Last week, I wrote about how our new Secretary of Health and Human Services Robert F. Kennedy, Jr. had purged all 17 members of the CDC’s Advisory Committee on Immunization Practices (ACIP) and replaced them with a rogue’s gallery of the rabidly antivax, the antivax-adjacent or -curious, and the unqualified, the last of whom don’t possess the necessary deep knowledge of vaccination, infectious disease, and public health to recognize antivax tropes and propaganda likely to be spewed by the rabid antivax contingent of ACIP. At the time, I realized that I’d probably have to write about ACIP one more time; however, I had expected that it would be a followup post to discuss a second round of appointees to the committee. To my surprise, RFK Jr. didn’t add any new members beyond the eight that he had already appointed. Now, with the next ACIP meeting scheduled for this week starting Wednesday, there’s no time to appoint more sycophants, toadies, and lackeys along with the outright incompetent or unqualified. No doubt he’ll find more such people in the time between this week’s meeting and the next one, but in the meantime we have to consider what will happen this week. Let me be, if not among the first, one to predict that it will be nothing good if you support public health and a science-based vaccination policy, which is why I might have to write one more time about this next Monday, after we can see the results of the meeting.
To recount, ACIP is the CDC committee that examines the evidence and then decides which vaccines will be included on the CDC’s recommended immunization schedule, both childhood and adult. It should be understood that ACIP does not determine which vaccines are licensed for sale and use in the US. That role belongs to the FDA, specifically the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which examines applications for licensure of vaccines and biologics, weighs the evidence for safety and efficacy, and advises the FDA Commissioner on whether to approve the products under its purview. Once VRBPAC and the FDA decide to license a vaccine for sale and use in the US, it is then up to ACIP to decide how the new vaccine is to be integrated into the CDC’s recommended schedule.
According to the ACIP charter:
The Committee shall provide advice for the control of diseases for which a vaccine is licensed in the U.S. The guidance will address use of vaccines and may include recommendations for administration of immune globulin preparations and/or antimicrobial therapy shown to be effective in controlling a disease for which a vaccine is available. Guidance for use of unlicensed vaccines may be developed if circumstances warrant. For each vaccine, the Committee advises on population groups and/or circumstances in which a vaccine or related agent is recommended. The Committee also provides recommendations on contraindications and precautions for use of the vaccine and related agents and provides information on recognized adverse events. The Committee also may provide recommendations that address the general use of vaccines and immune globulin preparations as a class of biologic agents, use of specific antibody products for prevention of infectious diseases, and special situations or populations that may warrant modification of the routine recommendations.
Committee deliberations on use of vaccines to control disease in the U.S. shall include consideration of disease epidemiology and burden of disease, vaccine safety, vaccine efficacy and effectiveness, the quality of evidence reviewed, economic analyses, and implementation issues. The Committee may revise or withdraw their recommendation(s) regarding a particular vaccine as new information on disease epidemiology, vaccine effectiveness or safety, economic considerations, or other data become available.
In accordance with Section 1928 of the Social Security Act, the ACIP also shall establish and periodically review and, as appropriate, revise the list of vaccines for administration to children and adolescents eligible to receive vaccines through the Vaccines for Children Program, along with schedules regarding the appropriate dose and dosing interval, and contraindications to administration of the pediatric vaccines. The Secretary, and as delegated the CDC Director, shall use the list established by the ACIP for the purpose of the purchase, delivery, and administration of pediatric vaccines in the Vaccines for Children Program.
Further, under provisions of the Affordable Care Act (Section 2713 of the Public Health Service Act, as amended), immunization recommendations of the Committee that have been adopted by the Director of the Centers for Disease Control and Prevention must be covered by applicable health plans.
I’m quoting at length because ACIP is a really big deal. If it recommends a vaccine and includes it in the CDC recommended vaccine schedule, then health insurers must cover the vaccine. Moreover, ACIP recommendations determine which vaccines are purchased and distributed by the Vaccines for Children (VFC) program. VFC is a federally funded program that provides vaccines to the states to be given free to children whose families might not otherwise be able to afford them. This includes children covered by Medicaid, as well as underinsured children, who can receive vaccines at Federally Qualified Health Centers, Rural Health Clinics, or deputized local health departments. Under VFC, the CDC purchases vaccines at a discounted price and then distributes them to state, local, and territorial immunization programs. Overall, the program has been a huge success and helped to insure that even disadvantaged children can receive vaccines recommended by the CDC, which is one reason why, when I discussed strategies that RFK Jr. would likely use to undermine the vaccination program in the US, I specifically mentioned VFC and that he might find ways to defund or otherwise weaken or eliminate it.
