The MAHA Diaries

[Delight]

I am actually more shocked than I ought to be by the unfolding MAHA saga. I came across this thread today. I am posting it here.

[TrumanCash]

The Shot Heard Around the Nation: MAHA Movement Forces Policy Shift -- Sayer Ji

The People Pressured. The System Moved. MAHA Turns Protest into Policy. There are times when the veil lifts, and for a brief moment, we witness government not as an abstract machinery, but as a stage where truth meets resistance—and sometimes, prevails. This week in Washington, D.C., was such a time.

Bobby’s Testimony: Integrity Under Fire
Inside the hearing room of the House Appropriations Subcommittee on Health and Human Services, history didn’t whisper—it roared.

Robert F. Kennedy Jr. didn’t just testify; he testified with fire in his bones. Through two intense hearings, he held the line on behalf of the American people—often under fierce interrogation.

One of the most searing revelations came when Kennedy exposed the corruption within the National Institutes of Health (NIH), blaming it for the stagnation in Alzheimer’s research:

“For 20 years, because of utter corruption and fraud, we were directing Alzheimer’s research to one hypothesis, and any other approach was essentially blacklisted.”

His words struck like lightning. They didn’t just challenge a narrative—they shattered it.

Rep. Lois Frankel attempted to reduce Bobby’s vision for HHS reform to “Elon Musk plugging random numbers into a computer.” His reply was firm and fearless:

“Everything that you said was essentially dishonest.”

He spoke not from ego, but from moral clarity backed by data, integrity, and a lifetime of advocacy. Later, he addressed Rep. Rosa DeLauro with a stark truth:

“Look at our children—they're the sickest children in the world!”

In that moment, you could feel a tectonic shift—not just in the hearing room, but across the national conscience. It was a line drawn. And millions are standing behind it.

After the Fire: A Convergence of Purpose
Following the hearings, I joined RFK Jr., his family, and a constellation of changemakers: Dr. Tia Kansara, Tony Lyons, Senators Ron Johnson and Rand Paul, Jan Jekielek, Jeffrey Tucker, Dr. Eric Berg, Dr. Joel Bohemier, Charles Eisenstein, Leigh Merinoff, Leslie Manookian, and Jeffrey Rose.

Together, we sat, connected, and bore witness to a moment larger than ourselves. We weren’t just reacting to history. We were participating in its rewriting.

This is not a movement of isolated voices. This is a convergence.

The MAHA Movement—Make Americans Healthy Again—is not theoretical. It is embodied, it is organized, and it is producing results.

https://sayerji.substack.com/p/the-s...und-the-nation

[TrumanCash]

RFK Jr.'s Next Target: A Common Weedkiller

After targeting dyes and other chemicals allowed for use in food, Health and Human Services Secretary Robert F. Kennedy Jr. is zeroing in on the active ingredient in Roundup in his bid to root out what he calls environmental toxins that contribute to chronic disease.

Why it matters: The herbicide glyphosate is expected to feature prominently in a report due out this week from President Trump's Make America Healthy Again Commission, which was charged with identifying top contributors to America's chronic health problems.

But some warn that clamping down on pesticides could cause major disruption of the food supply, with repercussions for agriculture interests and consumers.

In a speech last week, White House senior health adviser Calley Means previewed the report's findings, pointing to chemical pesticides as contributors to Americans' poor health.

"Obviously it's because of environmental toxins. We produce and ingest 25% of the world's pesticides," Means said at an event in D.C. launching the MAHA institute. "The leading herbicides and pesticides that we use in the United States -- many of them are phased out or banned in every other country in the world."

The big picture: While some environmentalists and wellness influencers have long decried the to use of herbicides and pesticides, glyphosate is the most widely used weedkiller worldwide and the key ingredient in Bayer's Roundup.

Read complete article at https://greenmedinfo.com/content/rfk...mon-weedkiller

[TrumanCash]

Laser Weeding Robot Kills 100,000 Weeds Per Hour

A Company by the name of Carbon Robotics made an Autonomous Laser Weeding Robot, that kills 100,000 weeds per hour, using nothing but lasers.

The Robot, uses GPS and Lidar sensors, to autonomously drive within the bounds of a field, navigate furrows, and automatically turn around to start on the next row.

Because the Robot uses thermal energy to eradicate weeds, rather than a physical intervention like tilling, the machine doesn't disturb the soil below. That means reduced farm costs, no more herbicides, and most importantly, happier, healthier crops.

While the Robot moves around its plot at about 5 miles per hour, its 12 high-resolution cameras continuously scan the ground below. Meanwhile, an onboard supercomputer uses machine learning to identify unwanted plants in mere milliseconds.

Once the robot pinpoints undesirable weeds, it fires its eight carbon dioxide lasers at them.

The Robots laser array can kill a combined 100,000 weeds per hour, or about 28 weeds per second. And a single robot can weed 15 to 20 acres in a day.

Source: https://youtube.com/watch?v=_2s-0wgQWXM

[onawah]

Breaking: CDC Removes COVID Vaccines for Kids, Healthy Pregnant Women From Schedule of ‘Recommended’ Shots
by Brenda Baletti, Ph.D.
May 27, 2025
https://childrenshealthdefense.org/d...tm_id=20250527

(Podcast at the link. Hyperlinks in the article not embedded here.)

UPDATE: Sadly, the veracity of the contents of this article is cancelled by the following article entitled "The Deception of the FDA’s New COVID-19 Vaccine Guidance", posted here: https://projectavalon.net/forum4/sho...=1#post1671073

"As of today, the CDC will no longer recommend COVID-19 vaccines for children and healthy pregnant women, HHS Secretary Robert F. Kennedy Jr. announced this morning.
In a video posted on X, Kennedy was flanked by Dr. Jay Bhattacharya, director of the National Institutes of Health, and Dr. Marty Makary, U.S. Food and Drug Administration commissioner, as he made the announcement.

https://x.com/SecKennedy/status/1927...on-schedule%2F

See new posts
Conversation
Secretary Kennedy@SecKennedy
Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from
@CDCgov recommended immunization schedule. Bottom line: it’s common sense and it’s good science. We are now one step closer to realizing
@POTUS’s promise to Make America Healthy Again.
9:16 AM · May 27, 2025
https://x.com/i/status/1927368440811008138

“I couldn’t be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,” he said.

Kennedy said the Biden administration had recommended the boosters, even though it had no clinical data to support the recommendation.

“That ends today. It’s common sense and it’s good science,” Bhattacharya added.

Mary Holland, CEO of Children’s Health Defense (CHD) — which early on urged the CDC not to recommend the vaccines for children, and challenged the agency after it did, celebrated the news.

“Hallelujah!” Holland said. She added:

“These dangerous, poorly tested shots have caused injuries and death to far too many children. And many of the vaccines’ long-term side effects remain unknown. This is a major step in the right direction.

“CHD urged the CDC not to add these dangerous vaccines to the childhood schedule. When we were ignored, we fought relentlessly to get them removed. This is a victory for all children and pregnant women.”

In 2022, CHD sued the FDA for granting emergency use authorization of the COVID-19 shots for children and babies. The lawsuit alleged the FDA misused emergency power to push dangerous biologics on minors. The organization appealed the case all the way to the U.S. Supreme Court, which declined to hear it.

Even at the height of the pandemic, experts agreed that children were at extremely low risk from COVID-19. Soon after the shots were authorized, vaccine injury reports and peer-reviewed studies showed the vaccines were linked to myocarditis and pericarditis, particularly for young people, in addition to many other risks.

Yet, the public health agencies authorized the shot for people ages 16 and up from the start, and expanded that authorization to 12-year-olds by May of 2021. The FDA authorized the drug for children ages 5 and up in October 2021, and for babies 6 months and older in June 2022.

The COVID-19 vaccine never received FDA approval for children under age 12 — it remains under emergency use authorization.

Yet, the CDC added COVID-19 vaccination in February 2023 to its routine immunization schedule for children and adults, the agency’s vaccine advisers unanimously recommended it. The CDC has continued to recommend annual boosters for children.

The schedule is the basis for vaccine recommendations made by most physicians.

The CDC’s immunization schedule also provides formal guidance for state and local public health officials who set the rules for which vaccines are required to attend school. Children typically must receive all of the vaccines on the schedule to be considered “up to date” on their vaccinations.

Vaccines included on the childhood schedule are also paid for by the Vaccines for Children Program, which distributes cost-free vaccines to children whose families cannot afford to pay for them. More than 50% of children have their vaccine costs covered by the program, according to the CDC.

The Wall Street Journal (WSJ) reported earlier this month, citing anonymous inside sources, that HHS was working on an imminent plan to stop recommending the shots. However, the agency never confirmed the WSJ report, which said an announcement was expected “in the coming days.”

Last week the FDA announced plans to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.

According to the announcement, new COVID-19 shots for healthy children and adults must go through placebo-controlled clinical trials before they can be approved.

The announcement generated criticism from those who noted that because the approval plan would make the shots available to anyone in a high-risk group, many children and all pregnant women would still be eligible for the shots.

Today’s announcement appears to address the concern about pregnant women.

No one from the CDC was present at the announcement. The acting director, Susan Monarez, Ph.D., stepped down in March when she was nominated permanently to the position. Kennedy has reported that attorney Matthew Buzzelli is currently acting director."

Related articles in The Defender
FDA to Limit Approvals of New COVID Vaccines to Elderly, High-Risk Groups — But Hundreds of Millions Still Eligible for the Shots
HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports
Scientists Call for Global Moratorium on mRNA Vaccines, Immediate Removal From Childhood Schedule

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.

[TrumanCash]

Robert F. Kennedy Jr.: How to Fix America’s Health Crisis as HHS Secretary

Source: https://youtube.com/watch?v=sODZSAuxTTw

During the interview, Kennedy shared what some might call a “conspiracy theory”—but it offers a compelling explanation for why TV news suddenly stopped criticizing the pharmaceutical industry.

Twenty years ago, it wasn’t uncommon to see news segments questioning the safety or effectiveness of vaccines. But then it all went quiet. According to Kennedy, that silence was bought with pharmaceutical ad dollars.

Big Pharma doesn’t just advertise on TV news, he said. They want to “control the content.”

Kennedy revealed that Fox News founder Roger Ailes once told him 75% of his evening news ad revenue came from pharmaceutical companies.

So, when you see Jake Tapper on CNN? His paycheck may say CNN…

But the money comes from Pfizer and the other pharmaceutical giants flooding the airwaves with ads.

“And they know that,” Kennedy said.

“They know they’ve got to toe the line. They’ve got to frighten us all about infectious disease.”

“They’re not giving us the real news. They’re not asking the questions they ought to be asking. There’s no skepticism,” he added.

“Twenty years ago, they used to say, ‘Yeah, there’s problems with vaccines or other drugs.’ They will never do that today.”

Then, RFK Jr. put every medical journal bought off by Big Pharma on notice—including The Lancet, New England Journal of Medicine, JAMA, and all “those other journals because they’re all corrupt.”

He made it clear: their reign as the premier voices in medical science is coming to an end.

Kennedy pointed to the warning from Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine, who declared it is “no longer a science journal.”

Instead, she called it a “vessel for pharmaceutical propaganda.”

Now, Kennedy is shaking up the status quo, cutting ties with these captured publications and building something better.

“We’re going to stop NIH scientists from publishing there,” he said. “And we’re going to create our own journals in health in each of the institutions.”

He added that these new, government-backed journals will become the “preeminent journals” in the world because they’ll be grounded in real science, not corporate spin.

“If you get NIH funding,” Kennedy said, “it is anointing you as a good, legitimate scientist.”

The second announcement dropped when Kennedy said, “We’re going to end the war at FDA against alternative medicine.”

That includes stem cells, chelating drugs, vitamins, peptides—“anything that is not going to make Big Pharma rich.”

Kennedy revealed he had to travel all the way to Antigua, in the Caribbean, just to receive stem cell treatment for his throat.

“They helped me enormously,” he said. “But I shouldn’t have to leave the country to get them.”

[rgray222]

Mars, the manufacturer of Skittles, has confirmed that it removed titanium dioxide from its U.S. Skittles portfolio at the end of 2024. The decision follows years of consumer advocacy, a class-action lawsuit (since dismissed), and a European Union ban on the substance in 2022. Although titanium dioxide remains legal in the U.S., scrutiny of the ingredient has intensified, especially after President Trump appointed Robert F. Kennedy Jr. as head of the Department of Health and Human Services, which has reinvigorated national debates around food safety.

[onawah]

[More blatant hypocrisy from the CDC and shills.

Posted by onawah (here)
Media, Health Officials Lash Out at RFK Jr. Over New COVID Vaccine Recommendations — CDC Was Likely to Make the Change Anyway
by Brenda Baletti, Ph.D.
May 28, 2025
https://childrenshealthdefense.org/d...tm_id=20250528

update: But much more disappointing is the article posted here:https://projectavalon.net/forum4/sho...=1#post1671073

(Podcast at the link. Hyperlinks in the article not embedded here.)
"After HHS Secretary Robert F. Kennedy Jr. announced the CDC will stop recommending COVID-19 vaccines for healthy children and pregnant women, the media and medical associations attacked the decision as out of line with current thinking. However, the CDC’s vaccine advisory committee was poised to make a similar recommendation next month.

Tuesday’s announcement that the Centers for Disease Control and Prevention (CDC) will no longer recommend COVID-19 vaccines for healthy children and pregnant women ignited a firestorm of criticism from many mainstream public health officials, organizations and doctors.

The new recommendations don’t preclude pregnant women and children from getting the vaccines — the CDC just isn’t recommending them any longer for those groups.

The American College of Obstetricians and Gynecologists (ACOG) said in a statement that the organization is “concerned about and extremely disappointed” by the new recommendations, announced yesterday by U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr.

“As ob-gyns who treat patients every day, we have seen firsthand how dangerous COVID-19 infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection,” said Dr. Steven J. Fleischman, ACOG president.

“It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth,” he added.

ACOG didn’t cite any evidence for its claims.

The American Academy of Pediatrics said the removal of the vaccines from the schedule “ignores independent medical experts and leaves children at risk.”

The organization, which typically aligns its recommendations with those of the CDC, told MedPage Today that it “may have to rethink how we harmonize with the federal government.”

The New York Times conceded there isn’t scientific evidence to support vaccination among healthy children. However, the Times still called the move “Kennedy’s latest salvo in dismantling decades of vaccine safety policies, especially those intended for children.”

Others criticized the process behind the decision-making. MedPage Today cited a retired pediatrician, who said it was unusual for the HHS secretary to bypass typical agency processes.

STAT News said it was “unprecedented” for the secretary to announce such a change, and cited a law professor who said it might open the decision up to being challenged.

