Two weeks ago, I wrote about the opening of a new clinic at the National Institutes of Health Clinical Center, specifically a new clinic ostensibly portrayed as intended to study “vaccine injuries.” In my usual inimitable way, I described what a farce this clinic was (and is) and why I view it as a thinly veiled way to justify “studying” supposed adverse events due to vaccines for which we already have more than sufficient evidence to reject a causal link between vaccines and the injury. I also noted that, far more worrisome than the “vaccine injury clinic,” which as of yet is not even seeing patients, as far as I’ve been able to ascertain, a proposal by the Centers for Medicare and Medicaid Services (CMS) to introduce a new ICD10 code for reporting “vaccine injury” to the Vaccine Adverse Events Reporting System (VAERS) would incentivize all manner of quacks who make their living treating fake vaccine “injuries” to flood the system with dubious reports—and to be reimbursed by CMS for contaminating the VAERS database to make it more difficult to detect real vaccine safety signals versus stimulated reporting. Indeed, the heavy involvement of the antivax (or at least anti-COVID vaccine) group React19 in the roundtable and ribbon cutting ceremony on October 5 also gave the game away, although the roundtable was pretty much closed to the public, and the ceremony gave every appearance of having been hastily arranged and not well thought out. It is yet another tactic by which Robert F. Kennedy Jr. is definitely coming for your vaccines, and I want to expound on that a bit more.
A couple of developments prodded me to revisit the “vaccine injury center.” The first was a statement issued a week ago by NIH Director “Podcast Jay” Bhattacharya and the acting director of the National Institute for Allergy and Infectious Diseases (NIAID), John H. Powers III about the center.
People who report serious health problems, including those that occur after vaccination or long-term symptoms after infections, deserve to be heard, taken seriously, and evaluated with the best tools science can offer. In 1986, Congress established the National Vaccine Injury Compensation Program. In doing so, it recognized that vaccines have benefited many people, and that, like every medical intervention, they can also cause adverse effects in some who receive them. Recently, the experiences of Americans suffering from Long COVID have highlighted the reality that many infections can cause long-term symptoms often indistinguishable from adverse events after vaccination.
Therefore, the NIH is establishing a new research study called the Vaccinology and Immunology Center, the opening of which we marked on October 5. The center will bring together patients, physician-scientists, and laboratory researchers to investigate health problems following vaccination and infections, and turn discoveries into better care and safer vaccines.
Well, at least the clinic has an official name now. Unbelievably, it did not have an official name three weeks ago when it was announced; at least, if it did, I couldn’t find it in any of the NIH press releases, social media posts by Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr., or other government and press sources. There was, of course, another huge gaping hole in the information doled out at the closed door roundtable and ceremony on October 5, and I noted it in my post about it. Conspicuously lacking from the roundtable discussion or speeches at the ceremony was any mention of how one might refer patients to this new “Vaccinology and Immunology Center.” Indeed, just to remind you, some antivax quacks noticed. I’ll cite just one again:
This oversight was in my mind when I came across another article from an antivax source commenting on the new “Vaccinology and Immunology Center.” Then, I came across stories in the press about how, one week ago at a meeting of the NIH Clinical Center Research Hospital board meeting, the chair was…not pleased about the Vaccinology and Immunology Center:
The board overseeing the National Institutes of Health research hospital delivered a harsh rebuke of Health Secretary Robert F. Kennedy Jr. on Friday, voting unanimously to support a statement by its chairman accusing Mr. Kennedy of undermining trust in science and politicizing the hospital’s work.
The chairman, Jack Leslie, opened the board’s quarterly meeting by reading aloud a six-minute statement that said he was “troubled” by Mr. Kennedy’s recent unannounced visit to the N.I.H., where the secretary held a ribbon-cutting ceremony for a new clinic to study vaccine injuries and led a round table discussion with patients who said they had been injured by vaccines.
Mr. Leslie said that serious vaccine injuries are “rare but real” and that rigorous research is required. But after Mr. Kennedy announced the initiative on social media last week, along with a video of the round table featuring signs that said “Vaccine Injured,” Mr. Leslie said he grew concerned.
