I had hoped to get through the first month of the year without revisiting this topic. In retrospect, I should have known that that would be a fool’s errand, given that antivax activist turned Secretary of Health and Human Services Robert F. Kennedy Jr. decided to start the first full week of January by, as Dr. Steven Novella accurately characterized it, following an executive order by President Donald Trump issued as 2025 faded into 2016 to alter the US CDC-recommended vaccine to turn it into, basically Denmark’s recommended vaccine schedule, in essence outsourcing our vaccine policy to Denmark. Why? It’s certainly not because Denmark’s vaccine schedule is in any way superior based on science. Rather, it’s because, of all the nations in the European Union, Denmark vaccinates against the fewest diseases and RFK Jr. wants to eliminate as many vaccines. as he can as fast as possible. We are now one of the outliers when it comes to vaccine policy, and as a result we can expect in the next few years to see resurgences of rotavirus, meningitis, influenza, and other vaccine-preventable diseases for which the vaccine was dropped from the US schedule. Seriously, Brazil, Mexico, Saudi Arabia, and Greece now recommend vaccinating against more diseases than the US does.
The drive to make the US Denmark derives from an old antivax lie that portrays US children as “overvaccinated” and suffering health damage because of it, none of which is true:
Vaccine experts disagree with their conclusions.
“They want you to believe that we’re way out of sync, and that we give way more vaccines than everybody else. But we don’t,” said Anna Durbin, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health.
But RFK Jr. is antivax to the core and has been so for over two decades, which means that “too many too soon” is one of the main antivax tropes that are driving forces behind his (anti-)vaccine policy.
Although I missed what I consider to be the window of opportunity to discuss why this change is so transparently not science-based, I do still consider it worth directing you to a post from a decade(!) ago in which I described why the fact that different countries recommend different vaccine schedules does not mean that any of them are necessarily less science- and evidence based than others. Basically, different countries have different infectious disease risk profiles, healthcare systems, and priorities, and crafting a science- and evidence-based vaccine schedule requires taking those into account and then using science and evidence to devise a vaccine schedule that is as optimal as humanly possible. RFK Jr. has most definitely not done that, and that’s because he is coming for your vaccines and his endgame has always been to eliminate as many vaccines as he can.
Given our alignment of our vaccine schedule with Denmark, a tiny country with universal health insurance, a much more homogeneous population than that of the US, and vastly different needs, I came across an op-ed in the Washington Post by Ezekiel J. Emanuel, an oncologist, medical ethicist and professor at the University of Pennsylvania, and Paul Friedrichs, the inaugural director of the White House Office of Pandemic Preparedness and Response Policy, entitled How RFK Jr. plans to bankrupt vaccine manufacturers. Of course, bankrupting the Vaccine Injury Compensation Program (VICP) has long been one of the tactics that I’ve been warning about that RFK Jr. will use to eliminate vaccines, but it’s good to see that these warnings are finally showing up in mainstream news publications. I just hope it’s not too little, too late. That being said, and particularly in light of recent updates regarding RFK Jr.’s very own attempt to replicate the unethical nature of the Tuskegee syphilis experiment by outsourcing an unethical vaccine trial to Africa, I thought this a good time to revisit early in 2026 where I think RFK Jr.’s plans to eliminate vaccines will go next in the coming year. Spoiler alert: It will involve what fellow SBM blogger Dr. Jonathan Howard once called “policy-based evidence-making,” in which evidence, no matter how poor quality, is created in order to further a policy. It will also involve a wholesale attack on the VICP.
First, though, as I do in every post in this series in order to bring everyone who might not have encountered my predictions before, let’s revisit the specific strategies by which RFK Jr. has attacked the vaccine program and will continue to do so. What depresses me the most every time I write a new installment in this series is how accurate my predictions have been. Yes, I know that anyone who’s been paying attention to RFK Jr. and his antivax activism over the last two decades could have made the same predictions. I don’t claim any particular genius or prescience. It still depresses me.
