The day before Donald Trump won the 2024 Presidential election, I wrote a post describing his health advisor, longtime antivaccine activist Robert F. Kennedy Jr., as an “extinction-level threat” to federal public health and science-based health policy, if Trump were to win. Unfortunately for those who care about public health, Trump did win the election and two weeks later nominated RFK Jr. to be Secretary of Health and Human Services. Soon to follow RFK Jr. in joining the Trump administration were a collection of antivaxxers, grifters, and quacks nominated to take over various federal health agencies. Ultimately, as we all unfortunately know, RFK Jr. was confirmed by the Senate, thanks largely to the cravenness of Senator Bill Cassidy (R-Louisiana), who could have stopped RFK Jr.’s confirmation in committee, but instead voted both to forward his nomination to the full Senate and then, after a nauseatingly self-serving speech, voted to confirm him. However, even before RFK Jr. was confirmed, the Trump administration started attacking federal science by postponing NIH study sections with no warning, suddenly barring NIH investigators from traveling to give talks or present their research at scientific meetings, and attempting to slash indirect costs attached to NIH grants to universities with no warning, in essence, a massive, immediate, and unexpected budget cut to universities that do a lot of NIH-funded research. The day after RFK Jr.’s confirmation as HHS Secretary by the Senate, the administration began mass firing NIH employees, jeopardizing intramural research and clinical trials.
There are a lot of ostensibly “pro-vaccine” physicians out there who, because they like how RFK Jr. includes an emphasis on “chronic disease” in his dubious “Make America Healthy Again” (MAHA) slogan, have been willing to ignore RFK Jr.’s 20 years of rabid antivaccine activism, in which he has consistently promoted pseudoscience, quackery, misinformation, and conspiracy theories and support him. They chose to believe RFK Jr.’s claims that he is “not antivaccine,” or even that he is “pro-vaccine,” or, even more risibly and unbelievably, that he is “fiercely pro-vaccine,” the last of which being a claim that he’s made for over a decade. However, as I like to say, whenever RFK Jr. says he’s “not antivaccine,” he is lying. Whenever he claims to be “pro-vaccine,” he’s lying even harder. Finally, when he claims that he “won’t take away anyone’s vaccines,” he’s lying harder still and assuming that his audience has a lot of useful idiots in it who will believe him.
So, to those physicians, like the most useful and idiotic of useful idiots, Sen. Bill Cassidy, who believe RFK Jr. when he says he won’t take away anyone’s vaccines or think that they system will prevent him from doing much damage to federal vaccination programs, I’m here to school you. Here, I will predict, based on my having followed RFK Jr. and debunked his antivax misinformation for two decades, as well as my knowledge of how vaccines are approved by the FDA and recommended by the CDC, as well as of current science and vaccine safety monitoring systems, how RFK Jr. will go about dismantling the federal vaccine program and, ultimately, seriously hobbling state and local vaccination programs. Unlike certain contrarian physicians, if, two or four years later, events show that I am mistaken in this, I will happily admit it because I want to be mistaken. I desperately want to be mistaken and don’t want my predictions to come true. Unfortunately, I suspect that I will get more right than wrong, but time and history will be the judge of that, and you can even call me out on it in 2028—or even sooner, if you like.
It’s very fortuitous that Jonathan Howard wrote his post yesterday about policy-based evidence-making, because that will be a key strategy that RFK Jr. will use to upend the vaccination program. I’ve long noted that this is how RFK Jr. does things, although I had, amazingly, been unaware of this pithy little sarcastic name for putting the cart before the horse by taking a desired policy and then cherry picking and manufacturing evidence to cloak that policy in the illusion of being evidence-based and thereby providing a justification for implementing it. What I do like to point out is that lawyers, like RFK Jr., tend to approach data and studies very differently than scientists. While scientists test a hypothesis by doing experiments and studies to test it, potentially falsifying it—i.e., they care if the hypothesis is actually aligned with nature and reality and will reject it if it fails to stand up to experimental testing—lawyers are trying to make a case for they position that they are defending. To that end, they will cherry pick evidence to support their case and look for any way to denigrate or discredit evidence that does not. This is exactly what RFK Jr. will do, but even more so. Now that he controls the CDC and NIH, he will be in a position to fund new research and cherry pick existing research that results in “evidence”—no matter how dubious—to support his policies, namely undermining confidence in vaccines and removing them from the market, and that is exactly what he will do.
So let’s dig in. This is how RFK Jr. will greatly hobble or even destroy federal vaccination programs. Suffice to say, he will definitely take away at least some of your (and your children’s) vaccines, or do his damnedest to take them away, no matter how much his supporters ignoring his antivax stances try to delude themselves otherwise. Two main federal agencies now controlled by RFK Jr. in his role as HHS Secretary will be the focus of his efforts, the Centers for Disease Control and Prevention, which oversees public health efforts, vaccine safety, and and the Food & Drug Administration. Also, HHS is intimately involved with the Vaccine Court that operates under the National Vaccine Injury Compensation Program. Let’s start with the CDC.
CDC: Policy-based evidence making to fuel antivax messaging
The CDC has long been a hated target of the antivaccine movement going back to before the time when I started paying attention to and writing about the antivaccine movement over two decades ago, mainly because it is the epicenter of public health in the US and antivaxxers are hostile not just to vaccines but to public health in general. There are many functions carried out by the CDC relevant to vaccines, including communications, the CDC-recommended vaccine schedules for children and adults, vaccine safety monitoring through systems such as the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), and the Vaccines for Children program, which provides vaccines to children whose parents might not be able to afford them.