Mr. Kennedy said the government “must listen to patients and families who report vaccine injuries — not dismiss or gaslight them.” But Mr. Leslie said the signs suggested a foregone conclusion to the research, ordered by a secretary who is openly critical of vaccination.
Ouch. And also, kudos to Jack Leslie! He’s absolutely correct in recognizing that what was being introduced at the ceremony had nothing to do with the science-based study of vaccine injuries and everything to do with legitimizing antivax quackery, its findings a foregone conclusion flowing from the assumption that vaccines cause the serious “injuries” that the antivaxxers at the roundtable assumed that they did. In addition, from various sources, I learned why there is as yet no process for referring patients to the center. First, however, let’s finish looking at what Podcast Jay and the temporary lackey running NIAID have to say:
Through the new center, NIH will:NIH is finalizing the study protocol and anticipates launching the study before the end of 2026. We expect to enroll several hundred participants initially, focusing on individuals experiencing the most serious adverse effects following vaccination or long-term symptoms post-infection. Participants will enter through research enrollment and attend scheduled study visits. The center will not accept walk-in patients or offer routine appointments to the general public.
- Understand symptoms and pathophysiology of disease. Evaluate participants’ illnesses, examine the immunology of how vaccination or infection may have contributed, and investigate other related biological mechanisms.
- Identify risk factors. Study why some people experience symptoms and what may make them more vulnerable to these consequences of vaccination or infection.
- Explore treatment options. Provide treatment as appropriate under the research protocol and seek to connect participants with ongoing care closer to home.
- Inform vaccine safety. Use findings to guide efforts to improve vaccines and vaccination practices.
That last paragraph is key, and here’s why.
The NIH Clinical Center versus the Vaccinology and Immunology Center
When I wrote my first post about the Vaccinology and Immunology Center two weeks ago, I forgot something that, in retrospect, I should not have. The NIH Clinical Center is not like normal hospitals. It is a clinical center that is dedicated completely to clinical research. As it says on its website:
The NIH Clinical Center has been in the business of understanding, diagnosing and treating illnesses since it opened its doors in 1953. We focus on innovations that help millions but also help understand rare diseases that may only directly impact a few. All of this work, in partnership with our patients, helps us understand diseases and illnesses and search for solutions that can improve health for all Americans.
We are a unique resource with over 1,200 credentialed physicians, dentists, and PhD researchers; 620 nurses; and 450 allied health care personnel work in patient care units and laboratories focused on medical care and clinical study.
What this means is that a patient cannot be treated at the Clinical Center unless that patient is enrolled on one of the 1,600 clinical studies currently in progress there, most of which are phase I and II clinical trials. If you are not eligible for one of those clinical trials, you cannot be treated there. In other words, the NIH Clinical Center and Research Hospital are research institutions, and the clinical care there is only administered under the auspices of clinical study protocols, which, of course, have to be approved by the Center’s Institutional Review Board (IRB), to assure that the study is ethical and that human subjects in the study are protected. Part of that process, which might or might not be done by a separate committee, is to assure that the study being considered is scientifically valid, because the very first requirement for a human subjects research study to be ethical is that it be scientifically sound.
From the Helsinki Declaration, which proclaims ethical principles that dictate human subjects research:
Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.
You can see where I’m going with this, I suspect. Podcast Jay outright says that the reason that the Vaccinology and Immunology Center isn’t taking patients yet is because the research protocol for the center is either not approved yet or, as I suspect, not even finished being written. Moreover, I pity the principal investigators (whose identities I now know but will not reveal here), because they are career NIH scientific and medical staff. They are charged with coming up with a protocol that will satisfy the very antivax RFK Jr. while at the same time meeting the ethical requirements of the Declaration of Helsinki and, more pertinent to federal agencies, the Common Rule, which requires that all federally funded research be approved and overseen by appropriately constituted IRBs following accepted ethical guidelines for human subjects research. Truly, these poor PIs are caught between the proverbial rock and a hard place, and I would be surprised if they can get a protocol that is acceptable to the real PI of this study (RFK Jr.) approved by the NIH Clinical Center IRB by the end of the year.
