigation, below:

Laura Loomer’s X post is here: https://x.com/LauraLoomer/status/1947103566239289523.

Last, but not least, is the situation now at the CDC (Centers for Disease Control and Prevention.) The United States Senate, on a strictly “party-line vote”, just confirmed Susan Monarez, PhD, who had been serving as Acting Director of the agency, to be Director of the CDC. Dr. Monarez is a well-known proponent of “vaccines save lives.” Please see: https://apnews.com/article/susan-monarez-cdc-director-senate-hearing-rfk-c7c883f604711238643a9ffd1681bcc0, “CDC nominee Susan Monarez sidesteps questions about disagreements with RFK in Senate hearing”, by Jonel Aleccia, 25 June 2025. Please see the screenshots from this article, below:

Note Dr. Monarez’s emphasis on the role of “public health interventions, including immunizations…”.

Yours Truly’s opinion on all the above in today’s offering is that there are real and divisive issues with the FDA and the CDC, who both appear to be in opposition to HHS Secretary Robert F. Kennedy, Jr. In her opinion, it is time to shut down both agencies and to rebuild them from top to bottom, so that the new entities truly reflect their duty to serve the public health of Americans.

FLASH! JUST ON THE WIRES NOW: https://www.politico.com/newsletters/politico-pulse/2025/07/31/why-trump-ordered-ouster-of-fda-official-00485966, 31 July 2025. It appears that it was President Trump 47 himself who ordered the firing of Dr. Vinay Prasad, overruling both HHS Sec. Robert F. Kennedy, Jr., and Dr. Martin Makary, who opposed Dr. Prasad’s ouster. (Since it’s POLITICO, perhaps a “measure of salt” should be in order… it’s that “people with knowledge of the decision” stuff in the POLITICO article.)

THERE. MUST. BE. ACCOUNTABILITY.

THERE. MUST. BE. JUSTICE.

THERE. MUST. BE. TRUTH.

Peace, Good Energy, Respect: PAVACA

Health Friday 5.30.2025 Open Thread: What is Going On at HHS, the FDA, and the CDC?

The above graphic is with thanks to https://www.thefocalpoints.com/p/fda-recommends-more-mrna-shots-despite, “FDA Recommends More mRNA Booster Shots Despite New Study Showing Booster Failure — and Major Public Outcry”, by Nicolas Hulscher, 26 May 2025.

Health Friday is a series devoted to information about Big Pharma, vaccines, general health, and associated topics. As today’s offering has to do with the disaster of the COVID-19 “vaccines” (Bioweapon Toxin Injections), Yours Truly dedicates it to all persons, of whatever age or location, who have passed away due to the negative effects of the COVID-19 “vaccines” that they had injected into their bodies.

There are Important Notifications from our host, Wolf Moon; the Rules of 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 any AI-generated content. To the best of her knowledge and belief, there is none. If readers wish to use any AI-generated material in the discussion thread for today’s post, they must cite their source. Thank you.

Yours Truly has been researching, reading about, and writing about, the COVID-19 disaster since March 2020. She had a sense, early in 2020 when the speculation about the development and use of a COVID-19 “vaccine”, that something was “off” in the hype regarding “how this will stop the spread” of the virus, “how this will prevent COVID-19 infection”, and so on. As it turns out, that “Suspicious Dog” feeling was the correct one — the COVID-19 “vaccines” have been, are now, and will be, a disaster. These injectables do not prevent COVID-19 infection. These injectables have injured, sickened, disabled, and even killed, millions of “vaccinated” persons all over the world. These “vaccines” will continue to injure, sicken, disable, and even kill, those who have them put into their body — not only because of the ingredients and mechanisms of these injectables, but now also because of the “new and improved” (not) faulty foundation of “lab-created antibody titer levels tests” that will be used in the development of the “latest mutation version” of the “vaccines”, instead of doing actual clinical trials with lab animals and/or with human subjects. I will make it clear at the start that today’s offering is not meant to “stir the pot.” There are, in my opinion, legitimate questions that need to be asked regarding certain recent news items.

There are several central elements of the current situation regarding the “2025-2026 COVID-19 Vaccine Formula”, and the actions of certain people and entities. One such entity is the FDA. The current Commissioner of the FDA is Dr. Martin Makary, MD, MPH, who is also a proponent of COVID-19 “vaccination” (including in pregnant women), and is himself “vaccinated.”

On 22 May 2025, the FDA’s VRBPAC (Vaccines and Related Biological Advisory Committee) members met to “consider” and then to “recommend” the “2025-2026 COVID-19 Vaccine Formula.” The committee voted unanimously, after “presentations” by Pfizer-BioNTech, by Moderna, and by Novavax, to “recommend” the “formulas” for the modRNA (Pfizer-BioNTech and Moderna) and the “inactivated protein” (Novavax) COVID-19 “vaccines.” Please see: https://www.contagionlive.com/view/fda-makes-recommendations-for-2025-2026-formula-for-covid-19-vaccines, 23 May 2025. A screenshot from this article is below:

These “vaccines” will be lab-developed, then lab-tested regarding the amount of “antibody titers” that “might” be “effective” in the “2025-2026 Formula COVID-19 Vaccines.” There will be no clinical trial testing of these “vaccines.” This protocol, outlined in the “Option 4” method, was adopted by the FDA on 28 June 2022. Please see the Briefing Document for this meeting: https://www.fda.gov/media/159452/download. “Option 4” is located on page 19. Please see the screenshot below:

Therefore, it appears that any person who takes an injection of the “2025-2026 Formula COVID-19 Vaccine” by Pfizer-BioNTech, by Moderna, or by Novavax, will be, in essence, a “human lab rat”, since these “vaccines” will only have been tested under “Petri-dish conditions” in a lab to confirm whether the “antibody titer amounts” expressed by the “vaccine” ingredients “might” be “effective” in humans.

There were over 95,000 public comments that were submitted to the FDA regarding the VRBPAC meeting of 22 May 2025, indicating a “major public outcry” against the “recommending” of more COVID-19 “vaccines.” Nonetheless, the VRBPAC members voted to endorse the “2025-2026 COVID-19 Vaccine” formulas, as described above, using the “Option 4” method. Please see: https://www.thefocalpoints.com/p/fda-recommends-more-mrna-shots-despite, “FDA Recommends More mRNA Booster Shots Despite New Study Showing Booster Failure — and Major Public Outcry”, Nicolas Hulscher, MPH, 26 May 2025. Please see the screenshot from this article, below:

The phrase, “immunogenicity data” refers to the “Petri-dish lab experiments” as described above.

