The U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) Meeting of December 4 and 5, 2025
PART I
I’ll make the connection to the poor timing in Part II, but first an explainer of what happened at the end of last week with the ACIP meeting.
A vote on a possible change to the hepatitis B vaccine schedule was deferred from the September meeting after much confusion and lack of adequate preparation. The issue was taken up again at this meeting.
Unfortunately, unlike meetings prior to the newly constituted committee, meeting materials were not distributed, at least to the public, if not the committee, in advance of the meeting. Even the language of the vote to be taken was modified so many times that neither the public nor the members understood what would be voted on prior to the presentations and discussions.
It was stated that the ACIP would consider a very narrowly defined issue regarding the hepatitis B vaccine schedule – newborn infants born to mothers who test negative for hepatitis B surface antigen (HBsAg), meaning that the mother has no serological evidence of hepatitis B infection and the current recommendation for a universal birth dose (meaning it is recommended for all newborn infants in the period following birth prior to discharge home) of the hepatitis B vaccine.
First, let me provide readers with some background and facts about hepatitis B and children:
- Hepatitis B is a virus that causes acute hepatitis and, in some people, this will result in chronic infection that can in turn cause ongoing liver damage that can manifest as cirrhosis (liver scarring that leads to liver failure) and/or hepatocellular carcinoma (cancer of the liver). Of those who develop chronic hepatitis B, between 15 and 25 percent will eventually die from complications of their liver disease or cancer.
- In adults, hepatitis is most often spread through exposure to blood and bodily fluids, generally through unprotected sex, contaminated needles either by intravenous drug abusers who share needles or health care workers who experience an accidental needle stick in the care of a patient who is infected with the virus, or through contact with open cuts or sores of someone who is infected.
- Transmission of infection to infants is entirely different. A significant risk is transmission from an infected mother to her infant during the birthing process. (If the mother is infected, vaccine + hepatitis immune globulin administration is between 95 – 100 percent effective at preventing hepatitis B infection of the infant.) Unfortunately, because many persons infected with hepatitis B virus are unaware of it (at least 50 percent) until they develop the end-state complications and because the hepatitis B virus can remain infection on surfaces for up to a week and is more contagious than the HIV virus, infants and toddlers are at risk of transmission of the virus from other household contacts, nannies or babysitters, grandparents and other relatives and in childcare or Sunday school settings, especially given the proclivity of young children to put objects and their fingers in their mouths and for young children to bite other children when frustrated. Hepatitis B vaccine administered to children before this exposure is roughly 95% effective at preventing infection.
- Without preventative treatment or vaccination of infants born to mothers who are infected, up to 90 percent (based upon factors such as whether the virus is actively replicating in the mother and what her viral load [amount of virus particles in her blood] is) will become infected with the hepatitis B virus, and of these infected infants, approximately 90% will develop chronic hepatitis B infection.
- The risk of acute hepatitis B infection becoming a chronic infection is inversely related to age, with newborns being at the highest risk. For children who become infected later in childhood, but before age 5 years, the chance of them developing chronic hepatitis B infection is 25 – 50 percent. Infection after age 5 is associated with about a 5 percent chance of developing chronic infection.
- From 1982 until 1991, the U.S. first attempted a hepatitis B vaccination strategy aimed at vaccinating infants born to high-risk mothers (those who tested positive for HBsAg), however, this risk-based strategy was not successful in achieving the desired level of reduction in the number of childhood hepatitis B infections. It was conceded that this strategy failed because we are notoriously bad at identifying and predicting which mothers are at high risk, testing was not always done before delivery (many women still do not receive adequate prenatal care and currently only about 85 percent of mothers get screened during their pregnancy [~88 percent with commercial insurance and ~84 percent on Medicaid]), the delivering provider may be different than the provider who obtained the testing result and may not know that the mother tested positive, the test could be a false negative or the mother may have been negative at the point in her pregnancy at which she was tested, but then may have become infected subsequently, but prior to delivery. Only 26 states actually require hepatitis B screening of pregnant mothers. All of these factors contribute to roughly 1500 infected mothers being undetected and about 950 infant infections each year.
- Further, only immunizing infants born to HBsAg+ mothers does nothing to mitigate the risk of transmission during early childhood post-delivery related to close contacts who may or may not be aware of their hepatitis B status.