A recap: RFK Jr.’s six strategies to eliminate all vaccines if he can
In a time that seems long, long ago, I first predicted and then started describing the strategies that RFK Jr. would use to undermine federal vaccination programs. It’s worth listing them again, so that those who are just entering this series don’t have to go back and read a lot (although I do encourage you to do so if you are interested):
- Co-opt the CDC to change its evidence-based policy-making apparatus to policy-based evidence-making designed to fuel antivax messaging.
- Co-opt the NIH to direct research funds away from vaccines and towards studying “vaccine injury” and other antivax narratives (to support the policy-based evidence-making).
- Remake ACIP as an antivax committee, in order to remove recommended vaccines from the CDC recommended immunization schedule and refuse to approve new vaccines.
- Influence the Vaccine Court and the NVICP to compensate “vaccine injuries” that antivaxxers believe in but that are not supported by science.
- Take control of the vaccine safety monitoring systems, the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safetylink Database (VSD), to cherry-pick evidence designed to portray vaccines as dangerous.
- Co-opt the FDA to make approval of new vaccines more difficult and issue black-box warnings based on antivax fear mongering for existing vaccines.
It is clear from the events of last few months that RFK Jr. is doing all of these things. Given that we’ve discussed #2, #3, #5, and #6 recently, this post is going to be primarily about #1 and #4, specifically recent efforts to create evidence to justify RFK Jr.’s already chosen policy objectives (although arguably his move to align the US vaccine schedule with that of Denmark didn’t even bother to generate or use evidence to justify it, which suggests that I need to add a seventh pillar of RFK Jr.’s antivax strategy). Also, I will discuss what I see coming with respect to the VICP and how RFK Jr. will do his best to expose vaccine manufacturers to the same frivolous lawsuits that in the 1980s were driving vaccine manufacturers out of the US market, leading Congress to pass and President Reagan—no liberal he!—to sign the National Childhood Vaccine Injury Act of 1986 that created the VICP, the Vaccine Court, and much of the current vaccine safety monitoring systems in use today.
The pending attack on the VICP
In their WaPo op-ed, Drs. Emanuel and Friedrichs begin by discussing how, contrary to the claims of the antivax movement, the vaccine program is fragile because most vaccines are not that profitable for their manufacturers:
Economics makes Americans’ access to vaccines very fragile. Research trials to prove that vaccines are safe and effective must enroll tens of thousands of patients. Consequently, they take a long time and are very expensive. Yet, to ensure access to all Americans, particularly 70.4 million children, vaccines must be cheap. Thus, the profit margins for manufacturers are very small. Studies have shown that many physicians barely break even from administering vaccines. To ensure both the availability of vaccines for all Americans and sufficient and predictable demand for manufacturers, the federal government purchases vaccines through the Vaccines for Children Program and provides them free to more than half of all U.S. children through Medicaid, Children’s Health Insurance Program and similar programs to help the uninsured, underinsured and Native Americans.
This is an accurate assessment of the program. Of course, antivaxxers love to point to various quality initiatives by the Centers for Medicaid and Medicare Services (CMS, which is now run by “America’s Quack” Dr. Mehment Oz) and private insurance companies that incentivize pediatricians and primary care physicians to adhere to the evidence-based vaccine schedule as evidence of “corruption” and undue influence, claiming that doctors are getting rich from “pushing vaccines.” I love to respond to that question by asking: How is it, then, that pediatricians and primary care physicians tend to be the lowest compensated specialties in medicine?
In any event, Emanuel and Friedrichs go on to point out how the economics works:
The economics only work because of the National Vaccine Injury Compensation Program. All medical procedures and treatments carry some risks, but fortunately, we have decades of data from the United States and other countries showing that the adverse effects and risks from vaccines, while not zero, have been remarkably low. By 1986, lawsuits drove many commercial manufacturers to stop making vaccines, creating vaccines shortages and reduced vaccination rates.
To ensure vaccine availability, President Ronald Reagan signed the law creating the VICP. Manufacturers pay 75 cents from each vaccine dose they manufacture (or sell) into a pool which is used to compensate anyone who was injured by a vaccination, without the need for lengthy lawsuits. Since the VICP was established, about one vaccination recipient has received compensation for every 1 million vaccine doses administered.
