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 7.18.2025 Open Thread: Moderna, the FDA, and the NIH/NIAID

The header image for today’s post 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 speaks to the disaster of the COVID-19 “vaccines”, Yours Truly dedicates it to all persons, of whatever age or location, who have passed away from the negative effects of the COVID-19 “vaccines” that they had injected into 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 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 one AI-generated image in The Focal Points article, cited below. If readers wish to add any AI-generated content to the discussion thread for today’s offering, they must cite their source. Thank you.

The phrase to keep in mind when reading today’s post is: Follow the money.

Today’s post begins here: https://www.thefocalpoints.com/p/fda-commits-grave-betrayal-fully, “FDA Commits Grave Betrayal: Fully Approves Deadly Genetic Injections for Infants”, by Nicolas Hulscher, MPH, 11 July 2025. There is an embedded video interview with Mr. Hulscher in this article. This article and interview regard the FDA “full approval” on 10 July 2025 of the Moderna modRNA COVID-19 “vaccine”, SPIKEVAX, to be used on infants and young children from age 6 months to 11 years old. A screenshot of a portion of the Table 2. from this article is below, showing the amounts of “loose” DNA in this “vaccine”:

The published scientific paper that is linked in the above Hulscher article is here: https://publichealthpolicyjournal.com/review-of-calls-for-market-removal-of-covid-19-vaccines-intensify-risks-far-outweigh-theoretical-benefits/, “Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits”, Nicolas Hulscher, Mary Bowden, Peter A. MCullough, 28 January 2025.

Yours Truly now turns to a crucial component of the Moderna modRNA COVID-19 “vaccine” situation: the “tied to the hip” relationship that this company has with the NIAID (National Institute of Allergy and Infectious Diseases), part of the NIH (National Institutes of Health.) Both the NIAID and the NIH are institutes of the federal government Department of Health and Human Services (HHS.) Katherine Watt, of Bailiwick News, has studied and written about the “coziness” between Big Pharma entities such as Pfizer-BioNTech and Moderna with federal government agencies, such as the FDA. Please see: https://bailiwicknews.substack.com/p/why-pfizer-and-moderna-and-fda-are, “Why Pfizer and Moderna and FDA are working toward government authorization to inject babies and small children”, 23 March 2022. Ms. Watt includes a statement made by Robert F. Kennedy, Jr. in 2021, on this situation. Please see: https://wsau.com/2021/12/31/robert-f-kennedy-jr-explains-why-fauci-is-going-after-children/, by Meg Ellefson, 31 December 2021. A screenshot from the Bailiwick News article on this is below:

There are SEC filings and “Confidential Agreements” between Moderna, the FDA. and the NIAID, regarding the funding and development of mRNA “vaccines.” There are patent co-ownership and revenue-sharing agreements between Moderna and the NIAID. There is a Moderna – NIH Confidential Agreement that goes back to 2015.

The trail begins here: https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-make-milestone-payments-nih-covid-vaccine-2023-02-24/,”Moderna to make milestone payments to NIH for COVID vaccine”, 24 February 2023. Please see the screenshot from this article, below:

By the way, milestone payments would include payments for items such as, developing the “latest version” of a COVID-19 modRNA “vaccine” — for examples: the Moderna (SPIKEVAX) “2025-2026 COVID-19 Formula Vaccine” that was just “recommended” by the ACIP committee of the CDC; and, the FDA “full approval” of SPIKEVAX being used on infants and young children age 6 months to 11 years old, which “full approval” was granted on 10 July 2025. It appears that Moderna had attempted to “modify” or “avoid” certain types of sharing agreements stipulations, royalty payments to the HHS (via the NIAID), and HHS – Moderna co-owned patents agreements; and, for which, the company was taken to court by the HHS. The decision was rendered against Moderna, with an order to make a multi-million dollar “catch-up payment” to HHS -NIAID.

Another aspect of the trail is here: https://thehill.com/opinion/congress-blog/4533574-how-the-national-institutes-of-health-became-a-den-of-cronyism/, by Sen. Rand Paul, MD (R-KY), 15 March 2024. Please see the screenshot from this article, below:

Now, to the 2015 “Confidential Agreements” between Moderna and the NIH. The document is found here: https://www.documentcloud.org/documents/6935195-NIH-Moderna-Confidential-Agreements/, November 2015. This document has numerous “amendments” and “additions” that go through the year 2018 — and, the last of which appears to “cover” all items related to COVID-19 “vaccines”. On page 16 of the document, with special attention to page 19, start the CRADA stipulations (Cooperative Research and Development Agreement stipulations between Moderna and the NIH.) The language here has numerous Proprietary Information redactions; however, it appears to be broad enough to cover the later co-ownership by Moderna and the NIH of the SPIKEVAX patents and their Expiry Dates (more on these below.)

Here are page 19 and a portion of page 20 of the NIH/NIAID and Moderna CRADA agreement, below:

Recall that the director of the NIAID in 2015 was Dr. Anthony Fauci; and, the director of the NIH in 2015 was Dr. Francis Collins.

The third part of the trail is here, the SEC filing that details the NIH – Moderna agreements to share COVID-19 “vaccine” development, patents, and royalty payments for use of said “vaccines”, is found here: https://www.sec.gov/ix?=docs/Archives/edgar/data/1682852/000168285223000011/mrna-20221231.html, filed 31 December 2022.

Page 41 of this document names the “partners” that will be included in the agreements: DARPA; BARDA; and, the Bill and Melinda Gates Foundation.

Page 43 of this document details the SPIKEVAX patents and Expiry Dates that will be co-owned by Moderna and the NIH. A screenshot of this page is below:

There is also a “vaccine mechanisms” series of sections in this agreement. A screenshot of one of these sections is below:

And, there is a section regarding the “Drug Design Studio” section of the SEC document. Please see the screenshot from this section, below:

On 7 July 2025, HHS Secretary Robert F. Kennedy, Jr., cancelled the 10 July meeting that was scheduled for the USPSTF committee of the HHS (United States Preventive Services Task Force committee.) If Sec. Kennedy, Jr., can do this, why can’t he do something to modify / rescind / cancel the NIH / NIAID – Moderna “Confidential Agreements”, the related royalty-sharing payments agreements, and the 31 December 2022 SEC filing? Is it because of the “SPIKEVAX Patents and Expiry Dates” agreement, the screenshot of which from the SEC filing is above, and which runs, in total, until 22 October 2041? Are his hands tied? “Inquiring minds want to know.”

