The U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) Meeting of December 4 and 5, 2025
PART II
In part I of this blog series posted yesterday, I gave you a taste of the most recent ACIP meeting. It was painful for me to listen to, and I am going to jump ahead in this Part II of the series to summarize where we are, what decisions were made, the implications of those decisions and what we can expect in the future (this is not a mystery that will require the likes of Sherlock Holmes to figure out because they have given us many previews of coming attractions and shown us how they go about their work trying to make it seem like a logical and scientific approach when it is anything but).
First, the newly reconstituted ACIP under Secretary Kennedy lacks the necessary expertise to make the kinds of decisions this committee is charged with. A number of the members have previously well-documented histories of anti-vaccine bias and some have disseminated misinformation and disinformation.
Second, to make the recipe for failure all the more likely, that lack of expertise among the members is now coupled with replacing serious experts with known disinformation purveyors and persons without the necessary qualifications to present background information to the committee. For example, one presenter on the hepatitis B vaccine was Cynthia Nevison, a climate researcher who co-authored a paper on vaccines and autism that was retracted by the publication due to methodological errors and undisclosed conflicts of interest https://www.thetransmitter.org/spectrum/contentious-study-prompts-backlash-from-autism-researchers/. I already mentioned Mark Blaxill above, who gave a presentation on vaccine safety, however he is a long-time anti-vaccine activist, who was trying to dissuade parents from vaccinating their children for measles in the midst of a measles outbreak, which put children’s lives in danger. He is not a physician, epidemiologist, scientist nor is he trained in any other field that would qualify him to give the presentation, and as I mentioned above, he made ludicrous statements during his presentation.
Fortunately, there is one physician with expertise who did speak up and criticized Mr. Blaxill’s presentation. Shame on the other physicians on the committee for not doing the same.
Just when you thought things couldn’t get worse and more of a clown show, the committee brought in a well-known anti-vaccine attorney to make a presentation on the vaccine schedule. As an attorney myself, while Mr. Siri is well-qualified as an attorney and could competently practice law in court, no court would ever qualify him to testify in a case as a vaccine expert, yet this is exactly what ACIP invited him to do.
Finally, one of the ACIP members gave a presentation on aluminum in vaccines and cherry-picked the studies and data she used without referencing very large and recent studies that have demonstrated the safety of aluminum in vaccines, even though almost no vaccines currently in use have aluminum in them.
As more evidence of the dysfunction of ACIP, voting, once again, had to be delayed a day because members were unclear as to what they were being asked to vote on. This is poor leadership and poor preparation, and is just further evidence that this is not a serious endeavor. Apparently, the motion went through a number of iterations before the vote that further confused members.
Lest you believe that I am overreacting, here is what some others had to say.
You know it is bad when a Republican U.S. senator tweets: “Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.” Of note, this senator, Bill Cassidy from Louisiana is a physician who has specialized in gastroenterology, which includes the care and treatment of patients with liver disease.
Stat News published an article whose title sums the current state up very well: “CDC’s vaccine advisory panel faces a crisis of its own making.” In that article, three former high ranking officials within the CDC (the former director of the CDC’s National Center for Immunization and Respiratory Diseases, the former director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases and the former CDC chief medical officer) wrote:
The “ACIP has drifted toward … inflating speculative risks while downplaying well-established vaccine benefits.”
“CDC publications now introduce ambiguity where none exists.”
They warn: “Misguided discussions don’t remain theoretical. They shape public perception, influence future votes, and trigger ripple effects in vaccine supply and coverage.”
They also point out another concern that I frankly had not thought of. “Altering the hepatitis B birth dose could destabilize the entire childhood schedule. Combination vaccines that include hepatitis B depend on stable timing. If timing shifts, combination products may become unusable, forcing a return to single-dose formulations that the U.S. currently lacks the capacity to produce. Manufacturing new standalone vaccines could take months to years, leaving gaps in protection and risking increases in hepatitis B and other vaccine preventable infections.”
The public may not appreciate that the attack on vaccines is multidirectional. Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research was already identified as a spreader of vaccine misinformation prior to his appointment. Recently, Dr. Prasad stated in an internal memo that the FDA would be changing its vaccine approval process alleging that COVID-19 vaccines had resulted in the deaths of ten children, which was alarming in that there was not data to support this serious claim, and the FDA has declined to release it despite the FDA Director’s claim that his leadership would be characterized by radical transparency. It is baffling to think of why evidence would not be provided to the medical community for information and review if in fact these apparently irresponsible claims were supported. Instead, I find the timing interesting that his memo was released just before the ACIP meeting and, in fact, the specious claims from that memo were referenced by one of the ACIP members to support questioning the claims made by experts at the meeting.