The VICP is a win-win-win-win arrangement: Injured patients are fairly compensated without expensive, lengthy, and uncertain trials and legal fees. Manufacturers keep producing low-cost vaccines and developing new ones, and the government pays nothing. Meanwhile, the American public stays healthy.
Of course, the “make America healthy again” (MAHA) movement doesn’t accept that evidence-based public health interventions like vaccines help to keep Americans healthy because MAHA, through RFK Jr., is inextricably tied with soft eugenics and the antivax movement. Nonetheless, Emanuel is another accurate characterization of the situation with respect to vaccines as it exists now. Regular readers will likely recall that, as has been discussed here many times over the years, antivax lawyers hate the VICP. They really, really, really hate it. You might wonder why. After all, one feature of the VICP is that legal expenses and other reasonable costs of that complainants incur bringing their cases before the Vaccine Court complainants are paid, whether they win or lose. Indeed, lawyers can make quite a good living bringing cases before the Vaccine Court. My suspicion, however, has always been that these attorneys aren’t satisfied with reasonable (but still impressive) hourly rates for their legal work. They want the big splash, the huge settlements or judgments from which they can take a 30+% commission and get lots of publicity. Some of them, like RFK Jr., believe that vaccine manufacturers are evil and therefore want to punish them, to make them bleed.
To drive them out of business, as Emanuel and Friedrichs correctly perceive:
Kennedy understands he can take vaccines away from Americans if he makes vaccines unprofitable. If the VICP is overwhelmed by too many claims and goes bankrupt, manufacturers become financially liable. Facing new risks of lengthy and expensive litigation, they will stop selling vaccines in the U.S.
That is—and has always been—part of RFK Jr.’s plan, #4 on my list of antivax strategies to weaponize the CDC, FDA, and NIH—all of HHS, actually—to eliminate vaccines. Basically, he wants to turn back the clock to 40 years ago, when the very situation described by Emanuel and Friedrichs was actually threatening to drive the last manufacturers of vaccines out of the US market. I’ve discussed how RFK Jr. could go about doing that as well, and Emanuel and Friedrichs basically say similar things.
The thing to remember about the VICP and the Vaccine Court is that there are certain conditions on what is called the Vaccine Injury Table that are considered automatically eligible for compensation. Colloquially referred to as “table injuries,” these are known potential injuries from vaccines that are accepted based on scientific, clinical, and epidemiological evidence. I’ve long predicted that RFK Jr. would do his damnedest to add to the Table “injuries” from vaccines that are not supported by scientific, clinical, and epidemiological evidence, such as autism, autoimmune diseases, and the like, and Emanuel and Friedrichs correctly perceive that danger, pointing out how recently the CDC website was altered in order to make the false claim that the conclusion that vaccines do not cause autism is “not evidence-based.” I discussed this alteration before in depth and why it’s nonsense, and so I will not dwell on it here. You can read my previous post if you want the details, where I explained why the CDC is now lying to you about v vaccines and autism.
The reason behind this change, besides RFK Jr. being an antivax activist who has been claiming that vaccines cause autism for over two decades, is as a prelude to doing what I’ve been warning about and adding autism to the table, which Emanuel and Friedrichs correctly perceive:
This is the latest step toward adopting a claim that “vaccines can cause autism” and allow parents of autistic children to seek compensation from the VICP.
If this change happens, over 100,000 children who are diagnosed with autism each year could claim compensation from the VICP. And thanks to Kennedy and the Children’s Health Defense he founded, somewhere between 25 and 50 percent of parents with autistic children believe vaccines caused their child’s condition. The expected groundswell of compensation claims and lawsuits will easily bankrupt the vaccine compensation pool, while enriching lawyers like Kennedy.