FLASH ADDENDUM: Our good Gail Combs asked to have the following added to today’s offering, regarding the development of a new BLACK PLAGUE strain variation that was just done by scientist in Israel. Yours Truly is also adding another item related to other work developing BLACK PLAGUE strain variations.

ISRAELI scientists have just developed an mRNA-based BLACK PLAGUE (Yersinia Pestis, or Y. Pestis) vaccine, using a lab-modified gene and adding N1-Methylpseudouridine as the lipid nanoparticle “delivery system.” Please see: https://jonfleetwood.substack.com/cp/168494356, “Israel Engineers Mutant Plague — Puts Its Genes in mRNA Shot That Makes Human Cells Produce Virulence and Immune-Evasion ‘Black Death’ Proteins: Journal ‘Advanced Science'”, 16 July 2025. This is the “BLACK PLAGUE version” of the modRNA + N1-Methylpseudouridine COVID-19 “vaccines” — except that the “payload” is a lab-created genetically altered and more virulent version of the BLACK PLAGUE.

Recall that Yours Truly has written extensively about the mechanism of the N1-Methylpseudouridine used in the Pfizer-BioNTech and in the Moderna modRNA COVID-19 “vaccines” (there’s the connection to Moderna.) This lab-created compound ingredient replaces the natural Uridine in the COVID-19 “vaccinated” person’s body, kicking the door wide open for catastrophic immune system evasion by said “vaccine”: evasion that will occur throughout the body and also the brain. The connection to both Moderna and to Pfizer-BioNTech in regards the use of N1-Methylpseudouridine is that BOTH companies specifically included this lab-created chemical compound in their modRNA COVID-19 “vaccines”, the description of which inclusion IS IN THE PATENT DOCUMENTS THAT WERE FILED BY EACH COMPANY. This begs the question: Did the Israeli scientists pay either Pfizer-BioNTech or Moderna for the “rights” to use this compound IN THEIR BLACK PLAGUE VARIATION “VACCINE” EXPERIMENTS?

The peer-reviewed paper that is referred to in the Jon Fleetwood article is here: https://doi.org/10.1002/advs.202501286, “Novel Bivalent mRNA-LNP Vaccine for Highly Effective Protection Against Pneumonic Plague”, Dan Peer, et al., 25 April 2025. A screenshot from the Fleetwood article is below:

But wait, there’s more! The Fleetwood article links to a paper published in 2024 regarding research by the United States Army Combat Capabilities Development Command Chemical Biological Center in Gunpowder, Maryland, ALSO on lab-creating a variation of the BLACK PLAGUE. This variation was “cultured” in a “bath” of Escherichia coli (E. coli, the same type of “culturing material” that is used by both Pfizer-BioNTech and by Moderna to produce their respective modRNA COVID-19 “vaccines.” The paper is here: https://doi.org/10.1099/acmi.0.000723.v3, “Towards a Yersinia Pestis lipid A recreated in an Escherichia coli scaffold genome”, Nathan D. McDonald, Erin E. Antoshak, 17 July 2024. A screenshot of the Abstract of this paper is below:

In Yours Truly’s opinion: The entire “let’s make a lab-created RNA + lipid nanoparticle vaccine” situation is out of control. The entire “let’s alter a gene or two from a deadly infectious disease and make a variation of this disease” situation is out of control.

THERE. MUST. BE. JUSTICE.

THERE. MUST. BE. TRUTH.

Peace, Good Energy, Respect: PAVACA

Health Friday Open Thread 6.20.2025: The “New FDA” — Did HHS Secretary Robert F. Kennedy, Jr., Approve All of This?

The above free image of an approval stamp is courtesy of Depositphotos and Google Images.

Health Friday is a series regarding Big Pharma, vaccines, general health, and associated topics. As today’s offering speaks to the disaster of the COVID-19 “vaccines” (in reality, dangerous and deadly 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 the COVID-19 “vaccines” that they had permitted be injected into their bodies.

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. There appears to be an AI-generated image in the Children’s Health Defense article by Dr. Brenda Baletti, PhD, that is cited below in today’s offering, just below the header title. If readers wish to add any AI-generated content to today’s discussion thread, they must cite their source. Thank you.

Note 2: Yours Truly is aware that there are other very important news stories and events that are unfolding that are not health-related. However, the following needs to be presented.

Robert F. Kennedy, Jr., an attorney, an outspoken critic of Big Pharma and other entities that, up to now, had an undue influence on government health agencies, and who is the founder of Children’s Health Defense (https://childrenshealthdefense.org/), has been confirmed as the Secretary of the Department of Health and Human Services (HHS) under the new administration of the 47th President of the United States, Donald Trump. Secretary Kennedy, Jr., has already done several things to re-focus the mission and activities of HHS in the direction of being more responsive to the public health of all Americans. Among these moves was his rescinding a previously-awarded HHS grant of $590 million dollars to Moderna to develop Avian Influenza and “pandemic vaccines.” This grant was awarded to Moderna by outgoing HHS Secretary Xavier Becerra in the final days of the previous administration of former President Joe Biden. Please see: https://www.cidrap.umn.edu/avian-influenza-bird-flu/hhs-cancels-funding-moderna-s-candidate-h5-avian-flu-and-pandemic-vaccines, by Lisa Schnirring, 29 May 2025.