Another expert quoted by MedPage Today, Dr. Tina Tan, said the decision would make it harder to access vaccines because insurers may decide not to maintain coverage for a vaccine not listed on the schedule.

As of today, no changes to the schedule appear on the CDC website.

Advisory committee poised to make similar recommendation anyway

For vaccines to get onto the childhood schedule, typically the CDC Advisory Committee on Immunization Practices (ACIP) recommends them, after which the CDC director approves them.

At least one other vaccine has been taken off the schedule. When Rotashield, Wyeth’s (now Pfizer) rotavirus vaccine, caused intussusception in infants one to two weeks following vaccination, the vaccine was suspended pending ACIP review. ACIP then recommended removing it, and the CDC took it off the schedule in 1999.

However, experts who spoke with The Defender said ACIP is only an advisory committee, and the CDC director — and HHS more generally — aren’t bound by ACIP’s recommendations. They can and sometimes do make independent decisions.

For example, in September 2021, former CDC Director Rochelle Walensky overruled ACIP when she decided to recommend COVID-19 boosters for everyone age 16 and older. ACIP recommended against the boosters, citing the lack of safety and efficacy data on the vaccine for 16- and 17-year-olds.

Several news outlets highlighted the absence of a CDC representative when Kennedy announced the news Tuesday, flanked by the directors of the National Institutes of Health and the U.S. Food and Drug Administration (FDA).

The acting director of the CDC, Susan Monarez, Ph.D., stepped down in March when she was nominated for the permanent director’s position. Kennedy has reported that attorney Matthew Buzzelli is currently acting director, while Monarez awaits U.S. Senate confirmation hearings.

Despite the consternation reported that the process for removing the vaccine is atypical, and not based on public debate, ACIP discussed the issue extensively in its April meeting, and was reportedly poised to make a similar recommendation.

STAT News reported that the ACIP subgroup focused on vaccine recommendations is intending to recommend at their June meeting that the universal vaccination for all people ages 6 months and up be replaced with one that “urges people at high risk of severe illness if they contract Covid to continue to be vaccinated.”

The subgroup made a detailed presentation to ACIP in April, and explored three potential recommendations: keeping the universal recommendation, reducing it to only people at high risk or reducing it to high risk for everyone under age 64.

In April, a poll of ACIP members showed that 76% supported switching to a non-universal recommendation.

The full committee is set to vote on that recommendation next month. It will be up to the CDC whether to accept the recommendation or make a different one.

Last week, the FDA announced plans to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.

The agency also said it will require new clinical trial data to approve new COVID-19 shots for healthy children.

Under the new rules, between 100-200 million Americans would still be eligible for the shots, because so many people have conditions that are considered comorbidities, the FDA said.

Will children and pregnant women lose access to COVID vaccines?

The CDC’s Vaccines for Children Program is a federal program that provides free vaccines to uninsured or underinsured children and children who are eligible for or enrolled in Medicaid.

Medicaid compensates pediatricians for the costs associated with administering the vaccines. It also requires physicians who participate in the program to administer all vaccines on the childhood vaccination schedule to every child.

Attorney Rick Jaffe represents Dr. Samara Cardenas, a California pediatrician who treats children on Medicaid, in a lawsuit funded by Children’s Health Defense. Cardenas sued the CDC because she was kicked out of the Vaccines for Children Program when she refused to give COVID-19 vaccines to healthy kids.

Jaffe told The Defender that if the COVID-19 vaccine is no longer on the CDC schedule, the Vaccines for Children Program would no longer recommend it, and doctors would no longer be compelled to purchase and administer it as part of the program.

However, “there’s a big qualifier,” he said, which is that the recommendation is changing only for healthy children. “According to RFK Jr. and the health authorities, there are a lot of sick kids out there.”

Jaffe said that given the large number of children excluded from the new recommendation, he believes it’s likely the CDC-funded program will still cover the costs of the vaccine for those who want it.

He also said that most insurance carriers will likely still pay for the shot for those who want it. “In general, insurance carriers are pro-vaccine,” he said.

Jaffe said he thought the qualification was a good thing because it meant no one would be compelled to get the shot.

Currently, doctors in the Vaccines for Children Program are being forced to give the shots to little kids “even though it’s only emergency use authorized and never proven to have any clinical benefit.”

That will now change, he said. However, any parent who wants their kid to get the shot will likely be able to do so, because risk factors like allergies are so prevalent.

The Vaccines for Children Program did not respond to The Defender’s inquiry about its plans to cover the vaccine. The top three U.S. health insurance providers — United Healthcare, Kaiser Permanente and Elevance Health (formerly Aetna) — did not respond either.

Will new recommendations have ‘devastating consequences’ for pregnant women?

The Guardian reported that doctors fear “devastating consequences” for pregnant women, citing ACOG’s statements.

The article also quoted a doctor from March of Dimes who said she once cared for an unvaccinated pregnant woman who died from COVID-19, and the Society for Maternal Fetal Medicine, which also said it still recommends the vaccine as safe and effective for pregnant women, but without citing evidence to support the claim.

However, risks to pregnant women have been known — and ignored or hidden by public health agencies and professional organizations — since even before the CDC began recommending pregnant women take the vaccines.

Pfizer clinical trial data showed the shots were linked to miscarriages and preterm births. Pfizer’s pregnancy and lactation report also detailed extensive side effects for nursing babies, including fever, vomiting and edema, or swollen tissue, among many other issues.

Pfizer sent its report to the FDA on April 20, 2021. Three days later, Walensky gave a White House press briefing, during which she told women there was no bad time to get vaccinated — before, during or after pregnancy.
https://x.com/CDCDirector/status/144...women-media%2F

CDC Director
@CDCDirector
There is NO bad time to get a #COVID19 vaccine. Whether you are thinking about having a baby, currently pregnant, recently delivered your baby, or are breastfeeding, it is safe for you to get vaccinated. Protect yourself and your growing family: http://vaccines.gov.
There Is No Bad Time to Get Vaccinated for COVID-19
Pregnant people are at higher risk for being hospitalized and dying from COVID-19. The vaccines keep moms with their babies, are safe for pregnant people, and do not change fertility.
https://x.com/i/status/1443658153191694353
2:25 PM · Sep 30, 2021

Earlier this month, Dr. Sara Brenner, a preventive medicine physician who has worked at the FDA since 2019, including as itss principal deputy commissioner — and briefly its acting commissioner — admitted she refused the COVID-19 mRNA vaccine while pregnant, even as her agency promoted it as “safe and effective” for all pregnant women.

Brenner explained on May 15 at the “MAHA Institute Round Table” that her decision was driven by a lack of safety data, particularly around the biodistribution of the vaccine’s lipid nanoparticles (LNPs) — the tiny fat particles used to deliver the mRNA into cells.

She warned that unintended toxic effects — especially in vulnerable populations like pregnant women — could not be ignored.

A recent analysis of reports submitted to the Vaccine Adverse Event Reporting System (VAERS) found safety signals for 37 adverse events when COVID-19 vaccines were administered during pregnancy.

Meanwhile, few pregnant women are opting to take the shot. In the 2022-2023 season, only 27.3% of women chose to take the shot. In the 2024-2025 season, only about 14% opted in. "

Related articles in The Defender
Breaking: CDC Removes COVID Vaccines for Kids, Healthy Pregnant Women From Schedule of ‘Recommended’ Shots
FDA to Limit Approvals of New COVID Vaccines to Elderly, High-Risk Groups — But Hundreds of Millions Still Eligible for the Shots
HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports
Study Finds 37 Safety Signals for COVID Vaccines During Pregnancy, CDC Still Urges Women to Get the Shots

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.

Posted by onawah (here)
Breaking: CDC Removes COVID Vaccines for Kids, Healthy Pregnant Women From Schedule of ‘Recommended’ Shots
by Brenda Baletti, Ph.D.
May 27, 2025
https://childrenshealthdefense.org/d...tm_id=20250527

(Podcast at the link. Hyperlinks in the article not embedded here.)

"As of today, the CDC will no longer recommend COVID-19 vaccines for children and healthy pregnant women, HHS Secretary Robert F. Kennedy Jr. announced this morning.
In a video posted on X, Kennedy was flanked by Dr. Jay Bhattacharya, director of the National Institutes of Health, and Dr. Marty Makary, U.S. Food and Drug Administration commissioner, as he made the announcement.

https://x.com/SecKennedy/status/1927...on-schedule%2F

See new posts
Conversation
Secretary Kennedy@SecKennedy
Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from
@CDCgov recommended immunization schedule. Bottom line: it’s common sense and it’s good science. We are now one step closer to realizing
@POTUS’s promise to Make America Healthy Again.
9:16 AM · May 27, 2025
https://x.com/i/status/1927368440811008138

“I couldn’t be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,” he said.

Kennedy said the Biden administration had recommended the boosters, even though it had no clinical data to support the recommendation.

“That ends today. It’s common sense and it’s good science,” Bhattacharya added.

Mary Holland, CEO of Children’s Health Defense (CHD) — which early on urged the CDC not to recommend the vaccines for children, and challenged the agency after it did, celebrated the news.

“Hallelujah!” Holland said. She added:

“These dangerous, poorly tested shots have caused injuries and death to far too many children. And many of the vaccines’ long-term side effects remain unknown. This is a major step in the right direction.

“CHD urged the CDC not to add these dangerous vaccines to the childhood schedule. When we were ignored, we fought relentlessly to get them removed. This is a victory for all children and pregnant women.”

In 2022, CHD sued the FDA for granting emergency use authorization of the COVID-19 shots for children and babies. The lawsuit alleged the FDA misused emergency power to push dangerous biologics on minors. The organization appealed the case all the way to the U.S. Supreme Court, which declined to hear it.

Even at the height of the pandemic, experts agreed that children were at extremely low risk from COVID-19. Soon after the shots were authorized, vaccine injury reports and peer-reviewed studies showed the vaccines were linked to myocarditis and pericarditis, particularly for young people, in addition to many other risks.

Yet, the public health agencies authorized the shot for people ages 16 and up from the start, and expanded that authorization to 12-year-olds by May of 2021. The FDA authorized the drug for children ages 5 and up in October 2021, and for babies 6 months and older in June 2022.

The COVID-19 vaccine never received FDA approval for children under age 12 — it remains under emergency use authorization.

Yet, the CDC added COVID-19 vaccination in February 2023 to its routine immunization schedule for children and adults, the agency’s vaccine advisers unanimously recommended it. The CDC has continued to recommend annual boosters for children.

The schedule is the basis for vaccine recommendations made by most physicians.

The CDC’s immunization schedule also provides formal guidance for state and local public health officials who set the rules for which vaccines are required to attend school. Children typically must receive all of the vaccines on the schedule to be considered “up to date” on their vaccinations.

Vaccines included on the childhood schedule are also paid for by the Vaccines for Children Program, which distributes cost-free vaccines to children whose families cannot afford to pay for them. More than 50% of children have their vaccine costs covered by the program, according to the CDC.

The Wall Street Journal (WSJ) reported earlier this month, citing anonymous inside sources, that HHS was working on an imminent plan to stop recommending the shots. However, the agency never confirmed the WSJ report, which said an announcement was expected “in the coming days.”

Last week the FDA announced plans to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.

According to the announcement, new COVID-19 shots for healthy children and adults must go through placebo-controlled clinical trials before they can be approved.

The announcement generated criticism from those who noted that because the approval plan would make the shots available to anyone in a high-risk group, many children and all pregnant women would still be eligible for the shots.

Today’s announcement appears to address the concern about pregnant women.

No one from the CDC was present at the announcement. The acting director, Susan Monarez, Ph.D., stepped down in March when she was nominated permanently to the position. Kennedy has reported that attorney Matthew Buzzelli is currently acting director."

Related articles in The Defender
FDA to Limit Approvals of New COVID Vaccines to Elderly, High-Risk Groups — But Hundreds of Millions Still Eligible for the Shots
HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports
Scientists Call for Global Moratorium on mRNA Vaccines, Immediate Removal From Childhood Schedule

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.

[onawah]

RFKennedy Jr. talks about the years when he was addicted to heroin and his spiritual rebirth when he quit.

The next article is not very promising, however...

[onawah]

The Deception of the FDA’s New COVID-19 Vaccine Guidance
by Jeremy R. Hammond
Jun 3, 2025
https://www.jeremyrhammond.com/2025/...X63DasbH6iUIig

(This looks really, really bad. Kennedy has not brought about any changes at all, apparently, as far as this "guidance" goes, and still no mention here of the nanotechnology in the jabs.
I am a staunch supporter of RKF, but I can just imagine the kinds of threats that could be held over his head and that of his family, if he doesn't cooperate.
He must have known the risks when he volunteered for the high profile post, but it can't be easy, or simple...)
Hyperlinks in the article not embedded here.)

"New FDA guidelines for COVID-19 vaccines are being hailed as “evidence-based” policymaking—despite relieving Big Pharma of that burden.
Reading Time: 42 min ( Word Count: 9209 )

Table of Contents
The Great ‘MAHA’ Divide
Misdiagnosing the “Public Trust” Problem
The Lie about ‘Herd Immunity’
The Lie about mRNA Persistence
The Lie about Spike Protein Persistence
The Lie about the ‘Harmless’ Spike Protein
The Lie about Genomic Integration
The FDA-Ignored DNA Contamination
Prasad and Makary’s Cognizance of the Lies
The Unproven Mortality Benefit of COVID‑19 Vaccines
‘Safe and Effective’ or Highly Dangerous?
The ‘Badly Designed’ COVID‑19 Vaccine Clinical Trials
The Regulatory Malfeasance and Scientific Fraud of FDA Authorizations
The Scientific Fraud of PCR Testing
Critical Analysis of the Proposed FDA Guidance
An Opinion Piece, Not FDA Policy
Regulatory Sleight-of-Hand
Making Randomized Controlled Trials Voluntary
The Broad Exclusionary Criteria for Voluntary Trials
The FDA’s Preferred Study Design
“Balancing” Pharma Profits with Public Health
Conclusion
Epilogue
The Great ‘MAHA’ Divide

Administration (FDA) published an article in the New England Journal of Medicine (NEJM) titled “An Evidence-Based Approach to Covid-19 Vaccination”.

The article proposed new FDA guidance for the pharmaceutical industry characterized as a dramatic shift in the FDA’s approach to regulating COVID‑19 vaccines.

It indicated a move away from the FDA’s rubber-stamping of these vaccines, we were told, and toward “evidence-based” policymaking.

The authors were Dr. Vinay Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), which is responsible for the vaccine approval process; and Dr. Martin (“Marty”) Makary, the FDA Commissioner.

Prior to joining the FDA, both men were vocal critics of the COVID‑19 vaccine recommendations made by the Centers for Disease Control and Prevention (CDC).

They were not otherwise known, however, for seriously questioning the CDC’s routine childhood vaccine schedule like everyone in the health freedom movement.