Here’s another thing. When and if a protocol is approved, it must also be published on the ClinicalTrials.gov website, and I am most definitely keeping an eye on that website. Unfortunately, its search function is crap, and there is no good way that I’ve been able to ascertain to set up a search to notify me if new clinical studies including specified search terms (such as the name of the PI or various key words) appears. (If there is a way that any of my readers knows of, email me and tell me how to do this, as I want to monitor the site and be aware when the protocol appears on it!)
Unfortunately, the information about clinical trials on ClinicalTrials.gov is generally only a summary, which usually includes the institutions, the names of the PIs, inclusion criteria, and a general schema of how the study is organized. Detailed protocols are not available there. For this, I’m hoping that an intrepid reporter gets a hold of the protocol and is willing to share it with me (and real experts like Drs. Paul Offit or Peter Hotez) or that someone at the NIH is willing to email me a copy when it is finally approved. (Use my Signal handle gorskon.01 or encrypted email [email protected].)
Now that you know this, where do I think there will be problems getting any RFK Jr.-approved protocol through the Clinical Center IRB? First of all, there’s the requirement for a rationale for the study based in rigorous science. For example, the first bullet point (or, if you want to use research protocol lingo, specific aim) states:
Understand symptoms and pathophysiology of disease. Evaluate participants’ illnesses, examine the immunology of how vaccination or infection may have contributed, and investigate other related biological mechanisms.
And the second “specific aim” is:
Identify risk factors. Study why some people experience symptoms and what may make them more vulnerable to these consequences of vaccination or infection.
The first aim doesn’t ask if the subjects’ illnesses are due to vaccination. It assumes that they are and proposes to examine the “immunology of how vaccination or infection might have contributed.” (I do like the inclusion of “infection” in the specific aim, as though to say, “Hey, we’re not antivax. We’re about infection too!” It’s a misdirection that might work, but any of us who have followed the antivax movement know that it is nothing more than a misdirection to try to convince reviewers that this isn’t just a fishing expedition. Also, those of us who know the antivax movement know that antivax “scientists” excel at handwaving invocations of various immunological and biological mechanisms as the “mechanisms” behind “vaccine injury.” I mean, just look at how antivaxxers invoked oxidation-reduction pathways as the manner by which vaccines supposedly cause “oxidative stress” and autism. Then there’s the favorite of antivaxxers, the Autoimmunity/Autoinflammation Syndrome Induced by Adjuvants (ASIA), a vaguely defined catch-all diagnosis that encompasses vague symptomatology and unproven links to certain autoantibodies, all caused by adjuvants in vaccines, especially aluminum, promoted by Israeli scientist Yehuda Schoenfeld. And don’t get me started on “homologous recombinaltion tiniker,” which was how an antivaxxer in 2011 somehow misspelled the actual process of homologous recombination that she had been twisting to her antivax ends. The idea was that “aborted fetal DNA” from vaccines was somehow “permanently” altering a child’s DNA through homologous recombination. I could go on and on, as antivaxxers are always inventing new “mechanisms,” the most recent of which is the highly dubious claim that SV40 promoter sequences in the plasmids used to generate the mRNA for COVID-19 vaccines can integrate into the genome to cause “turbo cancer.
Next, look at the third bullet point, or specific aim #3:
Explore treatment options. Provide treatment as appropriate under the research protocol and seek to connect participants with ongoing care closer to home.
On the surface, of course, this sounds benign, almost banal. However, those of us who know RFK Jr. and antivax groups like React19 know that this is code for: Sending the subject back to antivax quacks to use various quackery to “treat” their “vaccine injury.” I can easily envision the protocol bringing in “researchers” from the National Center for Complementary and Integrative Health (NCCIH) to “study” various integrative quackeries applied to “vaccine injury,” certainly along with the recruitment of some of RFK Jr.’s “make America healthy again” (MAHA) quack buddies.
It’s not just ethics that could trip up the Vaccinology and Immunology Center. As an Ars Technica article on the Clinical Center Board’s rebuke of RFK Jr. notes:
In fact, the NIH already has a center that studies vaccine injuries, and Kennedy’s splashy new clinic does not come with more funding or clinic space. The hospital’s CEO, Jonathan Green, who sat next to Leslie at the meeting, chimed in to confirm that “the NIH has conducted research on the safety and efficacy of vaccines for decades in the past, and it ongoes.” Green described Kennedy’s vaccine injury clinic as merely a new, individual “protocol” for the hospital.