It didn’t take long before RFK Jr. asserted control over communications, the most prominent example being its cancelation of the CDC’s Wild-to-Mild campaign:
The agency’s Wild to Mild initiative, launched at the start of the 2023–24 flu season, aimed to inform the public that while getting immunized against the flu doesn’t guarantee you won’t catch an influenza virus, it can protect you from severe illness, hospitalization, and death. With the catchphrase “A flu vaccine can take flu from wild to mild,” the campaign’s marketing materials featured hulking, wild animals juxtaposed against domesticated, sometimes stuffed, counterparts, such as a blowfish versus a goldfish. Wild to Mild targeted high-risk groups in particular, including children and pregnant people, whose vaccination rates had suffered during the COVID-19 pandemic.
The CDC, part of the Department of Health and Human Services (HHS), ditched the campaign Feb. 19, as first reported by NPR. That is, six days after the Senate confirmed outspoken vaccine skeptic Robert F. Kennedy Jr. as President Donald Trump’s health secretary. National Center for Immunization and Respiratory Diseases leaders broke the news to CDC staff following an HHS review of the campaign, NPR reported.
The death of Wild to Mild also coincides with the worst flu season the nation has seen in nearly 30 years. The percentage of outpatient and emergency department visits involving patients with influenza-like illness hit 7.79% the week ended Feb. 8—the highest percentage recorded since at least the 1997–98 flu season, CDC records show. The previous high was during the H1N1 swine flu pandemic: 7.72% the week ended Oct. 24, 2009.
Wild-to-Mild was, of course, a very reasonable messaging campaign. It didn’t make overblown claims, such as saying that if you are vaccinated against the flu you won’t get the flu, and instead concentrated on the real benefits of seasonal influenza vaccines, that they can both prevent the flu and, even when they fail to prevent the flu, greatly decrease the severity of disease. The press release announcing the campaign, oddly enough is still available, and it says:
The intent of the Wild to Mild campaign is to reset public expectations around what a flu vaccine can do in the event that it does not entirely prevent illness. Participants found this information useful and even motivational in consumer testing. For pregnant women, the information about how vaccination during pregnancy could not only protect the pregnant woman but also her baby for several months after birth was particularly persuasive.
To me, this sounds as though the CDC did learn some of the lessons of the COVID-19 pandemic, when the messaging around COVID-19 vaccines might arguably have been too definitive in claims of efficacy of preventing transmission.
RFK Jr. and HHS officials are denying that they had anything to do with the nixing of the Wild-to-Mild campaign, with HHS spokesperson Andrew Nixon telling reporters, “”Unfortunately, officials inside the CDC who are averse to Secretary Kennedy and President Trump’s agenda seem to be intentionally falsifying and misrepresenting guidance they receive” and HHS denying that the removal of the campaign was intentional. If you believe that, I have a bridge or two that I’d like to sell you, but let’s assume, for the moment, that Nixon isn’t lying. (As someone who was alive in the 1970s that phrase cracks me up.) Even so, one could easily see how pulling the Wild-to-Mild campaign could have been the result of anticipatory obedience.
Whatever the true story regarding the cancelation of the Wild-to-Mild program, RFK Jr. wants to “refocus” CDC messaging about vaccines on a very common antivax trope about vaccines, “informed consent”:
The Centers for Disease Control and Prevention was ordered to shelve promotions it developed for a variety of vaccines, including a “Wild to Mild” advertising campaign urging people to get vaccinated against flu, two sources familiar with the decision told STAT.
The Department of Health and Human Services’ assistant secretary for public affairs informed the CDC that HHS Secretary Robert F. Kennedy Jr. wanted advertisements that promote the idea of “informed consent” in vaccine decision-making instead.
With the likely result:
Shifting the framing of advertising for vaccines that the CDC has long recommended — like flu shots — to put more focus on the possible risks of vaccines could undermine people’s willingness to get vaccinated, or to have their children immunized.
There you have it: This is almost certainly the reason RFK Jr. ordered some existing CDC advertising campaigns, like Wild-to-Mild, to be canceled. He wants to change CDC messaging to a very deceptive framing of “informed consent” that has long been a favorite of the antivax movement ever since I first started writing about it and likely long before that. There’s a reason, for instance, that an antivax physicians group named itself Physicians for Informed Consent and so many antivax groups include something about “informed consent” in their names and/or propaganda. In actuality, “informed consent” is anything but informed. When I first noted antivax framing of “informed consent,” I renamed it to “misinformed consent.” Sadly, it took me nearly six years to realize that “misinformed consent” wasn’t really quite right as a descriptor, because to antivaxxers it’s not about the consent for vaccines, but rather the refusal of vaccines. That’s why I now refer to antivax “informed consent” (not to mention tropes about “informed consent” by quacks for other forms of medicine) as “misinformed refusal.” The idea behind misinformed refusal is simple: Vastly exaggerate the potential harms of vaccines beyond what any evidence can support, while simultaneously minimizing or denying the benefits, weaving a story that, if believed, would lead any reasonable person to refuse to be vaccinated because the message they get is that it’s a big probability of harm and a low-to-nonexistent probability of benefit.
Yes, the CDC is going to pump out antivax messaging that seems reasonable on the surface. No doubt my physician colleagues who like the MAHA message so much that they desperately need reasons to ignore RFK Jr.’s long history of antivaxxers messaging will find the focus on “informed consent” compelling. This brings us to the next part of how the CDC will be turned into an antivaccine organization. The problem with informed consent misinformed refusal is that there needs to be evidence to support vaccines’ harms and lack of efficacy. Of course, antivaxxers are very good at cherry-picking evidence and studies to weave a false narrative of dangerous and ineffective vaccines, but imagine what they could do if they had control of the research apparatus of the CDC! Well, you don’t have to imagine anymore. Soon you’ll see!