On the other hand, HHS has, under Secretary Kennedy, Jr., also made some decisions that have raised eyebrows: for example, in April 2025, the Food and Drug Administration (FDA, a division of HHS) granted “Fast Track” approval for the self-amplifying modRNA H5N1 “pandemic vaccine”, ARCT-2304, to be tested in the United States. Please see: https://www.contagionlive.com/view/fda-grants-fast-track-status-to-arct-2304-for-h5n1-influenza-protection, by Sophia Abene, 10 April 2025. ARCT-2304 is expected to submit the BLA (Biologics License Application) documents and data for ARCT-2304 by early fall 2025. However, there’s something else that’s eyebrow-raising about this situation: The clinical trial for ARCT-2304, the data from which is going to be used in the BLA submission, has no true Placebo Control Group (a Placebo that uses Saline solution) — instead, the “Placebo Control Group” in the clinical trial is being injected with a “Placebo Vaccine.” How does this fit in with the “new FDA” that requires Placebo testing? Does the “new FDA” concept of “Placebo” now mean anything that is not the actual “candidate” drug or injectable when used in a clinical trial? Please see: https://sashalatypova.substack.com/p/arcturus-self-amplifying-rna-shots, “Arcturus self-amplifying RNA: US approval expected this year”, 11 June 2025. A screenshot from this article is below:

Also, the FDA granted “full approval” for Moderna’s “next-generation” COVID-19 “vaccine”, mNEXSPIKE, on 31 May 2025, despite a clinical trial in which there was no placebo Control Group. Please see: https://www.fda.gov/vaccines-blood-biologics/mnexspike, 31 May 2025. Please also see: https://www.theqtree.com/2026/06/06/health-friday-6-6-2025-open-thread-tlr4-s1-and-mrna-1283-mnexspike-a-scientific-gourmanderie/.

It is now well known that the modRNA COVID-19 “vaccines” can, and do, cause multiple types of serious adverse events reactions, medical conditions of both body and mind, and death, among the COVID-19 “vaccinated.” Thousands of these reports are found in the VAERS database, and can also been searched here: https://openvaers.com/. But the FDA still has not removed these dangerous, deadly injections from the market. However, one new drug, for certain types of Multiple Sclerosis (MS) — ELEVIDYS — was just removed by the FDA after ONLY TWO DEATHS in the “post-marketing trials” group. Please see: https://www.pharmaceutical-technology.com/news/sarepta-and-roche-halt-dmd-gene-therapy-use-after-second-death/?cf-view&cf-closed, 16 June 2025. ELEVIDYS was FDA-approved on 20 June 2024. As with the modRNA COVID-19 “vaccines”, the FDA required Sarepta / Roche to perform “post-marketing trials” of the injectable (in effect, using the persons who would take ELEVIDYS as “human lab rats” to see if the injectable really worked, and to see if there would be serious adverse events in the persons who took the injectable.) Please see the FDA-issued Package Insert for ELEVIDYS, here: https://www.fda.gov/media/184855/download. Screenshots of section Warnings and Precautions; of section 11 Description; and, of section 13 Nonclinical Toxicology are below:

And, by the way, ELEVIDYS apparently “sheds” into areas around inside the body of the person who takes this injectable. Please see section 12.3 Pharmacokinetics Vector Distribution and Vector Shedding of the ELEVIDYS Package Insert linked above.

Then, there is the recent FDA approval of the use of the meningococcal “vaccine”, MenQuadfi, in infants between two months and two years of age (although it appears that this injectable may be used in infants as young as six weeks of age.) MenQuadfi is already FDA-approved for use in persons age two years and older. Attorney Aaron Siri believes this FDA “extension of use” approval is based on the “Pyramid Scheme of Vaccine Safety.” Please see: https://www.2ndsmartestguyintheworld.com/p/all-vaccines-will-kill-you-menquadfi, “ALL VACCINES WILL KILL YOU: MenQuadfi Approval and the Pyramid Scheme of Vaccine Safety”, 15 June 2025. A screenshot of Attorney Siri’s statement from the article is below:

Which reminds Yours Truly of FDA approvals of “the latest version modRNA COVID-19 vaccine”, approvals based solely on “safety and efficacy data” from earlier “latest version modRNA COVID-19 vaccines.”

Before Yours Truly turns to yet another eyebrow-raiser FDA approval, a new article by Dr. Martin Makary, MD, MPH (FDA Commissioner) and Dr. Vinay Prasad, MD, MPH (director of the CBER division of the FDA) in the Journal of the American Medical Association: https://jamanetwork.com/journals/fullarticle/2835314, “Priorities for a New FDA”, 10 June 2025. This article is discussed by Dr. Meryl Nass, MD, on her Substack: https://merylnass.substack.com/p/another-makary-prasad-article-lists, “Another Makary-Prasad article lists the changes they are making at FDA: but again, it comes with flaws”, 10 June 2025. Screenshots from Dr. Nass’ article are below. The passages with the orange line are from the Dr. Makary – Dr. Prasad article; the rest of the language is from Dr. Nass:

This new article follows on the heels of the first one published by Dr. Makary and Dr. Prasad in the New England Journal of Medicine in May 2025: https://www.nejm.org/doi/full/10.1056/NEJMsb2506929, “An Evidence-Based Approach to COVID-19 Vaccination”, in which Dr. Makary and Dr. Prasad made it clear that the FDA would follow “new guidelines” in the approval process and implementation of “new versions” of the COVID-19 “vaccines”, including in numerous “high risk” populations. Among the populations now considered by the FDA to be at “high risk” of severe complications from COVID-19 infection (and, therefore, “in need” of being COVID-19 “vaccinated”) is that of healthy pregnant women.

Yours Truly now turns to the most recent eyebrow-raising move by the FDA: the agency’s approval of lab-grown salmon, an approval based only on the manufacturing company’s “safety claims.” Please see: https://childrenshealthdefense.org/defender/fda-approves-first-lab-grown-salmon-based-solely-manufacturers-safety-claims/, “FDA Approves First Lab-Grown Salmon Based Solely on Manufacturer’s Safety Claims”, by Brenda Baletti, PhD, 10 June 2025. The manufacturer is a company in San Francisco called Wildtype Foods. Please see the screenshot from this article, below:

The FDA Letter of Approval for the lab-grown salmon is found here: https://www.fda.gov/media/186752/download. Below are screenshots from the FDA Letter of Approval:

Mark A. Hartman is a holdover appointee from the Biden Administration. His job at the FDA began on 29 December 2024. Previous to this, Mr. Hartman worked for the EPA. Please see: https://www.lawbc.com/oppt-deputy-director-mark-hartman-will-become-will-become-director-of-fdas-office-of-food-chemical-safety-dietary-supplements-and-innovation/, 13 December 2024. From what Yours Truly can find, Mr. Hartman has no background in chemistry, in health, or in science. His Master’s degrees are in Environmental Studies and in Public Administration. To Yours Truly, this begs the following questions, among many more: Did HHS Secretary Kennedy, Jr., know about this man? Did he know in advance about the FDA’s approval of lab-grown (“cell-cultured”) salmon to be sold and used for consumption in the United States? Exactly what “testing” was performed on this “cell-cultured” salmon to make quite sure that is not carcinogenic? What exact “ingredients” are “fed” to the “cell-cultured salmon cells” in the “steel tanks” at Wild Type Foods (aka Wildtype, Inc.) during the “culturing” process? How many unsuspecting people will be eating this “cell-cultured” salmon in restaurants and other places? What exactly was the “Cell Culture Consultation CCC ooooo5” listed in the FDA’s Approval Letter about? What data were presented?