“The space in which this protocol will be conducted, the vaccine evaluation center inside the clinical center, has been in existence for decades,” Green said. Like all protocols, it needs to undergo rigorous scientific and ethical reviews before it’s implemented at the hospital. Green said the protocol is still under review.
None of this was made clear in Kennedy’s ceremony, and Leslie condemned the optics of the event, particularly the signs labeling patients “vaccine injured.” Those patients “must come first,” Leslie said. “They deserve our care and respect and they deserve answers.” But Kennedy does them—and the hospital—a disservice, Leslie argued.
“The secretary has spent two decades arguing that vaccines are dangerous,” Leslie said. “Those signs announce the conclusion that the research has not yet reached and that the research exists to test. Think about what that means for those patients. If this research finds evidence of harm, many will dismiss it as the work of a secretary who has long argued that vaccines are dangerous. If it finds none, patients will be told that the clinic was a sham. Either way, they’re left with answers no one trusts, and science only helps patients when the public believes it.”
Indeed. Of course, what Mr. Leslie either doesn’t understand or neglected to mention in the name of politics, doubt is the intent. The very reason for this clinic is to do what antivaxxers always do: Cast doubt on the safety and efficacy of vaccines. That’s its raison d’être! Or at least, that’s one of its purposes. It also exists to legitimize antivax quackery. Doubt is the intended product of this clinic’s “research”! If it weren’t, RFK Jr. wouldn’t have needed to order his useful idiot lackey Podcast Jay to create the center, even though there’s no funding or clinic space budgeted for it. If this were about using the most rigorous science possible to study adverse events (AE) after vaccines, determine if vaccines caused the AEs, and seek ways to treat the AEs and make vaccines safer, all of this could have been done in existing NIH research clinics and laboratories.
Antivaxxers’ reactions give the game away
There are probably readers out there who think I’m being…ungenerous. You might think that I’m being too cynical and that maybe—just maybe—the Vaccinology and Immunology Center might turn out to be a good thing if it actually does study what it purports to study. Oh, you sweet summer children! I’ve been following the antivax movement for a quarter century and RFK Jr. in particular for over two decades, and I know of what I speak!
However, if you don’t believe me, let’s take a look at it from the horse’s mouth. To find this take, I only had to go to peruse Brownstone Institute, the antivax, antipublic health, right wing “think tank” founded by Jeffrey Tucker, the neo-Confederate conspiracy theorist responsible for bringing together Podcast Jay and two other “contrarian” scientists to draft the Great Barrington Declaration in October 2020, which advocated a eugenicist “let ‘er rip” approach to the pandemic to build up “natural herd immunity” as rapidly as possible—within six months!—by letting the virus circulate through the “healthy population” while claiming to have a strategy to “protect the vulnerable.” Never mind that they never actually had such a strategy other than platitudes used to browbeat public health officials and that “natural herd immunity” never would have worked as a strategy given how easily SARS-CoV-2 could evolve new variants to evade immunity from infection with previous variants. There, I found an article entitled When Vaccine Injury Research Becomes Political, Patients Disappear. It’s authored by Brianne Dressen of React19, whom I mentioned when I first wrote about the new “vaccine injury clinic” two weeks ago and whose story I had discussed in more depth in 2023.
Unsurprisingly, Dressen frames the issue as people definitely “injured” by COVID vaccines seeking answers:
For years, people experiencing serious health problems due to Covid vaccination have asked for something fundamental: rigorous scientific investigation into what happened to them, why it happened, and what might help.
Many have spent years seeking answers through a fragmented healthcare system, encountering clinicians unfamiliar with their symptoms, struggling to access appropriate evaluation, and trying to find researchers willing to investigate their conditions.
Now, the National Institutes of Health has announced a dedicated research effort intended to investigate health problems following vaccination and infection. The October 5 opening of the new Vaccinology and Immunology Center represents a meaningful development in a process that patients have long urged federal institutions to undertake.
Yet once again, much of the public conversation risks becoming about politics rather than the people who need this research.