Let me go back in time to, the very first antivax conspiracy theory about the CDC that I tackled. It was promoted by RFK Jr. himself in 2005, when he published the conspiracy-fest of a “revelation,” Deadly Immunity, in which he claimed that the mercury-containing preservative thimerosal used in some CDC-recommended childhood vaccines until around 2001 was the cause of an “autism epidemic” and that the CDC tried to cover it up at a meeting in 2000. What was really happening is that the raw data in the study at the center of RFK Jr.’s conspiracy theory did show a correlation between thimerosal-containing vaccines and autism but that that correlation went away as the data were corrected for appropriate confounders. To RFK Jr. and antivaxxers, of course, this was a conspiracy by the CDC to “cover up” evidence that vaccines caused autism, rather than epidemiologists doing what epidemiologists do with their data and adjusting for factors likely to produce misleading correlations. Unsurprisingly, evidence produced over the intervening several years failed to support a link between mercury in vaccines and autism; it is a dead hypothesis that, these days, even antivaxxers don’t harp on much anymore.
The second big CDC conspiracy theory that I discussed was the so-called “CDC-whistleblower” conspiracy theory, whose creation and spread I first witnessed in 2014, when an antivax scientist named Brian Hooker secretly recorded several phone calls with a disgruntled CDC vaccine scientist named William Thompson, who had started calling him to voice his unhappiness with a 2004 study for which he was a co-author. I won’t go into the specifics much, other than that Williams accused the CDC of scientific fraud, with no basis for such charges and include some relevant links. For example, the transcripts of Thompson’s conversations with Hooker (and why they don’t show what antivaccine activists claim they show) have been discussed in detail here. Thompson also gave a large number of documents to Rep. Bill Posey (R-FL), a number that is sometimes claimed by antivaxers to be “100,000 documents” but in reality was far fewer. (A detailed discussion of these documents can be found here, here, and here.) I’ll also point out links to some of my writings and delving into how Thompson became the “CDC whistleblower.” Ultimately, Del Bigtree and Andrew Wakefield produced a successful antivax propaganda film disguised as a documentary, VAXXED, that promoted the conspiracy theory nine years ago. (Has it really been that long since I reviewed that dreck?) In any event, antivaxxers have periodically funded “studies” designed to show that vaccines cause autism or are in some way dangerous. They tend to backfire. this time around it will be the federal government funding such studies through the CDC or even the NIH.
Now, imagine that RFK Jr. were in charge of HHS and the CDC when the two studies at the heart of the Simpsonwood conspiracy theory and the CDC whistleblower conspiracy theory were being readied for publication. I think you get the idea. He could easily respin the studies in the way that antivaxxers wanted, emphasizing, for instance, the raw data in one that showed a correlation between thimerosal-containing vaccines and autism and the unadjusted data in Thompson’s paper that showed a correlation between MMR vaccination and autism risk in a subset of African-American boys. But wait! Surely CDC scientists wouldn’t go along with this? Perhaps. Some probably wouldn’t and as a result would either quit or be fired. Likely they would quickly be replaced by antivax “scientists” chosen by Dr. Dave Weldon, the antivaxxer who has been nominated to be CDC Director but not yet confirmed. Others might go along to save their jobs.
Let me point you to an already existing example: The Florida Department of Health, which did have competent and talented scientists when Gov. Ron DeSantis appointed ivermectin- and hydroxychloroquine-promoting quack Dr. Joseph Ladapo as Florida Surgeon General to head it. The Department soon started publishing dubious studies not-so-subtly “massaged” to produce the result desired by the state’s new Surgeon General, namely the claim that COVID-19 vaccines are more dangerous than effective and “natural herd immunity” is all. If you think the same thing can’t happen at the CDC, all I can say in response is, “Oh, you sweet summer child” and move on to the NIH, before coming back to the CDC and, finally, the FDA.
The NIH: Directing research grants to antivaxxers
The NIH is under HHS as well, and the nominee to be NIH Director is Dr. Jay Bhattacharya. He was, as readers recall, one of the co-authors of the Great Barrington Declaration, which—before there even was a vaccine—advocated a “let ‘er rip” approach to the COVID-19 pandemic, the better to reach “natural herd immunity” within 3-6 months, with an ill-defined strategy of “focused protection” that would supposedly keep those vulnerable to severe disease and death from the coronavirus safe while all the “young and healthy” people bravely caught the bug and opened up society again. It was an impossible strategy that never would have worked and did massive damage to public health, as well as a profoundly social Darwinist idea that basically threw the most vulnerable to the corona-wolves. As I’ve documented before, RFK Jr. has said that he wants an eight year “pause” on research on infectious disease and drug development, the better (supposedly) to shift effort to studying “chronic disease.” You can bet that any research on new vaccines will be included under that ban, if it ever happens. You can also bet that funding studies of “vaccine injury” as a cause of chronic disease will become a focus of the NIH, because his claim that the current generation of children is the “sickest generation” assumes that vaccines are one of the major root causes of chronic disease in children (and adults).
The obvious retort to that is that the NIH has a system of peer review, which takes place in committees called study sections. These committees consist of scientists with appropriate expertise, statisticians, and other relevant experts who review incoming grants and assign them a priority score based on the scientific impact, merit, and feasibility of each proposal. These scores are then used by higher level committees called scientific councils to determine which grants actually make the cut to receive funding. Surely, you might reassure yourself, study sections are going to keep obvious bad science such as what antivaxxers generally propose, from receiving funding. All I can say again is: Oh, you sweet summer child.