What on Earth is really going on at the “new FDA”?

THERE. MUST. BE. JUSTICE.

THERE. MUST. BE. TRUTH.

Peace, Good Energy, Respect: PAVACA

Health Friday 6.6.2025 Open Thread: TLR4, S1, and mRNA-1283 (mNEXSPIKE): A Scientific Gourmanderie

The above image of TLR Signalling Pathways is courtesy of BioFinder 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 disaster of the COVID-19 virus itself, and 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 Biological Toxin Weapons.

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 any AI-generated content in today’s discussion thread, they must cite their source. Thank you.

And now, to the reader’s Edification Smorgasbord, a “feast of information” regarding just how dangerous and potentially deadly mRNA-1283 (mNEXSPIKE) is, Yours Truly offers the following Menu:

APPETIZER: WHAT IS TLR4?

TLR4 (aka Toll-like receptor 4) is a transmembrane protein that exists across a cell membrane. TLR4 functions as a kind of “sensing device” within the body. It detects foreign bacteria and viruses. When a foreign element is detected by TLR4, it begins to send messages to the natural immune system to activate the immune response. TLR4 is crucial to the correct functioning of the natural immune system. Please see the screenshots below for more information:

Citation: https://en.wikipedia.org/wiki/Toll-like_receptor_4

Citation: https://doi.org/10.1016/j.intimp.2007.05.016, “Toll-like receptors in inflammation, infection and cancer”, Keqiang Chen, et al., October 2007. Found via: https://www.sciencedirect.com/topics/immunology-and-microbiology/tlr4.

FIRST COURSE: THE FDA APPROVES “mNEXSPIKE” IN MAY 2025:

The “newest version” COVID-19 “vaccine”, mRNA-1283 (aka mNEXSPIKE), was “fully approved” by the FDA on 30 May 2025. Yours Truly wrote about this situation here: https://www.theqtree.com/2025/06/01/stop-press-edition-hhs-secretary-robert-f-kennedy-needs-to-resign-now/. This “vaccine” claims to be “more effective” in “preventing” an infection of COVID-19. The claim is based on the fact that mRNA-1283 (aka mNEXSPIKE) uses “only” the S1 protein and the N sector of said S1 protein of the COVID-19 virus spike protein, as opposed to using the entire spike protein (as in mRNA-1273, the original “flagship” modRNA COVID-19 “vaccine” by Moderna.) Please see: https://doi.org/10.1093/infdis/jiaf022, “Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine”, Spyros Chalkias, et al., 15 April 2025 (most of the authors of this “informational paper” are either affiliated with Moderna, or are employees of Moderna.) A screenshot of the Background section of the Abstract of this paper is below:

At first glance, this “new development” by Moderna may appear to be a “positive” achievement. However, there are other issues that arise:

First, there is the fact that the S1 protein of the SARS-CoV-2 virus contains both the RCB (Receptor-Binding Domain) AND the N-terminal domain of the virus. It is the RCB that allows the virus to “attach” itself , or to “dock” itself, to cells in the body — for example, to the ACE2 cell receptors; and, to TLR4 cells. The N-terminal domain is the “end part” of the S1 protein; it is a “free” group at the end of the protein, while, at the same time, it “initiates” a polypeptide chain.

Second, there is the fact that the S1 protein of the SARS-CoV-2 virus interacts with TLR4 cells. Yours Truly begins with this: https://news-medical.net/news/20210510/Research-suggests-Pfizer-BioNTech-COVID-19-vaccine-reprograms-innate-innate-immune-responses.aspx, Sally Robertson, B.Sc., 10 May 2021. Please see the following screenshots from this article:

While the above article refers to the Pfizer-BioNTech modRNA COVID-19 “vaccine” BNT162b2, the modRNA COVID-19 “vaccine” from Moderna, mRNA-1273, also targets the RBD, which interacts with TLR4 cells in the “vaccinated” person’s body. In addition, all of the modRNA “descendant clone” COVID-19 “vaccines” by both companies also use the RBD, there interacting with TLR4 cells in the “vaccinated / boosted” person’s body.

TLR4 cells are also present in multiple areas and organs of the body. The modRNA COVID-19 “vaccines” will interact with these cells. This is due to the fact that the S1 protein of the SARS-CoV-2 virus contains certain amino acids residues (numbers 1-1208) that interact with TLR4 cells. Please see: https://doi.org/10.1016/j.heliyon.2021.306187, “SARS-CoV-2 spike protein S1 subunit induces pro-inflammatory responses via toll-like receptor 4 signaling in murine and human macrophages”, Ken Shirato, Takako Kizaki, February 2021. A screenshot of the Abstract of this paper follows:

Regarding the S1 amino acids residues 1-1208 and TLR4, please see this paper, from 2020: https://europepmc.org/article/ppr/ppr170060, ” Structural characterization of a nanobody derived from a naive library that neutralizaes SARS-CoV-2″, M Dumoux, et al., 1 June 2020. Below are screenshots from the Methods section and from a portion of the Supplementary Table section of this paper (the Supplementary Table portion shows some of the gene code for the S1 1-1208 residues):

Further information regarding SARS-CoV-2 spike protein and its interaction with TLR4 is found here: https://doi.org/10.3389/fimmu.2024.1368946, “TLR2/4 are novel activating receptors for SARS-CoV-2 spike protein on NK cells”. Nadine Landolina, et al., 30 May 2024. “NK” stands for “Natural Killer” cells in the body. A screenshot from this paper is below:

Then, there is the issue of clinical trial used by the FDA to “justify” the “full approval” of mRNA-1283 (aka mNEXSPIKE), NCT05137236 (https://clinicaltrials.gov/study/NCT05137236.) There was NO Placebo Control Group in this study. The study participants (study subjects) were injected with the following Moderna modRNA COVID-19 “vaccines”: mRNA-1273; OR, mRNA-1283; OR, mRNA-1283.211; OR, mRNA-1283.529. Why was there no Placebo Control Group? Assuming that the study subjects knew, in advance, they would be injected with any one of FOUR different variations of a modRNA COVID-19 “vaccine”, were they fine with that?