The image below is from the “opinion piece” written and published by Dr. Martin Makary and Dr. Vinay Prasad, MD, MPH. Dr. Prasad is another important person in the current situation regarding the HHS / FDA / CDC. As of 6 May 2025, Dr. Prasad is the new Director of the FDA’s CBER department (Center for Biologics Evaluation and Research.) The “opinion piece” was published on 20 May 2025, two days prior to the FDA’s VRBPAC meeting. Please see: https://www.nejm.org/doi/full/10.1056/NEJMsb2506929. A screenshot of the combined Figure 2 and Figure 3 from the “opinion piece” are below:

Dr. Prasad made it clear, in a podcast, that the FDA will implement the elements outlined in the “opinion piece” as the “new framework” for COVID-19 “vaccination.” Please keep this in mind for later on in today’s offering.

The paper regarding the failure of COVID-19 “booster shots”, already online-published but will appear in a medical journal in June 2025, is found here: https://doi.org/10.1016/j.vaccine.2025.127257, “Effect of the 2022 COVID-19 booster vaccination campaign in people aged 50 years in England: Regression discontinuity analysis in OpenSAFELY-TPP”, Andrea L. Schaffer, et al., journal Vaccine, Volume 59, 20 June 2025, 127257. The salient image from this paper is below:

Regarding the impact of COVID-19 “vaccination” on the lifetime supply of eggs in a female’s ovaries, it is now known that BOTH the modRNA AND the “inactivated” COVID-19 “vaccines” have a devastating impact on this egg supply. Please see: https://doi.org/10.3390/vaccines/13040345, “Impact of mRNA and Inactivated COVID-19 Vaccines on Ovarian Reserve”, Enes Karaman, et al., 30 January 2025. This paper demonstrates that there is a 30% conception failure rate, and an overall loss of up to 60% of the lifetime egg supply in the female ovaries, both induced by COVID-19 “vaccination” in a female of child-bearing age.

Then, there is Dr. Jay Bhattacharya, MD, PhD, the new Director of the NIH (National Institutes of Health.) It appears that Dr. Bhattacharya may be “betting on both sides of the game” regarding COVID-19 and the COVID-19 “vaccines.” While it is true that Dr. Bhattacharya has stated that lockdowns, “mandated masking”, “social distancing”, and so on, are not real methods to deal with the virus, he also said this, in 2021, regarding the COVID-19 “vaccines”:

Link to the above: https://www.newsweek.com/stanford-doc-jay-bhattacharya-calls-vaccine-mandates-unethical-says-patients-can-choose-1611938. The above statement from Dr. Bhattacharya raises some questions: One, if COVID-19 is “basically a cold”, how can a “vaccine” protect against it? Two, if COVID-19 is “basically a cold”, why are there so many persons who have had a COVID-19 infection (either from the mechanisms of the COVID-19 “vaccines” themselves, or from the virus itself) and have since presented with symptoms of “Long COVID”? Three, if indeed a person who had a COVID-19 infection and recovered, is “protected against new disease”, why are people (COVID-19 “vaccinated” or not) still coming down with COVID-19 virus mutation infections?

Next is Susan Monarez PhD, the current Acting Director of the CDC. Previously, she had worked in the Department of Homeland Security with BARDA and with other HHS departments. Dr. Monarez is a “biosecurity expert” who has also endorsed the COVID-19 “vaccines.” Please see: https://www.nytimes.com/2025/03/24/health/cdc-director-monarez.html, “Trump Nominates Susan Monarez to Lead C.D.C.”, 24 March 2025. The pullquote from the article: “Monarez is a biosecurity expert who endorsed the Covid vaccines, and her selection may signal a growing impatience with anti-vaccine sentiment.”

And, finally, there is current HHS Secretary Robert F. Kennedy, Jr., an attorney who founded the Children’s Health Defense organization (https://childrenshealthdefense.org/), and who has been an outspoken opponent of the COVID-19 “vaccines.”

And here begins Yours Truly’s presentation of the Kabuki theater going on at HHS / FDA / CDC:

On Tuesday 27 May 2025, HHS Secretary Kennedy, Jr., appeared in a video with Dr. Markary and Dr. Bhattacharya to announce that the COVID-19 “vaccines” that are “recommended” (in actual practice, they are called “routine”) by the CDC for healthy children under age 18, and for healthy pregnant women, would be removed from the CDC Immunization Schedules. Please see: https://x.com/bennyjohnson/status/1927374665745342535, a screenshot of which is below:

Where was Dr. Monarez, the Acting Director of the CDC? Why wasn’t she included in the video? An “announcement” of this importance would surely have required her to be included. To the best of Yours Truly’s knowledge and belief, neither Dr. Makary (FDA), nor Dr. Bhattacharya (FDA CBER), have the direct authority to remove vaccines from the CDC Immunization Schedules. The CDC is a separate departmental entity of HHS.

However: In reality, nothing has changed regarding the CDC Immunization Schedules. The CDC is still using the same 2025 Immunization Schedules that were issued on 21 November 2024. Please see: https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html. The CDC is still “recommending” that pregnant women get COVID-19 “vaccinated”. Please see: https://www.cdc.gov/vaccines-pregnancy/about/index.html. This “recommendation” was issued by the CDC on 17 June 2024.

The “elaborate costumes and dance of Kabuki theater” approach were on display during this video with Secretary Kennedy, Jr., Dr. Makary, and Dr. Bhattacharya. But it was a “performance.” And the audience suspended reality for the “performance.”

Yours Truly now turns to the blog article by Sasha Latypova, a former medical technology and pharmaceutical technology professional, about this “Kabuki theater performance” of 27 May: https://sashalatypova.substack.com/p/eugenics-for-dummies-aka-hhss-evidence, “Eugenics for Dummies, aka HHS’s “Evidence-Based Approach” to covid shots.”, 29 May 2025. Please see the screenshots from her article, below:

It appears that, in reality, what has happened is that the current CDC Immunization Schedules have been neatly “absorbed into” the “new evidence-based approach to the COVID-19 vaccines” so-called “opinion piece” of Dr. Makary and Dr. Prasad (see the links to their “opinion piece”, above; and, also, the statement by Dr. Prasad that this “new approach” will be implemented at the FDA / CDC (so, it seems, they aren’t “opinions” at all.)