Were RFK Jr. to succeed in adding autism to the table—and I no longer see any reason why he will not ultimately succeed—then Congress would be forced with the choice of vastly increasing the budget of the VICP, which would likely require a large increase in the tax on vaccines that funds it, or simply altering the law to allow vaccine injury lawsuits to bypass the VICP and go straight to federal courts. The latter possibility is much more likely, although even if Congress does nothing the results would likely be equally catastrophic. Any outcome other than Congress stepping in to fund VICP to be able to handle the flood of claims for “vaccine-induced autism” (that wasn’t caused by vaccines) would likely achieve the same end. Vaccine manufacturers would leave the US market, and antivax lawyers would feed at the trough.
And autism is just the beginning of all the conditions that antivaxxers blame on vaccines and might add to the table. For example, now that COVID-19 vaccines are fully FDA-approved, he could conceivably add the fantastical diagnosis of “turbo cancer” to the table. What’s to stop him, with his own “experts” like once-respected oncologist-scientist Dr. Wafik El-Deiry providing material to support this unproven—nay, disproven—myth? Not coincidentally, Dr. El-Deiry and his co-author on a recent highly speculative—to be very, very kind—review on COVID-19 vaccines as a cause of cancer are chairing a workgroup on Safety Uncertainties of mRNA COVID vaccines for the CDC Advisory Committee on Immunization Practices (ACIP), which they used to spread typical antivax talking points about COVID-19 vaccines. Basically, unless he is stopped, eventually RFK Jr. will be able to add almost anything he wants to the table. Sure, he’ll encounter bureaucratic, legal, and regulatory hurdles, but he has three years left to overcome them, and he knows the system.
Which brings us to policy-based evidence making.
No evidence to support your antivax policies? No problem!
In the past, the drafting of policies and regulations in HHS and its various agencies like the CDC and FDA, was a long, laborious process that required the input of real experts doing real science and presenting real and valid scientific evidence, followed by debate and public input. The process took months (minimum) to years (more typical). Unfortunately, with his move to make America Denmark with respect to its vaccine schedule, RFK Jr. demonstrated that he can, at least in the current administration, bypass that process.
Indeed, I suspect that he did so because even the reconstituted ACIP, which he purged of real experts and stacked with his favored antivax cronies, didn’t move fast enough for him, likely because its members are incompetent and have been unable to maneuver deftly through the bureaucratic requirements of ACIP’s mission in order to make more than incremental changes in the recommended vaccine schedule, such as eliminating the recommendation for the birth dose of the hepatitis B vaccine and moving COVID-19 vaccines into a gauzy “shared decision making” category that has more in common with the twisted antivax version of “informed consent” that I routinely refer to as “misinformed refusal,” in which unproven and disproven claims about the harms of vaccines and their supposed lack of efficacy are treated as factual for purposes of informed consent, than it does to real shared decision-making.
Even so, RFK Jr. knows that he has to maintain at least the illusion of evidence-based policy making, to hide what he is really doing, namely policy-based evidence-making. That’s why he’s hired a number of his antivax cronies to various HHS agencies, longtime antivax activists such as David Geier and Mark Blaxill, as well as more recent antivax-adjacent recruits like Drs. Tracy Beth Høeg and Vinay Prasad. They’re there to start generating “evidence” to justify the antivax policies that RFK Jr. wants to impose anyway, by seemingly following the process if he can, by fiat if he must. Geier, for instance, was the son half of the father-son duo who promoted the myth that the mercury-containing preservative thimerosal, which was used in several childhood vaccines until it was removed in 2001-2002, was the cause of the “autism epidemic” and subjected autistic children of quackery consisting of a combination of puberty blockers with chelation therapy to treat their autism. (I don’t think that it’s a coincidence that last week the CDC altered its webpage about autism to remove warnings about quack treatments, commonly referred to by antivaxxers as “autism biomed” and including quackery like chelation therapy. I need to write more about that sometime.) Dr. Prasad is an evidence-based medicine fundamentalist, willing to use methodolatry to further RFK Jr.’s mission to eliminate vaccines by making vaccines much more difficult to approve.