The bottom line is simple. By completely remaking ACIP, RFK Jr. has turned the committee into a weapon against vaccines, no matter how much certain Pollyannas try to say that it won’t be so bad and that, other than the two members who even RFK Jr.’s most avid apologists must admit are rabidly antivacccine—Robert “Inventor of mRNA Vaccines” Malone and Vicky Pebsworth of Barbara Loe Fisher’s National Vaccine Information Center (NVIC), the oldest currently existing antivax group in the US—are “not antivaccine.” I quipped last week to look for ACIP to start shedding vaccines from the CDC schedule faster than antivaxxers think that those vaccinated with COVID-19 mRNA vaccines shed spike protein, but even I must admit that this is an exaggeration. The process of eliminating as many vaccines as RFK Jr. can from the vaccine schedule and finding ways to make them and others, for all practical purposes, unavailable will be a process played out over the remaining years of the second Trump administration, not a “bolt out of the blue.” Even so, look for this process to proceed faster than you might expect.
To understand why, let’s take a look at the agenda for this week’s ACIP meeting. Before I do that, I’ll leave this little bon mot from Malone:
Also, on his Substack, Malone has been ranting that the press is “smearing” him, even repeating antivax misinformation about the MMR vaccine, including way understating the effectiveness of the measles vaccine at only 60-80% effective. Its one-dose effectiveness is more like 93%, and its two-dose effectiveness is 97%. (Challenge accepted, Dr. Malone to “fact check” you, “baby.”) He also spews this blather:
Some in the surrounding region who thought they were protected by being “fully vaccinated” became infected and developed measles disease. See above statistics. Two young girls died. Their medical records demonstrated that their immediate cause of death were 1) inadequately treated mycoplasma pneumonia, and 2) inadequately treated hospital acquired E coli pneumonia. Not measles. Verifiable facts vs dead media fearporn and defamation.
Seriously, Dr. Malone. This is one of the oldest antivax tropes in the book, to try to claim that because a child with measles died of a superimposed bacterial pneumonia, it wasn’t measles that killed them. Never mind that one of the ways measles all too frequently kills is by causing lung inflammation that makes the lungs susceptible to bacterial pneumonia in a way that they wouldn’t have been susceptible if the child hadn’t developed measles. That’s the way viral pneumonias in general all too often kill, including COVID-19.
Red flags in the ACIP agenda
The ACIP agenda was finally posted last week and includes some of what you might expect in a “normal” time, such as discussion of influenza vaccines for the fall, as well as discussion of COVID-19 vaccines. There has also been jockeying about the agenda. For example, as Katherine Wu notes in The Atlantic, votes on certain vaccines have been removed from the agenda, likely because in the beforetime it was widely expected that ACIP would use these votes to expand recommendations for specific vaccines. For example, the human papilloma virus (HPV) vaccine (e.g., Gardasil) was to be voted on, but that’s all gone now:
ACIP was initially expected to put to a vote, as early as next week, the questions of HPV-vaccine dosing and, simultaneously, whether to strengthen the recommendations that advise vaccination starting at 9 years of age. Several experts told me that they had tentatively expected both motions to pass, making HPV vaccination easier, cheaper, and quicker. The HPV vaccine is one of the most powerful vaccines ever developed: It is unusual among immunizations in that it durably prevents infection and disease at rates close to 100 percent. If it was deployed more widely, “we could see the end of cervical cancer,” Kirthini Muralidharan, a global-health expert and HPV-vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, told me.
That was before Robert F. Kennedy Jr., the nation’s health secretary, abruptly dismissed all 17 members of ACIP. Among their replacements—each apparently handpicked by Kennedy—are several researchers who have spread misinformation about vaccines or been embroiled in litigation against vaccine manufacturers; at least one of the new members has exaggerated the harms of the HPV vaccine specifically. Now the anticipated votes on the vaccine, among other immunizations, have been removed from the proposed agenda for ACIP’s.