The FDA is a subagency of the Department of Health and Human Services (HHS), which is headed now by Secretary Robert F. Kennedy, Jr., a longtime critic of so-called “public health” policies who joined with “warrior moms” to found the organization Children’s Health Defense (CHD) to address the threat to children’s health from the incessant onslaught of environmental toxins—including from the CDC’s vaccine schedule.

Mr. Kennedy is now in the position of serving under the proud executor of “Operation Warp Speed”, the taxpayer-funded project to rapidly develop and distribute COVID‑19 vaccines—the stated endgame of the lockdown madness.

Kennedy had been an independent candidate for president until he quit his campaign to join forces with Donald Trump—despite Kennedy having promised his campaign supporters that “UNDER NO CIRCUMSTANCES” would he do that.

At that point, Kennedy rebranded his political campaign “MAHA”—Make America Healthy Again. It was a play on Trump’s “Make America Great Again” brand, “MAGA”.

“A Vote for Trump Is a Vote for Kennedy”, a banner at the top of the campaign’s website proclaimed.
The campaign website “TeamKennedy.com” was redirected to “MAHAnow.org”, where members of the health freedom movement were encouraged to help make America healthy again by joining the “MAHA Movement”—which meant by voting for Trump.

“A Vote for Trump Is a Vote for Kennedy”, a banner at the top of the campaign’s website proclaimed.

And members of the health freedom movement lined up in droves to do so. Senior aides in the White House told Politico they believed this alliance was a decisive factor in the November 2024 presidential election.

Since then, the acronym “MAHA” has been used as a euphemism for “the health freedom movement” despite the obvious logical distinction between a grassroots movement and a political campaign.

That distinction has been increasingly forcing itself into the public discourse.

In particular, the controversy over Trump’s nomination of tech entrepreneur Casey Means for the position of Surgeon General has revealed a deep and growing divide within the health freedom movement.

In one group are those who supported Trump from the start or who were so adamantly loyal to Kennedy that they voted for Trump even if only to get Kennedy into a government position, who believe that any perceived lack of significant change is just because Kennedy has to “play the game” of politics, and who insist that we should “trust” his behind-the-scenes plan to get the job done.

In the other group are those who refuse to compromise when it comes to our children’s health, who see recent developments as mere public relations stunts instead of meaningful change, and who do not withhold criticisms of the Trump administration and of Kennedy for what they perceive as his new role of giving his own stamp of approval to the continuation of criminal policies.

At the top of the list of those policies, as agreed by everyone in the grassroots movement, is the FDA’s rubber-stamping of and the CDC’s recommendations for COVID‑19 vaccines—including for infants and pregnant women.

On May 21, the day after the FDA officials’ article was published in the New England Journal of Medicine, Secretary Kennedy hailed it as “a long-overdue return to scientific integrity and medical freedom”— proof that “[the FDA] is finally breaking away from the one-size-fits-all vaccine policy that authorized the COVID shots for every American over 6 months old.”

Secretary Kennedy
https://www.jeremyrhammond.com/2025/...X63DasbH6iUIig
@SecKennedy
Under the leadership of FDA Commissioner
@DrMakaryFDA
and CBER Director Vinayak Prasad,
@US_FDA
is finally breaking away from the one-size-fits-all vaccine policy that authorized COVID shots for every American over 6 months old. The era of rubber-stamping COVID boosters is over. Boosters will now focus on high-risk groups, and low-risk individuals won’t face new authorizations without gold-standard clinical data. This shift marks a long-overdue return to scientific integrity and medical freedom.
Quote
U.S. FDA
@US_FDA
·
May 21
🧵 Recap: FDA announced an important move yesterday toward a Covid-19 booster program that embraces both gold-standard science and common sense. Here are the details: 🧵
1:41 PM · May 21, 2025
·
408.8K
Views

Many in the MAHA movement have interpreted the article as an announcement of the intent by FDA officials to require COVID‑19 vaccine manufacturers to conduct randomized, placebo-controlled trials to receive continued authorizations or approvals for their products for use in healthy and non-elderly people.

It’s been hailed as a great victory of evidence-based policymaking over the previously prevailing rubber stamping of pharmaceutical products—a clear proof that things are heading in the right direction now that Mr. Kennedy is HHS Secretary under President Trump.

But is it really a victory for health freedom? Or is it just a public relations ploy from the administration that executed “Operation Warp Speed” that aims to disarm longtime critics of public vaccine policies?

Between these two opposing views that have emerged within the health freedom movement, who is right?

As a member of the movement myself since well before Covid and author of the book The War on Informed Consent, which features a Foreword by Robert F. Kennedy, Jr., I respectfully submit that this question is sufficiently answered by a critical examination of FDA guidance proposed by Prasad and Makary in the New England Journal of Medicine.

So, let’s get to it.

Misdiagnosing the “Public Trust” Problem
To answer the question, we must first analyze the operative framework adopted by Prasad and Makary.

Echoing the view of Warp Speed’s executor, they assert that “the rapid development” of COVID‑19 vaccines in 2020 was “a major scientific, medical, and regulatory accomplishment”.

Then they lament that Americans “remain unconvinced” about the benefits of repeated booster doses.

Uptake of the vaccines “has been poor”, they write. Even health care workers “remain hesitant, with less than one third participating in the 2023–2024 fall booster program.”

The central problem, in their view, is that “public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles-mumps-rubella (MMR) vaccination”.

“public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs”
Prasad and Makary thus make clear that their aim is to restore “public trust” in the CDC’s vaccine recommendations.

It is from within that narrow framework that they seek to provide “guidance” to “foster evidence generation.”

The problem, though, is not that the authoritarian COVID‑19 lockdown madness and coerced mass vaccination endgame caused masses of people now distrust the “public health” establishment.

That is rather a necessary part of the solution because the real problem is that the government’s “public health” agencies have perpetually proven themselves to be completely unworthy of our trust.

By misdiagnosing the problem, Prasad and Makary arrive at the predetermined conclusion that the “evidence” generated under their proposed “guidance” will support the goal of restoring “trust” in the continuation of the government’s barbaric vaccine policies.

The Lie about ‘Herd Immunity’
To help illustrate why the goal should not be to convince Americans that they should trust the CDC et al., let’s consider just a few of the countless lies government officials told for the purpose of supporting their policy goal of achieving high vaccine uptake.

Tossed down Orwell’s memory hole by Prasad and Makary is the fact that the entire “public health” establishment brazenly lied that the shots would end the pandemic by creating “herd immunity”.

Supposed health “authorities”—from the CDC on down to healthcare providers—claimed that it was scientifically proven that two doses of an mRNA COVID‑19 vaccine would confer durable sterilizing immunity, stopping infection and transmission of SARS‑CoV‑2.

To support that assertion, they said “the science” said so—a euphemism meaning whatever anti-science preposterousness came out of the CDC or the mouths of people like Dr. Anthony “I represent science” Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID) under the National Institutes of Health (NIH), another subagency of HHS.

According to Fauci, any criticism of his person ipso facto constituted “attacks on science”.


NIAID Director and Chief Medical Adviser to President Biden Dr. Anthony Fauci and CDC Director Dr. Rochelle Walensky hold a White House press briefing on August 2, 2021 (White House/Public Domain)

The truth, of course, was that the clinical trials were not designed to test the hypothesis that the vaccines would stop infection and transmission of the virus. Nor were the vaccines expected to confer this “sterilizing immunity” because—as Fauci later admitted—they weren’t designed to.

As CDC Director Dr. Rochelle Walensky and White House Coronavirus Response Coordinator Dr. Deborah Birx both later admitted, their claims of wondrous vaccine effectiveness were based not on science but “hope”.

When deceiving people into getting the vaccines didn’t work, the method was coercion.

When people including myself tried to warn the public about how the government and mainstream media were lying, the truth was systematically censored from social media by Big Tech companies colluding with the criminal organization in Washington to shred the First Amendment to the US Constitution.

The sin that we truthtellers were guilty of was not the spreading of “vaccine misinformation” but heresy against the vaccine religion.

The Lie about mRNA Persistence
Another lie told by the “public health” establishment was that the mRNA from the vaccines is eliminated from the body “within a few days”.

The faux “fact check” industry insisted this was true, of course, because the CDC said so.

But it wasn’t true.

It was another assumption,or belief,or hope—expressed as fact but subsequently falsified by scientific research.

The purpose of the mRNA in the vaccines is to instruct human cells to produce the spike protein of “severe acute respiratory syndrome coronavirus 2”, or SARS‑CoV‑2.

That’s the official name of the probable creation of dangerous “gain of function” research promoted and funded by Fauci’s NIAID and other government agencies."


Bill Gates with NIH Director Francis Collins and NIAID Director Anthony Fauci at the NIH in June 2017 (Photo by the NIH, licensed under CC BY-NC 2.0)

Infection with this virus is a necessary but insufficient factor in the pathogenesis of the clinical disease called “coronavirus disease 2019”—abbreviated “COVID‑19” and colloquially referred to as just “Covid”.

To ensure delivery into human cells, the mRNA is encapsulated in a lipid nanoparticle, with the idea being to cause the immune system to generate neutralizing antibodies against the SARS‑CoV‑2 spike protein.

It is therefore concerning that the CDC’s claim of mere days of persistence in the human body turned out to be untrue.

A study published in the journal Cell in January 2022, for instance, found vaccine mRNA persisting in some people two months after vaccination.

As observed by the authors of a study published in the Journal of Pathology, Microbiology and Immunology in January 2023, the persistence of vaccine mRNA would enable “prolonged spike protein production”—and therefore, expectedly, continued immune activation and chronic inflammation.

The Lie about Spike Protein Persistence
Accompanying the lie about the vaccine mRNA was the lie that the spike protein persists for at most “a few weeks”.

It was another claim based on hope, not science.

In fact, the spike protein has been found to persist in the body for months if not years.

A study published in Proteomics Clinical Applications in August 2023 found persistence of spike protein at six months post-vaccination.

On May 13 of this year, a study in Human Vaccines & Immunotherapeutics found persistence of spike protein at over eight months post-vaccination.

A study published the previous month found persistence of spike protein in the brains of hemorrhagic stroke patients at seventeen months post-vaccination.

A preprint study in February found persistence of spike protein in individuals at nearly two years post-vaccination.

So much for at most “a few weeks”.

Concerningly, one of the theoretical explanations in the literature for this persistence is continued generation of spike protein because of genetic material from the vaccines integrating into the DNA of vaccinated individuals.

The Lie about the ‘Harmless’ Spike Protein
Accompanying the lies about how long vaccine mRNA and spike protein would last in the body was the lie that the spike is a “harmless” piece of genetic material.

The media uncritically parroted that lie from the CDC despite study after study finding the spike protein to be toxic and pathogenic.

The persistence of spike protein from vaccination is associated with “post-COVID‑19 vaccine syndrome” (PCVS)—a term used in the literature to describe vaccine injuries resembling symptoms of what’s called “Long Covid”.

The Lie about Genomic Integration
The claim was also made by the CDC—and therefore reported as fact by the media—that it was scientifically impossible for the vaccine mRNA to become integrated into human DNA.

The CDC argued that since the mRNA never enters the cell nucleus, where the DNA resides, therefore it cannot integrate into the host genome.

But that is a non sequitur fallacy. The conclusion doesn’t follow from the premise because it overlooks the possibility of mRNA being reverse transcribed into DNA that could potentially enter the cell nucleus and integrate into the host genome.

An in vitro study published in February 2023 proved in the lab that reverse transcription of vaccine mRNA into DNA is possible in human cells.

It’s a salient fact that the vaccines were literally developed using gene therapy technology.

Whenever you would hear the “fact checkers” argue that it’s a “myth” that the vaccines were a brand-new technology because there were decades of research behind them, the allusion was to years of development of mRNA technology for gene therapy applications.

The professional propagandists masquerading as journalists just left out that little detail.


AI-generated visualization of foreign DNA integrating into chromosomal DNA inside a human cell (Generated by Jeremy R. Hammond using ChatGPT)

The FDA-Ignored DNA Contamination
In the literature, one argument made in favor of mRNA is that it is safer for gene therapy since DNA products would pose a greater risk of permanent alteration of the host genome.

And it has been known since early 2023 that reverse transcription of mRNA into DNA isn’t even necessary for genomic integration to theoretically occur because the vaccines are contaminated with plasmid DNA from the manufacturing process.

Accompanying the DNA contamination is what’s called a “promoter” sequence from simian virus 40—the “SV40” virus that infamously contaminated polio vaccines in the 1950s and 1960s.

While it is a short segment contaminating COVID‑19 vaccines, not the whole viral sequence, the SV40 promoter is known to help transport DNA through the nuclear membrane.

And once inside the nucleus, the foreign DNA can theoretically integrate into the host genome.

In fact, it is to reduce that risk that the FDA has set regulatory safety limits on the levels of DNA allowed in injectables.

As accurately observed by intrepid reporter Dr. Maryanne Demasi—a rare honest journalist—in an article about the FDA guidance proposed by Prasad and Makary,

Multiple independent labs have shown that residual DNA in the vaccines far exceeds safety limits. Student researchers in FDA’s own lab found residual DNA levels exceeded safety limits by up to 470 times. Yet the FDA continues to ignore this evidence. [Emphasis added.]

Prasad and Makary, too, ignore this evidence in their proposal to restore “trust” in the CDC’s vaccine recommendations while continuing push the mRNA COVID‑19 vaccines on the population.

Prasad and Makary’s Cognizance of the Lies
The two individuals proposing the new guidelines in the New England Journal of Medicine are certainly not incognizant of how the COVID‑19 vaccines were sold to the public based on lies.

As Demasi also pointed out, both men signed a Citizen Petition to the FDA in January 2023 criticizing government officials for claiming that the COVID‑19 vaccine would confer “herd immunity”, even though the clinical trials were not designed to determine whether the vaccines would prevent infection and transmission of the virus.

The petition also observed the dramatic increase in reports to the Vaccine Adverse Event Reporting System (VAERS) following the COVID‑19 vaccine rollout, dwarfing all other events reported for the entire history of the program.



They don’t mention it, but that includes over 38,000 reports of death following COVID‑19 vaccination—more than the number of deaths reported for all other vaccines combined for the life of the program.

Whenever safety signals are indicated by VAERS, the mainstream media feel it obligatory to point out that a causal relationship cannot be established by this data.

It is highly instructive how the media, to reassure the public about the safety of vaccines, tout VAERS as a robust post-marketing surveillance system that would identify any existent harms of vaccination; yet when the data show alarming safety signals, suddenly VAERS becomes terribly unreliable and unfit for purpose.

This is institutionalized cognitive dissonance.

The Unproven Mortality Benefit of COVID‑19 Vaccines
Another lie told by government officials was that the clinical trials demonstrated high vaccine effectiveness against severe illness or death from COVID‑19.