Further confirmation of the “Kabuki theater” element regarding the 27 May “announcement” by Secretary Kennedy, Jr., Dr. Makary, and Dr. Bhattacharya, comes from The Kingston Report: https://karenkingston.substack.com/cp/164733998, “Who’s Calling the Shots at HHS?”, 29 May 2025.

WHO IS IN CHARGE OF HHS? If Secretary Kennedy, Jr., can take the time to write letters to ask that ostriches in Canada are not “culled” due to a “possible” infection from Avian Influenza; if he can issue a directive to have titanium dioxide removed from candy (Skittles) — why did he participate in a “Kabuki theater performance” on 27 May regarding something incredibly important to the health of every American — the dangerous, deadly COVID-19 “vaccines”? Did he, or anyone else, at HHS, inform Dr. Monarez about the “change” in the CDC Immunization Schedules? If so, did she agree?

In Yours Truly’s opinion, there appears to be some sort of “issues” going on at HHS, the FDA, and the CDC. HHS Secretary Kennedy, Jr., needs to get to the bottom of all of them.

FLASH! AS OF TODAY, 30 MAY 2025: THE CDC HAS JUST ISSUED THE “NEW CHILDHOOD VACCINE IMMUNIZATION SCHEDULE” RELATED TO THE COVID-19 “VACCINES”:

It appears that Dr. Susan Monarez, PhD, has finally weighed in regarding the 27 May “announcement” (aka “Kabuki theater performance”) by HHS Secretary Kennedy, Jr., Dr. Makary, and Dr. Bhattacharya COVID-19 “vaccines” and the CDC Childhood Immunization Schedule. Please see Sasha Latypova’s presentation here: https://sashalatypova.substack.com/p/cdc-issued-the-anticipated-updates, “CDC issued the anticipated updates to the children’s schedule for covid shots”, 30 May 2025.

HOWEVER, there’s some “catches” in the “updates.” Huge “catches.” These have to do with the CDC “definition” of what a “healthy child” means. In short summary: It will be the CDC who decides if a child meets their “criteria” for being a “healthy child” (meaning, the COVID-19 “vaccines” aren’t “necessary” or “recommended”); it will be the CDC’s “guidance” on this that will be in control of any discussion between a child’s parent(s)/guardians, and the clinician who can administer COVID-19 “vaccines”; there are no provisions that Yours Truly can see in the CDC “guidance” for exemptions on religious or other grounds; and, that ANY clinician who is cleared to administer COVID-19 “vaccines” will ultimately make the decision on whether or not to COVID-19 “vaccinate” a child who does not fit the CDC “criteria” for a “healthy child.” This includes clinicians who have never treated the child (in other words, a CVS pharmacist, for example.) Please see the screenshots below, from the Latypova article of today:

Peace, Good Energy, Respect: PAVACA

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 4.25.2026: The AMA is Still Pushing “Strategies” for Physicians to “Combat Vaccine Hesitancy”

The free vintage image above of children being vaccinated is courtesy of iStock and Getty Images, via Google Images.

Health Friday is a series devoted to information regarding Big Pharma, vaccines, general health, and associated topics. As today’s post speaks to the disaster of the COVID-19 “vaccines” (Bioweapon Toxin Injections), 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 lab-created 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 any AI-generated content. To the best of her knowledge and belief, there is none. If readers wish to post anything in the discussion thread for today’s post that is AI-generated, they must cite their source. Thank you.

Yours Truly has written about the American Medical Association (the AMA) on previous occasions. The AMA is one of the most powerful professional organizations for physicians in the United States. The organization, which does not provide a list of its members to the general public, is also one of the most powerful lobbying agents in Congress. In addition, the AMA owns the rights to use the CPT codes, which are the codes for medical procedures, examinations, tests, for ordering medical equipment, and much more. The CPT codes are used to bill CMS (Medicare / Medicaid), and to bill private insurers. Please see below for screenshots from, first, https://www.opensecrets.org/orgs/american-medical-association-summary; and, second, https://www.influencewatch.org/non-profit/american-medical-association/, regarding AMA spending on lobbying:

And, not surprisingly, the CPT code royalties paid to the AMA for use of these codes appear to generate the bulk of income for the organization — no wonder the AMA can spend over $21 million on lobbying efforts. Please see: https://paddockpost.com/2024/12/16/how-revenue-is-spent-at-the-ama-2022/.

The AMA has multiple “sub-units” within the organization. These “sub-units” range from DEI (Diversity, Equity, and Inclusion), to “health equity”, and to LGBTQ++ “health inclusion”, among others. The organization offers numerous CME (Continuing Medical Education) online courses and webinars for AMA members, to assist them in accumulating the yearly CME credits they must earn in order to maintain their License to Practice Medicine. It also publishes numerous medical papers, articles, and other media; among them, JAMA (the Journal of the American Medical Association.) Please see: https://www.theqtree.com/2024/04/24/the-ama-edhub-window-to-establishment-medicine/.

An example of an AMA-published article regarding “physician strategies to combat vaccine hesitancy among patients” is here: https://www.ama-assn.org/delivering-care/public-health/covid-19-vaccine-hesitancy-10-tips-talking-patients#, “COVID-19 vaccine hesitancy: 10 tips for talking with patients”, by Tanya Albert Henry, 15 December 2023. Here are the “10 tips”: “Know you are the most trusted information source”; “Tell patients they need to get the vaccine”; Understand your patients’ concerns”; “Ask why a patient is hesitant”; Counter any misinformation”; “Tailor your message”; “Address patients’ fear about side effects”; “Prepare our staff to answer questions”; “Show your vaccination pride”; “Tell stories to make impact”.

But, what are physicians supposed to say to the patient in order to “convince” them to take a COVID-19 “vaccine”? Again, the AMA has answers: for example, the “templates” in this published study: https://www.sciencedirect.com/science/article/pii/S0264410X24004377, “Patient concerns and physician strategies for addressing COVID-19 vaccine hesitancy”, Joy Melnikow, et al., 22 May 2024. Below are three screenshots from this paper: section 2.1 Study sample; followed by Table 2, then Table 3:

All of above is to get a patient to agree to having a COVID-19 Bioweapon Toxin Injection (aka a COVID-19 “vaccine”) injected into their body. In Yours Truly’ opinion, if a physician follows the above “templates”, they are functioning not as physicians who swore to “Do No Harm”; in fact, they may be considered as “government representatives” under the current “extension” of the PREP Act for COVID-19 Countermeasures” that was signed by then-HHS Secretary Xavier Becerra in December 2024. Notice also the use of various aspects of direct psychological manipulation and of gaslighting in the “templates” for the physicians to follow. One wonders: What would these physicians say in response to a “vaccine-hesitant” patient who gives them a hard copy of a published study that clearly shows what the COVID-19 “vaccines” actually do to damage a “vaccinated” person’s body?