Three weeks ago, I discussed just how far RFK Jr. would go to manufacture scientific “evidence” to cover his policy-based evidence-making with the veneer of actual evidence-based policy when I discussed how the CDC had on the down-low awarded $1.6 million to Danish investigators Peter Aaby and Christine Stabell Benn to do unethical randomized controlled clinical trial involving the birth dose of the hepatitis B vaccine in the African country of Guinea-Bissau. It was a trial that I and others compared to the infamous Tuskegee syphilis experiment. It turns out that two stories were published last week that show that the whole process by which RFK Jr. tried to use our tax dollars to generate evidence to justify his desire to rid the country of the birth dose of the hepatitis B vaccine was even worse than thought. One appeared in Rolling Stone; written by Katherine Eban, it was entitled HHS gave a $1.6 million grant to a controversial vaccine study. These emails show how that happened. (I had guessed before reading the article how it had happened, and I wasn’t too far from the truth, as you will see.) Then there was a newsletter published on the Substack Inside Medicine by Dr. Jeremy Faust entitled Scoop: The leaked protocol of the CDC-funded Hepatitis B vaccine trial in Guinea-Bissau. “This is another Tuskegee.” Although I could have done without the “scoop,” I did nonetheless find this a disturbing and highly informative look at the actual study.
One thing the Rolling Stone article demonstrated to me is that I hadn’t realized just how discredited Peter Aaby and his wife Christine Stabell Benn had become by the time they pitched their study to RFK Jr.:
On Oct. 1, 2025, two prominent Danish vaccine researchers, Peter Aaby and Christine Stabell Benn, faced potential career ruin.
A group of top Danish statisticians completed a withering analysis of the duo’s research, which would be published in the international journal Vaccine weeks later. The analysis documented “questionable research practices” and unspooled a veritable rap sheet of poor scientific practices. It followed a devastating series of articles in the weekly Danish newspaper Weekendavisen, exposing how Aaby and Stabell Benn had allegedly oversold their research findings.
Aaby, 81, and Stabell Benn, 57, who are married, are best known for pioneering a theory that vaccine opponents have embraced: that vaccines have potentially unknown and nonspecific effects on the immune system, and while some vaccines that use weakened live viruses can reduce mortality, others using inactivated viruses can increase it. For decades, they’d studied this idea, using a research outpost in the impoverished West African nation of Guinea-Bissau.
In my previous post , I discussed how ethically dodgy their work has been, as it appeared to take advantage of underprivileged impoverished people in a poor country to do work that would not pass ethical muster in their home country. I also mentioned how RFK Jr. loved to cite their work on “nonspecific effects” of vaccines, which, according to the couple, could be either beneficial or detrimental. Unsurprisingly, RFK Jr. ignored the work suggesting that the measles vaccine protects against more than just measles through its prevention of “immune amnesia” that measles infection can cause and focusing predictably on work suggesting that children who received the DTP vaccine was associated with a five-fold increase in all-cause mortality. It was not a good study, and I’ll leave you again to competent dissections of it by Skeptical Raptor and yours truly. None of this, according to Rolling Stone, stopped antivax recruits Lyn Redwood and Stuart Burns from shepherding the no-bid grant proposal “through HHS’ bureaucratic maze.” Hilariously (to me), Rolling Stone obtained the documents not from our government, but from a Danish journalist named Gunver Lystbæk Vestergård, who while working for the Danish publication Weekendavisen had obtained them through a Danish freedom of information request to the University of Southern Denmark, where Stabell Benn is a professor. (The emails were published by the Rolling Stone on DocumentCloud here.)
The documents answer one question that I had, namely why only $1.6 million. I thought that this was too little money, but it turns out that the CDC wasn’t the only organization being hit up for funding by Aaby and Stabell Been:
I am copying in my contacts at Pershing Square Foundation (PSF), so we are all on the same page. As you know, PSF has kindly offered to support the hepatitis B trial with 1.8 milion USD, provided we can raise the remaining 1.8 mill USD, with a deadline this week. Bluebell Foundation has agreed to‘support the tial with 300,000 USD.
The trial benefits from a unique window of opportunity: The Guinean goverment has decided to implement hepatitis B vaccine at birth, but it will only be implemented in 2027. Once it is.implemented, we can no longer randomize children, so that puts a limit to the sample size and the power of the trial. The sooner we can get started, the better the trial.