This is where I must point out how so many MAHA- and MAGA-adjacent scientists and physicians, such as Dr. Vinay Prasad, have been castigating NIH funding mechanisms as promoting “mediocrity.” The basic attack, which goes back years and years, claims that NIH study sections do not choose the most scientifically meritorious applications, but rather “safe” science. It’s a narrative I’ve been hearing over and over going back 15 years. While there is a grain of truth to the narrative, a lot of the examples cited by, for instance, Dennis Slamon and John Ioannidis are subject to retrospective bias, in which those making such arguments know that the projects that had difficulty funding were successful and assume that it was always obvious that they would be, all while forgetting that at the time it was not nearly so obvious that these projects would succeed, not to mention ignoring all the other similarly risky projects that didn’t succeed. My retort to such complaints has always been to acknowledge that the NIH becomes more conservative as paylines get tighter, meaning that the best solution would be to increase the NIH budget, so that it can fund more grant applications.
In any event, while attacking study sections as unable to pick the most meritorious grants, these people are advocating for new systems to pick grants to be funded that would make it potentially easier for antivaxxers to receive NIH grants. How? By diminishing the role of study sections—or eliminating them altogether—as gatekeepers. How? Think about the proposals, which I’ve discussed in depth here and here, to add a “modified lottery” element to the system whereby grant applications are chosen for funding. The overall ideas here range from scoring grants, taking twice as many of the best-scored applications as there are funds to support, and then making final funding determinations by lottery. That’s not so scary, but other proposals involve almost total randomness, with a fairly perfunctory review of grant applications to make sure they check all the boxes, after which they are funded according to lottery.
It’s worse than that, though. After all, lotteries are too unreliable, especially when less than there is funding for less than 10% of grant applications. That brings us to ideological purity tests being proposed and touted by people like—you guessed it—Jay Bhattacharya and Vinay Prasad:
And yes, just as NIH grants currently consider the university’s ability to provide lab space, and central core laboratory facilities, NIH grants should consider a university’s ability to provide an environment of open inquiry. FIRE rankings or a modified alternative may serve as a starting point. Creating an NIH hotline to report instances of academic freedom being threatened, perhaps anonymously, would also discourage universities from these actions.
In short, there is nothing “outlanding” about Jay Bhattacharya considering academic freedom alongside other facilities and opportunities present at universities in deciding whether federal funding should be invested. We already ensure universities treat women fairly, lest they loose funding. We already ensure universities have the physical space to conduct the work that is being funded. We now ask only that universities offer the intellectual environment that is conducive to free and open thought. That is not only in the interest of universities, it is directly in the public interest as well.
Guess who will determine what constitutes an adequate commitment to “academic freedom”? No doubt such “commitment” will involve refusal to call quackery quackery, bad science bad science, and pseudoscience pseudoscience, at least with respect to ideological beliefs about COVID-19, masking, public health, and vaccines to which RFK Jr. clings. Remember, to science deniers, appeal to “debate” is a shield against criticism and a grievance to which they can point when the scientific community knows that what they are promoting is not worthy of debate because it has no basis in evidence and/or is an obvious conspiracy theory. For them, “debate” is performative, more designed to impress what they view as the rubes with a false narrative that their pseudoscience is worthy of serious consideration by actual scientists.
A long time ago, I wrote about the antivax view of NIH funding. Actually, it’s a view of NIH funding held by many quacks, pseudoscience pushers, and cranks. Specifically, it’s embodied in the narrative during the pandemic that suggested that Anthony Fauci, as the Director of the National Institute for Allergy and Infectious Diseases, personally doled out grant funds to reward scientists and universities that “toed the line” with respect to COVID-19, while punishing contrarians not because their science was poor but rather because they didn’t toe the line. Basically, the narrative portrayed Fauci (or the NIH Director) as akin to Michael Corleone at the end of The Godfather, when all the capos came to kiss his ring and pledge their fealty to him as the new Boss, with Corleone doling out favors to reward loyalty. I’ve long suspected that the origin of this misconception about how NIH grants are funded is based on projection. Basically, antivax conspiracy theorists who portray the NIH as doling out grant funds to reward supporters and withholding them to punish “dissidents” is exactly how antivax conspiracy theorists would determine whose research is funded and whose is not, leading them to assume that this is how the NIH has always done it. With RFK Jr. in charge of HHS and Jay Bhattacharya soon to be in charge of the CDC, there is now a chance for antivaxxers and “contrarians” opposed to public health science to modify NIH funding mechanisms to resemble more closely what I now call the Godfather model; i.e., adding a component to grant funding decisions based on the ideology and loyalty of the scientists applying.
As I’ve long said, whatever its flaws (and there are many), the study section mechanism by which the NIH makes its grant funding strives to be as close to a true meritocracy as any human organization can attain. If RFK Jr. gets his way, look for the NIH to pivot away from vaccines and infectious disease to whatever RFK Jr. designates as “chronic disease.” In fact, I can’t help but think that the pseudoscience- and alternative meidcine-promoting National Center for Complementary and Integrative Health is likely due for a huge budget increase under him, in addition to grant mechanisms to study “vaccine injury.”
Having described the policy-based evidence-making by CDC and NIH that RFK Jr. will likely begin as soon as he can, assisted by Dr. Jay Bhattacharya as NIH Director and Dr. Dave Weldon as CDC Director as soon s they are confirmed by the Senate, I now must move not to what scientific evidence produced as a result of that process will be used for, supporting antivax policy. The first strategy to do that will be through the Advisory Committee on Immunization Practes
RFK Jr. will control and thereby co-opt ACIP for the antivax movement
One of its most important functions, if not the most important function, of the CDC with respect to vaccine policy is its recommended schedule of childhood and adult vaccines. These CDC-recommended schedules are used by states to determine which vaccines will be required for school enrollment and which vaccines must be covered under law by health insurance companies, Medicaid, Medicare, and insurance plans under the Affordable Care Act is the CDC Advisory Committee on Immunization Practices (ACIP), the committee that formally recommends the childhood and adult vaccine schedules. He who controls ACIP controls the CDC-recommended vaccine program. RFK Jr. has long known this.