This prompted a letter to the New England Journal of Medicine by a dozen former FDA commissioners who served under Republican and Democratic administrationgs warning that the proposed changes would “upend core policies governing vaccine development and updates” and “undermine the public interest.”
They referenced Dr. Prasad’s irresponsible claims stating: “We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most.” They go on to criticize current FDA leadership for offering “no explanation of the process and analyses” used to make the claims concerning the 10 pediatric deaths alleged in Prasad’s memo, nor offering an explanation that would “justify wholesale rewriting of vaccine regulation.”
The dysfunction of the ACIP and predominating anti-vaccine sentiment is why a number of organizations have now taken over putting professional committees to review vaccines and publish their own recommendations, notably the American Academy of Pediatrics, the Infectious Disease Society of America, and the Vaccine Integrity Project at CIDRAP. This will be of even greater importance as I explain where things are headed below.
The decisions made:
- The Committee voted 8-3 to end the 34-year recommendation for the universal birth dose of hepatitis B vaccine.
This was the outcome even though the vaccine policy has been very successful (there were around 16,000 cases of childhood hepatitis B infections in 1991 and only 7 cases reported in 2023). A recent study suggests that ending the birth dose will result in approximately 1,400 additional infections each year and eventually nearly 500 deaths per year. This, of course, is difficult to reconcile with the Secretary of HHS’ espoused vision to “Make America Healthy Again.” This change was the outcome even though there are no new safety signals or safety concerns. I am old enough to remember when the U.S. was the model country for public health and other countries followed in our steps. Now the ACIP thinks we should follow the lead of other countries and not be an “outlier,” even when our infection rates are among the best and even when these other countries’ populations and health care systems are not remotely close to ours, and despite the fact that 115 countries administer the birth dose of hepatitis B vaccine and the WHO recommends it. Now, we will become an outlier for exactly opposite reasons.
The Committee decided to return to a risk-based strategy that was employed prior to 1991, which was changed because experts determined that it was not successful. What this means:
- If mother is HBsAg+ (infected), give the birth dose;
- If the hepatitis B status is unknown, give the birth dose;
- If the mother is HBsAg-, use shared clinical decision-making. If the parent chooses to delay, delay for at least 2 months.
Interestingly, we may be able to infer the real reason for the committee’s actions from interviews and tweets by key members following the meeting. First of all, one of the members who voted no described the new recommendation as: “making things up” and stated we are now in “Never-Never Land.” One of the members who particularly pushed this action through tweeted “Mission accomplished!” to a Tweet replying to President Trump from RFK, Jr., which suggests to me what most of us have already been thinking was that this was a preordained outcome rather than a effort to engage in open-minded discussion and debate. Another member may have tweeted out the real motivation: “ACIP’s recommendations re Hep B vaccine reflect strong objection to vaccine mandates that prevent access to school & even clinical care from [sic] children not up to date with the vaccine schedule (including Hep B).” I take this to acknowledge that this was an ideological vote, not an evidence-based one.
- In a bizarre twist, the Committee then voted 6-4-1 on an issue outside their purview and clearly demonstrating their lack of understanding of immunology and vaccinology that parents may ask their clinicians to get an antibody blood test before receiving hepatitis B vaccine doses 2 and 3.
First of all, it is already well-established that the three-dose series is needed for the long-term, durable immunity that we know results in protection for at least three decades, and likely for life unless the person becomes immunocompromised. Second, why do we want to increase costs for parents, adding two more visits to the doctor and performing two blood draws on infants and unnecessary laboratory tests?
Third, I have been advising my blog readers and the radio show listeners that a tell-tale sign of people who are confused or lying to you is that if they talk long enough, you find that their arguments are not internally consistent. That is the case here. The anti-vaccine argument for doing away with the childhood hepatitis B vaccine is that you get infected from sex or drug use and young children don’t engage in these risky behaviors, so it is unneeded. Of course, that represents a misunderstanding of how hepatitis is transmitted to infants and children (see part I for the correct information on this). So, if parents think that if the ACIP is recommending this, this must be a sound approach (and certainly, if you don’t understand immunology and vaccinology as most parents wouldn’t, this seems to make sense and be a practical approach), and they may follow it, which would be serious misdirection. Unfortunately, since approximately 55 percent of infants will have detectable antibodies following the first dose, this may lead parents of those children to not proceed with doses 2 and 3 that would provide the infant with durable protection into their adulthood, all the while being misled by the CDC that these children are protected.