That claim was made, for instance, by CDC Director Rochelle Walensky and NIAID Director Anthony Fauci.

In an article published in February 2021 in JAMA, the journal of the American Medical Association, Walensky and Fauci brazenly lied that “Clinical trials have shown that the vaccines authorized for use in the US are highly effective against COVID-19 infection, severe illness, and death.”

In fact, the outcome measured in the trials as the basis for estimating vaccine efficacy was symptomatic infection.

Measurement of this outcome was based on the existence one or more symptoms of COVID‑19—whether severe or mild—plus a positive PCR test.

“Clinical trials have shown that the vaccines authorized for use in the US are highly effective against COVID-19 infection, severe illness, and death.”
The trials were not designed to determine effectiveness against the most important outcomes: severe disease, hospitalization, and death.

While severe outcomes were considered a “secondary endpoint” of the trials, they lacked adequate statistical power to assess vaccine efficacy for those outcomes.

Then once the FDA granted the vaccines “Emergency Use Authorization” (EUA) in December 2020—which is a regulatory status for products still considered experimental—the trials were effectively ended by vaccinating away the control groups.

Consequently, there remains a total absence of data from randomized controlled trials from which to determine long-term health outcomes between vaccinated and unvaccinated individuals, including the effects of these mRNA products on all-cause mortality.

This is not a trivial oversight.

Even if effective for preventing death from the target disease, vaccines can have an overall negative impact on mortality.

This is because vaccines can have what are termed in the literature “non-specific effects”, which refers to effects of vaccinations unrelated to the intended effect of preventing illness and death from the target disease.

Two top researchers in this field are Dr. Peter Aaby and Dr. Christine Stabell Benn. An example of a detrimental non-specific effect they have highlighted is the diphtheria, tetanus, and whole cell pertussis (DTP) vaccine, which—like “non-live” vaccines in general—is associated with an increased rate of childhood mortality.

Aaby and Benn were among the authors of a study published in the Lancet journal eBioMedicine in 2017 finding that children who received the DTP vaccine “had 5-fold higher mortality than still unvaccinated children.”

As the researchers appropriately remarked:

It should be of concern that the effect of routine vaccinations on all-cause mortality was not tested in randomized trials. All currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase susceptibility to unrelated infections. [Emphasis added.]

Government policymakers, however, refuse to learn from the lessons offered by scientific inquiry.

They completely ignore the need for long-term studies to determine the effects of vaccines on overall health and all-cause mortality, just like they completely ignore the need to consider superior natural immunity as an opportunity cost of vaccination, or the need for an individualized risk-benefit analysis.

To obtain authorization, the FDA did not require the COVID‑19 vaccine manufacturers to provide evidence for a mortality benefit of their products—and hence the pharmaceutical companies did not design their studies to test the hypothesis that there would be.

In fact, the six-month follow up data from Pfizer’s trial, published in the New England Journal of Medicine, showed fourteen deaths in the placebo group, only two of which were attributed to COVID‑19, and fifteen deaths among vaccinated subjects, resulting in an equivalent rate of death in both groups.

A notable disparity was one death from heart attack in the placebo group versus four among the vaccinated.

“I guess most of you think that we know what all our vaccines are doing. We don’t.”
Aaby and Benn were also coauthors of a Lancet preprint study published in April 2022 that reanalyzed clinical trial data for both Pfizer’s and Moderna’s products and found no mortality benefit from the mRNA COVID‑19 vaccines.

As another illustration of the institutionalized cognitive dissonance, observational studies are routinely touted by the CDC and media as absolute proof of an absence of harm from vaccines—yet whenever such a study does find an association between vaccination and some harm, we are reminded that this type of study design cannot prove causality.

As Dr. Aaby stated during a talk he gave in March 2019, “it’s important to recognize that no routine vaccine was tested for all the effect on mortality in randomized trials before being introduced.”

“I guess most of you think that we know what all our vaccines are doing,” he added. “We don’t.”

Source: https://youtube.com/watch?v=kncohD7yWIc

‘Safe and Effective’ or Highly Dangerous?
Setting aside the unproven claims of a beneficial effect on mortality, the FDA’s rubber stamping of COVID‑19 vaccines allows them to be marketed as “safe”.

We’ve already seen how that assertion is challenged by VAERS data. The many harms from the shots are also abundantly documented in the literature by observational studies, but even the data from the randomized controlled trials used by the FDA as supporting evidence call the description of “safe” into question.

A reanalysis of trial data published in the journal Vaccine in September 2022 found that the mRNA COVID‑19 vaccines “were associated with an excess risk of serious adverse events of special interest [AESI] of 12.5 per 10,000 vaccinated”—a 43% greater risk of an AESI in the vaccinated relative to the placebo control group.

In both Pfizer and Moderna trials, the excess risk of such serious adverse events “was higher than the risk reduction for COVID‑19 hospitalization relative to the placebo group”.

In other words, getting vaccinated was more likely to result in hospitalization for a serious adverse event of special interest than to prevent hospitalization for COVID‑19.

The ‘Badly Designed’ COVID‑19 Vaccine Clinical Trials
Problems with the COVID‑19 vaccine trials were also highlighted in a paper published this past January in the Journal of the Academy of Public Health.

The notable authors were Dr. Jay Bhattacharya and Dr. Martin Kulldorff, who also co-authored the Great Barrington Declaration of October 2020, which criticized the lockdowns and advocated the more sensible approach of “focused protection”.

Dr. Bhattacharya was nominated by Donald Trump to direct the National Institutes of Health (NIH) and has served in that role since April.

As Bhattacharya and Kulldorff noted in their paper, the original trials were “badly designed”.

The “fundamental design flaws” included the failure to measure the most important clinical endpoints: severe disease, hospitalization, and death.

They also acknowledged how government officials who routinely made claims about vaccine effectiveness that were unsupported by the scientific evidence—which they generously attributed to “a failure in the interpretation of the trials”.

As Bhattacharya and Kulldorff also observed,

When the bivalent booster was developed in 2022, pharmaceutical companies did not conduct proper randomized control trials. Instead, Pfizer and Moderna ran trials that had the immunogenicity of the bivalent boosters as the primary clinical endpoint. [Emphasis added.]

In other words, the FDA “looked only at whether the vaccine could produce antibodies in the patient population.”

Data from human subjects wasn’t even required. Pfizer’s trial “looked only at immunogenicity in mice.”

It was on that basis that the FDA rubber-stamped the shots.

In conclusion, Bhattacharya and Kulldorff called on the FDA to “require pharmaceutical companies to conduct trials with clinically and epidemiologically meaningful endpoints”—instead of trials that are “not useful.”

So, there you have it, straight from the current NIH director: the clinical trials used by the FDA rubber stamp the mRNA COVID‑19 were useless."

Continued

[onawah]

Continued
"The Regulatory Malfeasance and Scientific Fraud of FDA Authorizations
The Regulatory Malfeasance and Scientific Fraud of FDA Authorizations
When it comes to the continued practice of mass vaccinating children and pregnant women, it gets even worse.

To this day, the COVID‑19 vaccines remain FDA unapproved for children aged six months through eleven years.

Instead, the shots continue to be administered for this age group under “emergency use” authorization—notwithstanding the complete absence of any kind of emergency that could possibly justify such a mass uncontrolled experiment on the US childhood population.

To describe this as criminal recklessness is an understatement.

The FDA’s authorizations for young children were also not based on clinical trial data demonstrating safety and efficacy.

Instead, the FDA relied on “immunobridging” data. The FDA assumed vaccine effectiveness based on an arbitrarily defined level of antibodies in the blood.

In other words, the FDA relied on measurement of antibody levels generated by vaccination as a surrogate measure of immunity—even though no correlates of immunity have been scientifically validated for SARS‑CoV‑2.

In essence, to push through authorization of the vaccines for children, the FDA relied on scientific fraud.

Vinay Prasad and Marty Makary are perfectly aware of how unscientific the FDA’s authorizations were.
In their citizens petition to the FDA, they also criticized the agency for not requiring COVID‑19 vaccine manufacturers Pfizer and Moderna to disclose in their package inserts that the measurement of antibody levels as a “surrogate endpoint” for vaccine effectiveness “has not been validated”.

Additionally, they cited an FDA advisory committee meeting in which a Pfizer representative acknowledged that they were “unable to really come up with an antibody threshold” because immunity is “a much more complex story and not just easily addressed with neutralizing antibodies.”

The FDA itself admitted at the meeting that measurement of antibodies has not been established as an “immune correlate of protection”, so in lieu of clinical trials demonstrating efficacy, the FDA was “using poor man’s immune correlates of protection”.

Additionally, pregnant women were excluded from the COVID‑19 vaccine clinical trials on the grounds that it would be unethical to subject expectant mothers to experimentation.

Yet the CDC recommends the shots for pregnant women, anyway, thus effectively moving the experiment out of a controlled clinical setting and instead treating the general population of pregnant women as subjects of a mass uncontrolled experiment in which properly informed consent is a logical impossibility.

So, ask yourself: Who is HHS really serving?

Is this really in the best interests of public health—or primarily to serve the financial interests of the pharmaceutical industry?

The answer to that question ought to be glaringly obvious to any sane person capable of rational and independent thought.



Flu Shots During Pregnancy
The CDC recommends influenza and pertussis vaccines for pregnant women despite the vaccine manufacturers stating in their package inserts that adequate safety studies have not been done to determine the risk of this practice. (Public Domain photo courtesy of Max Pixel)

The Scientific Fraud of PCR Testing
We’ve already seen how the original trials asked the wrong question: whether the vaccines reduced the risk of symptomatic infection, instead of whether they reduced the risk of severe disease and death.

Aside from that problem, the resulting estimates of vaccine effectiveness may have been exaggerated due to the tool used to measure the primary endpoint: a positive PCR test.

The PCR tests for COVID‑19 are designed to detect tiny fragments of viral RNA, not to confirm the presence of whole viable virus.

Consequently, a positive result does not necessarily mean that the patient has an active infection.

The tests work by reverse-transcribing viral RNA into DNA and then cyclically amplifying the DNA until it meets a certain threshold for positivity.

This is called the “cycle threshold”, or “Ct” value.

The PCR tests for COVID‑19 are designed to detect tiny fragments of viral RNA, not to confirm the presence of whole viable virus.
During the lockdown madness, cycle thresholds for test positivity were set so high that, as the New York Times admitted in August 2020, “up to 90 percent of people testing positive carried barely any virus” and were “not likely to be contagious.”

Dr. Anthony Fauci himself admitted in July 2020 that PCR tests were being run at such high cycle thresholds that “the chances of it being replication competent are miniscule”, and the amplified RNA most likely represented “just dead nucleotides, period.”

This didn’t stop the “public health” establishment from counting anyone testing positive as a “COVID‑19 case”—regardless of symptoms.

In other words, to support “lockdown” policies and their coerced mass vaccination endgame, PCR tests were used to perpetrate systematic scientific fraud in the counting of “COVID‑19” cases.

The clinical trials for COVID‑19 vaccines upped the standard a bit: instead of just a positive PCR test, the FDA also required the presence of one or more symptoms of COVID‑19. Any mild symptom would do.

Exclusion of other potential causes for the reported symptoms was not required.

While that minimal standard may have reduced the likelihood of false positive PCR results, it did not solve the inherent problem of a false discovery rate.

“There are no credible COVID‑19 vaccine trial data.”
The false positive rate is related to test specificity and indicates the proportion of tested individuals who receive a positive PCR test despite not having a viral infection.

The false discovery rate is related to disease prevalence and indicates the probability that someone who receives a positive PCR test result does not actually have a viral infection.

The distinction is in the denominator: for the false positive rate, it’s everyone tested who does not have a viral infection, whereas for the false discovery rate, it’s everyone in the population who tests positive.

Imagine that the PCR test is 99% specific, meaning that, among everyone in a population who is tested, one out of every hundred people who are uninfected will receive a positive result. The false positive rate is 1%.

Now suppose that only one out every hundred people in the population have an infection, or a disease prevalence of 1%.

For every 1,000 people tested, only ten will have an infection. That leaves 990 people who are not infected—but among whom about 1% will still receive a positive PCR test result.

The result is twenty positive results, including ten false positives. That’s a false discovery rate of 50%.

Thus, when testing large numbers of people in a low-prevalence setting, even a highly specific PCR test can produce a high proportion of incorrect “positive” results.

In an October 2022 study in the journal Science, Public Health Policy & the Law, Dr. Sin Hang Lee, a pathologist and director of the Milford Molecular Diagnostics Laboratory in Connecticut, explained how the cycle threshold values for PCR tests were “an unproven surrogate” for detection of whole viable virus.

Technically, these are “reverse transcription quantitative polymerase chain reaction” assays, or RT-qPCR tests, typically referred to by the media as just “PCR” tests.

Dr. Lee used Sanger sequencing, a gold-standard method for verifying the nucleotide sequence of PCR-amplified DNA fragments, to reexamine test-positive patient samples acquired that January.

He found that SARS‑CoV‑2 was detected by both PCR and Sanger sequencing in only twenty-nine of fifty samples—a false discovery rate of 42%.

As Dr. Lee remarked,

Using RT‑qPCR tests with false-positive results to evaluate the endpoint in COVID‑19 vaccine development might have artificially inflated the vaccine effectiveness. . . . Without confirmatory Sanger sequencing of the RT‑qPCR products, the claim of the BNT162b2 [Pfizer-BioNTech COVID‑19 vaccine] being 95% effective against COVID‑19 becomes questionable. [Emphasis added.]

Dr. James Lyons-Weiler, Editor-in-Chief of the publishing journal, Science, Public Health Policy & the Law, further elucidated the implications. Assuming a 5 percent disease prevalence rate in the population, the 42% false discovery rate would mean that for every fifty true positives, there will be thirty-six false positive results. The number of “COVID‑19 cases” reported based on PCR testing would be overstated by a factor of 72%.

As Dr. Lyons-Weiler concluded, “There are no credible COVID‑19 vaccine trial data.”

That’s in addition to all the fatal flaws that prompted the current NIH director to characterize the clinical trials as worthless.

The argument could easily be made that the trials were much less than worthless.

Critical Analysis of the Proposed FDA Guidance
There’s also much more that could be said about the problems with COVID‑19 vaccines, like the immunological phenomenon of “original antigenic sin”, the problem of antibody class switching from neutralizing antibodies to IgG4 and potential “immune tolerance” to the spike protein, or the institutionalized failure to consider superior natural immunity as an opportunity cost of vaccination; but all of the above information is sufficient context for putting the newly proposed FDA guidance into proper perspective.

Recall the key question: Was this journal article by FDA officials a big victory for health freedom, or a public relations ploy aimed at disarming the health freedom movement?