- Having failed to achieve the desired impact, the U.S. decided to pursue and has followed a vaccine policy of universal hepatitis B immunization for all infants at birth since 1991 – for 34 years now. That initial dose of vaccine is then followed by two more doses to provide durable protection for at least 30 years, and likely for lifetime, as there is no evidence of chronic hepatitis developing in someone who has been fully vaccinated (3-doses) unless they have an immunocompromising condition.
- Prior to that, around 18,000 children, on average, contracted the hepatitis B virus infection before their 10th birthday. About half of these infections were acquired at birth.
- Since that vaccine policy has been in place, now, fewer than 1,000 U.S. children or adolescents contract hepatitis B virus infections every year – a 95% reduction in cases.
- In the past 34 years, we have had extensive experience with the hepatitis vaccine and it is extremely safe. The only confirmed adverse risk of the vaccine is severe allergic reactions (anaphylaxis) which occurs at a rate of approximately 1 per every 600,000 doses of vaccine.
For more information, see Hepatitis B Vaccines, The Journal of Infectious Diseases, vol. 224, Issue Supplement _ 4, 1 October 2021, pages S343 – S351. https://doi.org/10.1093/infdis/jiaa668.
Once again, there was confusion during this meeting as to why the issue of the hepatitis B birth dose was even being discussed. There have been no new safety signals or issues. We have post-marketing surveillance data spanning more than three decades showing that the vaccine is safe. An answer was offered for the reconsideration including:
- Feedback from stakeholders;
- Misalignment of existing recommendations in most developed countries;
- Prolonged time since last comprehensive review as per ACIP’s charter.
As I have written before, I want to teach you how to evaluate some of the outrageous claims being made for yourselves, as I won’t always be here to do it for you. (But, don’t worry, I will do it for as long as I can!). The onslaught of misinformation is only growing and unfortunately, now permeates the once highly respected ACIP meetings.
I have studied carefully patterns used by coordinated networks of vaccine disinformation purveyors. A common tactic is to make their claims sound legitimate by referencing a study with a title that suggests that it supports their point, but is not at all what the study or article actually says. However, most people will not bother to read the article and so those spreading the disinformation accomplish their objective of frightening people, or at least sowing the seeds of doubt. The current leaders of HHS, CDC and FDA have already done this previously when they cited to articles that showed the exact opposite of what they suggested the study provided evidence of and I have called it out in prior blog posts.
In the presentation regarding this topic, the presenter points to an Institute of Medicine (this is one of the most prestigious and most highly regarded and authoritative medical organizations for physicians) report published in 2002 which is referenced on the slide as “Multiple Immunizations and Immune Dysfunction.” First, this seems a bit out of context for the current discussion about hepatitis B since this is a single antigen vaccine, but I assume her intent was to put this in the context of a later issue they will deal with as to whether children receive too many vaccines (spoiler alert – they don’t). Second, it accomplishes the desired effect by seemingly confirming a misconception common among some parents that we are giving our children too many vaccines and it is overwhelming their immune systems. This seems to be supportive of that misconception by referencing multiple immunizations and immune dysfunction together in the title.
So, here is what you do. Google the report as I did. These reports are generally lengthy, so if you don’t have the time or interest, you can skip down to the “Scientific Assessment” section, and the report conveniently bolds their conclusions for you. Here are the pertinent ones:
- Therefore, the committee concludes that the epidemiological and clinical evidence favors rejection of a causal relationship between multiple immunizations and an increased risk of heterologous infections. [This just means that since one manifestation of immune dysfunction is that you would be more prone to infections other than those you were vaccinated against that the committee found no evidence to support any such connection.]
- Therefore, the committee concludes that the epidemiological and clinical evidence favors rejection of a causal relationship between multiple immunizations and an increased risk of type 1 diabetes. [Because another manifestation of immune dysfunction can be the development of autoimmune disease, the committee looked at one of the most common autoimmune conditions in children that is easy to diagnose and for which there are many studies, namely insulin-dependent diabetes (type I) and there was no causal relationship between multiple vaccines and a risk for type I diabetes.]
The full report goes into a lot more areas and details, so you can read that if interested. However, it remains true today that vaccines do not cause immune dysfunction, however, we do see immune dysfunction, at least on a temporary basis with some viral infections, most notably measles.
The next report under “IOM Stakeholder Concerns” is a 2013 report on “The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.” So, let’s just see what the report to see if the IOM is concerned about the safety of the childhood immunization schedule.
When we open the report, we can read the first paragraph of the report:
“Vaccines are among the most effective and safe public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans have no firsthand experience with such devastating illnesses as polio or diphtheria. Widespread immunizations have resulted in a decline in vaccine-preventable diseases.”