So, what is the internal inconsistency? They argue that the risk of hepatitis B is extremely low in childhood, but one or two doses is essentially only giving those children protection during childhood, while they argue the real risk is in adults, yet this approach is likely to mean that most of these children will be under the impression that they are vaccinated and protected, but in fact are not during the time that this committee believes they will be at highest risk. It makes no sense.
Further demonstrating their incompetence, they provide no guidance as to how long after vaccination do they think the child should be tested and what levels of antibody are protective? Of course, the logical explanation is because (and the committee was informed of this by a true hepatitis B expert) antibody levels are not good surrogates of protection. We have never recommended this approach. Here is the next internal inconsistency. They want to do away with the universal birth dose because we are an “outlier,” yet, I am not aware and certainly they did not reference even one other country that takes the approaches they just voted to recommend; thus, they have just made us an outlier.
So, why the title for the blog post about the unfortunate timing?
- By all indications, this is going to be a very severe, and perhaps elongated flu season this year. We are seeing an A(H3N2) influenza virus predominate among the circulating variants – a strain that we have not seen in three years (and therefore, likely have little immune protection without immunization. We have seen that this virus wreaked and, in some cases, still is wreaking havoc on Australia, China, South Korea, and Japan, and most recently Canada, just to name a few countries, some of which have closed schools to try to decrease the transmission and overburdening of their hospitals. The flu vaccine is probably even more important this year both because H3N2 viruses are known for causing more severe disease than we normally experience with the more common H1N1 viruses, and because recent studies have demonstrated additional benefits of the flu vaccine, yet rates of vaccination appear to be on the decline.
- Influenza vaccination was associated with a reduced risk of incident dementia in high-risk populations for dementia. Influenza vaccination and risk of dementia: a systematic review and meta-analysis | Age and Ageing | Oxford Academic July 2, 2025.
- A meta-analysis published in November 2023 of studies involving more than 9,000 patients reported a 26% decreased risk of heart attacks in people who received a flu vaccine and a 33% reduction in cardiovascular deaths. Influenza vaccination and major cardiovascular risk: a systematic review and meta-analysis of clinical trials studies | Scientific Reports November 19, 2023.
- Influenza is a known risk factor for developing myocarditis or pericarditis, and this large Danish study looked at the prevalence of the inflammatory condition across three flu seasons, from 2022 to 2025. Of 332,438 participants randomized, 331,143 did not have a history of myocarditis or pericarditis. The incidence of myocarditis or pericarditis was lower among participants randomized to receive high-dose influenza vaccine compared to standard dose (19 vs 35 events; relative vaccine effectiveness, 45.7%; 95% confidence interval [CI], 2.5% to 70.7%). Risk of Myocarditis or Pericarditis With High-Dose vs Standard-Dose Influenza Vaccine: A Prespecified Secondary Analysis of the Randomized DANFLU-2 Trial | Public Health | JAMA Network Open | JAMA Network August 30, 2025.
- A study across 164 hospitals in China found that administering the flu vaccine during hospitalization for patients with acute heart failure was tied to a 17% lower risk of all-cause mortality or any hospital readmission over 12 months. Influenza vaccination to improve outcomes for patients with acute heart failure (PANDA II): a multiregional, seasonal, hospital-based, cluster-randomised, controlled trial in China – The Lancet September 6, 2025.
- Most aggressive cervical cancers are caused by underlying HPV (human papilloma virus) infection and we currently recommend 2 doses of HPV vaccine for teenagers as HPV has also been associated with head and neck cancers, anal and penile cancer in addition to cervical cancer. The HPV is highly effective in preventing aggressive cervical cancer, so much so that many of us believe that it would be possible to eliminate this disease. A recent study showed that one dose was essentially as effective as the two doses we currently recommend. This will make HPV vaccination more feasible and accessible across the globe, hopefully encourage more people to get vaccinated, and reduce the time and costs associated with vaccination. Noninferiority of One HPV Vaccine Dose to Two Doses | New England Journal of Medicine December 3, 2025.
- Shingles vaccine may prevent, delay or slow dementia. https://www.cell.com/cell/fulltext/S0092-8674(25)01256-5. December 2, 2025.
- Evidence that COVID-19 vaccines protected young and middle-aged adults, reducing their all-cause mortality. Also, evidence against the “turbo cancer” claims of anti-vaccine activists during this four-year follow-up. In this cohort study including 22.7 million vaccinated individuals and 5.9 million unvaccinated individuals, vaccinated individuals had a 74% lower risk of death from severe COVID-19 and no increased risk of all-cause mortality over a median follow-up of 45 months. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2842305. December 4, 2025.
Our understanding of immunology and vaccinology is exploding. We have more effective vaccines that use fewer antigens to elicit the desired immune response. We have learned how to use computer models to identify which antigens in a new virus are likely to be the best targets for vaccines, and we can make new vaccines in months rather than years.