And, there is the “opinion piece” by Dr. Martin Makary (FDA Commissioner) and Dr. Vinay Prasad (new head of the FDA’s CBER division), regarding the “new approach” that the FDA will use for COVID-19 “vaccines.” Please see:

SECOND COURSE: WHAT DOES THE modRNA COVID-19 “VACCINE”, mNEXSPIKE, CONTAIN?

Please see the FDA-issued Fact Sheet for Healthcare Providers (aka the Package Insert) for mRNA-1283, mNEXSPIKE: https://www.fda.gov/media/186738/download. Below is a screenshot of section 11 Description, section 12 Clinical Pharmacology, and section 13 Nonclinical Toxicology of this document:

Which plainly states that mNEXSPIKE contains the same types of dangerous, deadly lipid nanoparticle and excipient that all the other modRNA COVID-19 “vaccines” by Moderna contain: SM-102, and PEG2000-DMG. This means that mNEXSPIKE will be rapidly spread into every cell in the “vaccinated” person’s body. It is also clear that mNEXSPIKE has NOT been tested for mutation potential, cancer-inducement potential, or reproductive impairment potential.

Yours Truly then performed a search to ascertain whether or not mNEXSPIKE contains N1-methylpseudouridine. She has written extensively on this board about this lab-created “fake Uridine plus a form of methane”, which completely replaces the natural RNA in the Uridine in the body. Recall that natural Uridine is crucial to multiple body functions and mechanisms: regulation of mood, of learning and memory, and of “gut-brain connection” functions. Lo and behold, the US Patent for mRNA-1283 (aka mNEXSPIKE) does have language describing “various types” of pseudouridine, including N1-methylpseudouridine, are used in all of Moderna’s modRNA COVID-19 “vaccines” — which would also include mNEXSPIKE. The US Patent for mRNA-1283 is found here (US 20240382581A1): https://patents.google.com/patent/US20240382581A1/en?q=(mRNA-1283)&oq=mRNA-1283, “Pan-human coronavirus vaccines”, ModernaTX, published 21 November 2024. Please see sections 0120, 0121, 0122, and 0123 of this document for descriptions of the “various types” of pseudouridine.

Lastly, there is the question as to whether mNEXSPIKE contains any saRNA (self-amplifying RNA) component. Yours Truly searched for information regarding this, since the IM dose (intramuscular injection dose) of this COVID-19 “vaccine” is a very small amount — 0.2mL. She found this, which appears to be a “dancing all around the truth” description of this “vaccine.” Please see: https://synapse.patsnap.com/article/what-is-mrna-1283-used-for?, 28 June 2024. A screenshot from this article is below:

Read the last sentence in the second paragraph above, especially “…a robust and durable immune response, potentially requiring fewer doses and offering longer-lasting immunity compares to other vaccines.” Sounds like a description of the saRNA H5N1 “vaccine”, KOSTAIVE, currently approved for use in the EU / Scandinavia, and in Japan; and, a version of which “vaccine” is to begin clinical trials in the United States (NCT06602531), under the name ARCT-2304.

DESSERT AND BEVERAGES: REACTIONS AND QUESTIONS:

First, this: https://www.thefocalpoints.com/p/maha-movement-flabbergasted-covid, “MAHA Movement Flabbergasted COVID-19 Vaccines Remain on Market”, Peter A. McCullough, MD, MPH, 2 June 2025. There is an embedded interview with Dr. McCullough in this article, along with a linked copy of the “Kabuki Theater performance” regarding “stopping” the COVID-19 “vaccines” in the United States by Dr. Martin Makary (FDA), Dr. Jay Bhattacharya (NIH DIrector), and HHS Secretary Robert F. Kennedy, Jr., on 27 May 2025. A screenshot from the McCullough article is below, giving his views on the current situation:

Second, this tweet, from Dr. William Makis: https://x.com/MakisMD/status/1930296443434348771, 4 June 2024. Two screenshots from his tweet are below: first, a statement from HHS Secretary Kennedy, Jr.; and, second, from Dr. Makis:

Questions, posed by Yours Truly: Why did the FDA “fully approve” a “new”, modRNA COVID-19 “vaccine” that specifically targets person over age 65, and persons who “fit” a detailed list of “persons at risk of severe COVID-19 infection”, as complied by Dr. Martin Makary and Dr. Vinay Prasad? Why was there a “Kabuki Theater performance” on 27 May 2025 by Drs. Makary and Bhattacharya, along with HHS Secretary Kennedy, Jr., when it was obvious by that date that the FDA “full approval” of mNEXSPIKE was “a done deal”? Why did the FDA issue an Approval Letter to Moderna for mNEXSPIKE that has so many “caveats”, “requests for more information”, and an “order” for the company to perform a Phase 4 clinical study on the “vaccine” — a “vaccine” that the FDA had just “fully approved”? Please see: https://www.fda.gov/media/186740/download; and, the screenshot of Page 9 of this document, regarding the “order” for the Phase 4 study, below:

More questions, posed by Yours Truly: How many elderly persons are going to be pressured / cajoled / “mandated” (by the nursing home or care facility where they live), to take mNEXSPIKE? Will they be told that this injectable is “safer” than mRNA-1273, “because the dose is smaller”? What about persons who “fit” into the multiple categories of “persons at high risk for severe COVID-19 infection” according to Drs. Makary and Prasad? What pressure will these persons be subjected to in order to get them to agree to take mNEXSPIKE? Finally, will people be told the truth that mNEXSPIKE, just because it does not contain the S2 portion of the SARS-CoV-2 spike protein, is NOT “mRNA-1273 Lite” — but, rather, it is another version of a dangerous, potentially deadly modRNA COVID-19 ‘”vaccine”?