As we are reaching the PSF deadline, it would be most appreciated and very helpful if you could give us a time frame for the CDC process.
Note how Stabell Benn outright admits that the rationale for the study is more opportunistic than scientific. Given that I have already once discussed why, even in light of the government in Guinea-Bissau implementing the birth dose of hepatitis B until 2027, doing this study is still unethical given what we knew about it, I’ll move on.
I note that Bill Ackman, an American billionaire hedge fund manager, is the listed as the CEO of Pershing Square Capital Management, the company responsible for the Pershing Square Fund. I further note that during the pandemic, Ackman made a lot of money early in the COVID-19 pandemic by spending $27 million on credit default swaps to hedge against a sharp market downturn and making $2.6 billion from the investment. As the pandemic dragged on, he increasingly posted on social media standard anti-lockdown antivax talking points. One particular post occurred in 2023:
In the post, he trashed vaccine expert Dr. Peter Hotez and wanted someone to “debate”—excuse me, have a “discussion” with—RFK Jr. to prove him wrong, in other words standard “debate me, bro” nonsense. A couple of excerpts:
Vaccines have saved millions of lives. A world without polio, small pox, and tetanus is a healthier, happier, and safer world. This does not mean, however, that multiple Covid vaccines should have been administered to every human being regardless of their age or condition during the crisis.
I love the strawman argument and the false equivalence. Next up in the long “Tweet,” he parroted Great Barrington Declaration talking points:
Had we listened to the skeptics of our government’s approach to vaccination or extended lockdowns for all, rather than censoring them — for example, those who suggested that the vaccine be principally given to the aged and those with co-morbidities and not to healthy children, or had we followed the recommendations of the Great Barrington Declaration — many lives may have been saved with reduced negative long-term effects on the economy, the education of our children, and our citizens’ mental health.
And then he trashed Dr. Hotez:
I was, however, mistaken in encouraging a debate between @RobertKennedyJr and @PeterHotez as based on my further research Hotez does not appear to be a credible advocate for vaccine policy in light of the repeated inaccuracies of his public statements during the crisis and potential conflicts he may have.
What about RFK you might ask? RFK is not a scientist, but he has assumed the mantle as one of the most aggressive critics of vaccine policy, and he is extremely articulate and has a highly visible public profile as a presidential candidate. These are all qualities which make him an excellent choice for an antagonist in the vaccine discussion.
Hoo boy. Notice how Ackman doesn’t state what “errors” Dr. Hotez allegedly made, and his admiration for RFK Jr. makes me wonder if he took a hand in promoting Aaby and Stabell Benn’s proposed project. It’s all starting to make more sense. I will admit, however, that the involvement of Bluebell Foundation is even odder. It doesn’t appear to be the sort of charity that donates to medical research projects, at least from what I can tell from Grantable, which states that its philanthropy involves “funding initiatives in various subject areas, including arts and culture, performing arts, music, orchestral music, education (elementary, secondary, and higher education), and religion, particularly Christianity.” Still, this is all making more and more sense.
Indeed, as Rolling Stone reports, RFK Jr.’s fingerprints are all over this, and it seems very unlikely that this proposal was truly “unsolicited” as claimed:
In Denmark, vaccine researcher Anders Hviid gives little credence to the idea that Stabell Benn’s study was somehow unsolicited. Kennedy’s “fingerprints are all over it,” he says, pointing to the study’s stated objective to examine secondary outcomes such as eczema and neurological disorders. “It makes absolutely no sense to study associations between this vaccine and these outcomes,” except that’s what interests Kennedy. Perhaps Bill Ackman took a personal hand after being cc’d on Stabell Benn’s email. However it happened, the grant application soon became a “funding priority,” and the rest, as they say, is history.