So now, to try to find a reasonable answer to that critical inquiry, let us continue our examination of the guidance proposed by Prasad and Makary under the leadership of HHS Secretary Kennedy, who is in turn acting under the ostensible “leadership” of President Trump.

An Opinion Piece, Not FDA Policy
To start with, the article by Prasad and Makary in the New England Journal of Medicine does not represent any kind of official FDA guidance to the industry.

It is instead essentially an opinion piece reflecting the authors’ views and stated intentions, which is quite different from a change in government policy.

There is no legal or regulatory force behind their proposed guidance, and the ideas proposed would still need to be formally adopted within the FDA regulatory apparatus.

It’s a proposed change, not an achieved one—and this is not a trivial distinction.

Regulatory Sleight-of-Hand
According to Secretary Kennedy, the proposed new guidance shows that the FDA “is finally breaking away from the one-size-fits-all vaccine policy that authorized the COVID shots for every American over 6 months old.”

However, that conclusion is unsupported by Prasad and Makary’s description of the proposed FDA guidance for vaccine manufacturers.

Consider the following points:

Under the current regulatory structure, the FDA authorizes or approves formulations of COVID‑19 vaccines—not their specific use as a primary series versus booster doses.
The original vaccine trials were conducted for—and the initial authorizations were based on—formulations that are no longer in use and that aimed to generate neutralizing antibodies to the original Wuhan strain of SARS‑CoV‑2, which has long since been extinct outside of laboratories.
Because this coronavirus is constantly evolving, the manufacturers are instructed by the FDA produce “updated” formulations.
Each new formulation is designed to induce a sufficient level of neutralizing antibodies against the mutated spike protein to meet the regulatory “immunobridging” requirement.
The FDA does not require the manufacturers to provide clinical trial data supporting the safety and effectiveness of new formulations.
It is important to recognize that by limiting their proposed new FDA guidance strictly to booster doses, Prasad and Makary are indicating that, when it comes to the primary series of COVID‑19 vaccinations, absolutely nothing will change.

The FDA will not require supporting data from randomized controlled trials to support any new authorizations or approvals of “updated” COVID‑19 vaccines intended for use in previously unvaccinated individuals, including children and pregnant women.

On that basis alone, the proposed guidance must be seen as a cynical public relations stunt, not a sincere and honest effort to establish an evidence-based approach to vaccine regulation.

Making Randomized Controlled Trials Voluntary
After establishing the goal of restoring “trust” in the CDC’s vaccine recommendations and limiting their questioning of those recommendations to only annual COVID‑19 booster shots, Prasad and Makary begin to outline their proposed new FDA guidance as follows:

Moving forward, the FDA will adopt the following Covid‑19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titres in people—the FDA anticipates that it will be able to make favorable benefit-risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid‑19 outcomes, as described by the CDC. For all healthy persons—those with no risk factors for severe Covid‑19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a Covid‑19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of the post-marketing commitment. [Emphasis added.]

Let’s break that down and read between the lines.

First, they clearly indicate that, to ensure future authorizations of COVID‑19 booster doses for the elderly or anyone else with a “risk factor”, the FDA will continue relying on its “immunobridging” fraud—not placebo-controlled trials.

That is, the FDA would predetermine that “booster” doses of new COVID‑19 vaccines are “safe and effective”, provided the shots induce an arbitrarily determined level of antibodies.

Only if the manufacturers also wish their target market to include non-elderly people deemed “healthy” would the FDA require new randomized controlled trials.

In other words, whether new trials are conducted is entirely up to the vaccine manufacturers.

It doesn’t take a genius to anticipate the outcome of that disincentivizing framework.

The Broad Exclusionary Criteria for Voluntary Trials
As if it weren’t bad enough already that the proposed FDA guidance would essentially make new clinical trials voluntary, Prasad and Makary go further in their instructions to COVID‑19 vaccine manufacturers for how to ensure EUA status or licensure.

In their journal article, they provide a table listing “underlying conditions” that the CDC has defined as “risk factors” for severe COVID‑19.

The list includes asthma; heart disease; diabetes; obesity; kidney, liver, or lung disease; immunodeficiency; cancer; use of corticosteroids or other immunosuppressive drugs; and current or former smoking.

Here is the full list presented in the NEJM article:



By their own reckoning, Prasad and Makary anticipate that these criteria will facilitate the continued use of COVID‑19 booster shots for between 30% and 60% of the US population without requiring evidence from randomized controlled trials to support the policy.

Note that the list also includes pregnancy.

So, these top FDA officials—now branded as “MAHA” leaders—are instructing COVID‑19 vaccine manufacturers, if they would like to conduct voluntary trials, to exclude pregnant women.

The FDA’s Preferred Study Design
Continuing in their article, Prasad and Makary further detail “the FDA’s preferred study design” for any voluntary trials.

To start with, they describe the “ideal population” for such trials as “the 50–64 year-old age group”.

In other words: Go ahead and exclude anyone under age fifty.

Prasad and Makary also tell Big Pharma what endpoint they should measure:

The FDA’s preferred primary end point in these trials will be symptomatic Covid‑19, with special attention paid to several secondary end points: severe Covid‑19, hospitalization, and death.

In other words: Go ahead and repeat the same poor design of your original trials that rendered them useless in the first place.

Under the proposed FDA guidance, the primary endpoint any new clinical trials would remain the same as the original trials: one or more symptoms of COVID‑19 plus a positive PCR test.

Like the original trials, meaningful clinical outcomes will be mere “secondary end points” to which the manufacturers should pay some attention, but for which they won’t be required to generate statistically significant data.

For the original trials, the FDA required an average estimated effectiveness against symptomatic infection of 50%. Prasad and Makary don’t specify what it would be for new trials. They only state that

Sample-size calculations should aim to demonstrate that vaccines reduce the incidence of the primary end point with a lower confidence interval bound that is ideally above 30%.

They don’t say what the upper confidence interval bound should be.

Why cite a lower bound without an upper bound? And instead of providing expected boundaries for confidence intervals, why wouldn’t they just state what average vaccine effectiveness would be acquired to gain FDA authorization or approval? Unless the aim was to leave enough wriggle room to authorize the shots even if falling short of 50% effectiveness against the practically meaningless endpoint of symptomatic infection?

In one regard, at least, the FDA officials appear to suggest a modest improvement over the original trials, which generally excluded people with a prior history of SARS‑CoV‑2 infection.

Of course, that didn’t stop the CDC from recommending the shots for people who’d already acquired natural immunity—which Prasad and Makary concede is “robust.”

Ostensibly to correct that oversight, Prasad and Makary suggest, “People who have had Covid‑19 in the past year should not be excluded—since evidence is needed for the average American.” (Emphasis added.)

That makes it sound as though the aim of their guidance is to produce data representative of the general US population. But that can’t be true since the average American isn’t healthy.

Ergo, there is again an encrypted underlying instruction here for the vaccine manufacturers wishing to target “healthy” Americans with their products: Go ahead and exclude from your trials anyone whose natural immunity to SARS‑CoV‑2 prevented them from getting COVID‑19 within the past year.

“The control group could receive a saline placebo, to permit documentation of the full adverse-event profile.”
Continuing, the FDA officials state that to “provide reassurance” to Americans that the “repeat-boosters-in-perpetuity strategy is evidence-based”, the duration of follow-up would need to be at least six months.

That’s enough time to enable the FDA to say it hasn’t lowered the standards from the original trials while enabling the vaccine manufacturers to hopefully avoid a finding of negative vaccine effectiveness, as observational studies have found when looking beyond six months since vaccination—including for children.

Furthermore, the use of a saline placebo would not be required.

Instead, Prasad and Makary explain that “The control group could receive a saline placebo, to permit documentation of the full adverse-event profile.” (Emphasis added.)

One must assume that the choice of the verb “could” instead of “must” was not unintentional.

“Balancing” Pharma Profits with Public Health
After providing those instructions to the vaccine manufacturers for how they can essentially rig any voluntarily conducted trials, Prasad and Makary preposterously assert that their proposed guidance “balances competing values.”

Just what “values” are they trying to “balance”?

“First,” they explain, “our acceptance of immunologic end points ensures that we can provide timely approval to a broad population.”

Translation: We need to serve Big Pharma’s financial interests by continuing the mass uncontrolled experiment of injecting millions of people with annual COVID‑19 shots, and so, to achieve that predetermined goal, we are going to continue perpetrating scientific fraud.

As they point out, “The range of diseases in the CDC definition of high risk of severe disease is vast, including obesity and even mental health conditions such as depression.”

Not to mention pregnancy.

“Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”

Hooray. Mission accomplished.

The first “value” they wish to “balance” against other “competing” interests is thus to ensure profits for Big Pharma.

“The FDA’s new Covid‑19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.”
“Second,” they write, “our policy also balances the need for evidence.”

Translation: We must lower on our standards of evidence to be able to continue the policy of mass COVID‑19 vaccination.

They assert, “This policy will compel much-needed evidence generation.”

Except that it won’t. Any randomized controlled trials the manufacturers might conduct will be strictly voluntary, and even if they are conducted, they will just be more sham studies.

Demand for the shots is already low. As of April, according to the CDC, only 20.4% of adults have received the 2024 – 2025 formulations of COVID‑19 vaccines, with highest coverage among the elderly, among whom uptake is still just 39.1%.

Consequently, we can anticipate that Big Pharma will be willing to deprioritize healthy people under age 65 as a target population for their products to avoid having to produce evidence that the vaccines are safe and effective.

And even if not, whether a saline placebo is used for the control group will likewise be up to the manufacturers.

“Third,” Prasad and Makary continue, “our proposed postmarketing study does not preclude the conduct of additional randomized studies, particularly studies in pediatric populations.”

Translation: We’re not going to require you to conduct trials to provide evidence for our continued authorization of your products for children.

In concluding, they assert that “The FDA’s new Covid‑19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.”

But that is an inherent self-contradiction.

If they were committed to gold-standard science, they wouldn’t try to “balance” the need for evidence with their policy goal of continuing to inject millions of people with COVID‑19 shots annually.

The “regulatory flexibility” they refer to requires them to adopt such standards of evidence that the word “abysmal” hardly even applies; a more proper description is outright scientific fraud.

Their assertion that this represents “gold-standard science” is preposterous, an outrageous ongoing effort to gaslight the public—and now with the approval of the “MAHA” leadership.

The proposed FDA guidance would essentially continue to place the burden on the public to prove that a pharmaceutical product is dangerous and ineffective before it is pulled from the market—as opposed to requiring COVID‑19 vaccine manufacturers to prove that their gene therapy products are “safe and effective”.

Conclusion
This is a defining moment for the health freedom movement, and all the warrior moms and dads who’ve long been active in the grassroots health freedom movement are now being asked by people in the political “MAHA” movement to accept extraordinary compromises.

That is not an easy ask for many of these warriors—including all the “ex-vaxxers” who did follow the CDC’s recommendations only to see their children injured or killed by vaccines.

These victims of medical tyranny should not be told to be silent and withhold criticism on the grounds that we must support Bobby Kennedy and “trust” the plan.

People long involved in the fight against medical authoritarianism—whether parents or not—should not be ridiculed and dismissed with the strawman fallacy that they are expecting miracles from Secretary Kennedy when the miracle of government reform is precisely what Mr. Kennedy promised them if they voted for Donald Trump.

It comes down to the question of correct diagnosis.

Secretary Kennedy and many of his MAHA supporters diagnose the problem as “corporate capture” of government agencies like the FDA and CDC, and they fervently believe that if only the right person can be put into position within the halls of power that America will be made healthy again.

But the fundamental problem isn’t that corporations use government power to circumvent the free market to advance their financial agendas. The problem is that government agencies like the FDA and CDC exist to be captured in the first place.

It simply isn’t the case that the CDC et al. are “broken” and need to be “fixed”. There are no reforms that could possibly fix them because they are functioning exactly according to design.

Epilogue
Since I first conducted and started writing this analysis of the journal article by Prasad and Makary, on May 27, Secretary Kennedy posted a message to X stating that the recommendation “for healthy children and healthy pregnant women” had been removed from the CDC’s vaccine schedule.

His post contained a video of him making the announcement while standing alongside NIH Director Bhattacharya and FDA Commissioner Makary.

https://x.com/SecKennedy/status/1927...ne-guidance%2F

Secretary Kennedy

@SecKennedy
Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from
@CDCgov
recommended immunization schedule. Bottom line: it’s common sense and it’s good science. We are now one step closer to realizing
@POTUS’s promise to Make America Healthy Again.
0:28 / 0:58
9:16 AM · May 27, 2025
·
7.2M
Views

Accessing the CDC’s routine childhood vaccine schedule on the CDC’s website at the time showed that the last time this page had been updated was November 21, 2024. The page has now been updated as of May 29. The COVID‑19 vaccine, of course, remains on the schedule, with a link directing users to an updated “Notes” page.

The recommendation remains for COVID‑19 vaccination of children “Ages 6 month – 17 years who are NOT moderately or severely immunocompromised.”

The relevant change is that the CDC now states,

Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.

A link is provided to another page further explaining that a “shared clinical decision-making recommendation” is “when individuals may benefit from vaccination, but broad vaccination of people in that group is unlikely to have population-level impacts.”

Of course, all vaccinations should be based on an informed decision process between the health care provider and the patient or parent, and the fact that the CDC rejects this for other vaccinations just illustrates how perverse the system is.

There is nothing about the recommendation for COVID‑19 vaccination to occur as part of this “shared clinical decision-making” excluding healthy children.

As I’m writing this, the CDC’s page “COVID‑19 Vaccination for Women Who are Pregnant or Breastfeeding” still recommends the shots for pregnant women, declaring this “safe and effective” despite the absence of clinical trial data to support that claim.

The page indicates it was last updated on September 10, 2024, but a banner under the page title says, “COVID-19 vaccine recommendations have recently been updated for some populations. This page will be updated to align with the updated immunization schedule.”

Clicking the link to “learn more” lands one on the CDC’s vaccine schedule page, updated on May 29. Clicking from there to view the adult schedule, the COVID‑19 vaccine is listed as a “Recommended vaccination for adults who meet age requirement, lack documentation of vaccination, or lack evidence of immunity”.

Clicking to view the “Notes” page, it states that COVID‑19 vaccination is recommended for adults “Age 19–64 years”.

There is nothing on either page about healthy pregnant women being excluded from the CDC’s recommendation.

The only relevant change is to a second table listing recommendations by medical condition instead of by age. Previously, this table explicitly recommended COVID‑19 vaccination for pregnant women, whereas now “Pregnancy” is shown as a category for which the CDC offers “No Guidance”.

The CDC’s “Notes” page explains that healthcare providers should first look at the table listing recommendations by age, then by medical condition, then to consult the CDC’s dosing information on the same page, and finally to review the CDC’s contraindications and precautions.