And now RFK Jr. controls ACIP.
Soon after RFK Jr. suspended his independent campaign for President in August, Dr. Paul Offit wrote about what sort of mischief that could be done to ACIP by antivaxxers in a Trump administration, although he focused on The Heritage Foundation’s Project 2025 and its plan to eliminate the CDC as a recommending body for vaccines. At the time, I said that I didn’t think that even RFK Jr. would do that. I stand by that assessment because controlling the CDC-recommended vaccine schedule is a far more powerful tool than giving up that CDC power. In that light, I note that the February meeting of ACIP was abruptly postponed (although ACIP workgroups did apparently meet as scheduled this month) and reports have suggested that RFK Jr. is planning to replace the existing ACIP members with antivax fake vaccine “experts.” (More on that in a moment.) In a rather…interesting…twist:
The fresh scrutiny comes as a meeting scheduled for next week of the CDC’s external vaccine committee was canceled, according to a person familiar with the decision. HHS spokesperson Andrew Nixon said the meeting is being “postponed to accommodate public comment in advance of the meeting.”
The federal public comment portal for the meeting — which was set to be open from Feb. 3 through Feb. 17 — was never activated, a contributing factor to the postponement. The public historically has had an opportunity to comment on the meeting agenda and request time to make oral statements.
Incompetence or malevolence? To be honest, I’m not sure which is the explanation. Normally, I like to go by the adage, “Never ascribe to malevolence what can be explained by incompetence.” However, with RFK Jr. and Donald Trump, I’m having a difficult time hewing to that rule of thumb. I’ll assume for now that it’s convenient incompetence. Why is ACIP so important, though?
First, Dr. Offit describes ACIP and its history:
During the 1940s and 1950s, the United States Public Health Service (USPHS) relied on committees that met intermittently to address various vaccine issues. For example, in 1955, the USPHS convened experts to determine who should get Jonas Salk’s polio vaccine. By the early 1960s, with the licensure of new vaccines, it became evident that these committees needed to meet regularly. In March 1964, the Surgeon General created the Advisory Committee on Immunization Practices (ACIP), which was composed of experts in virology, immunology, microbiology, pediatrics, epidemiology, public health, and preventive medicine. The charge to the ACIP was clear: “The Committee shall concern itself with immunization schedules, dosages and routes of administration and indications and contraindications for the use of these agents. The Committee shall also provide advice [to the CDC] regarding the relative merits and methods for conducting mass immunization programs.”
Since 1964, ACIP experts have recommended many safe and effective vaccines. Prior to these recommendations, every year in the United States polio caused 20,000 cases of paralysis and 1,500 deaths; measles caused 48,000 hospitalizations and 500 deaths; mumps was the most common cause of acquired deafness; rubella (German measles) caused 20,000 cases of congenital birth defects; rotavirus caused 70,000 hospitalizations from severe dehydration; and bacteria such as pneumococcus and Haemophilus influenzae type b (Hib) caused tens of thousands of cases of pneumonia, sepsis, and meningitis and hundreds of deaths. Thanks to vaccines, and the clear, strong recommendations by the ACIP and CDC, these diseases have been dramatically reduced or eliminated. Indeed, in a recent report published on August 8, 2024, researchers found that among 117 million children born between 1994 and 2023, CDC-recommended vaccines prevented about 500 million illnesses, 32 million hospitalizations, and 1.13 million deaths.
All of this is true, which is why I don’t think RFK Jr. would eliminate ACIP, even though he could. Rather, it is far more likely that he will subvert ACIP. The Secretary of HHS picks the members of ACIP, after a nomination and selection process. These members serve staggered terms, and the current roster has four members, including the chair Dr. Helen Keipp Talbot, whose term expires June 30, 2025, four whose terms expire in 2027, with the rest expiring in 2028. (The reason for this is that, for whatever reason, the Biden administration left a number of ACIP committee positions vacant after the members’ terms had expired and then appointed several new members in February.) By the end of a Trump administration, all members of ACIP could be replaced; that is, if RFK Jr. were to wait until the terms of existing members expire. He could easily decide not to wait and replace the entire committee now. Such is the power he now holds. In any event, RFK Jr. can now decide who is in charge of vetting potential new ACIP Members, or even vet them himself, a process that could be used to place four antivax and/or contrarian “scientists” and physicians on the committee, qualifications that prospective members be “acknowledged experts with an outstanding record of achievement in their own field and an understanding of the immunization issues covered by ACIP” be damned.
Regular readers can only imagine the disaster that would be. Likely no new vaccines would be added to the CDC-recommended schedule, while some might even be removed, as committee members harass CDC and FDA scientists to torture the safety and efficacy data to make it “confess” that vaccines are unsafe and ineffective. (Remember my discussion of policy-based evidence-making above. There’s its relevance!) RFK Jr. might well be working on doing what I feared and replacing real vaccine experts on ACIP with antivax quacks and pseudoscientists, as reported by Politico:
HHS Secretary Robert F. Kennedy Jr. is preparing to remove members of the outside committees that advise the federal government on vaccine approvals and other key public health decisions, according to two people familiar with the planning.
Kennedy plans to replace members who he perceives to have conflicts of interest, as part of a widespread effort to minimize what he’s criticized as undue industry influence over the nation’s health agencies, said one of the people, who were granted anonymity to speak freely. Kennedy has long argued that drugmakers have too much sway over the approval of their products.
Unsurprisingly, in his first speech to the HHS, RFK Jr. invoked rooting out what he perceives as “conflicts of interest”, saying:
“We will remove conflicts of interest from the committees and research partners whenever possible or balance them with other stakeholders,” he said on Tuesday. “We will shut the revolving door.”