And now, to the most recent AMA “strategies for physicians to use on patients with vaccine hesitancy” effort, from the AMA EdHub series: https://doi.org/10.1001/jama.2025.4882, “Strategies for Communicating with Parents About Vaccines”, Sean T. O’Leary, MD, MPH, 9 April 2025. This article is full-access for AMA members; through an institution; or, via renting it through DeepDyve. Yours Truly went to DeepDyve and was able to get the following screenshot from the first page of Dr. O’Leary’s article, below:

Note the “strategies” that are to be used by the physician, listed in the Table above. Again, it appears to be yet another mixture of “your physician is the most trusted source of information”; plus, “It’s the responsible thing to do for your child”; plus, something new, “Prebunking“, which appears to be a type of psychological manipulation of / gaslighting of, the parent regarding any information they may find online from other physicians (say, Dr. Peter A. McCullough) regarding the dangers of taking the COVID-19 “vaccines”; or, other researchers (say, Steve Kirsch, about how childhood vaccination can induce autism [via the aluminum in the vaccines], and who cites medical statistics to support his contention.) Please see: https://kirschsubstack.com/p/two-pieces-of-evidence-that-together, “Two pieces of evidence that together show that vaccines cause autism”, 21 April 2025. Please also see: https://jessicar.substack.com/p/aluminum-exposure-and-autism-prevalence, 19 April 2025. Dr. Rose cites the following image, from data collected by the CDC:

The following article describes various adjuvants to vaccines, including Aluminum: https://www.chop.edu/vaccine-education-center/vaccine-safety/vaccine-ingredients/aluminum, Children’s Hospital of Philadelphia, 15 December 2022, reviewed by Dr. Paul A. Offit, MD.

Why is the AMA still pushing psychological manipulation / gaslighting “strategies” for physicians to use to “convince” patients to take a COVID-19 “vaccine”, or to allow their child (children) to be COVID-19 “vaccinated”, or to allow their child (children) to be “vaccinated” with injectables that contain substances such as Aluminum? Why does the CDC have dozens of “vaccines” listed on the agency’s Child and Adolescent Immunization Schedule (https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf)? With “vaccines” that are to be administered to newborns immediately after birth? Why do almost all public school systems “require” certain “vaccines” to be given to a child in order to attend public school? Why do state legislatures give the force of law to the CDC Child and Adolescent Immunization Schedule through legislative fiat for public school attendance — given that the CDC states on the schedule that the injectables are “Recommended”, not “Required”? Why do the AMA, the CDC, and the FDA refuse to acknowledge that the COVID-19 “vaccines” are dangerous and deadly, given the mountain of evidence currently in print which proves this to be the case?

THERE. MUST. BE. JUSTICE.

Peace, Good Energy, Respect: PAVACA

Health Friday 4.4.2025 Open Thread: the COVID-19 “Vaccines” Decimate the IgG Immune System Cells

The above free image of an 1867 vaccination certificate is courtesy of iStock and Google Images.

Health Friday is a series devoted to information regarding Big Pharma, vaccines, general health, and associated topics. As today’s post speaks to the disaster of 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 lab-created bioweapon toxin injections.

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 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 the discussion thread for today’s post, they must cite their source. Thank you.

Today’s Health Friday offering is one of a “mini-series” devoted to one topic and to one important news item related to that topic (although there may be other items related to the topic presented as supporting and/or clarifying information. The topic for today is what the COVID-19 “vaccines” do to damage and/or destroy the crucial IgG3 immune system cells in the “vaccinated” person’s body.

Yours Truly begins here, with the news item, and the paper cited in the article: https://www.theburningplatform.com/2025/03/27/immune-changes-from-repeated-mrna-jabs-are-linked-to-a-higher-risk-of-covid/, by Alex Berenson. Below is a screenshot from the article:

This 80% higher risk was found in persons who had had multiple injections of COVID-19 “vaccines.”

The COVID-19 “vaccines”, especially via repeated injections, damage and destroy the crucial IgG3 (“fight it off”) immune system cells in the “vaccinated” person’s body; while, at the same time, fostering the increase of the IgG4 (the “tolerate but never clear”) immune system cells. Another screenshot from the Berenson article is below:

Among the many other online media outlets that have reported on the Monocunill, et al., paper are these: https://www.thefocalpoints.com/p/breaking-study-covid-19-mrna-injections, “BREAKING Study — COVID-19 mRNA Injections Dangerously Reprogram the Immune System, Increasing Infection Risk”, by Nicolas Hulscher, MPH, 27 March 2025; and, https://justthenews.com/politics-policy/coronavirus/spanish-fluke-repeat-covid-jabs-provoke-two-kinds-inferior-antibodies. “Repeat COVID vaccines provoke two kinds of inferior antibodies, study finds”, by Greg Piper, 30 March 2025.

The paper referred to in the Berenson article is here: https://doi.org/10.1016/j.jinf.2025.106473, “Post-Vaccination IgG4 and IgG2 class switch associates with increased risk of SARS-CoV-2 infections”, Gemma Monocunill, et al., 18 March 2025. Below is a screenshot from this paper:

An important paper regarding descriptions and functions of the IgG immune system cell class in the human body is here: https://journals.aai.org/jimmunol/aticle/205/12/3400/107683/IgG-Subclasses-Shape-Cytokine-Responses-by-Human, “IgG Subclasses Shape Cytokine Responses by Human Myeloid Immune Cells through Differential Metabolic Reprogramming”, Willianne Hoepel, et al., 15 December 2020. A screenshot of the Abstract of this paper is below:

Note that this paper was published after the modRNA COVID-19 “vaccines” by Pfizer-BioNTech and by Moderna were granted their initial EUAs in the United States by the FDA (this occurred on 11 December 2020), but before these bioweapon toxin injections entered widespread use.

Yours Truly has written about the IgG immune system cells subclasses, and what the modRNA COVID-19 “vaccines” do to damage the IgG3 cells, here: https://www.theqtree.com/2024/12/06/health-friday-open-thread-12-6-2024-the-immune-system-after-covid-19-vaccination-and-a-note-on-the-virus-itself/.