The report goes on to provide some background:
“The current recommended U.S. childhood immunization schedule is timed to protect children from 14 pathogens by inoculating them at the time in their lives when they are most vulnerable to disease. Under the current schedule, which applies to children younger than 6, children may receive as many as 24 immunizations by their second birthday and may receive up to five injections during a single doctor’s visit. Technological advances have reduced the number of antigens—that is, inactivated or dead viruses and bacteria, or altered bacterial toxins that cause disease and infection—in vaccines. New vaccines undergo rigorous testing prior to approval by the Food and Drug Administration (FDA).”
Again, we can skip to the conclusion:
“No Evidence of Safety Concerns
Upon reviewing stakeholder concerns and scientific literature regarding the entire childhood immunization schedule, the IOM committee finds no evidence that the schedule is unsafe. The committee’s review did not reveal an evidence base suggesting that the U.S. childhood immunization schedule is linked to autoimmune diseases, asthma, hypersensitivity, seizures, child develop mental disorders, learning or developmental dis orders, or attention deficit or disruptive disorders. Existing mechanisms to detect safety signals—including three major surveillance systems of FDA-approved products maintained by the CDC and a supplemental vaccine safety monitoring initiative by the FDA—provide further confidence that the current childhood immunization schedule is safe.
In this most comprehensive examination of the immunization schedule to date, the IOM committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule, which should help to reassure a diverse group of stakeholders. Indeed, rather than exposing children to harm, following the complete childhood immunization schedule is strongly associated with reducing vaccine-preventable diseases.”
Undeterred, the presenter then goes on to show the results of two surveys that reflected parental concerns in 13 percent of those surveyed in the most recent poll about the hepatitis B birth dose.
Ironically, the presenter cites these surveys of stakeholder concerns as a reason to reexamine the hepatitis B birth dose, but fails to follow the advice of the report she just cited in the previous slide that states:
“While stakeholder concerns should be one, but not the only, element that drives continued searches for scientific evidence, the committee writes that these concerns alone, absent epidemiological or biological plausibility of potential safety problems, do not warrant further study.”
It is also always so amusing to me that those who spread disinformation to the public, do not see (or more accurately, don’t admit) their own role in parental confusion or concern over vaccines. Perhaps if ACIP members were to take a serious approach to their work and the meetings and would involve experts, correct disinformation out in the public and gather the best and most accurate data and information to educate the public, there would be fewer concerns and less confusion among those surveyed.
The presenter then shows a graph of various countries plotted out along the abscissa (x-axis) and the prevalence of HBsAg positivity along the ordinance (y-axis) with a color-shading of each bar corresponding to a country with the type of hepatitis B birth dose policy they have. She points to the U.S. as being an “outlier” because we have a universal policy, yet asserts the fact that the U.S. has the lowest prevalence of HBsAg positivity relative to the other countries with similar policies (Australia, Poland, Portugal, S. Korea, Bulgaria and Romania) is evidence that the birth dose is unnecessary instead of realizing that the low prevalence is exactly what you would expect to see with a very successful universal birth dose vaccine policy in place now for more than 30 years! She completely misses the point that this graph demonstrates the success of our policy. She does not point out that with our program now in place for more than three decades, we have a lower prevalence of hepatitis B infection among our population than do 74 percent of the countries that do not have such a policy.
The Committee then spiraled down to a new low when the presenter handed the microphone over to Mr. Mark Blaxill, who is neither a physician nor a scientist to review the safety data for the vaccine. Realize that in the past, there would have been extensive reports assembled by subject matter experts, researchers and epidemiologists to present the most up-to-date and best evidence that we have, and these reports would have been made available to the members and the public in advance of the meeting.
In a cringe-worthy moment, demonstrating how unqualified and unknowledgeable about the information he was presenting, he presents findings from a study that showed that 18 percent of children experienced fatigue, weakness, diarrhea or irritability after the first dose of vaccine, and then in an effort that I can only imagine that is intended to cause confusion and conflate two completely different topics and sources, adds at the bottom of the slide a quote from a different source than the study he was discussing: “symptoms of encephalitis… watch for fever, lethargy (weakness or drowsiness), poor feeding, vomiting, body stiffness, unexplained/unusual irritability or crying,” and concludes that the side effects of immunization may actually be encephalitis, which is simply an outrageous and irresponsible claim, and fortunately, at least one physician on the ACIP was brave enough to call him out on this ridiculous claim.
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