The shake-up is likely to target the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which makes recommendations for the licensing and administration of vaccines.
The whole appeal to “conflicts of interest” with Big Pharma is a longstanding antivax trope. HHS already has very rigorous requirements for ACIP members to report their financial conflicts. Moreover the members with direct interests in vaccines tend to be nonvoting members. I’m referring to representatives of pharmaceutical companies, as well as advocacy groups such as the American Academy of Pediatrics, the AMA, and Pharmaceutical Research and Manufacturers of America (PhRMA).
As I like to say, I consider it rather telling how RFK Jr. seems only to consider it a financial “conflict of interest” if it’s Big Pharma. As I also like to say, I support transparency when it comes to all financial conflicts fo interest. One wonders if RFK Jr. will be so rigorous when it comes to enforcing COI reporting requirements when the COI is with Big Supplement, Big Wellness, or Big Antivax (I’m looking at you, RFK Jr., with your massive COIs with respect to suing pharmaceutical companies that manufacture vaccines, so expertly called out by Sen. Elizabeth Warren during your confirmation hearings), all of which I consider to be under the umbrella of Big Quackery. Somehow—just somehow—I suspect that he won’t. That’s the idea. He’ll just shift ACIP COIs from Big Pharma to Big Quackery.
In any event, one can’t help but note:
There was also a discussion scheduled for the HPV vaccine, a product known as Gardasil that’s the subject of personal injury litigation on which Kennedy has worked.
Quelle surprise. But don’t worry! RFK Jr. has a reassuring answer to that:
In a revised ethics pledge, the secretary said he would direct to his son any proceeds won from the lawsuit over Merck’s vaccine and to which he’s entitled through a referral arrangement with the law firm Wisner Baum.
Well, that makes it no longer a COI, doesn’t it? (Yes, that’s sarcasm, in case that wasn’t painfully obvious.) I’m reassured. Aren’t you?
Meanwhile, RFK Jr.’s old antivax org Children’s Health Defense—you know, the one that he had founded and run for several years and then tried to disavow when Bernie Sanders asked him about the onesies with antivax slogans it’s selling—is salivating at the prospect of RFK Jr. replacing ACIP members, unsurprisingly echoing RFK Jr.’s claim of “conflicts of interest” and quoting other antivaxxers:
Once a vaccine is included on the childhood schedule, the drugmaker is protected from liability for any injuries associated with the shot. The combination of school vaccine mandates and no liability guarantees a steady revenue stream for vaccine makers.
“Most ACIP members have a financial conflict of interest with the pharmaceutical companies,” Dr. Meryl Nass, internist, biological warfare expert and long-time ACIP watchdog, said.
“Their decisions almost always appear to reflect pro-industry bias,” she said. “Although they are there to protect the public, few decisions seem to take the public interest into account as the primary concern.”
Meryl Nass, of course, is an antivax quack. I’ll also translate from antivax-speak what “pro-industry bias” means, namely any decision based on solid science, clinical trials, and epidemiology, rather than on antivax pseudoscience, conspiracy theories, and fear mongering. Interestingly, they quote another antivax and pro-quackery activist Sayer Ji, who cites the outgoing Biden Administration’s appointments to ACIP as justification for getting rid of ACIP members:
“This postponement raises questions about whether there are internal conflicts or strategic recalibrations underway at the CDC,” said Sayer Ji, founder and editor of GreenMedInfo.
“Given that the outgoing administration stacked ACIP with staunchly pro-vaccine appointees, one could speculate that the postponement is a stalling tactic to ensure continuity of their agenda. Alternatively, it could reflect an effort to re-evaluate and possibly restructure ACIP under new leadership.”
In its final days, the Biden administration quietly stacked ACIP with several new pro-vaccine members, a move intended to “insulate the scientific integrity of the panel from the incoming administration,” STAT News reported.
The outlet said these appointments were a direct response to President Donald Trump’s nomination of Kennedy to head HHS. However, Kennedy could override or otherwise bypass these selections.
Actually, as I wrote the last time I discussed what RFK Jr. might do to ACIP, I noted that the Biden administration had, for whatever reason, left a number of ACIP committee positions vacant after the members’ terms had expired and only eventually appointed several new members last February. In other words, the picture is more complicated. If anything, I blame the Biden administration for not keeping up-to-date with ACIP appointments and keeping the committee at full strength.
Unfortunately, now RFK Jr. controls ACIP, the single most important decider when it comes to which vaccines are on the CDC-recommended schedule, because, although the CDC Director isn’t required to accept ACIP recommendations, he almost always does. ACIP is also the single most important watchdog regarding existing vaccines on the schedule that decides when a vaccine shows too much evidence of being unsafe to remain on the schedule. Remember, too, that More importantly for this discussion, such health insurance plans are not required to pay for vaccines not on the schedule.
Who controls ACIP controls the CDC-recommended schedule and controls the choice of science used to justify the CDC schedule. Over time, with antivaxxers on ACIP, the accumulation of policy-based “evidence” falsely showing vaccines to be unsafe, to cause autism, and to be ineffective could lead to the slow drip of vaccines coming off the recommended schedule, one by one.
Then there’s the Vaccine Court.