Back to the Monocunill, et al., paper. There is mention in the paper regarding the involvement of the T17 cells in the “vaccinated” person’s body in the IgG subclass switching. Yours Truly wrote about the importance of the T17 cells (also called Th17 cells or T17 Helper Cells), and the role of the N1-Methylpseudouridine in the modRNA COVID-19 “vaccines” in “turning off” these cells in the “vaccinated” person’s body (thus paving the way for continuous inflammation of many types) here: https://www.theqtree.com/2025/03/21/health-friday-3-21-2025-open-thread-more-on-the-n1-methylpseudouridine-in-the-modrna-covid-19-vaccines/.

However, there is another aspect of the situation discussed in the Monocunill, et al., paper that is of huge importance: The similarities between malaria, COVID-19 infection, and the class switch to IgG4 that the COVID-19 “vaccines” induce. Below is a screenshot from the Discussion section of the paper regarding this:

Yours Truly will now blow something out of the water regarding the FDA’s and the CDC’s official opposition to, and prohibition of, using Ivermectin or Hydroxychloroquine to prevent or to treat COVID-19 infection.

Malaria and COVID-19 infect the lungs in similar ways. Ivermectin can be used to treat malaria. Please see: https://www.isglobal.com/en/-/nueva-evidencia-respalda-el-uso-de-ivermectina-como-una-herramiente-en-la-eliminacion-de-la-malaria, “New Evidence Supports the Use of Ivermectin as a Tool for Malaria Elimination” (article in English translation regarding malaria treatment in Africa), 28 March 2018.

And, Hydroxycholoquine (and also Chloroquine) can be used to treat malaria AND COVID-19. Please see this paper from September 2020: https://pmc.ncbi.nlm.nih.gov/articles/PMC7476892/, “Chloroquine and hydroxychloroquine in the treatment of malaria and repurposing in treating COVID-19”, Zi-Ning Lei, et al. (USA and CCP), 8 September 2020.

In Yours Truly’s opinion, it is inconceivable that the NIH / NIAID / FDA / CDC did not know about the existence of these papers. Instead, by September 2020, these entities were hell-bent in pushing through the unproven modRNA “technology” for the Pfizer-BioNTech and the Moderna modRNA COVID-19 “vaccines” then in development. This meant that the FDA / CDC accepted the manipulated / incorrect “data” that were given to them from the truncated “clinical trials” for these “vaccines” by Pfizer-BioNTech and by Moderna. This meant that the FDA / CDC did not question the sudden “vaccine”-manufacturing switch from the original “Process 1” method to the “Process 2 method” that occurred in August 2020, that is still in use by both companies in the production of their respective “new formula” COVID-19 “vaccine booster shots”, and is based on “culturing” the modRNA of the said “vaccines” in a “bath” of E. coli.

Further confirmation that malaria and COVID-19 infect the lungs in similar ways is here: https://pmc.ncbi.nlm.nih.gov/articles/PMC9445119/, “The striking mimics between COVID-19 and malaria: A review”, Emadeldin Hassan E Konozy, et al. A screenshot from this paper is below:

Note the mention of the ACE2 receptors as regards malaria infection. These cells are also attacked by the COVID-19 virus itself (and, therefore, since they are based on the virus, so do the COVID-19 “vaccines” attack the ACE2 receptors of the “vaccinated” person’s body.)

In short: the FDA / CDC pushed, and continue to push, COVID-19 “vaccines” to “prevent” COVID-19 infections, while knowing that Ivermectin and Hydroxychloroquine also prevent — and treat — COVID-19 infections. Why is this still going on? How about ASKING BILL GATES. UNDER OATH.

This is aside from the fact that those who lab-created the bioweapon of the COVID-19 virus itself, and those who lab-created-and-enhanced the bioweapons of the COVID-19 “vaccines” — knew that malaria and COVID-19 would attack the lungs in similar ways. They knew what would “turn off” the T17 cells that are so important for the immune system and for Uridine in the human body. They knew what would damage or destroy the crucial IgG3 cells of the natural immune system of the human body, while fostering the increase of the IgG4 cells that allow illness and medical conditions to take hold and thrive. These things they incorporated into the creation of the COVID-19 virus itself, and into the creation of the COVID-19 “vaccines.”

THERE. MUST. BE. JUSTICE.

Peace, Good Energy, Respect: PAVACA

The 2024-2025 Formula COVID-19 “Vaccines”: Injection Dose #10

The above is a vintage image of mass vaccination. (Courtesy Google Images.)

This series on the disaster of the COVID-19 virus itself, and of the COVID-19 “vaccines”, is dedicated to the memory of Yours Truly’s cousin Bill, who “died suddenly and unexpectedly” in September 2023.

The origination of today’s post begins here: www.dossier.today/p/double-digits-biden-admin-tells-americans, “Double Digits: Biden Admin tells Americans that it’s soon time for their 10th Covid shot“, by Jordan Schachtel, 13 June 2024. (Mr. Schachtel wrote about the ninth COVID-19 “vaccine” injection here: www.dossier.today/p/dose-number-nine-cdc-panel-green, “Dose number NINE: CDC panel green lights yet another Covid mRNA shot“, 29 February 2024. The CDC recommended that persons over age 65 take another “booster shot” of either the Pfizer-BioNTech or of the Moderna “2023-2024 Formula COVID-19 Vaccine” of these manufacturers.) A person age 65 or older, if that person adhered to every CDC recommendation regarding taking a COVID-19 “vaccine” injection since December 2020 (when the FDA granted first Emergency Use Authorization (EUA) to Pfizer-BioNTech and to Moderna for these companies’ “flagship” modRNA COVID-19 “vaccines” (BNT162b2 by Pfizer-BioNTech; and, mRNA-1273 by Moderna), would have taken injection number nine starting on 28 February 2024.

Today’s post is long. There is a large amount of information to “unpack.” Stay with me here.

Below is an image from the FDA’s 13 June “updated” authorization announcement for the “2024-2025 Formula COVID-19 Vaccine”, the TENTH injection dose of the modRNA “vaccine” formula: www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024.

Note the language regarding the “selection of a specific JN.1 lineage SARS-CoV-2 strain…” More about that later.