This is, of course, a transparent attempt to frame legitimate scientific criticism of RFK Jr.’s antivax clinic at the NIH as being nothing more than “political” or ideological, rather than being about science and about RFK Jr.’s two decades-plus record of extreme antivax activism. React19 makes it even more explicit by praising Podcast Jay for supposedly trying to get the politics out of the science of “vaccine injury”:
The study has not yet launched, eligibility requirements are still being developed, and no one should mistake an announcement for proof that the research will deliver the answers patients need. And let’s be honest about the intention; while I write this as a representative of over 40,000 Covid vaccine-injured Americans, the NIH’s mission is not to push any agenda. For the first time in a long time, Dr Bhattacharya is working to get politics out of the way of good science. The protocol, its implementation, the quality of the science, and the transparency of its findings all deserve scrutiny.
But scrutiny should begin with an accurate understanding of what has actually been announced.
I actually agree with that last sentence, but not in the way Dressen wants me to. Indeed, scrutiny should begin with an accurate understanding of what has been announced and what this Vaccinology and Immunology Center actually is intended to be. Let’s just say that it’s about anything but getting politics out of good science, as Dressen claims. Indeed, I facepalmed when I read that sentence.
But what does Dressen think that this clinic should be? Let’s take a look:
Recent mainstream reporting has included claims that NIH staff do not actually want to conduct this research. At the same time, the agency’s own published description of the center and its intended work is in complete contrast with this reporting. The public should be able to examine the primary source, ask legitimate questions, and distinguish between documented facts, political interpretations, and mainstream news slants.
First of all, I can understand why NIH staff don’t want to be associated with this new clinic, if such is the case. They recognize an ideological, political, and pseudoscientific endeavor when they see it. I also note that not wanting to be associated with this new clinic is not the same thing as not wanting to conduct research into vaccine adverse events. Indeed, the NIH has, as mentioned above, conducted research into vaccine adverse events for decades. What NIH staff don’t want is to conduct research that is poor quality and unethical in which the outcome is predetermined, which is what this clinic is clearly going to be all about. (Clinical Center Board members Leslie and Green could clearly see that when they pointed out that the new clinic was being shoehorned into space that had long been dedicated to studying vaccine adverse events and that the labeling of some of the participants of the roundtable held at the ribbon cutting ceremony as being definitely “vaccine injured” gave the game away, signaling that the results of this study are already predetermined.
One wonders if Dressen has considered what would happen if, even with RFK Jr.’s finger on the scale, this effort finds little. RFK Jr., certainly, will be most unhappy if that happens, as will his antivax supporters in MAHA. As I said, I don’t envy the PIs of this study, who want to be scientifically rigorous but will certainly face enormous pressure from their bosses to find more and more “vaccine injuries.” Dressen remarks:
For people living with serious symptoms, research is not an abstract policy debate. It is an opportunity to understand biological mechanisms that may have gone unexamined, identify risk factors that could help clinicians recognize similar cases, and explore treatment approaches that may improve lives. It is also an opportunity to establish what the evidence does not support. Good science must be willing to reach either conclusion.
Here’s the thing. Antivaxxers like RFK Jr. will not be willing to reach either conclusion. That is the difference between science-denying conspiracy theorists and actual science. Show me strong evidence that a certain vaccine causes a certain adverse event in a certain percentage of patients who receive that vaccine, and, after examining the studies myself, I will provisionally accept the conclusion, subject to revision as more evidence comes in. In contrast, to cite one example, RFK Jr. has been shown the evidence failing to find even a hint of a whiff of a link between MMR vaccination and autism, and, even 20 years later, refuses to accept that MMR doesn’t cause autism. He has been repeatedly shown the evidence that finds no link between thimerosal-containing vaccines and autism, and he never believes it or changes his views. Instead, he dismisses large volumes of high quality evidence from large epidemiological studies as either wrong, bought and paid for by big pharma, or the result of scientists who refuse to believe what he wants them to believe.
Indeed, RFK Jr’s two decade history of promoting antivax pseudoscience and conspiracy theories is not, as Dressen would have you believe, irrelevant to how we evaluate this new Vaccinology and Immunology Center. Given his history, both the twenty years before he became HHS Secretary and the year and a half since he assumed his current position in the Trump Administration, it would be irresponsible not to consider his ideology and long history of antivax activism highly relevant. This is particularly so, given how this clinic was thrown together and announced. Its entire existence is rooted in antivax conspiracy theories that the NIH (and the CDC and FDA) “covered up” vaccine injuries for decades and COVID vaccine injuries over the last five years.
Moreover, I note that the NIH did take Dressen’s claim of vaccine injury seriously, as documented by Scientific American in an article in which it also pointed out the disconnect between RFK Jr.’s stated goal of more rigorous scientific study of vaccine safety and what he has actually done since becoming HHS Secretary. Indeed, in her Brownstone Institute article Dressen herself states that when “I was evaluated at the NIH and diagnosed with post-vaccine neuropathy, they provided treatment that I attribute with saving my life” and noted that a “follow-up call from the NIH team to my home physicians changed everything” and that “I no longer had to spend so much of my limited energy fighting to prove that something was wrong.”
That hardly sounds as though she was completely ignored, as she seems to be implying that those believing they have suffered “vaccine injury” are.
Vaccine pseudoscience vs. career NIH staff
At the very end of her article, Dressen states:
Let the science proceed. Let the questions be asked. Let the answers follow.
This is, of course, another favorite antivax trope. Why is it a trope? The science has been proceeding. The questions have been asked. It’s just that antivaxxers don’t like the answers that have been found thus far, which nearly all go against their idée fixe that vaccines routinely cause autism, autoimmune diseases, cancer, neurological disorders, and all sorts of other health problems. They cannot accept that the true incidence of serious vaccine injury is very, very low and that such adverse events are rarely severe. That’s not to say that serious adverse events never happen after vaccination, which is how antivaxxers like to portray the scientific consensus surrounding vaccine safety. It’s just that such complications are indeed quite rare and that the benefits of vaccines far outweigh their risks.
This is why I will conclude with a plea to NIH staff associated with the Vaccinology and Immunology Center in general and to the PIs of the research protocol that will govern how this clinic operates in particular. As much as I feel sympathy for their plight in being tasked with doing RFK Jr.’s bidding when it comes to running this clinic, I say: Do not accept a protocol that is not both scientifically rigorous and ethical. Indeed, I say the same thing to the IRB tasked with evaluating this protocol: Do not be afraid to reject it if it has the tiniest whiff of unethical treatment of human research subjects, which would include referring them to undergo quack treatments, something that will almost certainly be desirable to RFK Jr., React19, and the antivax MAHA contingent pushing for this clinic.
Most likely, any ethical and scientifically rigorous protocol to study vaccine adverse events in a clinic like this will end up being mostly observational, rather than interventional. In fact, it will likely closely resemble the same sorts of protocols that the NIH and other federal scientific institutions, as well as other researchers studying vaccine safety, have used for years and years to study adverse events after vaccination. And that would be just fine although RFK Jr. will not like it. The scientists working at the NIH now are the lattest carrying out the proud 80 year heritage of rigorous research funded and carried out by the NIH, and it’s up to them to do what they can to limit the damage RFK Jr. is causing. I understand that it will be difficult. I understand that the once awesome NIH has become a very toxic place to work if you are unlucky enough to be working on an area related to vaccines and aren’t on board with MAHA and antivax pseudoscience. I understand, and wish it weren’t so. NIH scientists should be supported, not abused the way RFK Jr. and his lackey podcast Jay are abusing them.
Finally, whenever the protocol is approved, which it no doubt will be at some point, I hope that someone will make sure a copy of the actual protocol finds its way into the hands of reporters (and even me). In the meantime, I’ll be monitoring ClinicalTrials.gov periodically to look for the protocol, and I urge those interested in protecting public health to do the same thing. After all, Podcast Jay, Brianne Dressen, and all the antivaxxers demand “transparency” from the Vaccinology and Immunology Center. I agree. Transparency is essential, and what could be more transparent than publicly releasing a full copy of the research protocol behind the clinic? After all, doesn’t RFK Jr. want everyone interested in vaccine safety to have a say? That’s what he claims, anyway.
We, of course, know the true situation. RFK Jr. is definitely coming for your vaccines, and the Vaccinology and Immunology Center is just another tool for him to manufacture “evidence” to justify eliminating as many vaccines as he can.