Peace, Good Energy, Respect: PAVACA

STOP PRESS EDITION: HHS Secretary Robert F. Kennedy, Jr., Needs to Get Control, or to Resign — Now.

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

This post is a STOP PRESS EDITION. It has to do with the FDA BLA (Biologics License Application) approval of the Moderna COVID-19 modRNA “vaccine” mRNA-1283. This “vaccine” was FDA-approved without any clinical trial in which there was a placebo control group. mRNA-1283 contains a “shorter portion” of the COVID-19 virus spike protein. This “vaccine” also contains elements of the H7N9 Avian Influenza strain that was used in Gain-of-Function experiments by Dr. Yoshihira Kawaoka, DVM, PhD, in 2013, along with other scientists, at the University of Wisconsin (Madison.)

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 this 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 of today’s offering, they must cite their source. Thank you.

Today’s offering is short and to the point. Special Thanks to our good duchess01, to https://www.thefocalpoints.com/, and to http://mole.substack.com/. Please refer to the following posts by Yours Truly for relevant background information regarding today’s offering: https://www.theqtree.com/2025/05/30/health-friday-5030-2025-open-thread-what-is-going-on-at-hhs-the-fda-and-the-cdc/; and, https://www.theqtree.com/2025/05/16/health-friday-open-thread-5-16-2025-about-that-universal-vaccine-theres-more-than-meets-the-eye-part-two/.

Please see the following breaking news outlets pieces regarding the FDA granting the BLA for the Moderna “newest COVID-19 “vaccine”, mRNA-1283: First, this one: https://www.thefocalpoints.com/cp/164898171, “BREAKING: FDA Goes Rogue — Approves Moderna’s Next-Gen COVID-19 mRNA Injection Without a Placebo-Controlled Trial”, Nicolas Hulscher, May 2025. Please see the screenshots from this article, below:

HOWEVER, there is another aspect to the mRNA-1283 modRNA COVID-19 “vaccine” — this injectable appears to be a combination of BOTH the SARS-CoV-2 virus AND elements of the deadly H7N9 Avian Influenza virus. Please see: https://jonfleetwood.substack.com/cp/164803097, “FDA Approves Moderna COVID Jab Containing GOF Bird Flu Gene Segment That PCR Could Mistake for Infection”, 31 May 2025. The “bird flu gene segment” is from the Gain-of-Function experiments with the H7N9 Avian Influenza virus conducted by Dr. Yoshihiro Kawaoka, Ron Fouchier, and other scientists, under the aegis of the University of Wisconsin (Madison), where Dr. Kawaoka has his lab. These Gain-of-Function experiments were “outed” when serious lab accidents occurred; it appears that the experiments were then stopped. But not before Dr. Fouchier wrote this article: https://www.science.org/doi/10.1126/science.1243325, “Gain-of-Function Experiments on H7N9”, 9 August 2013, in which Dr. Fouchier attempted to justify further Gain-of-Function experimentation.

Please see the following screenshot, below, from the Wikipedia entry on H7N9 (https://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H7N9):

The archived article regarding the H7N9 experiments at the University of Wisconsin (Madison), is found here: https://archive.ph/LX7MP, “Study: Lab-derived H5N1 virus component binds to human receptors”, Robert Roos, 13 April 2013.

In Yours Truly’s opinion, Robert F. Kennedy, Jr., the Secretary of Health and Human Services, is not doing his job. BOTH the FDA and the CDC have now “gone rogue” — first, with the “sleight-of-hand” regarding the CDC’s “new recommendations” about the COVID-19 “vaccines” (per Dr. Susan Monarez, PhD, the current Acting Director of the CDC, as of 30 May 2025); and, second, with the FDA (Dr. Martin Makary, Commissioner) granting approval of the Moderna modRNA COVID-19 + H7N9 gene pieces combination “vaccine”, mRNA-1283 (as of 31 May 2025.) It is time, in Yours Truly’s opinion, for Secretary Kennedy, Jr., to either get control of the FDA and CDC — after all, these agencies are part of HHS — or, to resign, and allow President Trump47 to find someone who will.

FLASH UPDATES! MORE ON THE “DIRTY BACKSTORY” RELATED TO THE FDA’s APPROVAL OF mRNA-1283 ON 30 MAY 2025:

ONE: The FDA’s Approval Letter to Moderna on 30 May 2025, regarding mRNA-1283: https://www.fda.gov/media/186740/download. Please see the screenshot of page nine of this document, below:

This is the PHASE 4 clinical study that Moderna is requested to perform for mRNA-1283, but which has NOT begun yet, nor has it ENROLLED any subjects yet.

TWO. This is the slide presentation for the CDC’s ACIP committee meeting for April 2025 related to the “2025-2026 COVID-19 Vaccines Formula” selections. Notice that there is NO vote that ACIP planned to take regarding mRNA-1283. Please see: https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/05-Panagiotakopoulos-COVID-508.pdf. Below is a screenshot of the pertinent image from the slide presentation:

WHAT IS GOING ON HERE?

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 Open Thread 5.9.2025: About That “Universal Vaccine”–There’s More Than Meets the Eye, Part One

Antique London’s photographs: Goldsmith Hall, The Assay Office

The above free vintage image of a laboratory is courtesy of iStock and Google Images.

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

There are Important Notifications by 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.

Due to the nature of today’s topic, there will be two separate posts. Part One, today’s offering, starts here: https://www.hhs.gov/press-room/hhs-nih-announces-generation-gold-standard.html, “HHS, NIH Launch Next-Generation Universal Vaccine Platform for Pandemic-Prone Viruses”, 1 May 2025. Please see the following screenshots from the announcement:

To unpack the announcement, Yours Truly will begin with a 2016 document from the EPA regarding beta-propiolactone, aka BPL (as in BPL-1357): https://www.epa.gov/sites/default/files/2016-09/documents/beta-propiolactone.pdf. Please see the following screenshots from this document:

Notice the risks associated with inhalation of beta-propiolactone (which is being used in the development and testing of the “new Gold Standard” intranasal version of the “new Universal Pandemic Vaccine”, BPL-1357.)