The trail behind the 5 June 2024 FDA announcement begins with the VRBPAC Briefing Document for the meeting held on 28 June 2022: www.fda.gov/media/159452/download, “FDA Briefing Document Vaccines and Related Biological Products Advisory Committee Meeting June 28, 2022.” It was at this meeting that the FDA “codified” the types of “strain composition recommendations” that the agency would use regarding “new versions” of COVID-19 “vaccines.” Yours Truly presents page 17, page 18, and page 19 of this document:

It appears that the FDA simply decided that it would be permissible for the agency to authorize a new COVID-19 “vaccine” strain composition along what, in Yours Truly’s opinion, may be called “very flexible” options. For example, the Pfizer-BioNTech XBB.1.5 COVID-19 “vaccine”, which was FDA authorized in the fall of 2023, had test results only from mouse testing prior to FDA authorization. Following are: The link to the Pfizer-BioNTech slide presentation about this “vaccine” to the CDC’s ACIP committee (Advisory Committee on Immunization Practices) meeting of 12 September 2023; and, an image of slide CC4 from this presentation. First, the presentation: www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/10-COVID-Modjarrad-508.pdf.

Second, slide CC-4 from the above presentation:

The XBB.1.5. Pfizer-BioNTech COVID-19 “vaccine” had only been given as a single injection to humans in the company’s clinical trial; a clinical trial which had only just begun prior to the ACIP meeting. Slide CC-5 of the presentation, the start of the company’s human trial of this “vaccine”, is below:

Slide CC-6 of the presentation has to do with the mouse studies of this “vaccine”, which were of longer duration.

Notwithstanding the above, the FDA authorized the use of the company’s XBB.1.5 COVID-19 “vaccine” on 11 September 2023 (in Yours Truly’s opinion, it appears that the ACIP meeting of 12 September 2023 was a “catch-up” formality.) It also appears (again, in Yours Truly’s opinion), that the FDA used a very loose interpretation of “Option 4” on page 18 of the FDA Briefing Document above in granting the EUA for this “vaccine”.

** Now, on to the latest “new version” of the COVID-19 “vaccines”, the “2024-2025 Formula COVID-19 Vaccines”, that the FDA authorized in June 2024.

The following linked items are important regarding background information related to this situation and to the FDA: First, the FDA document, stating that the agency would “align” its COVID-19 “vaccine” antigen composition to the recommendations of the World Health Organization’s TAG-CO-VAC recommendations: www.fda.gov/media/179139/download (the TAG-CO-VAC recommendation for the “2024-2025 Formula COVID-19 Vaccines” was to use the JN.1 strain); second, the FDA document regarding “considerations and recommendations” for the “2024-2025 Formula COVID-19 Vaccine” composition: www.fda.gov/media/179145/download; third, the FDA announcement of the 5 June meeting of its VRBPAC committee (Vaccines and Related Biological Products Advisory Committee.): www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-5-2024-meeting-announcement. From this last link, chick on “Event Materials” to see the slide presentations and other items that were discussed at this meeting.

Two important items from the “Event Materials” list: the FDA Briefing Document; and the VRBPAC roster for this meeting. First, the FDA Briefing Document: www.fda.gov/media/179003/download; and, second, the VRBPAC roster for this meeting: www.fda.gov/media/179225/download. The roster for the 5 June 2024 meeting has some “familiar” members and speakers: Paul Offit, MD; and Peter Marks, MD (director of CBER [Center for Biologics Evaluation the Research of the FDA]); and, among the “Temporary Voting Members”, are: Bruce Gellin, M.D., M. PH., the Chief of Global Public Health Strategy for the Rockefeller Foundation; and, Melinda Wharton, M.D., M. PH., Associate Director of Vaccine Policy of the CDC. (Italics mine)

The VRBPAC members voted unanimously to endorse the Pfizer-BioNTech, the Moderna, and the Novavax “2024-2025 Formula COVID-19 Vaccine” by these companies, based on the presentations of these companies’ representatives at the meeting. Yours Truly can find no registered human clinical trials performed in advance of the 5 June VRBPAC meeting by Pfizer-BioNTech, or by Moderna, or by Novavax, for any “2024-2025 Formula COVID-19 Vaccine”; that would indicate that any “clinical trials” were performed in these companies’ facilities on mice; and that any “human trials” were also performed in these companies’ facilities, prior to the meeting. The FDA then issued the agency’s original announcement of 7 June 2024: www.fda.gov/news-events/press-announcements/fda-roundup-june-7-2024; and, a screenshot from this announcement:

Note in particular “…the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1. or KP.2) and expressed a strong preference for JN.1.” Here’s where it starts to “get interesting.”

First, on 12 April 2024 (well ahead of the 5 June VRBPAC meeting), Pfizer-BioNTech issues a statement regarding the company’s “taking reservations” for the coming “2024-2025 Formula COVID-19 Vaccine” (also, see the Pfizer-BioNTech presentation at the 5 June meeting, linked above): www.cvdvaccine-us.com/reservation. This is followed, after the meeting, by Moderna filing an application with the FDA for a “vaccine” to target the JN.1. COVID-19 strain (also, see the Moderna presentation at the 5 June meeting, linked above): https://investors.modernatx.com/news/news-details/2024/Moderna-Files-FDA-Application-for-the-JN.1-Targeting-COVID-19-Vaccine/default.aspx; then, Novavax files with the FDA for that company’s version (also, see the Novavax presentation at the 5 June meeting, linked above): https://ir.novavax.com/press-releases/2024-06-14-Novavax-Submits-Application-to-U-S-FDA-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine.

But then, “something happens”, and the FDA suddenly makes a large “about-face” and switches its “2024-2025 Formula COVID-19 Vaccine” choice to the KP.2 strain on 13 June 2024: www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024. This is the “second” announcement, which was cited at the beginning of today’s post.

What was it that happened? Part of the answer lies in the fact that the NIH and Moderna co-own the patents (and, therefore, share the royalties) for the Moderna “flagship” modRNA COVID-19 “vaccine”, mRNA-1273. This agreement would extend to “descendant clone COVID-19 vaccines” by Moderna. www.citizen.org/article/modernas-mrna-1273-vaccine-patent-landscape/. The NIH’s Dale and Betty Bumpers Vaccine Research Center (part of NIAID — which Dr. Anthony Fauci led from November 1984 until his retirement in December 2022) and Moderna co-developed mRNA-1273. https://covid19.nih.gov/news-and-stories/nih-vaccine-research-center; a screenshot from the article is below:

The other part of the answer is that Moderna was already developing a KP.2 strain COVID-19 “vaccine” for 2024-2025. This, and the FDA’s decision to shift away from the JN.1 strain to the KP.2 strain, are described in this post at Sasha Latypova’s blog: https://sashalatypova.substack.com/p/all-roads-lead-to-resilience, “All Roads lead to Resilience. FDA is removing competitors for the Pentagon & CIA’s baby…Moderna”, 23 June 2024.