Which brings us to the actual protocol itself, apparently obtained by the Substack Inside Medicine. Unfortunately, there does not appear to be a link to the full protocol; so I have to rely on what Dr. Faust writes about it. (Yes, I was dying to read the actual protocol, but sadly I was disappointed.) Before I enumerate the flaws in the study, first, I am grateful that a CDC employee apparently confirmed that the funding was pushed through by bypassing normal channels. Noting that it didn’t bother him that the CDC had funded a randomized controlled trial when it usually doesn’t do it this way, the contact explained:
Instead, it was that the usual pathway for approving and funding a clinical trial with human subjects had not been followed. Career staff were not asked to complete a “funding determination,” (a concise description of what the study would do) nor a “project determination” (a more detailed readout that would normally include the study protocol, and which would identify whether the research was on human subjects, which would indicate the need for much more oversight, including “Institutional Review Board” (IRB) approval, either the CDC’s or another US-based one.
None of that happened. “Staff in the Office of Science told Trump political appointees that they should not do this,” the official told Inside Medicine. “But they did it anyway.”Career CDC employees were disappointed. “The study should never have been approved, let alone funded,” the official said.
Moreover, he echoed the scientific concerns raised by others. “We would never do a study on a vaccine that has been in use for 40 years. That is a waste of taxpayer resources,” he said, adding that it’s “set up so that they’re likely to find a spurious association.”
Beyond that, though, the official seemed exasperated. “This is another Tuskegee,” he said. “We are allowing children, infants, to be exposed to Hepatitis B when we could prevent it, and then follow them for five years to see what happens. That’s not long enough to see the long-term benefits, but might be long enough to find some non-specific effects.”
Which is exactly what Paul Offit, Derek Beres, and a number of others were saying about it. As listed in Inside Medicine, let’s first look at the primary outcomes to be examined:
Primary outcome: Mortality and morbidity. The composite outcome of all-cause mortality and non-fatal admission with infection* from randomization to 42 days of age (before the next routine vaccination) in the group given HBV0 compared with the control group.
This is a huge flaw. After all, mortality from hepatitis B infection is generally not going to happen for several years, even decades, which is when complications from such infections, such as cirrhosis and liver cancer occur. Also note that all infections are included, not just hepatitis B. Dr. Faust notes that the study doesn’t even track hepatitis B infection rates, other than in a small substudy.
Then there are big “tells” in the secondary outcomes:
Secondary outcomes: Neurodevelopmental disorders and atopic dermatitis (AD).
- AD by 2 years of age. In a subgroup followed to 2 years of age (see sample size calculation): cumulative incidence of AD symptoms (self-reported at home visits or telephone follow-up) and cumulative incidence of AD diagnosed by an MD with special training.
- Neurodevelopment by 5 years of age. In a subgroup of 500 infants followed to 5 years of age: cognitive outcomes assessed by the Mullen Scales of Early Learning and the Kaufman Assessment Battery for Children. These tests have been tested for validity in Sub-Saharan African children.”
That’s right. Stabell Benn is going to try to prove that the birth dose of hepatitis B vaccine causes autism and atopic dermatitis, something that we already know that vaccines do not cause. These secondary outcomes are slam-dunk evidence (to me) that this study was designed to support antivaccine messaging and policy.
As for the flaws, I encourage you to read the Inside Medicine post for details, but in it Dr. David Bouleware, an infectious disease physician at the University of Minnesota. These flaws include:
- “Failure to test all mothers to exclude Hepatitis B.” Multiple sources mention that this is the most glaring ethical error, given that even RFK Jr. seems to grudgingly concede that it is a good idea to give the birth dose of the hepatitis B vaccine to mothers who are positive for the virus. Moreover, as has been mentioned in many stories about this study, close to 20% of the population of Guinea-Bissaue are hepatitis B carriers, which means that up to 20% of the infants in the no birth dose group would be denied standard of care and exposed to an elevated risk of hepatitis B and early death. Although some mothers will be tested, the majority will not, and it is dicey even to randomize infants of mothers who are negative for hepatitis B.
- “The trial’s endpoints do not measure Hepatitis B incidence in all participants. This is the most direct trade-off of withholding the birth dose of the vaccine.” This one also gives away the game, as actually measuring hepatitis B incidence in all participants would demonstrate that the birth dose of hepatitis B works.