RFK Jr. will influence the Vaccine Court
In 1986, because of a wave of litigation against vaccine manufacturers that threatened to force vaccine manufacturers to flee the US market, Congress passed the National Childhood Vaccine Injury Compensation Act of 1986, which set up the National Vaccine Injury Compensation Program (NVICP) and the Vaccine Court. Basically, the law says that claims for vaccine injury must go through the Vaccine Court first, the court funded by an excise tax on every dose of vaccine. There are many advantages to complainants, not the least of which is that they can recover reasonable court costs, win or lose, and the standard of evidence tends to be less onerous. There are also “table injuries” for which automatic compensation is granted. Antivaxxers hate the system because it does try to be science-based (although occasionally it tends to err on compensating injuries not caused by vaccines); antivax lawyers really hate it because they can only collect hourly rates and can’t gamble on obtaining a huge settlement and taking their huge contingency fees out of it. Here’s the thing. HHS controls what is on the list of table injuries and has a large role in recommending settlements to the Department of Justice, as the process for seeking compensation is described on the website for the NVICP:
What is the process?
- An individual files a petition with the U.S. Court of Federal Claims.
- The U.S. Department of Health and Human Services medical staff reviews the petition, determines if it meets the medical criteria for compensation and makes a preliminary recommendation.
- The U.S. Department of Justice develops a report that includes the medical recommendation and legal analysis and submits it to the Court.
- The report is presented to a court-appointed special master, who decides whether the petitioner should be compensated, often after holding a hearing in which both parties can present evidence. If compensation is awarded, the special master determines the amount and type of compensation.
- The Court orders the U.S. Department of Health and Human Services to award compensation. Even if the petition is dismissed, if certain requirements are met, the Court may order the Department to pay attorneys’ fees and costs.
- The special master’s decision may be appealed and petitioners who reject the decision of the court (or withdraw their petitions within certain timelines) may file a claim in civil court against the vaccine company and/or the health care provider who administered the vaccine.
You can see where this is going. With antivaxxers in ACIP and, over time, all over the relevant HHS offices, you can see HHS medical staff adding conditions that vaccines definitely don’t cause (e.g., autism) to the list of table injuries and recommending compensation at step #2 for more and more conditions, whether caused by vaccines or not. You might further envision that the policy-based “evidence” created by RFK Jr.’s minions could be used to justify greatly broadening the list of conditions viewed as “vaccine injury,” thereby bankrupting the fund that supports the Vaccine Court and building pressure to take certain vaccines off the CDC schedule. Manufacturers might take the most targeted vaccines off the market.
RFK Jr. will control vaccine safety monitoring systems VAERS and VSD
Speaking of policy-based evidence-making, it won’t just be the CDC and NIH that RFK Jr. will be able to weaponize to produce “evidence” that portrays vaccines as unsafe and causing conditions (like autism), diseases (like “the various autoimmune diseases antivaxxers like to attribute to vaccines “turbo cancer”), and complications that current evidence shows them not to cause. Although they are not the only vaccine safety monitoring systems, VAERS and VSD are the two primary ones. Other active monitoring systems include the Clinical Immunization Safety Assessment (CISA) project and the FDA’s Post-licensure Rapid Immunization Safety Monitoring System (PRISM).
VEARS is a passive reporting system, which relies on vaccinees, families, and healthcare professionals to report suspected adverse events after vaccines. Thus, as a system, VAERS was never intended to provide an accurate estimate of the frequency of AEs related to vaccines, but rather to serve as an early warning system, a “canary in the coal mine”, if you will, for possible new vaccine-related AEs. In other words, VAERS is a hypothesis-generating, not a hypothesis testing, system, and its hypotheses are tested using better systems, like VSD, CISA, and PRISM. In contrast to VAERS, these systems are active reporting systems in that electronic health records are actively monitored for AEs after vaccination in order to identify potential signals; there is a lot less bias that way and a lot less potential for misreporting. Indeed, the main problem with using VAERS to estimate the frequency of AEs after vaccination is that, in essence, anyone with access to the Internet, mail, or the telephone can report anything to VAERS, as was demonstrated by bloggers years and years ago when one autism advocate filed a report claiming that the flu vaccine had turned him into The Incredible Hulk and another claimed a vaccine had turned his daughter into Wonder Woman. Moreover, going back 25 years, antivaxxers have flooded the database with claims that vaccines cause autism, in order to support litigation.
RFK Jr., however, as HHS Secretary, will have access to the unfettered raw data from all of these systems, given that they are all maintained by agencies under his purview. If he wishes to commission “analyses” of data from VAERS, VSD, CISA, or PRISM, he can. If he wishes to commission antivax “scientists” like Brian Hooker, Anthony Mawson, or even Andrew Wakefield to “reanalyze” the data from these systems, he can. Antivaxxers have long gone “dumpster diving” into VAERS to find all manner of correlations that they use to blame vaccines for horrible adverse events, a process that accelerated after COVID-19 vaccines were granted an emergency use approval. Antivaxxers have long abused VAERS data. Imagine what they could accomplish with unfettered access.
As for the VSD, you might remember that around 21 years ago, the antivax father-son team of Mark and David Geier were granted access to the VSD database to explore the hypothesis that thimerosal in vaccines cause autism. At that visit, they were busted trying to merge databases in a manner that could compromise patient privacy and reveal protected health information (PHI) for patients whose health data were contained within the database. As a result, their IRB approval was revoked and their access to VSD terminated. Now imagine a whole horde of Geiers, given permission by RFK Jr. himself, swarming over the VSD database. You get the idea. None of this even considers changes in the VAERS or VSD systems that RFK Jr. could potentially make that would degrade the reliability of the systems in the name of “improving safety.”
Of course, to RFK Jr., that likely will not be enough. Even if all the policy-based “evidence” that he and his minions make lead to many vaccines no longer being covered by insurance and to more and more people being so afraid of vaccines that they refuse to use them, vaccines will still be legal. They will still be available to people who have the resources. Yes, I know that, were RFK Jr. to stop there, he could in essence have mostly destroyed the US vaccination programs without, technically, having “taken away” anyone’s vaccines. I predict that he won’t be able to stop there, however. That’s where the FDA comes in and where the policy-based evidence will be particularly useful.