We now have two vaccines that can guard against seven types of cancer. We are learning about new, unanticipated benefits from vaccines such as those I referenced above. In addition, there is active research as to how vaccines be used to enhance cancer treatments and prevent other types of diseases, including neurodegenerative conditions.
Unfortunately, childhood vaccines have been so effective in reducing or eliminating the risk of vaccine preventable diseases that most Americans don’t realize how bad these diseases were and how much the American people celebrated the development of vaccines that would protect their children from these diseases. Another aspect of the unfortunate timing is that we have a severe influenza strain on our doorsteps and an evolving risk for the potential of avian influenza (bird flu) to become our next pandemic. Also, despite increasing benefits being realized from some vaccines, vaccine skepticism due to anti-vax disinformation campaigns is on the increase.
At the same time, our public health infrastructure is being systematically dismantled and weakened by the current administration. Emboldened by the successful effort to upend the universal hepatitis birth dose policy, and probably unexpected success at undermining the three-dose series, President Trump on Friday asked RFK, Jr. to “fast track” a review of the vaccine schedule. See Politico, “Trump asks RFK, Jr. to ‘fast track’ vaccine schedule review”, by Lauren Gardner published 12/05/25 at 9:07 p.m. EST.
We also got a preview of coming attractions from the Friday portion of the ACIP meeting in which the committee had a plaintiff’s attorney present to the committee about the childhood vaccine schedule. This attorney has already advocated for the discontinued use of the polio vaccine. RFK, Jr. has said that he believes the polio vaccine has killed more people than polio, which is a shockingly ignorant or deceitful statement for a U.S. Secretary of Health to make to the public.
President Trump released a Presidential Memoranda following the meeting directing the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention to
“review best practices from peer, developed countries for core childhood vaccination recommendations – vaccines recommended for all children – and the scientific evidence that informs those best practices, and, if they determine that those best practices are superior to current domestic recommendations, update the Unites States core childhood vaccine schedule to align with such scientific evidence and best practices from peer, developed countries while preserving access to vaccines currently available to Americans.”
Of course, this memorandum, on its face may seem innocuous and very sensible, but realize this is based on the assumption that the U.S. is not the leader in this area and that we need to follow other countries, when for decades, we have led. Secondly, this current ACIP after two, two-day meetings, has not demonstrated any ability to evaluate scientific evidence or identify best practices, and has failed to acknowledge any of the many important differences in populations and public health and health care for these different countries that really begs the question as to whether these are truly “peer countries.” They seem to be enamored with Denmark, but did not acknowledge, if they are even aware, of the stark differences of that country being roughly only four times the population of Idaho, that keeps track of medical records from birth to death, and “all residents are entitled to publicly financed care, including largely free primary, specialist, hospital, mental health, preventive, and long-term care services.” https://www.commonwealthfund.org/international-health-policy-center/countries/denmark. Therefore, this is merely an invitation and instruction to wreak further havoc on our own current public health infrastructure.
No doubt some readers will feel that my concerns are exaggerated or fear mongering. However, while in most policy debates it is hard to know who is right or even to establish with time who was right, in this case, we shall receive a clear answer and it may not take more than a couple of few years, although it likely will take longer to prove for hepatitis because of the multi-year interval between infection and the development of symptomatic chronic disease and its life-threatening outcomes. Journalists and the public will have the answer because they and public health organizations will merely need to observe what happens to infection rates, hospitalization rates, numbers of outbreaks, long-term disabilities and deaths among our country’s children. Frankly, for those with eyes to see, we are already seeing some of the consequences with respect to measles outbreaks, cases, hospitalizations and deaths. The same could be said for pertussis. Now, I urge you to follow over the following years what happens as we look at the resurgence of the diseases and their complications implicated by the ACIP decisions made last week as well as those soon to come.
In yet another twist of irony, these anti-vax influencers who have alleged that we are experimenting on children with all our vaccines (despite often decades of data and surveillance), are now plunging us into experimenting with our children with all these diseases. The problem is that this was a natural experiment decades ago, we already know how this experiment turns out. Unfortunately, because we will not learn from history, our children are doomed to reenact it, and we are likely not to come to our senses until many thousands, probably tens of thousands, of pregnancies are lost, pregnant moms die, and innocent children are harmed, disabled, or killed. The bad news for all these anti-vax influencers with all their social media followers, their podcasts and cable network shows, their positions of influence in public health organizations is that those followers will eventually realize they were betrayed, lied to and deceived and they will turn quickly and harshly on those that mislead them and lied to them. And, history will record this as well.
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