The FDA’s “about-face” announcement regarding the switch from the JN.1 strain to the KP.2 strain was also covered here: www.contagionlive.com/view/fda-advises-manufacturers-to-consider-kp-2-strain-for-covid-19-vaccines, 14 June 2024, by Sophia Abene. Below is a screenshot from this article:

However, there’s yet another detail in play here, regarding the FDA’s switch, “based on evaluation of the most recent circulating strains of COVID-19”, from JN.1 to KP.2 — the CIA and the Pentagon. Here is a screenshot from Sasha Latypova’s Substack article:

Here is the report, linked from the Latypova blog article cited above, that describes the CIA-linked company, “National Resilience”, or “Resilience”, that manufactures the RNA for the Moderna modRNA line of COVID-19 Omicron “vaccines”: https://unlimitedhangout.com/2022/08/investigative-reports/rna-for-modernas-omicron-booster-manufactured-by-cia-linked-company/, by Whitney Webb, 17 August 2022. Below is a screenshot image from this blog article:

And here is story on this “interesting development”, from Resilience: www.businesswire.com/news/home/20210908005443/en/Resilience-to-Manufacture-mRNA-for-Moderna’s-COVID-19-Vaccine, 8 September 2021. Note that per this “multi-year contract”, Resilience manufactures the mRNA for the Moderna COVID-19 “vaccines” at this Canadian facility. Resilience was founded in 2020.

But wait, there’s more! Resilience lists multiple “partners”, such as the Mayo Clinic. The company also, apparently, has a “partnership” with the United States Army’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense https://resilience.com/learn/partnerships. Below is a screenshot from this website:

The website link in the screenshot above is broken. Here is the Army’s website on this: wwwt2.army.mil/T2-Laboratories/Designated-Laboratories/Joint-Program-Executive-Office-for-Chemical-Biological-Radiological-and-Nuclear-Defense/. Note: this link may or may not work. One will need to do a search for “Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense” to see links to this department of the United States Army. One such link: https://globalbiodefense.com/directory/name/joint-program-executive-office-for-chemical-biological-defense-jpeo-cbd/.

It appears, then, in Yours Truly’s opinion, that the FDA was perhaps “reminded” of the”details” regarding the NIH-Moderna co-ownership (and royalties – sharing) agreement related to Moderna’s modRNA COVID-19 “vaccines”; and, the role of the CIA-Pentagon-National Resilience (aka Resilience) in manufacturing the mRNA used in the Moderna COVID-19 Omicron “booster vaccines” — and the KP.2. strain is indeed a “descendant strain” in the Omicron lineage (as is the JN.1 strain.) Hence, the FDA’s 2024-2025 COVID-19 “vaccine” strain “sudden switch” announcement of 13 June 2024, only one week after the agency gave the nod to the JN.1 strain.

In Yours Truly’s opinion, it is statistically, medically, and ethically impossible for a new vaccine (let alone any COVID-19 “vaccine”) to be developed; tested (on lab animals, then on human subjects); the test data thoroughly collated and analyzed for “safety and efficacy” on both lab animals and on human subjects; then, which data is presented to the CDC / FDA for consideration; then, these agencies doing their own “due diligence” research; then, and only then, being granted an EUA by the FDA; then, and only then, manufactured for use in humans — in a time span of fewer than three to five years, let alone within a time span of only a few months. It appears, again in Yours Truly’s opinion, that the CDC and the FDA are playing “fast and loose” with the health and safety of the people who choose (or will be “mandated”) to take the “2024-2025 Formula COVID-19 Vaccine.” And, also, that “other entities” are in play here to perhaps “influence” decision making by these agencies.

All of above is in addition to the fact that the COVID-19 “vaccines” (actually, gene therapy injections) have caused, are causing, and will cause, multiple health issues, serious adverse reactions, and deaths, in those who are “vaccinated.” Just two of the most recent discoveries: One, the COVID-19 “vaccines” can cause brain damage, an article by Dr. William Makis: www.globalresearch.ca/brain-damage-covid-19-mrna-vaccines/5861012, “Brain Damage Caused by COVID-19 mRNA Vaccines”, 26 June 2024. Below is a screenshot from Dr. Makis’ article:

The second most recent discovery, that the COVID-19 “vaccines” reduce life expectancy (even in “all-cause” analysis) among COVID-19 “vaccinated” persons, by Dr. Peter A. McCullough: https://petermcculloughmd.substack.com/p/breaking-publication-a-critical-analysis, “BREAKING Publication — A Critical Analysis of All-Cause Deaths during COVID-19 Vaccination in an Italian Province”, 1 July 2024. The peer-reviewed paper is here: https://doi.org/10.3390/microorganisms12071343, “A Critical Analysis of All-Cause Deaths during COVID-19 Vaccination in an Italian Province”, Marco Alessandria, et al., published 30 June 2024. Below is a screenshot from the Conclusions section of this paper:

In Yours Truly’ opinion, it is apparent at “half a glance” that the COVID-19 “vaccines” (actually, gene therapy injections) must be completely withdrawn for human use until these products have been fully investigated, and then re-designed, before being re-introduced for human use; and, that there is no “co-ownership” or sharing of royalties between a government agency and a COVID-19 “vaccine” manufacturer; and, that there is no involvement of the United States military in the development or manufacture of such products.

Peace, Good Energy, Respect: PAVACA

Dear KMAG: 20240122 Joe Biden Didn’t Win ❀ Open Topic

Joe Biden didn’t win. This is our Real President:

AND our beautiful REALFLOTUS.

This Stormwatch Monday Open Thread remains open – VERY OPEN – a place for everybody to post whatever they feel they would like to tell the White Hats, and the rest of the MAGA/KAG/KMAG world (with KMAG being a bit of both).

And yes, it’s Monday…again.

But we WILL get through it!

We will always remember Wheatie,

Pray for Trump,

Yet have fun,

and HOLD ON when things get crazy!

We will follow the RULES of civility that Wheatie left for us:

Wheatie’s Rules:

No food fights.
No running with scissors.
If you bring snacks, bring enough for everyone.

And while we engage in vigorous free speech, we will remember Wheatie’s advice on civility, non-violence, and site unity:

“We’re on the same side here so let’s not engage in friendly fire.”