Note the language regarding irritations of various types; of damage to the corneas; convulsions; and “extreme acute toxicity.”

Note the language about cancer being induced in lab rats and mice by the use of beta-propiolactone, but no information being available regarding the inducement of cancer in humans by the use of beta-propiolactone.

The funds for Generation Gold Standard, in the amount of $500 million dollars, will come from reallocation of monies within BARDA (Biomedical Advanced Research and Development Authority: https://www.fiercebiotech.com/biotech/hhs-unveils-500m-universal-vaccine-initiative-calls-biden-era-covid-vax-accelerator, “HHS unveils $500M universal vaccine initiative, calls Biden-era COVID vax accelerator ‘wasteful'”, 1 May 2025. Please see the screenshots from this article, below:

Both Dr. Memoli and Dr. Taubenberger have been with the NIH / NIAID for years. Also, note the tiny subject pool of 45 adult subjects in the Phase 1 study of BPL-1357.

On a “tangential point”, there is this FDA announcement of 10 April 2025: https://www.fda.gov.media/186092/download, “Roadmap to Reducing Animal Testing in Preclinical Safety Studies”, by new FDA Director Dr. Marty Makary. Sasha Latypova analyzed the announcement here: https://sashalatypova.substack.com/p/you-didnt-want-that-mrna-vax-tested, “You didn’t want that mRNA vax tested only on 8 mice? Marty Makary, FDA, has a solution — no more mice!”, 28 April 2025.

That’s right. Dr. Makary wants to reduce, then end, animal testing for vaccines in the preclinical stage, and to substitute testing them instead by using in silico models; then, to move to human subject testing; and, even to NOT have ANY human subject clinical trials at all in “certain circumstances.” Please see the screenshots below from the Latypova article:

Yours Truly understands that the use of animals in lab experiments must be done in the most humane manner possible — no more of the “Fauci tortured Beagles” situations. However, one is of the opinion that there is a place for using animals in lab experiments — to study physical reactions and/or reproductive issues related to the drug or injectable under investigation before human tests begin: something that an in silico model or an AI model cannot do. And, the part about no clinical trials at all in “certain circumstances”:

Note: the red text in the screenshots above link to other articles and information from the Latypova article. Also, recall that Ms. Latypova worked in medical and pharmaceutical techology for years before retiring from the field.

This is the same Dr. Marty Makary who recommended that pregnant women get COVID-19 “vaccinated”:

To finish today’s Part One offering, Yours Truly presents the involvement of United States Defense Department in the use of the “AFLQ adjuvant” that is going to be tested in clinical trials for BPL-1357: https://hivresearch.org/hiv-research/alf-adjuvants. This is the United States military research program into “Military HIV.” This article had a link that led to the following press release by the United States Army, from 2021: https://wrair.health.mil/News-Media/Press-Releases/Article/3166852/phase-1-clinical-trial-of-wrair-developed-covid-19-vaccine-begins/, 5 April 2021. The clinical trial is NCT04784767, that began with 29 subject enrollees on 5 April 2021, and had an “Estimated Study Completion Date” of 30 October 2023 (https://clinicaltrials.gov/study/NCT04784767.) The title of the clinical trial: “SARS-CoV-2 Spike Ferritin Nanoparticle Vaccine with ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults.” Below is a screenshot of the WRAIR article (WRAIR stands for Walter Reed Army Institute of Research):

Note the statement by Dr. Modjarrad that this “US Army COVID-19 Vaccine” would “pave the way for a universal vaccine to protect against not only the current virus, but also counter future variants…” — “universal vaccine” — sound familiar? “Who is driving this bus?” comes to mind.

To be continued in Part Two.

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

STOP PRESS Edition: The FDA Just Granted “Fast Track” Approval for the ARCT-2304 saRNA Avian Flu “Vaccine”

The image of a “Suspicious Dog” is from Yours Truly’s files. The source is unknown, but to the best of Yours Truly’s knowledge and belief, it is not AI-generated.

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. If readers wish to post anything that is AI-generated on the discussion thread for today’s special edition post, they must cite their source. Thank you.

Today’s STOP PRESS Edition post is devoted to one topic: the “Fast Track” approval that the FDA just granted to CSL / Arcturus Therapeutics for the company’s self-amplifying RNA (saRNA, aka sa-mRNA) Avian Influenza “vaccine”, ARCT-2304. Another version of this type of “vaccine” by the same company, called ARCT-154 or KOSTAIVE, for COVID-19 infection “prevention”, is already “fully approved” and in use in Japan and in the European Union / Scandinavia. Both of these “vaccines” are discussed in this article: https://finance.yahoo.com/news/arcturus-gets-fdas-fast-track-154900033.html, “Arcturus Gets FDA’s Fast Track Tag for Influenza Vaccine Candidate”, 11 April 2025. Two screenshots from this article are below:

Take note of the last sentence in the screenshot above: “A biologics license application for Kostaive in the United States is expected to be filed later in 2025.”

Now, the press release from Arcturus Therapeutics in January 2025, regarding ARCT-2304, found here: https://ir.arcturusrx.com/news-releases/news-release-details/acturus-therapeutics-announces-initiation-phase-1-h5n1-flu, “Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine Trial”, 10 January 2025. The clinical trial for ARCT-2304 is registered here: https://clinicaltrials.gov/study/NCT06602531. Note that this is a PHASE 1 human clinical trial. Some of the details are below:

NCT06602531: Study Start Date: 12-12-2024

Primary Completion Date: 7-21-2025 (This means ONLY SEVEN MONTHS of a PHASE 1 human clinical trial before the Primary Completion Date. This is also a RED FLAG indication that Arcturus Therapeutics may likely apply for either a EUA or for a BLA (Biologics License Application, otherwise known as “full FDA approval”) BY THE LATE SUMMER / EARLY FALL OF 2025. In Yours Truly’s opinion, it is SCIENTIFICALLY IMPOSSIBLE to know in FEWER THAN AT LEAST TWO YEARS OF TESTING, WHETHER OR NOT A “VACCINE” ACTUALLY WORKS, LET ALONE BE “SAFE AND EFFECTIVE.”) In Yours Truly’s opinion, any claim by a “vaccine” manufacturer that a DNA-viral vector-based /RNA-based / “protein subunit”-based / “cell-based” / mRNA-based / saRNA-based / sa-mRNA-based “vaccine” — can be SAFELY developed, “tested” and granted either an EUA or “full approval” by the FDA, in fewer than at least two years, must be considered to be not only suspect — but as outright fabrication or wishful thinking.