And:
The group’s rigorous, data-driven approach is a primary reason the HPV-dosing strategy has yet to change. In particular, the committee was awaiting formal results from a large clinical trial in Costa Rica that has been comparing dosing strategies in adolescent girls. So far, the data, recently presented at a cancer conference, suggest that one dose is just as effective as two, the current CDC-backed regimen. Earlier this year, the ACIP working group focused on HPV vaccines was leaning toward supporting the dose drop, Brewer, who was part of that group, told me. The proposal to routinely recommend the vaccine as early as 9 years of age, he added, seemed likely to pass, too. (Currently, the CDC allows for HPV vaccination as early as 9 years of age, but only actively recommends it starting at 11 years of age.)
Those amendments to HPV-vaccination guidelines would make the shot simpler to get, for a wider range of children—which could dramatically increase its uptake, Gretchen Chapman, a health-psychology researcher at Carnegie Mellon University, told me: “The more you can make getting vaccinated easy and convenient, the higher vaccination rates will be.”
Expanding the number of children receiving Gardasil and other HPV vaccines is anathema to the antivax movement, as HPV vaccines have long been one of the vaccines most hated and feared by antivaxxers. Indeed, before there was the “died suddenly” myth regarding COVID-19 vaccines three years ago, there was an antivax myth among the antivaccine movement preceding it that falsely claimed that HPV vaccines were killing young girls and women en masse. Indeed, one antivax film even coined a name for the “victims” of HPV vaccines: Sacrificial virgins. Note the religious connotation suggesting that girls were being “sacrificed” to the altar of vaccination. In any case, Wu is correct. HPV vaccines have been incredibly effective in preventing cervical cancer. In any event, given that cervical HPV infection is a sexually transmitted disease, antivaxxers have been particularly hostile to it because they can’t imagine that “their girls” would ever engage in behaviors that might make them vulnerable to infection with cancer-causing strains of HPV.
Unsurprisingly, Vicky Pebsworth (formerly Vicky DeBold), wrote a fear mongering “analysis” for NVIC of adverse events following HPV vaccination…in 2007. (Yes, fear mongering about HPV vaccines dates back to the time when these vaccines were introduced and even before, back when they were still in clinical trials.) Then there was something that I forgot to mention about RFK Jr. ACIP appointee Martin Kulldorff last week, namely that he has a rather massive conflict of interest with respect to HPV vaccines, having provided expert witness testimony against Merck, the manufacturer of Gardasil, for plaintiffs for plaintiffs accusing Merck of concealing the risks of Gardasil. Of note, in March, a federal judge in North Carolina ruled in favor of Merck.
According to Reuters:
Kulldorff is also listed as an expert witness in a similar case pending against Merck in Los Angeles state court, records show.
Under ACIP’s rules, committee members cannot serve as a “paid litigation consultant or expert witness in litigation involving a vaccine manufacturer” during their tenure on the panel.
Prior work as an expert witness against drugmakers may require a waiver from the U.S. Centers for Disease Control and Prevention and recusal from votes involving Merck and HPV vaccines. The agency has said in its rules it “will generally consider issuance of waivers in specific situations.”
We’ll see. I suppose that we should be grateful that they won’t be voting to remove HPV vaccines from the schedule, although I have no doubt that that will be coming in a future meeting.
One huge red flag in the schedule is buried in the discussion of influenza vaccines, specifically:
- Presentation regarding thimerosal in vaccines
- Proposed recommendations regarding thimerosal containing influenza vaccine
You might remember that RFK Jr. first “came out” as an antivaxxer in 2005 with his article, jointly published in Rolling Stone and Salon.com, entitled Deadly Immunity, in which he wove a conspiracy theory about how the mercury containing preservative thimerosal had been the cause of an “autism epidemic” that added the false claim that the CDC had tried to “cover up” the evidence supporting that conclusion in a 2000 CDC meeting at the Simpsonwood Conference Center in suburban Atlanta. (My take on RFK Jr.’s fear porn of an antivax article was the first post of mine that ever went viral.) It’s an old antivax conspiracy theory that has come to be known as the Simpsonwood conspiracy theory, and, unsurprisingly, also a conspiracy theory that has been resurrected in the age of the pandemic as supposed example of the perfidy of the CDC.