- “The data safety monitoring board (DSMB) [an external body that keeps tabs on trials like this] has no explicit early stopping boundaries. There is no guidance on what endpoints are to have interim analysis.” This is another major failure. A DSMB needs to have rules and guidelines for when the trial should be stopped; for example, when the level of serious adverse events (like death) in one group become statistically significantly higher than in another group, it then becomes unethical to continue the study.
- “The claim of ‘no known disadvantages’ (Page 13 of the protocol) is clearly false if children develop chronic hepatitis B because vaccination was withheld.” Dr. Boulware also noted that it’s unlikely that the parents in this study will be given the information to give true informed consent, specifically that they will be informed of the greater risk in the delayed dose group.
It is further noted that it is unclear whether the trial has begun yet. Dr. Faust notes:
On January 7, it was reported that this trial had begun. But last weekend, rumors reached my group chats that it had been halted. Reporters raced to confirm the news, but were not able to. Asked whether the rumors that the trial had been halted were accurate, HHS Spokesperson Andrew G. Nixon said, “those rumors are false.”
Assuming that patients have been enrolled, that also means that the CDC and/or the Danish researchers now have 30 days to post the study’s protocol on the ClinicalTrials.gov website. I asked Nixon when the protocol would appear on that website. He didn’t answer that question. Instead he repeated a statement he had previously made to Politico and others, saying that HHS would ensure the “highest scientific and ethical standards are met,” and that the award “supports an independent study designed to answer important questions about the broader health effects of the hepatitis B birth dose.”
In other words, who knows when or even if the CDC and/or Stabell Benn and Aaby will post the full protocol, as required, to ClinicalTrials.gov.
The bottom line: It will only get worse in 2026
What this update let me to conclude was fairly obvious. Basically, in his quest to generate “evidence” for its policy-based evidence-making that can be used to justify what he wanted to do anyway, RFK Jr. will not be constrained by clinical trial ethics or good science. We already knew that, of course, but it is depressing to see it illustrated in such stark detail through an examination of how the Guinea-Bissau study was funded, most likely with the involvement of a MAGA-adjacent hedge fund billionaire, and how unethical and unscientific its actual design is.
Contemplating these recent developments, I now realize that my six pillars of RFK Jr.’s strategy to eliminate all vaccines from the US can really be reduced to a much smaller number:
- Change HHS policymaking from being science- and evidence-based, at least as much as possible, to being policy-based evidence making, where the evidence is generated solely to convince the rubes that the policies being implemented have science behind them. The consequences will be:
- Influence the Vaccine Court and the NVICP to compensate “vaccine injuries” that antivaxxers believe in but that are not supported by science.
- Failing #1 and #2, make changes by edict, as RFK Jr. did when he changed the US recommended vaccine schedule to be patterned on the Danish schedule.
a. FDA will use this “evidence” to weaponize EBM to make vaccines much more difficult and expensive to approve and allow it to attribute “injuries” to vaccines that vaccines don’t cause.
b. NIH will shift its funding away from new vaccines to studying “vaccine injury” and “nonspecific effects.”
c. CDC will use this “evidence,” through ACIP, to remove as many vaccines from the schedule as possible and use this technique to cherry pick evidence from vaccine safety monitoring systems to portray vaccines as dangerous.
d. CMS will use this “evidence” to justify ceasing to pay for specific vaccines through federal health insurance programs.
These are the tactics by which RFK Jr. will seek to eliminate vaccines. Sadly, I suspect that changing how the Vaccine Court compensates vaccine injuries will be the most effective means of eliminating vaccines. If he really leans into this method, he could conceivably drive all the remaining vaccine manufacturers out of the US market by 2027.
I will conclude, as I conclude every installment in this series by warning you. I am not exaggerating. I have watched RFK Jr. for over 20 years. He is antivax to the core, and he genuinely believes in the cause, even though that doesn’t stop him from grifting on the side. He will eliminate vaccines in the US if he can. We need to find a way to stop that, but time is running short to do that.