Estimated Study Completion Date: 12-19-2025 (This would mean that the Phase 1 human clinical trial would be “completed” IN ONE YEAR PLUS ONE WEEK.)

Recruitment Information: Not Yet Recruiting

Contacts and Locations: NO locations are listed; there is only an 888 area code number to call the “Clinical Trials Disclosure Manager” for further information (which, by the way, said information would only be released to “researchers.” One assumes this means “degree-holding scientific researchers”, not to non-scientific-degree-holding researchers, let alone to the general public.)

Clicking on the Researcher View tab on the main study registration page yields some ** interesting ** information. Some examples: There will be a total of 200 persons used in the clinical trial; the ages will range from 18 years old to 80 years old; there is a “control group” that will receive injections of what appears to be a “standard influenza vaccine” plus, and/or, a saline placebo; and, there will be THREE levels of injectable used on the study subjects, at a “low” dose, a “medium” dose, and a “high” dose — of which, NO amounts of “vaccine candidate” are delineated; among other information.

A short summary of how saRNA (aka sa-mRNA) “vaccines” work is here: https://www.promegaconnections.com/how-do-self-amplifying-rna-vaccines-work/, by Jordan Nutting, 6 February 2024. Please see the screenshots from this article, below:

Note the language above regarding what saRNA does in the body: “...it’s like having a built-in printing press that produces additional vaccine in cells.” (Yours Truly: This “printing press” is at work in the body of the person who takes an saRNA “vaccine” for an unknown time — perhaps indefinitely.)

Note the language about the very long length of the mRNA sequences that must be used in saRNA (aka sa-mRNA) “vaccines.”

WHY IS THERE THIS UNHOLY RUSH TO GET ARCT-2304 THROUGH THE CLINICAL TRIAL PROCESS AND INTO EITHER EUA OR BLA STATUS WITH THE FDA, AND THEREFORE GET INTO USE IN THE UNITED STATES? In Yours Truly’s opinion, the answer may involve: Peter Marks, MD, PhD.

When it relates to a new drug or biologic product (including vaccines and other injectables), BOTH the FDA’s CBER (Center for Biologics Evaluation and Research) AND CDER (Center for Drug Evaluation and Research) departments are involved. Peter Marks, MD, PhD, was the director of CBER from 1 January 2016 (this made him an Obama administration holdover at the FDA) until his resignation from CBER on 29 March 2025 (his resignation became effective on 5 April 2025.) It appears that unless Dr. Marks resigned, he was going to be fired by now-HHS Secretary Robert F. Kennedy, Jr. Please see the screenshots below from this article on the situation (https://www.thefocalpoints.com/p/breaking-peter-marks-issues-veiled, “BREAKING – Peter Marks Issues Veiled Threat to America About Man-Made Biological Threats”, by Nicolas Hulscher, MPH, 5 April 2025.) The first is from Dr. Marks’ resignation letter; the other is from the article by Mr. Hulscher:

The screenshot below is from the interview transcript with Dr. Marks on CNN on 4 April 2025:

During this CNN interview, Dr. Marks made the “oblique threat” above.

On 2 April 2025, the FDA chose Scott Steele, PhD, as the Acting Director of CBER. Dr. Steele has been a full-time CBER advisor in late 2022 (this makes him a “Biden administration” holdover; and, Dr. Steele started with the FDA in June 2020 as an advisor in that agency’s Office of Medical Policy Initiatives.) Please see: https://www.fiercepharma.com/pharma/fda-taps-scott-steele-lead-cber-acting-basis-after-marks-departure, 2 April 2025. On 10 April 2025, the FDA granted “Fast Track” process approval for ARCT-2304. Who chose Dr. Steele to be the Acting Director of CBER on 2 April 2025?

In Yours Truly’s opinion, it is inconceivable that Dr. Steele and his colleagues at the related department of CDER, Dr. Jacqueline Corrigan-Curay, MD, and Peter P. Stein, MD — do not know what saRNA (aka sa-mRNA) does and how dangerous it can be to the human body; and, do not know that a “vaccine” product needs at least two to as long as five years to be properly developed, tested, results analyzed, and applications submitted to the FDA for EUA or for “full approval” of the injectable.

In Yours Truly’s opinion, what may be going on at the FDA regarding ARCT-2304 is a combination of an “end-run” around what Secretary Robert F. Kennedy, Jr., is trying to do to bring the agency into account for what is it supposed to do — to work in the best interests of the public health of the American people; plus, what appears to be personal bias against Mr. Kennedy, Jr., himself; plus, what appears to be a “H3ll-bent mindset” in the FDA to force the use of self-amplifying RNA products on the American people without going through the proper (lengthy) processes of testing, analysis, and proof of “safety and efficacy.”

Yours Truly presents the situation and her opinions. Readers can do their own due diligence and make their own conclusions.

FLASH! UPDATES, MONDAY 15 APRIL 2025:

First, this: https://twitter.com/RenzTom/status/1910780397899964560

Then, these: https://www.vigilantfox.com/p/fda-fast-tracks-vaccine-nightmare, 14 April 2025. Please scroll down the page to find the interview with Attorney Tom Renz; also: https://sayerji.substack.com/p/the-self-amplifying-rna-vaccine-threat, “The Self-Amplifying RNA Vaccine Threat and the Rise of BIo-Digital Warfare”, 11 April 2025. A screenshot from this article is below:

And, finally, from 2024: https://www.theqtree.com/2024/10/04/health-friday-open-thread-10-04-2024-self-amplifying-fda-sarna-a-primer-on-how-to-amplify-a-disaster/.

Peace, Good Energy, Respect: PAVACA