Here’s the odd thing. As I explained way back in 2008, even then we had enough evidence to know that thimerosal, specifically the mercury in it, wasn’t causing autism, calling it a failed hypothesis. One huge part of the reason is that mercury was ordered removed from childhood vaccines in 1999—which is why I like to joke that adding thimerosal to the ACIP agenda is antivaxxers partying like it’s 1999—and, as a result, was gone from them by the end of 2001 or so. Autism prevalence, however, continued to rise unabated, even though one might reasonably predict that, if thimerosal in vaccines were a major cause of autism, autism prevalence would level off at least by 2008 and then start declining. It did neither of these. In any event, since 2001, vaccines intended for children 6 years of age and younger are thimerosal-free, with the exception of multi dose flu vaccines; however, thimerosal-free versions of the flu vaccine are available.
This background makes it odd to me that there are votes in the agenda on:
- Influenza Vaccines
- Thimerosal containing influenza vaccine recommendations
No, it’s not odd that there would be a vote on influenza vaccines per se, but it is odd that they would vote on influenza vaccines and thimerosal-containing flu vaccines. What I fear is that this new antivax ACIP will remove all thimerosal-containing flu vaccines from the CDC schedule, even though these vaccines are safe for adults and children over 6 and even though, as I describe above, there is no link between mercury and autism or thimerosal-containing vaccines and autism.
You might ask: Why would this matter if they keep the thimerosal-free versions? I think there are two problems here. First, discussing thimerosal in this way, even though in practice it’s only found in multidose vials of flu vaccine for adults, is a way for ACIP to spread more fear, uncertainty, and doubt about vaccines in general and flu vaccines in particular. From a more practical standpoint, however, eliminating thimerosal-containing flu vaccines would leave only single-dose versions of the vaccine, which are more expensive. Who will be harmed? Obviously, disadvantaged people and people in low resource parts of the country, for whom flu vaccines might become less available, an argument made ten years ago, ironically enough, by one of the new ACIP members appointed by RFK Jr. (and someone who had served on ACIP before many years ago), Dr. Cody Meissner, someone who in the interim appears to have become COVID-19 contrarian and very much anti-mask and anti-COVID vaccines for children.
More important to RFK Jr, as Dr. Jeremy Faust wrote on his Inside Medicine Substack:
The notion of using ACIP time and dedicating votes to the topic of thimerosal will be seen as a major win for the anti-vaccine movement—especially if the committee votes to recommend removing the compound from vaccines.
To be clear, removing the compound will do nothing to improve vaccine safety, but it certainly will undermine confidence in other existing vaccines. While there are many alternatives for influenza vaccines that do not contain thimerosal, elevating this debunked myth to national policy lends credence to misinformation, and sets the stage for other actions that may undermine vaccine confidence in the United States.
I agree that just discussing this hoary old antivax trope officially at ACIP is a huge win for antivaxxers. I also predict that this ACIP will likely remove all thimerosal-containing flu vaccines from the CDC-recommended schedule. I hope I’m wrong, but fear that I’m not. Moreover, I agree that doing so would undermine confidence in all vaccines, the way the 1999 decision to remove thimerosal from childhood vaccines, which seemed reasonable at the time “out of an abundance of caution,” actually fueled antivax rhetoric and fear mongering.
A second huge red flag on the ACIP agenda is its discussion of the MMRV (measles-mumps-rubella-varicella) vaccines. MMRV is basically the MMR with the vaccine against chickenpox added. No vote on MMRV recommendations is scheduled, but given the ongoing measles outbreak, the longstanding antivax belief, long debunked with science, that MMR causes autism, and the current makeup of the panel, it’s hard not to speculate that MMRV will serve as a stalking horse for what antivaxxers really want to go after and eliminate, the MMR vaccine. I rather suspect that MMRV is there to test the waters, to let ACIP dip its toe into the conspiracy theories surrounding MMR while discussing MMRV, all in order to start to lay the groundwork for taking the MMR (and MMRV) off of the CDC schedule.
COVID, RSV, and all the rest
One of the odd things about this ACIP meeting is that there is a discussion of COVID-19 vaccines scheduled, but no vote. Indeed, the discussion is near the beginning of the agenda. However, according to Fierce Pharma:
The meeting will now include voting decisions on infant and maternal respiratory syncytial virus (RSV) prophylactics, plus influenza vaccines, as well as non-voting discussions on COVID, chikungunya, anthrax and measles, mumps, varicella and Rubella (MMRV) vaccines.