FDA: Recalls, bans, and black box warnings
The FDA is also part of HHS and therefore now controlled by RFK Jr. As most people know, the FDA exists to assure the safety of food and the safety and efficacy of drugs and medical devices. As a result, vaccines must be licensed by the FDA for market before ACIP will even consider adding them to the schedule. (Yes, I know, in the case of the COVID-19 mRNA vaccines, emergency use approval by the FDA was enough to have ACIP consider the vaccine, but the idea stands. Any vaccine must be approved, either provisionally or fully, by the FDA before it can be added to the schedule.
Before even considering any other aspect of the FDA as it relates to vaccine approval, I predict that the approval of new vaccines by the FDA under RFK Jr. will grind to a halt. At the very minimum, in the name of his “concerns” about their “safety,” RFK Jr. will call for re-reviews of the data and applications for any vaccine in the approval pipeline, thus bogging things down, even if the FDA has already accepted the evidence for safety. I also predict that he will find ways to make the standards for vaccine approval more and more onerous beyond what is called for by science and reason, all while requiring, similarly, ever more onerous post-licensure monitoring. As a result, given that most vaccines are not exactly profit centers for pharmaceutical companies anyway, there will be a lot less financial incentive to develop vaccines for the US market and likely there will be few if any new vaccines submitted for FDA approval while RFK Jr. is HHS Secretary.
As ACIP is the key committee for determining which vaccines are in the CDC schedule, the key committee for vaccine approval by the FDA is its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is under the purview of the Center for Biologics Evaluation and Research (CBER). The VRBPAC charter describes its duties and functions thusly:
Objectives and Scope of Activities
The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective vaccines, allergenics, and related biological products for human use and as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.Description of Duties
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines, allergenics, and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and as required, any other products for which the FDA has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
Unlike ACIP, however, VRBPAC members are selected by the FDA Commissioner or his designee, in this case (assuming he’s confirmed by the Senate), Dr. Martin Makary.
To obtain FDA approval for a vaccine, a manufacturer submits a Biologics License Application (BLA) to the FDA. BLAs include preclinical and clinical data and information, as well as details of the manufacturing process and facilities. The FDA then examines the application and data submitted and decides whether to approve and license the vaccine. As for VRBPAC:
In some cases, FDA seeks the input of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). This committee is comprised of a panel of outside, independent, technical experts from various scientific and public health disciplines that provide input on scientific data and its public health significance in a public forum. The FDA will consider, but is not bound by, the input received from the VRBPAC when determining whether to approve a vaccine.
As you can see, there are multiple levels of review for any vaccine for which a manufacturer is seeking FDA approval. Now, imagine that Dr. Marty Makary, who has not yet been confirmed as FDA Commissioner but who will be working for RFK Jr. Jonathan Howard once asked what Dr. Makary would do if RFK Jr. pressured him to revoke the licensure of various vaccines and was not confident at all that Makary would do the right thing, even if it meant being fired. Neither am I, even when it comes to resisting the coming machinations of RFK Jr. and his cronies to game the approval system for vaccines.
Also, Makary will soon have the power to appoint members to VRBPAC. Imagine the policy/ideology-directed scientific evidence and studies that RFK Jr. and his minions will be cooking up being used as pretexts to bring “concerns” about the safety of specific vaccines to VRBPAC, which they will do. Also remember, VRBPAC is the committee that meets every spring to examine data about the flu strains circulating in order choose which flu strains should be used to produce vaccines in the late summer and fall that year, based on its predictions of which strains will likely be circulating in North America. Indeed, now that I think of this aspect, one can easily see a scenario where whatever VRBPAC picks will not be a “good enough” choice and flu vaccine production is hampered, leading to shortages and fewer people receiving the vaccine.
Finally, even if RFK Jr. can’t use the CDC, NIH, and FDA to manufacture and/or cherry pick “scientific evidence” falsely portraying specific vaccines as so unsafe that the FDA has to revoke their licensure, I can easily see a scenario where such dubious “science” can be used to produce just enough “evidence” to lead a compliant FDA to issue a “black box” warning for specific vaccines. Black box warnings are the FDA’s most stringent warning, alerting the public and health care providers to serious side effects, such as injury or death, from a drug, device, or biologic. In such an event, RFK Jr. will have, again technically, “not taken away” anybody’s vaccines, but will have ginned up so much fear of the vaccines, also while possibly inducing health insurance companies not to cover them, that the effect will be almost the same delicensing them.
Will RFK Jr. succeed in destroying the US vaccine program?
I realize that this post is long, even by Gorski standards. The reason is simple. As I thought more and more about what RFK Jr. can do to undermine the vaccine program as HHS Secretary, I kept thinking of more and more horrible things, things that I know RFK Jr. has undoubtedly already thought of. The more I thought of, the more I had to write about, and the longer this post became. I make no apologies, though. I’m hoping the sheer length and depth will convince you just what a dire threat RFK Jr. is to public health and the vaccination program as HHS Secretary.
From my perspective, even if the rest of MAHA aside from vaccines weren’t mostly a sham, what RFK Jr. will try to do to the vaccine system will far outweigh any potential good he could do in terms of public health by encouraging healthy eating and directing more research money to chronic disease. To my fellow physicians who, just because they like the superficial MAHA message RFK Jr. promotes about food, obesity, and chronic disease have in essence been in denial about how antivaccine RFK Jr. is and how much damage he can do to public health, I urge you: Wake up. You have been played. Nearly three months ago I characterized RFK Jr. as an “federal public health programs and science-based health policy.” Unfortunately, I fear, that extinction is nigh; that is, unless we resist.