Pregnancy is not listed as a contraindication to COVID‑19 vaccines or as a condition warranting any precautions.

The American Academy of Pediatrics (AAP), which colludes with the CDC to make its recommendations “standard of care” in pediatric practices across the country, “expressed relief” about the updated recommendations not matching Kennedy’s statement.
It appears that Kennedy’s claim that the CDC had removed its recommendation that healthy children and healthy pregnant women receive the shots was incorrect.

As Axios accurately observed, the CDC continues to recommend the shots for all children aged six months or older after consultation with a medical provider, thus “contradicting HHS Secretary Robert F. Kennedy’s push to drop the shots for healthy kids.”

The American Academy of Pediatrics (AAP), which colludes with the CDC to make its recommendations “standard of care” in pediatric practices across the country, “expressed relief” about the updated recommendations not matching Kennedy’s statement.

Similarly, the updated recommendations do not exclude pregnant women, healthy or otherwise. Instead, the CDC opted to provide no specific guidance for vaccination during pregnancy while generally recommending the shots for all adults, especially those considered at higher risk from COVID‑19, while also telling providers that this list includes pregnant women.

That is hardly the same thing as the CDC excluding healthy pregnant women from its recommendations.

Since I finished writing my above analysis of the proposed FDA guidance, the FDA has approved Moderna’s new mRNA COVID‑19 vaccine, “mNEXSPIKE”. According to Moderna’s May 31 press release, it’s been approved “for use in all adults 65 and older, as well as individuals aged 12–64 years with at least one or more underlying risk factor [sic] as defined by the Centers for Disease Control and Prevention (CDC).”

Actually, though, the FDA approved mNEXSPIKE “for use in individuals” meeting those criteria and who also “have been previously vaccinated with any COVID‑19 vaccine”. In other words, it has been approved specifically for use as a booster shot.

A footnote for that misleading statement in the press release links to the CDC’s page “Underlying Conditions and the Higher Risk for Severe COVID-19”, where it shows a list of these “risk factors”—including “Pregnancy and recent pregnancy”.

The press release explains how the FDA’s approval of the new vaccine was based on a clinical trial of “11,400 participants aged 12 years and older” designed “to demonstrate the non-inferior vaccine efficacy” compared to Moderna’s originally approved mRNA COVID‑19 vaccine, “Spikevax”.

The new vaccine “was found to have a similar safety profile” to the old one—which is hardly reassuring.

The new Moderna product was described as “a step toward next-generation coronavirus vaccines” by CBS News, which noted that it’s “a second option” and “not a replacement for the company’s existing shot”, which “doesn’t face those limits” of being approved only for individuals with “risk factors”.

Pregnant women were, of course, excluded from the clinical trial for Moderna’s new vaccine. It was a vaccinated versus vaccinated study, with no placebo control group.

For one arm of the study, only individuals previously vaccinated with a primary series were included, and for those over age 18, prior receipt of at least one booster does was required. A second arm did not require prior vaccination.

Moderna measured individuals’ “seroresponse” to the vaccine, or the change in antibody levels, and only estimated vaccine effectiveness relative to its original formulation.

The trial’s page on the database site ClinicalTrials.gov indicates that the trial data has not been published.

As with the original vaccines recommended by the CDC for pregnant women, the package insert for “mNEXSPIKE”—available on the FDA’s website—discloses that available data “are insufficient to inform vaccine-associated risks in pregnancy.”

Like the original vaccines, the new product “has not been evaluated for potential to cause carcinogenicity, genotoxicity, or impairment of male fertility in animals.”

The reference in that statement to “male” fertility only is because a study was done in female rats. Moderna claims no “vaccine-related” adverse effects were observed, which raises the question of what effects were observed that Moderna presumed were unrelated. Notably, the description of this animal study does not indicate that an unvaccinated group of female rates was used for comparison.

The data disclosed in the insert reveals that the estimated relative vaccine efficacy of 9.3% was not statistically significant. That is, the new shot was not shown to offer significantly greater protection against symptomatic infection with circulating SARS‑CoV‑2 variants than the original vaccine targeting the spike protein of the original Wuhan strain. Effectively, the FDA approved the shot based only on antibody data and the scientific fraud of assuming that an arbitrarily determined increase equates to immunity.

This is what the FDA vaccine approval process looks like for the “next generation” of mRNA products under the now “MAHA”-approved regime.

The critical distinction between the uncompromising grassroots movement and the political charade in Washington should not be lost on health freedom advocates."

About Jeremy R. Hammond
I am an independent journalist dedicated to exposing state propaganda designed to manufacture consent for criminal government policies. I provide deeply researched analyses on critical issues including US foreign policy, the economy, and health freedom.

I am a Research Fellow at The Libertarian Institute and author. My books include Obstacle to Peace: The US Role in the Israeli-Palestinian Conflict and The War on Informed Consent.

Learn more about my mission and core values
Follow and connect https://www.jeremyrhammond.com/links/

[TrumanCash]

U.S. Health Secretary RFK Jr. Fires Entire CDC Vaccine Advisory Panel in Stunning “Clean Sweep”

U.S. Health Secretary Robert F. Kennedy Jr. has abruptly dismissed all 17 members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP)—the federal body that shapes America’s vaccine policy.

In a blistering op‑ed published Monday in The Wall Street Journal, RFK Jr. declared the panel “plagued with persistent conflicts of interest” and branding the current members as a shadowy cabal heavily influenced by pharmaceutical money.

He demanded “a clean sweep is needed to re-establish public confidence in vaccine science.”

It can be recalled that the ‘unsafe and ineffective’ COVID-19 vaccine was formally added to the routine immunization schedule for both children and adolescents by the Centers for Disease Control and Prevention (CDC) on Thursday.

It is common knowledge that COVID-19 poses no threat to young children, that mRNA vaccinations against the virus are not effective or safe and that some people have even died after receiving a COVID vaccine. But the CDC and its advisory council continue to push for childhood vaccinations despite all these facts.

Back in October 2022, the CDC’s Advisory Committee on Immunization Practices (ACIP), which provides advice and guidance to the Director of the CDC regarding the use of vaccines for the control of vaccine-preventable diseases, voted to recommend COVID-19 to be included in the 2023 childhood immunization schedule in 15 unanimous votes.

ACIP recommended the use of COVID-19 vaccines for everyone as young as 6 months and older. The COVID-19 vaccine and other vaccines may be administered on the same day.

According to RFK Jr.:

ACIP evaluates the safety, efficacy and clinical need of the nation’s vaccines and passes its findings on to the Centers for Disease Control and Prevention. The committee has been plagued with persistent conflicts of interest and has become little more than a rubber stamp for any vaccine. It has never recommended against a vaccine—even those later withdrawn for safety reasons. It has failed to scrutinize vaccine products given to babies and pregnant women. To make matters worse, the groups that inform ACIP meet behind closed doors, violating the legal and ethical principle of transparency crucial to maintaining public trust.

In 2000 the House issued the results of an investigation of ACIP and another vaccine advisory committee under the U.S. Food and Drug Administration—the Vaccines and Related Biological Products Advisory Committee. It found that enforcement of its conflict-of-interest rules was weak to nonexistent. Committee members regularly participated in deliberations and advocated products in which they had a financial stake. The CDC issued conflict-of-interest waivers to every committee member. Four out of eight ACIP members who voted in 1997 on guidelines for the Rotashield vaccine, subsequently withdrawn because of severe adverse events, had financial ties to pharmaceutical companies developing other rotavirus vaccines. A 2009 HHS inspector-general report echoed these findings. Few committee members completed full conflict-of-interest forms—97% of them had omissions. The CDC took no significant action to remedy the omissions.

These conflicts of interest persist. Most of ACIP’s members have received substantial funding from pharmaceutical companies, including those marketing vaccines. The problem isn’t necessarily that ACIP members are corrupt. Most likely aim to serve the public interest as they understand it. The problem is their immersion in a system of industry-aligned incentives and paradigms that enforce a narrow pro-industry orthodoxy. The new members won’t directly work for the vaccine industry. They will exercise independent judgment, refuse to serve as a rubber stamp, and foster a culture of critical inquiry—unafraid to ask hard questions.

A clean sweep is needed to re-establish public confidence in vaccine science. In the 1960s, the world sought guidance from America’s health regulators, who had a reputation for integrity, scientific impartiality and zealous defense of patient welfare. Public trust has since collapsed, but we will earn it back.

No sooner had the news dropped than vaccine stocks took a dive. Moderna, Pfizer, BioNTech, and Novavax all saw notable declines, according to Reuters.

https://www.thegatewaypundit.com/202...-fires-entire/

[onawah]

Breaking: RFK Jr. Removes All Members of CDC Vaccine Advisory Committee
by Brenda Baletti, Ph.D.Suzanne Burdick, Ph.D.
June 9, 2025
https://childrenshealthdefense.org/d...tm_id=20250609

"HHS Secretary Robert F. Kennedy Jr. announced late today that he is retiring all 17 members of the CDC vaccine advisory committee. “A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy wrote in an op-ed published today in The Wall Street Journal.

U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. announced late today that the HHS is retiring all 17 members of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee.

Kennedy announced the move in an op-ed in The Wall Street Journal. “Today, we are taking a bold step in restoring public trust by totally reconstituting the Advisory Committee for Immunization Practices (ACIP),” he wrote.

Kennedy noted that some of the current ACIP members were appointed in the final moments of the Biden administration. “Without removing the current members, the current Trump administration would not have been able to appoint a majority of new members until 2028,” he wrote.

The ACIP committee is responsible for shaping U.S. vaccine policy by issuing recommendations that become official CDC policy once adopted by the CDC director.

ACIP is described as an independent, nonfederal expert body of professionals with clinical, scientific and public health expertise.

The committee decides which vaccines should be recommended to the public, who should take them and how often — recommendations the CDC typically rubber stamps.

However, most members have financial ties to pharmaceutical companies marketing vaccines, or have worked with public health agencies to promote controversial vaccines, including the COVID-19, RSV and HPV shots.

These problems have plagued the committee for decades. A 2000 investigation by the U.S. House of Representatives found that enforcement of conflict-of-interest rules was “weak-to-nonexistent.” A 2009 HHS inspector-general report made similar findings, Kennedy wrote.

Investigations by The Defender in 2021 and 2024 also found that most committee members had direct ties to pharmaceutical companies.

Kennedy wrote that the committee has “never recommended against a vaccine — even those later withdrawn for safety reasons. He said the committee has failed to “adequately scrutinize” vaccines for babies and pregnant women.

“A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy wrote. “In the 1960s, the world sought guidance from America’s health regulators, who had a reputation for integrity, scientific impartiality and zealous defense of patient welfare. Public trust has since collapsed, but we will earn it back.

According to an HHS press release, 13 of the 17 sitting ACIP members were appointed in 2024. The release stated, “The prior administration made a concerted effort to lock in public health ideology and limit the incoming administration’s ability to take the proper actions to restore public trust in vaccines.”

STAT News also reported at the time that the appointments were a move by the Biden administration to stack the committee, intended to “insulate the scientific integrity of the panel from the incoming administration.”

ACIP’s next meeting is scheduled for June 25-June 27 at the CDC headquarters in Atlanta, the press release said."

Related Articles in The Defender:
Biden Administration Stacked Key Vaccine Review Committee With Pro-vaxxers
9 New ‘Independent’ Advisers to CDC Publicly Promoted Vaccines or Took Money From Pharma — or Both
14 ACIP Members Who Voted to Jab Your Young Children — and Their Big Ties to Big Pharma

Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.

Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa.

[mountain_jim]

copying here

Posted by mountain_jim (here)
https://x.com/SecKennedy/status/1932580198198964241

Secretary Kennedy

@SecKennedy
·
14h

Yesterday, I retired 17 members of the Advisory Committee on Immunization Practices or ACIP, the @CDCgov external panel that wields the grave responsibility of adding new vaccines to the recommended childhood schedule. Over the coming days, I will use this platform to announce new members to populate ACIP. None of these individuals will be ideological anti-vaxxers. They will be highly credentialed physicians and scientists who will make extremely consequential public health determinations by applying evidence-based decision-making with objectivity and common sense.

I will also be tweeting examples of the historical corruption at ACIP to help the public understand why this clean sweep was necessary.

The most outrageous example of ACIP’s malevolent malpractice has been its stubborn unwillingness to demand adequate safety trials before recommending new vaccines for our children. Today, a compliant American child receives between 69 and 92 routine vaccines (depending on brand/dictated dosage) from conception to 18 years of age. This is up from 11 shots in 1986. ACIP has recommended each of these additional jabs without requiring placebo-controlled trials for any of them. This means that no one can scientifically ascertain whether these products are averting more problems than they are causing.

Many vaccine promoters have challenged this assertion. They are always wrong. Last week, @CNN, which has devolved into a shameless propagandist for Big Pharma, triumphantly announced that it had proof that my pronouncement that “there have been no placebo-controlled safety trials for any routine vaccines” was false. CNN gleefully proclaimed that it had found 257 placebo-controlled studies for routine vaccines.

So, allow me a moment to deconstruct CNN’s claims. Warning: this post may only be sufferable for science geeks like myself.

CNN is wrong. No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data. (See http://sirillp.com/noplacebo). As Secretary of @HHSGov, acknowledging this lamentable truth is part of my promise of radical transparency.

The 257 studies cited by CNN unwittingly reflect the lack of safety trials underpinning CDC’s schedule. Despite CNN’s worldwide effort to crowdsource trials with a placebo control (per @US_FDA/@CDCgov, an “inert substance”*), this list, on its face, reflects that 236 of the studies clearly did not use an “inert” safety comparator in a trial to license an injected routine vaccine for children on CDC’s schedule.**

For the remaining 21 studies CNN’s list claims used an inert injection, 9 plainly did not:

• RCT 251, 252 (Varivax) injected an antibiotic, neomycin – not inert.
• RCT 84, 97 (HPV-16 and 16/18) injected aluminum adjuvant – not inert.
• RCT 215 (Almevax) injected another vaccine – not inert.
• RCT 55 (Lyophilized PedvaxHIB) injected lactose, aluminum adjuvant, and thimerosal – not inert.
• RCT 197 (Salk vaccine) injected 199 solution, synthetic tissue culture, ethanol, phenol red, antibiotics, and formalin – not inert.***
• RCT 168 (Dow’s MMR) injected full vaccine minus virus, including all stabilizers, antibiotics, diluent, preservative, and buffers – not inert.****
• RCT 189 (Menveo) injected Tdap+saline or Menveo+saline – not inert.

For the remaining 12 listed studies which may have had an inert injection, none was a trial relied upon to license a routine vaccine on CDC’s childhood schedule:

• RCT 170, 171, 172 (MMR VaxPro), 228 (PCV11), 136 (Vaxigrip), 242 (Antitetanus), and 122 (Chinese flu shots) trialed vaccines never licensed in the U.S. nor relied upon to license a U.S. vaccine.
• RCT 124 (Fluzone IIV3), 102 (WVV/SPV), and 188 (Menveo) trials occurred after each respective vaccine was licensed, hence were not relied upon for their licensure.
• RCT 176 (Mumps vaccine) was not relied upon by the FDA to license the current MMR vaccine. (See MMR-II clinical trial report in link above.)
• RCT 53 (PRP-D) was for a vaccine withdrawn soon after its introduction and not relied upon by the FDA to license any U.S. vaccine.

While these 12 studies were not relied upon to license a routine vaccine on the CDC’s schedule, they do reflect that a placebo-controlled trial of a vaccine is possible. They also reflect what can be learned when a placebo trial is performed. For example: RCT 136 found the vaccine ineffective; RCT 122 found that “severe adverse effects occurred in 69 (0·6%, 95% CI 0·5–0·8) recipients of vaccine compared with one recipient (0·1%, 0–0·2) of placebo.”; and RCT 124 found “the rate of hospitalization was actually higher in the [Fluzone IIV3] vaccine group than in the placebo group.”

The unfortunate reality is that placebo-controlled trials, however, do not occur and have not been relied upon when FDA licenses vaccines for injection during childhood or ACIP recommends the shot for addition to the CDC’s routine schedule.

CNN would have reached the same conclusion had it reviewed the FDA documentation for each vaccine, instead of relying upon a random, crowd-sourced list from the internet. CNN’s list ironically proves the lack of adequate safety trials for routine childhood vaccines.

It is time to stop playing games, such as CNN’s false gotcha. We have gone from 3 routine injections by age one in 1986 (the year the National Childhood Vaccine Injury Act passed) to 25 routine injections by age one in 2025 (which now does not include Covid-19 vaccine). Because of the 1986 Act, every one of these products, save one, was developed by companies knowing they would almost never be liable for serious harm. During this same period, chronic diseases in our children exploded, most of which are caused by immune system dysregulation. If we are to identify the exposures that are causing this epidemic of autoimmune diseases, we need to rule out products given dozens of times to young children, specifically to modify the immune system, as potential culprits.

Our infants and children deserve the best safety trials possible to keep them safe. We should care as much about every child who could be injured by one of these products as we do every child who could be injured by an infectious disease. We must protect all children.

Notes:

* https://fda.gov/media/130326/download (“Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials.”); https://fda.gov/media/71349/download (“the placebo control design, by … including a group that receives an inert treatment…”); https://cdc.gov/vaccines/glossary/ (“Placebo: A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.”).

** While the above addresses injected vaccines, CNN’s cited list also includes 10 trials for rotavirus vaccine, given by oral drops, but none of these trials used saline only drops. Instead, RCT 205, 207, 208, 209, 210, 213 (Rotarix) contained dextran, sorbitol, amino acids, dulbecco’s modified eagle medium, calcium carbonate, and xanthan; RCT 211, 212 (RotaTeq) contained polysorbate 80, sucrose, citrate and phosphate; and RCT 206, 214 (Rotavac) included neomycin sulphate, kanamycin acid sulphate, trehalose, lactalbumin hydrolysate, human albumin, potassium dihydrogen orthophosphate, dipotassium hydrogen orthophosphate, and trisodium citrate dihydrate. The list also included three trials of an inhaled flu vaccine; the controls in RCT 104 were OPV+saline or LAIV (a vaccine), hence neither inert; in RCT 106 the control “consisted of normal allantoic fluid harvested from uninfected eggs stabilized with sucrose–phosphate–glutamate”; and, in RCT 109, the control was “intranasal spray of egg allantoic fluid containing sucrose-phosphate-glutamate.”

*** Note that the current polio vaccines used in the U.S. are a different product than the polio vaccine developed by Jonas Salk in the 1950s—which was discontinued in the 1960s—including because the currently-used polio vaccines are “grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.”

Hence, the Salk trial was not relied upon to license any current polio vaccine.

https://fda.gov/media/75695/download; https://pubmed.ncbi.nlm.nih.gov/6740101/;
https://‌http://admin.phe-culturecol...e-profile.pdf; https://atcc.org/products/all/ccl-81...haracteristics.

**** Dow Chemical’s MMR vaccine used different strains than any licensed U.S. MMR vaccine and also, after 14 days of safety review, this trial vaccinated all participants.

[onawah]

THAT'S the kind of action from RFK we've been waiting for!!
Considering the extremes of "idealogical pro-vaxxers" we've been subjected to so far, some "ideological anti-vaxxers" wouldn't be all that objectionable.

Posted by mountain_jim (here)
copying here

Posted by mountain_jim (here)
https://x.com/SecKennedy/status/1932580198198964241

Secretary Kennedy
@SecKennedy

Yesterday, I retired 17 members of the Advisory Committee on Immunization Practices or ACIP, the @CDCgov external panel that wields the grave responsibility of adding new vaccines to the recommended childhood schedule. Over the coming days, I will use this platform to announce new members to populate ACIP. None of these individuals will be ideological anti-vaxxers. They will be highly credentialed physicians and scientists who will make extremely consequential public health determinations by applying evidence-based decision-making with objectivity and common sense.

[mountain_jim]

https://x.com/RWMaloneMD/status/1932901388360847477

Thank you for the honor of serving my country in this way, @SecKennedy. I will do my best to serve with unbiased objectivity and rigor.

— Robert W Malone, MD (@RWMaloneMD) June 11, 2025

Secretary Kennedy

@SecKennedy

On Monday, I took a major step towards restoring public trust in vaccines by reconstituting the Advisory Committee for Immunization Practices (ACIP). I retired the 17 current members of the committee. I’m now repopulating ACIP with the eight new members who will attend ACIP’s scheduled June 25 meeting. The slate includes highly credentialed scientists, leading public-health experts, and some of America’s most accomplished physicians. All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense. They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations. The committee will review safety and efficacy data for the current schedule as well. I’m proud to announce ACIP’s new members:

Joseph R. Hibbeln, MD, is a psychiatrist and neuroscientist with a career in clinical research, public health policy, and federal service. As former Acting Chief of the Section on Nutritional Neurosciences at the National Institutes of Health, he led research on immune regulation, neurodevelopment, and mental health. His work has informed U.S. public health guidelines, particularly in maternal and child health. With more than 120 peer-reviewed publications and extensive experience in federal advisory roles, Dr. Hibbeln brings expertise in immune-related outcomes, psychiatric conditions, and evidence-based public health strategies.

Martin Kulldorff, MD, PhD, is a biostatistician and epidemiologist formerly at Harvard Medical School and a leading expert in vaccine safety and infectious disease surveillance. He has served on the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and the CDC’s Vaccine Safety Subgroup of the Advisory Committee on Immunization Practices, where he contributed to national vaccine safety monitoring systems. Dr. Kulldorff developed widely used tools such as SaTScan and TreeScan for detecting disease outbreaks and vaccine adverse events. His expertise includes statistical methods for public health surveillance, immunization safety, and infectious disease epidemiology. He has also been an influential voice in public health policy, advocating for evidence-based approaches to pandemic response.

Retsef Levi, PhD, is the Professor of Operations Management at the MIT Sloan School of Management and a leading expert in healthcare analytics, risk management, and vaccine safety. He has served as Faculty Director of MIT Sloan’s Food Supply Chain Analytics and Sensing Initiative and co-led the Leaders for Global Operations Program. Dr. Levi has collaborated with public health agencies to evaluate vaccine safety, including co-authoring studies on mRNA COVID-19 vaccines and their association with cardiovascular risks. His research has contributed to discussions on vaccine manufacturing processes, safety surveillance, and public health policy. Dr. Levi has also served on advisory committees and engaged in policy discussions concerning vaccine safety and efficacy. His expertise spans healthcare systems optimization, epidemiologic modeling, and the application of AI and data science in public health. Dr. Levi’s work continues to inform national and international debates on immunization safety and health system resilience.

Robert W. Malone, MD, is a physician-scientist and biochemist known for his early contributions to mRNA vaccine technology. He conducted foundational research in the late 1980s on lipid-mediated mRNA delivery, which laid the groundwork for later developments in mRNA-based therapeutics. Dr. Malone has held academic positions at institutions including the University of California, Davis, and the University of Maryland, and has served in advisory roles for the U.S. Department of Health and Human Services and the Department of Defense. His expertise spans molecular biology, immunology, and vaccine development.

Cody Meissner, MD, is a Professor of Pediatrics at the Geisel School of Medicine at Dartmouth and a nationally recognized expert in pediatric infectious diseases and vaccine policy. He has served as Section Chief of Pediatric Infectious Disease at Dartmouth-Hitchcock Medical Center and has held advisory roles with both the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Dr. Meissner has been a voting member of the CDC’s Advisory Committee on Immunization Practices and the FDA’s Vaccines and Related Biological Products Advisory Committee, where he has contributed to national immunization guidelines and regulatory decisions. His expertise spans vaccine development, immunization safety, and pediatric infectious disease epidemiology. Dr. Meissner has also been a contributing author to American Academy of Pediatrics policy statements and immunization schedules, helping shape national standards for pediatric care.

James Pagano, MD, is a board-certified Emergency Medicine physician with over 40 years of clinical experience following his residency at UCLA. He has worked in diverse emergency settings, from Level 1 trauma centers to small community hospitals, caring for patients across all age groups, including infants, pregnant women, and the elderly. Dr. Pagono served on multiple hospital committees, including utilization review, critical care, and medical executive boards. He is strong advocate for evidence-based medicine.

Vicky Pebsworth, OP, PhD, RN, earned a doctorate in public health and nursing from the University of Michigan. She has worked in the healthcare field for more than 45 years, serving in various capacities, including critical care nurse, healthcare administrator, health policy analyst, and research scientist with a focus on public health policy, bioethics, and vaccine safety. She is the Pacific Region Director of the National Association of Catholic Nurses. She is a former member of the Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee and the National Vaccine Advisory Committee’s 2009 H1N1 Vaccine Safety Risk Assessment Working Group and Vaccine Safety Working Group (Epidemiology and Implementation Subcommittees).

Michael A. Ross, MD, is a Clinical Professor of Obstetrics and Gynecology at George Washington University and Virginia Commonwealth University, with a career spanning clinical medicine, research, and public health policy. He has served on the CDC’s Advisory Committee for the Prevention of Breast and Cervical Cancer, where he contributed to national strategies for cancer prevention and early detection, including those involving HPV immunization. With research experience in hormone therapies, antibiotic trials, and immune-related conditions such as breast cancer prevention, Dr. Ross has engaged in clinical investigations with immunologic relevance. He has advised major professional organizations, including the American College of Obstetricians and Gynecologists, and contributed to federal advocacy efforts around women’s health and preventive care. His continued service on biotech and healthcare boards reflects his commitment to advancing innovation in immunology, reproductive medicine, and public health.

[norman]

With Malone on board it's possible the mRNA train is not going to get taken out of service.

From 2020 onwards he was in charge of 10 billion dollars of mRNA vax development money he was spending at a rate of 2 billion a year according to investigative journalist George Webb. I ask, is he bending RFK or is RFK bending Malone.

Malone was an advisor to RFK during RFK's election campaign.

He's got plenty of experience inside the vaccine development scene that could be useful in dismantling it but is that really the direction we are going ?

[TrumanCash]

Posted by norman (here)
With Malone on board it's possible the mRNA train is not going to get taken out of service.

From 2020 onwards he was in charge of 10 billion dollars of mRNA vax development money he was spending at a rate of 2 billion a year according to investigative journalist George Webb. I ask, is he bending RFK or is RFK bending Malone.

Malone was an advisor to RFK during RFK's election campaign.

He's got plenty of experience inside the vaccine development scene that could be useful in dismantling it but is that really the direction we are going ?

I'm wondering the same thing, Norman. I remember Malone filing lawsuits to attack good people who disagreed with him in much the same manner as Corey Goode. When I saw him doing that I pretty much stopped paying attention to him. Also, his mRNA vax development past indicates to me he's not the right fit for this job.

[onawah]

Six Executive Orders That Could Shake Big Pharma—and Protect Natural Health
Alliance for Natural Health
06/12/2025
https://anh-usa.org/six-executive-or...atural-health/

(Podcast at the link.
Malone is certainly an iffy factor as yet, but at least some good things appear to be happening...)



"A slew of recent Executive Orders quietly crack open Big Pharma’s monopoly, chip away at anti-competitive regulations, and defend Americans’ right to choose low cost options, including generic drugs and safe and effective natural health products.

THE TOPLINE

Some of the orders attack runaway drug prices by tying US costs to the lowest prices abroad, fast-tracking generics and biosimilars, and re-classifying certain pricey brands as over-the-counter.
Others tell agencies to catalog and kill any regulation that creates de facto monopolies or stretches statutory authority—targets that include FDA and FTC policies that sideline supplements through onerous pre-approval and clinical-trial demands.
Another order bars federal pressure to censor lawful speech, bolstering ANH efforts to let companies share truthful, science-backed claims about nutrients and natural remedies—an essential step toward a genuine right to rely on nature for health.
How many more headlines about record-shattering drug profits will it take before we admit the system is rigged? We could be a healthier nation and save billions in healthcare costs by embracing natural medicines. Instead, we have a system that has become completely dominated by Big Pharma and its government allies, one where disease treatment and prevention is the sole preserve of dangerous, expensive, often ineffective and often dangerous pharmaceutical drugs. The result? Record rates of chronic disease.

Yet several Executive Orders from the Trump Administration crack open the door to a different future. They challenge the price-gouging, dismantle the barriers that keep natural remedies in the shadows, and demand that bureaucrats stop twisting the law to protect corporate fiefdoms. We’re working on a number of exciting initiatives to leverage these actions into victories for the millions of Americans that wish to opt for natural health.

“We now have a rare opportunity to push back against Big Pharma’s dominance—built on anti-competitive practices, excessive regulation of natural products, distorted science, and censorship of truthful health information,” said ANH Executive Director, Rob Verkerk, PhD. “At ANH,” he continued, “we’re launching a raft of legal and regulatory actions that draw on executive orders, constitutional protections, legal precedent, and transparent science to help restore balance to our healthcare system.”

While commentators debate the broader political implications of the many actions taken by the Trump Administration over the last few months, our lens is simple: do any of these Executive Orders open doors for Americans to choose natural health options? If so, which ones? The answer, judged strictly on the text of some of these orders, is ‘yes’.

We’re cognizant of the polarized political climate we live in, but as ever, ANH is laser-focused on our mission and core principles: that is, fighting for everyone’s freedom to choose natural options to stay healthy. Whether Democrats or Republicans are in office, we look for opportunities to advance those goals.

Order What it does
EO 14212 – Establishing the President’s Make America Healthy Again Commission Establishes the President’s Make America Healthy Again Commission, creating a high-level federal task force to investigate and combat the alarming rise in chronic diseases—especially among children—by addressing root causes such as poor nutrition, environmental toxins, over-medication, and lack of transparency in health research.
EO 14297 – Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients Directs HHS, FDA and the US Trade Representative to peg US drug prices to the lowest price paid in peer nations and to permit drug importation. If no progress is made, the order directs HHS to pursue rulemaking to impose Most Favored Nation drug pricing.
EO 14273 – Lowering Drug Prices by Once Again Putting Americans First Orders increased transparency for the Medicare Drug Price Negotiation Program, improvements for Medicare’s ability to obtain better value for high-cost drugs, accelerated approvals of generic and biosimilars, and an FDA plan to “re-classify” expensive brand drugs as OTC drugs.
EO 14267 – Reducing Anti-Competitive Regulatory Barriers Tells every agency to catalog and then repeal rules that create de facto monopolies or “unduly limit competition,” including licensure rules.
EO 14219 – Ensuring Lawful Governance & the “Department of Government Efficiency” Deregulatory Initiative Requires agencies to identify and mothball rules that are unconstitutional, lack clear statutory authority, or rest on expansive “Chevron-style” interpretations, among other things. Enforcement resources must be de-prioritized for such rules.
EO 14149 – Restoring Freedom of Speech and Ending Federal Censorship Protects Americans’ free speech rights by stopping the federal government from pressuring or working with others—like social media companies—to censor speech.
The Emerging Themes—And Why They’re Game-Changing for Natural Health
Taken together, a clear picture starts to emerge. These Executive Orders chip away at Big Pharma’s price gouging and monopolistic practices while opening the door to more competition from the natural products sector.

1. Whittling away Big Pharma monopolies

EO 14297 and EO 14273 strike directly at monopoly prescription drug prices. Allowing Big Pharma to charge exorbitant prices for drugs while also censoring information describing the healing power of food and supplements that are alternatives to those drugs is a crony capitalist double-whammy. These executive orders represent an encouraging first step toward loosening Big Pharma’s grip on the market by hitting them where it hurts: their pocketbooks.

2. Rolling back anti-competitive rules

EO 14267’s mandate to list and rescind rules that “create, or facilitate the creation of, de facto monopolies” is tailor-made for the government’s multi-pronged effort to tilt the scales in favor of Big Pharma at the expense of natural medicine.

For example, the FTC has been trying to force supplement companies to fund full-scale RCTs before making truthful health claims—an impossibility for non-patentable nutrients. It is a backhanded way of censoring many truthful health claims, depriving Americans of vital health information. ANH is already fighting back against this censorship with our recently-filed petition to the FTC demanding the removal of these absurd standards. If proven benefits cannot be communicated to consumers, food and supplements are at an incredible competitive disadvantage to drugs which alone can claim to treat or prevent disease.

Another crucial instance of anti-competitive regulations is the “drug preclusion” clause—what we at ANH have labeled the “back-channel” at the FDA that allows drug companies to turn supplements into drugs. For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed (more on this below). But if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement. This creates a stacked deck in favor of Big Pharma monopolies. Several important supplements have been threatened or eliminated in this way, including pyridoxamine, CBD, and NMN.

Other anti-competitive government measures include the FDA’s war on homeopathy and compounded medicines, including compounded bioidentical hormones and bioidentical peptides.

3. A tool to rein in FDA overreach after Chevron

Executive Order 14219 tells every federal agency to drop any rule that isn’t the “best reading” of the law—language that arrives as the Supreme Court has scrapped Chevron deference, the doctrine that once let agencies stretch statutes with little push-back. Together, these shifts give natural-health advocates a powerful lever against government overreach.

A critical example of this kind of overreach is the FDA’s 2016 draft guidance on “new dietary ingredients” (NDIs). ANH has contended for years that the FDA’s guidance creates a de facto pre-approval system for “new” supplements that is not in accordance with the law, requiring expensive safety studies and the creation of extensive dossiers on new ingredients. This represents a major barrier to market entry that most supplement companies simply cannot afford—the complete antithesis of the Dietary Supplement Health and Education Act of 1994’s plain and intended meaning, which aimed to expand, not restrict, access to supplements.

Further, we’ve argued that the FDA has misapplied the law to widen the number of products subject to NDI rules while narrowly interpreting the exemptions.

All told, experts estimate that the FDA’s NDI requirements would lead to the elimination of over 41,000 supplements from the shelves.

By reining in the FDA’s anti-supplement interpretations, these legal shifts could further help dismantle the pharmaceutical monopoly over medicine and protect consumers’ access to affordable, science-backed supplements.

4. Re-opening the information pipeline

Executive Order 14149’s protections for free speech—especially when considered alongside the above-mentioned directives eliminating anti-competitive practices and excessive federal regulation—align closely with ANH-USA’s forthcoming petition on “authoritative statements.”

This initiative calls on the FDA to follow Congress’s 1997 mandate requiring that truthful, government-backed statements about nutrient-disease relationships be permitted on product labels and in advertising. Although the law allows supplement companies to use such statements to better inform consumers about the benefits of nutrients, the FDA has routinely blocked these claims in practice in direct violation of the statute.

When the White House says agencies may not suppress lawful speech, it strengthens the petition’s constitutional footing. Stay tuned for more details on this exciting project.

ANH General Counsel Jonathan Emord said, “The Executive Orders and Executive Memoranda compelling the agencies to abandon protectionist practices, open markets, and defend individual liberties are welcome and unprecedented, but there is so much to be done. Bureaucratic intransigence, the limits of power, and a timetable now of less than four years reveals these extraordinary measures to be not enough. Consequently, the battles for freedom, including freedom of informed choice, will depend on court victories, petitioning for changes in rules, and drafting and urging passage of new legislation atop the official measures from the White House. That’s where ANH plays a unique and indispensable role.”

Toward A Fundamental Right to Rely on Nature
Every American should enjoy the right to choose food‐ and nutrient-based strategies for health. By attacking monopoly pricing, dismantling anti-competitive regulatory moats, rescinding unlawful rules, and protecting truthful speech, these orders collectively nudge US policy toward recognizing that right.

ANH-USA has many irons in the fire at the moment to leverage these EO’s into tangible natural health victories. We will keep you updated on the latest developments."

[onawah]

RFK Jr. Rips CNN Over Claims on Vaccines and Placebo-Controlled Trials
Childrens' Health Defense
June 11, 2025
By Robert F. Kennedy Jr., HHS Secretary

https://childrenshealthdefense.org/d...tm_id=20250611

Editor’s note: In a post on X, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. dismantled claims made in a June 6 CNN article stating that the news team identified “258 randomized, controlled clinical trials of vaccines” and that “More than half of those studies — 153 — tested vaccines against placebos, and 127 of those studies used inert placebos.” Below is the full, unaltered text of Kennedy’s post.
“CNN is wrong,” Kennedy wrote. “No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data.”

B]"[/B]Yesterday, I retired 17 members of the Advisory Committee on Immunization Practices or ACIP, the @CDCgov external panel that wields the grave responsibility of adding new vaccines to the recommended childhood schedule. Over the coming days, I will use this platform to announce new members to populate ACIP. None of these individuals will be ideological anti-vaxxers. They will be highly credentialed physicians and scientists who will make extremely consequential public health determinations by applying evidence-based decision-making with objectivity and common sense.

I will also be tweeting examples of the historical corruption at ACIP to help the public understand why this clean sweep was necessary.

The most outrageous example of ACIP’s malevolent malpractice has been its stubborn unwillingness to demand adequate safety trials before recommending new vaccines for our children. Today, a compliant American child receives between 69 and 92 routine vaccines (depending on brand/dictated dosage) from conception to 18 years of age. This is up from 11 shots in 1986. ACIP has recommended each of these additional jabs without requiring placebo-controlled trials for any of them. This means that no one can scientifically ascertain whether these products are averting more problems than they are causing.

Many vaccine promoters have challenged this assertion. They are always wrong. Last week, @CNN, which has devolved into a shameless propagandist for Big Pharma, triumphantly announced that it had proof that my pronouncement that “there have been no placebo-controlled safety trials for any routine vaccines” was false. CNN gleefully proclaimed that it had found 257 placebo-controlled studies for routine vaccines.

So, allow me a moment to deconstruct CNN’s claims. Warning: this post may only be sufferable for science geeks like myself.

CNN is wrong. No routine injected vaccine on CDC’s schedule was licensed for children based on a placebo-controlled trial. In instances where a vaccine was used as a control, it too was never licensed based on a placebo-controlled trial. That is not conjecture. It is a fact based on FDA’s clinical trial data. (See sirillp.com/noplacebo). As Secretary of @HHSGov, acknowledging this lamentable truth is part of my promise of radical transparency.

The 257 studies cited by CNN unwittingly reflect the lack of safety trials underpinning CDC’s schedule. Despite CNN’s worldwide effort to crowdsource trials with a placebo control (per @US_FDA/@CDCgov, an “inert substance”*), this list, on its face, reflects that 236 of the studies clearly did not use an “inert” safety comparator in a trial to license an injected routine vaccine for children on CDC’s schedule.**

For the remaining 21 studies CNN’s list claims used an inert injection, 9 plainly did not:

RCT 251, 252 (Varivax) injected an antibiotic, neomycin – not inert.
RCT 84, 97 (HPV-16 and 16/18) injected aluminum adjuvant – not inert.
RCT 215 (Almevax) injected another vaccine – not inert.
RCT 55 (Lyophilized PedvaxHIB) injected lactose, aluminum adjuvant, and thimerosal – not inert.
RCT 197 (Salk vaccine) injected 199 solution, synthetic tissue culture, ethanol, phenol red, antibiotics, and formalin – not inert.***
RCT 168 (Dow’s MMR) injected full vaccine minus virus, including all stabilizers, antibiotics, diluent, preservative, and buffers – not inert.****
RCT 189 (Menveo) injected Tdap+saline or Menveo+saline – not inert.
For the remaining 12 listed studies which may have had an inert injection, none was a trial relied upon to license a routine vaccine on CDC’s childhood schedule:

RCT 170, 171, 172 (MMR VaxPro), 228 (PCV11), 136 (Vaxigrip), 242 (Antitetanus), and 122 (Chinese flu shots) trialed vaccines never licensed in the U.S. nor relied upon to license a U.S. vaccine.
RCT 124 (Fluzone IIV3), 102 (WVV/SPV), and 188 (Menveo) trials occurred after each respective vaccine was licensed, hence were not relied upon for their licensure.
RCT 176 (Mumps vaccine) was not relied upon by the FDA to license the current MMR vaccine. (See MMR-II clinical trial report in link above.)
RCT 53 (PRP-D) was for a vaccine withdrawn soon after its introduction and not relied upon by the FDA to license any U.S. vaccine.

While these 12 studies were not relied upon to license a routine vaccine on the CDC’s schedule, they do reflect that a placebo-controlled trial of a vaccine is possible. They also reflect what can be learned when a placebo trial is performed. For example: RCT 136 found the vaccine ineffective; RCT 122 found that “severe adverse effects occurred in 69 (0·6%, 95% CI 0·5–0·8) recipients of vaccine compared with one recipient (0·1%, 0–0·2) of placebo.”; and RCT 124 found “the rate of hospitalization was actually higher in the [Fluzone IIV3] vaccine group than in the placebo group.”

The unfortunate reality is that placebo-controlled trials, however, do not occur and have not been relied upon when FDA licenses vaccines for injection during childhood or ACIP recommends the shot for addition to the CDC’s routine schedule.

CNN would have reached the same conclusion had it reviewed the FDA documentation for each vaccine, instead of relying upon a random, crowd-sourced list from the internet. CNN’s list ironically proves the lack of adequate safety trials for routine childhood vaccines.

It is time to stop playing games, such as CNN’s false gotcha. We have gone from 3 routine injections by age one in 1986 (the year the National Childhood Vaccine Injury Act passed) to 25 routine injections by age one in 2025 (which now does not include Covid-19 vaccine). Because of the 1986 Act, every one of these products, save one, was developed by companies knowing they would almost never be liable for serious harm. During this same period, chronic diseases in our children exploded, most of which are caused by immune system dysregulation. If we are to identify the exposures that are causing this epidemic of autoimmune diseases, we need to rule out products given dozens of times to young children, specifically to modify the immune system, as potential culprits.

Our infants and children deserve the best safety trials possible to keep them safe. We should care as much about every child who could be injured by one of these products as we do every child who could be injured by an infectious disease. We must protect all children.

Notes:

* fda.gov/media/130326/download… (“Placebos, defined as inert substances with no pharmacologic activity, are commonly used in double-blind, randomized controlled clinical trials.”); fda.gov/media/71349/download… (“the placebo control design, by … including a group that receives an inert treatment…”); cdc.gov/vaccines/glossary/… (“Placebo: A substance or treatment that has no effect on living beings, usually used as a comparison to vaccine or medicine in clinical trials.”).

** While the above addresses injected vaccines, CNN’s cited list also includes 10 trials for rotavirus vaccine, given by oral drops, but none of these trials used saline only drops. Instead, RCT 205, 207, 208, 209, 210, 213 (Rotarix) contained dextran, sorbitol, amino acids, dulbecco’s modified eagle medium, calcium carbonate, and xanthan; RCT 211, 212 (RotaTeq) contained polysorbate 80, sucrose, citrate and phosphate; and RCT 206, 214 (Rotavac) included neomycin sulphate, kanamycin acid sulphate, trehalose, lactalbumin hydrolysate, human albumin, potassium dihydrogen orthophosphate, dipotassium hydrogen orthophosphate, and trisodium citrate dihydrate. The list also included three trials of an inhaled flu vaccine; the controls in RCT 104 were OPV+saline or LAIV (a vaccine), hence neither inert; in RCT 106 the control “consisted of normal allantoic fluid harvested from uninfected eggs stabilized with sucrose–phosphate–glutamate”; and, in RCT 109, the control was “intranasal spray of egg allantoic fluid containing sucrose-phosphate-glutamate.”

*** Note that the current polio vaccines used in the U.S. are a different product than the polio vaccine developed by Jonas Salk in the 1950s—which was discontinued in the 1960s—including because the currently-used polio vaccines are “grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.”

Hence, the Salk trial was not relied upon to license any current polio vaccine. fda.gov/media/75695/download…; pubmed.ncbi.nlm.nih.gov/6740101/; https://‌admin.phe-culturecollection...e-profile.pdf; atcc.org/products/all/ccl-81.aspx#characteristics….

**** Dow Chemical’s MMR vaccine used different strains than any licensed U.S. MMR vaccine and also, after 14 days of safety review, this trial vaccinated all participants. "