The panel will defer votes planned for COVID vaccine recommendations, adult protection against RSV and vaccination dose schedule reduction for human papillomavirus (HPV) shots, analysts at Leerink Partners highlighted in a Wednesday note to clients.
The updated agenda “extends uncertainty on the more controversial vaccine recommendation votes,” analysts at Leerink Partners wrote in a note to clients this week, referring to vaccines that have had their votes delayed from the likes of BioNTech, Merck & Co., Pfizer, Sanofi, Novavax and Moderna.
Why isn’t there a vote on COVID-19 vaccine recommendations, even though the vaccines are slated for a two-hour discussion the first morning? It could be because RFK Jr. had already bypassed the panel last month and updated COVID vaccine recommendations, removing the recommendation that pregnant people be vaccinated and changing the previous recommendation for for vaccinating children to vaccinating healthy children using “shared clinical decision making,” apparently meaning that children “may” get vaccinated if their doctors and parents want them to be vaccinated. But, then, why discuss COVID vaccines? My suspicion is that RFK Jr.—and, make no mistake, RFK Jr. is now running this clown car that ACIP has become—wanted them to discuss COVID vaccines as a way of ginning up—you guessed it!—fear, uncertainty, and doubt about them, as a prelude, perhaps, to voting on them next time.
Regarding the scheduled discussion of respiratory syncytial virus (RSV) vaccines, there will be a discussion of the efficacy of maternal vaccination against RSV and prophylactic use of clesrovimab and nirsevimab, two different brands of monoclonal antibodies against RSV used as a preventive. Clesrovimab was approved by the FDA under the trade name Enflonsia, on June 9. After that, there will be votes on
- RSV Vaccines-Maternal/Pediatric
- RSV Vaccines-VFC
I don’t know which way any of this will go, but given the makeup of the committee, I find it difficult to believe that it will turn out well. Similarly, there are to be brief discussions on chikungunya and anthrax vaccines; I can’t say that I can predict how those will go either.
Be afraid, be very afraid
Given that RFK Jr. has now appointed all the members of ACIP and, for now at least, decided to go with a committee half the size of the previous ACIP, I can no longer view ACIP as a reliable source of vaccine information and a body that engages in science- and evidence-based reasoning with respect to its vaccine recommendations. I’m going to repeat what I’ve been repeating since RFK Jr. was nominated for HHS Secretary, namely this: Do not underestimate RFK Jr.’s determination to eliminate all vaccines if he can. He is antivax to the core and has been since at least 2005, if not longer. ACIP is now nothing more than another tool in his quest to undermine confidence in vaccines, make them less accessible, and to systematically remove vaccines from the CDC schedule (and therefore also from VFC) based on bad science, pseudoscience, fear mongering, and conspiracy theories.
Of course, even if vaccines are removed from the CDC recommended immunization schedule, those vaccines do not lose their FDA approval. The vaccines would still exist. They would still be legal to use in the US. However, if a vaccine is not on the CDC schedule, health insurance companies don’t have to cover it, and VFC will not purchase it to be administered to disadvantaged and poor children. More importantly, ACIP is not the be-all and end-all of RFK Jr.’s efforts to eliminate vaccines. He can work on the FDA, where Dr. Vinay Prasad is now the Director of the Center for Biologics Evaluation and Research (CBER), the part of the FDA responsible for evaluating and approving vaccines and biologics (e.g., stem cell therapies), as well as Chief Medical Officer and Science Officer. Given his stance of “RCTs or STFU” and the brainworm mantra of “gold standard science,” it’s easy to imagine the demand for randomized controlled trials, even for vaccines for which RCTs would be unethical will result in no new vaccines being approved between now and the end of Trump’s term in 2029.
Dr. Peter Hotez and I were recently interviewed for a podcast (promoted here) where we were both asked what we thought the end result of RFK Jr.’s antivax and anti-public health reign would be. Let’s just say that I fear we’re going to be partying like it’s 1899 again, when few vaccines other than the smallpox vaccines existed and what have long been vaccine-preventable diseases ravaged huge numbers of Americans.