“Let’s not give the odious Internet Censors a reason to shut down this precious haven that Wolf has created for us.”

If this site gets shut down, please remember various ways to get back in touch with the rest of the gang:

Our backup site, The Q Tree 579486807, https://theqtree579486807.wordpress.com/
Our old alternative site, The U Tree, where civility is not a requirement
Our Gab Group, which is located at https://gab.com/groups/4178
Our various sister sites, listed in the Blogroll in the sidebar

Our beloved country is under Occupation by hostile forces.

Daily outrage and epic phuckery abound.

We can give in to despair…or we can be defiant and fight back in any way that we can.

Joe Biden didn’t win.

And we will keep saying Joe Biden didn’t win until we get His Fraudulency out of our White House.

Wolfie’s Wheatie’s Word of the Week:

doppelganger

noun

A ghostly double of a living person, especially one that haunts such a person.
An evil twin.
A remarkably similar double.
Alter ego.
A person who has the same name as another.
A book by anti-Trump feminist Naomi Klein, about Trump-friendly feminist Naomi Wolf.

From Wikipedia

A doppelgänger (/ˈdɒpəlɡɛŋər, -ɡæŋər/), sometimes spelled as doppelgaenger or doppelganger, is a biologically unrelated look-alike, or a double, of a living person. In fiction and mythology, a doppelgänger is often portrayed as a ghostly paranormal phenomenon and usually seen as a harbinger of bad luck. Other traditions and stories equate a doppelgänger with an evil twin. In modern times, the term twin stranger is occasionally used.

The Book Cover

MUSIC!

How about a “fiddle chicks X bagpipe grlz” video?

It turns out there is actually a song called “Doppelganger”. It’s not bad at all, but kinda sad.

How about some fresh country? Just found this song!

OK, let’s finish with a TRUMP RALLY SONG! WOOHOO!!!

THE STUFF

The stuff, this week, is about Naomi Klein vs. Naomi Wolf.

I began by picking up the recent “Naomi vs. Naomi” book, Doppelganger.

You’re all most likely familiar with feminist Naomi Wolf, that perennial guest of Steve Bannon. She, the anti-COVID-vaccine-fighter extraordinaire, whose stellar work on the Pfizer FOIA documents caused Rochelle Walensky to flee her harpy perch at CDC for better cover.

There is another feminist who is sometimes confused with Wolf, named Naomi Klein. Klein is a cabal defender, ultimately, but she has managed a bit of some weak “insider” criticism on the left – enough to be considered an intellectual – not enough to lose her perks and privileges.

Supposedly because Klein is sometimes mistaken for Wolf, and takes wrongly directed criticism from the left for it, Klein decided to attack Wolf, and hence the book. Or at least, that is her story.

Right now, both the Kindle version and the hardback version of Klein’s book are $15, which means that the hardcover is NOT doing well in those cabal bookstores like Barnes & Lucifer.

“WHAT???!!!” – you may be saying. Why would this Wolf (“DA WOOF”) be picking up RADICAL LEFT TRASH?

The book is basically one long REEEEEEEEEE!!!!!, and it’s glorious, and that is why I bought it.

More specifically, the book is a left-wing, globalist, overly verbose, incredibly narcissistic, and eye-rollingly navel-gazing attack by stereotypical “New York culture, Canada address” feminist Naomi Klein on “MAGA-friendly liberal” feminist Naomi Wolf.

Once I realized how much of a REEEEEEEEEE!!! this book was, I began laughing in the store at every breathless outrage, and eventually realized that I needed to buy it.

The thing is, Naomi Klein is OBSESSED with Naomi Wolf, and the more one reads, the more one understands that FAKERY is chasing AUTHENTICITY – obsessed – because Fakery cannot stand to be in the same room as Authenticity, and yet it MUST be in that room, getting all the attention, so it has to ATTACK what it cannot be.

In the same way that people like Romney, Pelosi, Obama, Kasich, and all the rest are OBSESSED with Trump, and simply MUST try to destroy him – in the same way that Satan is OBSESSED with Christ, and must try to destroy Him, so Naomi Klein is obsessed with the “other Naomi” whose coattails she rode in on, and from whose coattails she exited, in the name of holding onto respect by the media, the government, and the rest of the elite.

It is my belief that Naomi Klein is the real doppelganger, and that her work is a kind of sub-critical hysterical confession. IMO, Klein always benefited from confusion with Naomi Wolf – until Naomi Wolf “walked the walk” right into the fire – in a way that Naomi Klein could not follow, nor even pretend to “talk the talk” without losing her seat at the elite table.

Wolf lost her academic position for speaking the truth. Klein still has hers. Do the math.

Klein wrote a book called The Shock Doctrine, which was a very insightful look at how neo-liberal corporate capitalism piles into crisis to make money. Klein was basically starting to see the phoniness of things like the Green New Deal. The problem was, she could never go far enough, because she’s too close to the agenda. Whether Klein can’t see, won’t see, or is just pretending not to see, it doesn’t change the outcome – she doesn’t see.

Klein can never see – nor admit that she sees – the corruption of centralized government, working hand-in-hand with phony crisis capitalism.

COVID and the vaccines provide a perfect example. Klein simply can’t leave the plantation. She stays safely on the “Bad Wolf” designated cheer circle, criticizing Wolf for departing from “the science” into “conspiracy theories”, and utterly refusing to admit that “the science” is no longer interested in saving pleb lives, when government money, taken from the plebs, is there for the taking.

Does Klein know? Is she wise to the globalist scam? Probably, IMO.

Klein also takes some interesting heat from the left.

For example, Klein is seen as a bit too friendly toward big-government-big-corporation-big-NGO-big-academia solutions, and the “gang-green” take her out for not going totally Maoist and anarchist on climate change, like those brave souls who glue themselves to roads, art exhibits, and whatnot.

Has Naomi Klein Sold Her Soul?

Then there is this great work of TLDRism from the intellectual left, seeing the same thing in a more complicated way.

Klein vs. Klein

Whatever. The bottom line is that I took one for the team, to figure out what’s up with this Klein broad. Save your money – don’t buy the book unless you want to “see the REE“!

Just sayin’!

Until victory, have faith!

And trust the big plan, too!

And as always….

ENJOY THE SHOW

W

Dear KMAG: 20240115 Joe Biden Didn’t Win ❀ Open Topic

Joe Biden didn’t win. This is our Real President: