For many months now a historic debate about vaccine safety and effectiveness has been unfolding in America’s regulatory agencies and recently the debate has escalated into open partisan warfare.
It started on June 9, 2025 when Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr. dismissed all 17 sitting members of the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) and replaced them with his own picks. As one might have expected such a sweeping step was very controversial.
Critics asserted that Kennedy’s move was completely partisan, that he was replacing a group of reputable scientists with a bunch of unprofessional political hacks who would follow his agenda. Kennedy retorted that the dismissed committee were conflicted, that they were too close to the major drug companies that manufacture the vaccines. He pointed out that they had never recommended against introducing a new vaccine—including even those that were later withdrawn for safety reasons—and maintained that they had become “little more than a rubber stamp for any vaccine.” He also stressed that a clean sweep was necessary to restore public trust in vaccine science and policy as it had been seriously shaken by the controversy surrounding the Covid-19 vaccine mandates.
The first upshot from Kennedy’s revamp of the vaccine regulators occurred on September 4, 2025 when Food and Drug (FDA) Commissioner Dr. Marty Makary appeared on CNN’s The Lead and announced “We’ve been looking into the VAERS database self-reports, there have been children that have died from the Covid vaccine.” VAERS (Vaccine Adverse Event Reporting System) is the US government’s organization for reporting vaccine harms. It is a passive reporting system and, until Kennedy’s shakeup, was known for its lack of followup investigations. Makary’s words were momentous. They were a sharp break with past government messaging because—despite numerous reports in the media that had already put the idea of child deaths due to Covid vaccination in the air—up until then the official administration line had been that no child deaths were linked to the Covid-19 vaccine.
Makary’s announcement was a prelude to the reconstituted ACIP’s first undertaking which, not surprisingly, was to review the Covid vaccine. The committee held two meetings in September 2025 to review and debate government policy around the novel mRNA vaccine and they issued their advice at the second one on September 19.
As chair of ACIP’s Covid-19 vaccine work group MIT Professor Retsef Levi presided over these meetings, the terms of reference of any analysis are of utmost importance to its results because they set the scope of what may or may not be examined. Right from the get-go Levi set them as broadly as possible saying, “We don’t believe that terms like ‘safe and effective’ are scientific or appropriate. ACIP should be able to ask any questions relevant to vaccine policy.” It should be noted that Levi’s all-encompassing terms of reference were challenged by agency lawyers but in the end were finally accepted.
During its discussions about the Covid vaccine the committee heard testimony from two members of Levi’s work group who were experts in cancer research, Dr. Wafik El-Deiry, Director of the Legorreta Cancer Center at Brown University and Dr. Charlotte Kuperwasser, Prof. in the Department of Developmental, Molecular, and Chemical Biology at Tufts University School of Medicine. Along with her specialty in molecular biology Kuperwasser is also an internationally recognized expert in mammary gland biology and breast cancer prevention. El-Deiry’s knowledge of molecular oncology was important for probing potential integration into the body’s genetic system of the stray DNA particles which are known to be a byproduct of the novel mRNA Covid vaccine, while Kuperwasser’s expertise was also valuable for evaluating reproductive and pregnancy safety.
The research findings that they presented to ACIP were alarming. They reported evidence that repeated Covid-19 doses could compromise a patient’s immune system; that loose mRNA particles from the vaccine were distributed around the body including to the brain; that if the particles interfered with DNA sequencing in human sperm and ova, they could impact reproductive integrity; and finally, that there were reports of cancer emerging after vaccination.
Dr. Tracy Beth Hoeg, the Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER), was tasked by ACIP with doing the kind of followup that had hitherto been lacking in the VAERS system. In preparation for her testimony, she did extensive research on reported child deaths from the Covid vaccine by examining medical records and autopsy reports and by interviewing the parents of deceased children. She was present and had been slated to present her findings at the September 19 ACIP meeting, but for some reason that presentation never took place. She did not get to present her results until December.
The first child death that Dr. Hoeg described to the committee was that of 16-year-old Ernesto Ramirez, Jr. She testified that her research confirmed with absolute certainty that Ernesto’s death was caused by the Covid-19 vaccine. Her report exemplified what much of the public already knew from media reports about healthy young boys suddenly collapsing and dying on the playing field. Ernesto was a strapping, athletic youth from Texas who, five days after receiving the Pfizer Covid shot, suddenly collapsed and died while playing basketball with a friend in a park. He was the only child of Ernest Ramirez, a single father. Ernesto’s dad didn’t realize right away that his son had died from a vaccine injury.
It was only after cardiologist Dr Peter McCullough had reviewed the records that he informed Ramirez that what had brought about his son’s death was that the boy’s heart was twice the normal size it should have been. The boy had died from myocarditis, a vaccine injury that by now has been formally recognized by regulators.
In the end ACIP recommended a number of major changes regarding Covid-19 vaccine policy, the most significant of which was that henceforth the administration of Covid shots should no longer be based on blanket mandates but rather should be left to individual clinical decision-making. Henceforth decision-making was to be shifted from an ethic of one-size-fits-all to one of case-by-case patient-doctor consultation which would implicitly include informed consent. This too was a huge break with the past.
In addition, based on their discussions, the Covid-19 work group issued six specific recommendations to the CDC; that is, six categories of risk and uncertainty that it agreed must be disclosed clearly and accessibly to the public and must be further explored by researchers: 1) The evidence base for Covid vaccine effectiveness is of very low quality and must be described as such; 2) The vaccines can cause immune system changes that increase susceptibility to infections, which requires transparent communication; 3) There are documented deaths from myocarditis with a probable causal link to vaccination, and these must be acknowledged. 4) Post-vaccination syndromes can persist and overlap with long Covid, and need systematic recognition as well as regimens of care. 5) The spike protein, from Covid-19 injections can persist in organs and lymph nodes for months or years, raising safety concerns that require further study and, 6) Covid vaccines were never tested in properly randomised trials in pregnancy, and this gap must be corrected before continuing to recommend vaccination to expectant mothers.
Finally, as a first step in getting these recommendations implemented, ACIP voted unanimously to strengthen informed consent by overhauling the government communication apparatus known as the Vaccine Information Statement (VIS), a public document that is designed to inform patient-doctor decision-making. Following that meeting, in a press release of October 6, Jim O’Neill, then Deputy Secretary of Health and Acting Head of CDC wrote, “Informed consent is back…CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent.”
It is noteworthy that the second vaccine that ACIP reviewed raised similar issues to the Covid vaccine. Globally, unlike the Covid virus, only 3% of the population is infected by Hepatitis B. Moreover, unlike the Covid virus, which is airborne, Hepatitis B is spread through body fluids—most commonly through sex and unsterilized needles—but it can also be transmitted mother-to-child through breastfeeding. And yet, despite its very limited way of spreading within a very small portion of the population, up until now all newborn babies in America have been vaccinated for Hepatitis B at birth. In all these circumstances, because the vaccine poses a serious risk to newborn babies who may be allergic to it, an alternative policy to universal vaccination would be to screen all pregnant mothers for the virus and only the newborn babies of infected mothers would be given the shot. Indeed, outside of America, that is exactly the prevalent policy.
Conspicuously the common issue between the two vaccines is the one-size-fits-all mentality of the true believers in vaccine mandates. Given this mindset one might be forgiven for asking, why put children at risk of vaccine injury in order to protect adults? Indeed, this is precisely the point that was made by Dr Evelyn Griffin, an obstetrician-gynecologist, who during the discussion about the Hepatitis B vaccine asked the committee, “Are we asking our babies to solve an adult problem?”
In America, as opposed to Europe, early life Hepatitis-B vaccination has been promoted not because newborns faced substantial risk, but because adults may have missed screening or followup. As a result, babies were functioning as a sort of safety net for adults due to system failures. This concern resonated with committee members who recalled that during the Covid pandemic public health messaging urged vaccinating children in order “to protect granny.” In the end, in another break with the past policy, ACIP voted to end the universal recommendation that all newborns receive a Hepatitis B shot at birth.
Following these discussions ACIP turned to a related issue, the extent of the overall American vaccine schedule for children. It is commonplace that America is one of the most medicated nations on earth and this fact is reflected in its comparatively larger child vaccination schedule. America has more vaccines on its schedule than any other country in the world and American children receive more than twice as many jabs as children from anywhere else. Dr. Hoeg observed that the United States recommends 72 childhood vaccine doses while countries like Denmark use fewer than 30, making America “an international outlier.” She urged the committee to avoid “over-medicalising childhood” and, echoing a persistent theme in the discussion, encouraged regulators to rebuild trust by relying on proper placebo-controlled trials and science-based recommendations rather than the mandates that comprise the schedule.
In a related development with respect to pregnant women, following the appointment to ACIP on February 12 of Dr. Adam Urato, a Prof. of Obstetrics and Gynecology at Tufts Medical School who specializes in maternal-fetal medicine, the American College of Obstetricians and Gynecologists (ACOG) withdrew as a liaison to ACIP. In doing so they impugned ACIP’s credibility and invoked unspecified “scientific standards” to justify the move. Urato, a longtime member of ACOG disputed their claim about adhering to “scientific standards” on the grounds that in 2021, during the Biden administration’s promotion of Covid shots, ACOG strongly supported mandating Covid-19 vaccination for pregnant women, arguing that pregnancy should not provide an exemption.
Moreover, ACOG’s advocacy for vaccinating pregnant women with the Covid jabs was despite the fact that when the vaccine was tested pregnant women had been excluded from randomised trials and therefore the world had no idea how the shots might affect pregnant women or the babies that they were carrying. Patients asked about long-term side effects and obstetricians did not know, because at the time there was no evidence-based scientific answer to this question. Urato told ACIP: “Many pregnant women were put into the awful position of being coerced into getting a medical intervention that they didn’t want.” He added that in his opinion the mandates were “cruel and unethical…Make no mistake, this was coercion. These women were threatened with job losses, restricted travel, and participation in society in other ways.”
In making his argument Urato pointed to historical precedents of adverse side effects in obstetrics such as diethylstilboestrol (DES)—a synthetic estrogen that was prescribed from 1940 to 1971 for pregnant women to prevent miscarriages. It did not work as intended but did harm not to the pregnant women themselves but to their daughters who experienced greater instances of infertility, ectopic pregnancy, preterm delivery, miscarriage, stillbirth, and neonatal death compared to unexposed women. And then there was the travesty of Thalidomide, a sedative that was taken by pregnant women from 1957 to 1961 but was withdrawn from the market because it caused grotesque birth defects on their babies. Urato declaimed, “All were ‘safe and effective’ in pregnancy until eventually we discovered that they weren’t.”
In the world of regulation implementation is everything. Regardless of the recommendations of advisory committees such as ACIP, if they are not implemented then they are rendered meaningless. It is easy to imagine how ACIP’s recommendations would have rubbed the vested interests the wrong way, both in the federal regulatory bureaucracy and in the drug companies and, as might be expected, the pushback from these groups has been very strong.
First, Deputy Director Jim O’Neil who on October 6 had announced that “informed consent” is back was removed from his post on February 14.
Secondly, during an interview on Bloomberg television on December 15, FDA Commissioner Makary announced that the agency had no plans to add a black box warning for the Covid mRNA vaccines despite the fact that it has now been documented and officially acknowledged that the Covid vaccines have caused child deaths. It is impossible to overstate the significance of this illogical and therefore unexpected decision. It fundamentally undermines the entire review process. The FDA’s black box warning system is an important communication device for alerting doctors and their patients to potential rare but serious harms from medications.
Because such harms do not always appear until after drugs have been approved and marketed, it is standard procedure that these “black box warnings” are added to the long label of the product in question. For example, there is a black box warning on SSRI antidepressants because they may cause suicidality. Given the fact that vaccine regulators have officially acknowledged that the Covid vaccine may sometimes cause death—not only in children, as described above, but actually in all age groups—on the basis of standard protocol a black box warning about this possibility should by now most definitely have been added to the vaccine label. But that is not about to happen. When asked to explain this decision Makary confessed that, though adding the black box warning had been recommended by agency staff, he personally had not made the decision not to do so but rather had deferred to other FDA leaders.
In and of itself this is a troubling development but worse still, as medical investigative journalist Maryanne Demasi reported on December 16 on her blog MD Reports, the fact that there will not be a black box warning for the Covid vaccine has another notable consequence. Regulatory rules specify that no medication with a black box warning can be mass-marketed through advertising blitzes and the lack of a black box warning means that Covid vaccine manufacturers will continue to be allowed to launch their biannual “Get your booster” campaigns.
Third, also following the appointment of Urato to ACIP, dozens of Democratic lawmakers sent a letter to Secretary Kennedy accusing the administration of undermining ACIP. They wrote that what had once been “a trusted panel of vaccine experts had become a hand-selected group of unqualified vaccine sceptics who have undermined years of scientific integrity and vetted public health practices.” They called on Kennedy to remove the skeptics from the committee and reinstate the 17 members who had been dismissed. In response Urato replied on X: “My positions are clear — & there’re things we all agree on: Pregnant women deserve accurate counselling about vaccines. Vaccines carry risks & benefits. Pregnant women should be counselled properly & supported in their vaccine decisions.”
The letter from Democratic lawmakers was part of a coordinated effort to discredit ACIP. Around the same time that it was sent a paper was also published in the journal Vaccine by a number of the disgruntled former ACIP members that the Democratic politicians wanted reinstated which claimed that “the quality of ACIP deliberations continues to degrade” and that recent recommendations were “likely harmful to public health.”
And then on March 14, 2026 Rochelle Walensky, head of CDC under President Biden and Democratic Senator Edward J. Markey published an op-ed in Newsweek titled “America is Getting Sicker, Not Healthier, Under Trump and RFK Jr.” Among other things, they pointed to a recent outbreak in measles. “The evidence is stunning. In 2025, measles crossed 2,200 cases nationwide—the highest number in 34 years.” Coming from her this declamation was rather rich. As is often the case, the devil is in the details. Under her watch millions of migrants entered the United States with absolutely no health screening.
Indeed, she must have known—or should have known—that in March 2026, at the time she was penning her op-ed, an outbreak of 997 cases of measles occurred in Spartanburg County, South Carolina and that it originated in a migrant community from Ukraine but in time, through schools and other community organizations spread to other both vaccinated and unvaccinated groups. For the first two decades of the 21st century Ukraine was the most unvaccinated country in Europe. Moreover, a 2024 measles outbreak in Chicago involved primarily migrants from Venezuela which also experienced a steep decline in vaccinations.
Walensky does not come to the debate about vaccines with clean hands. It must also be remembered that as head of CDC Walensky issued a public apology in August 2022 for CDC’s suspended eviction of renters during Covid (struck down by the Supreme Court) and closed schools at the request of Randi Weingarten, President of the American Federation of Teachers, along with all the other guidelines like social distancing, masking, and perpetual Covid boosting which she confessed to being “pretty dramatic, pretty public mistakes,”
All of this posturing set the stage for the biggest blow to ACIP, which came from the American Academy of Pediatrics (AAP) America’s largest pediatric association. It launched lawsuits against the FDA and CDC that, at least for now, has effectively stopped ACIP in its tracks. On March 16, 2026 US District Court Judge Brian E. Murphy issued an injunction both blocking changes in the US childhood immunization schedule and also the appointments to ACIP. Notably, the case did not turn only on what the plaintiffs deemed to be “vaccine science” but on process. Murphy found that the reconstituted committee may have failed to meet its own charter requirements for relevant expertise and did not satisfy federal law requiring advisory bodies to be “fairly balanced.”
We can take it as a given that Judge Murphy, or any judge for that matter, is not qualified to adjudicate the scientific acumen or expertise of the new ACIP. Moreover his partisan leanings were on full display when he blocked the Trump administration from deporting criminals but got slapped down by the Supreme Court for his interference in executive authority, which is also an issue in this ruling. Meanwhile, as a consequence of Murphy’s injunction the ACIP meetings have come to a full stop. HHS has recently announced that they will be appealing Murphy’s injunction and in preparing to do so have also revised ACIP’s charter, thus pulling the rug out from under Murphy with respect to this aspect of his injunction. It will likely be overturned by the Supreme Court as was his injunction preventing the Trump administration from deporting criminals but meanwhile ACIP’s discussions are in limbo and who knows when they will resume?
So why did AAP, a professional organization that purportedly represents a large swathe of America’s pediatricians, launch this lawsuit? By now most medical organizations such as the AAP, much like their regulatory counterparts, have moved ideologically to the left and have been captured by the major drug companies. The AAP receives funding from the major drug companies including Pfizer, Merck, and Moderna.
In a September 4, 2025 article in Undark published by the Children’s Health Defense organization, “In August 2022, a policy statement recommending COVID-19 vaccines for children did not disclose any conflicts for its authors, noting that they had all filed conflict of interest statements with the AAP and any ‘conflicts have been resolved.’” However, “The chair of the committee responsible for the policy, according to Open Payments records, received $17,590 in consulting fees from Pfizer, which manufactures one of the vaccines, between 2018 and 2022, in addition to substantial research funding. The point about “conflicts have been resolved” is that this is done behind closed doors by AAP itself.
The AAP is exemplary of the trend of medical organizations being captured not only by the drug companies but by the hard ideological left. In 2017 it endorsed “gender affirmative care” for children diagnosed with gender dysphoria, renewed this endorsement in 2023, and supports these dangerous therapies to this day.
Politics is inescapable in the vaccine debates—the only question is which values are reflected in each side’s political stance. During the height of the Covid pandemic politicians such as Andrew Cuomo in New York and Justin Trudeau in Canada justified their lockdown mandates with the mantra, “If it only saves one life.” From a public health perspective this is rubbish. Public health is all about the greatest good for the greatest number. On the other hand, in light of what we know the inverse of this mantra is significant. What if public health measures gratuitously cause the death of one or more children?
The chance of a healthy kid dying from Covid now stands at 0.000057%. The chance of that kid dying of a vaccine injury such as myocarditis is also very small but we don’t know exactly what it is because of wholly inadequate vaccine injury reporting. What we do know is that vaccine injuries from the Covid vaccine far exceed those of any other vaccine in history. Even before the Covid vaccine was developed there was every indication that Covid was of no significant danger to children. In February 2020, early on during the Covid outbreak when the Diamond Princess cruise ship was quarantined, public health officials learned two very important things about the virus.
First, that it is very contagious as many people on the ship caught it. Secondly that though many people caught the virus only a few of the very oldest patients died. Given that the vaccine does not prevent its recipient from being contagious under all these circumstances, one would think that the child and his parents in consultation with a physician should be allowed to choose whether or not he gets the shot. This is why informed consent rather than mandates should govern the decision-making process because from this perspective a child death such as that of Ernesto Ramirez seems rather gratuitous.
In a recent interview of Prof. Retsef Levi by Maryanne Demasi he stated something that should by now be obvious because it is supported by certain undisputed facts of nature: Even if one grants that public policy should be geared toward the greater good it does not follow that the entire population should be treated as a homogeneous, uniform blob as do mandates. On the contrary scientists and even lay people have always known that it is anything but that. Children are different from adults in terms of their body chemistry, their stage of development, and their immune response. Women are also different from men, and women who are pregnant are different from those who are not and the babies that they are carrying are different still. Only by recognizing and tailoring policy to these differences is it possible to optimize vaccine effectiveness and minimize harms.
Kennedy’s critics were right. He did have an agenda and observing the workings of ACIP we now know what it is. Empiricism, transparency, adhering to the highest scientific standards of testing, and due diligence before marketing drugs. Likewise, during the course of this ongoing debate about vaccine safety and effectiveness we have also learned that his critics also have an agenda. It is basically the opposite of Kennedy’s and apparently stems from a combination of bureaucratic creep and pharmacological expansionism. This is a familiar divide.
We don’t know how this conflict will end, but we do know that the stakes are extraordinarily high both for the victims of vaccine injuries as well as for the drug companies. Speaking at the [January 2026] World Economic Forum in Davos Stéphane Bancel, [CEO of Moderna] said that without government recommendations, the vaccine market contracts — making large phase III trials financially unattractive…You cannot make a return on investment if you don’t have [mandated] access to the U.S. market.”
Even if Murphy’s injunction is overturned and ACIP is reinstated, there is no guarantee that the CDC will adopt their recommendations. As might be expected the Deep State and Big Pharma are fighting fiercely to keep the status quo. But at least the fight is now in the open and we know where each side stands. Moreover, one imagines that a well-informed public not governed by a climate of fear would probably side with the ACIP committee rather than the powers that be.
From the vaccine debate, we have learned that if government agencies truly want to promote the greater good and avoid gratuitous harms, then best practice in a public policy whose aim is to intelligently serve the greater good would be to take all of the differences among the various demographic groups in the population into consideration. It should insist that testing with inert placebos, the gold standard of medication testing, become standard practice and that standard practice should also include long-term followup after vaccines are released in the market. It should issue black-box warnings if they are warranted and routinely encourage informed consent. If it does so it will automatically restore individual autonomy in the decision-making process and in that case, it will bolster two goods at once, optimal safety and freedom for the public at large. That is what is at the heart of the great vaccine debate.
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