The vote on whether to continue the universal newborn hepatitis B vaccination policy was postponed, but the discussion at ACIP exposed how, for decades, the blanket directive to vaccinate infants immediately after birth rested on assumptions, theoretical models, and partial data rather than on a solid scientific foundation.
“As a father and a scientist, I do not understand how we have the courage to ask parents to vaccinate a healthy newborn at birth when the child’s risk is so low and the evidence so thin. I honestly do not know where that courage comes from.”
This statement by Prof. Retsef Levi during yesterday’s ACIP meeting captured, with his characteristic clarity and directness, the core theme that emerged from the entire session: significant scientific gaps in a universal vaccination policy that has been in place for more than three decades in the United States.
The committee had been scheduled to vote on what seemed like technical questions: whether to eliminate universal newborn vaccination and administer the hepatitis B shot only to infants whose mothers test positive, and whether to replace the current policy, which does not allow for full informed consent, with a shared decision-making model between parents and physicians regarding vaccination later in infancy.
The meeting ended without a vote. It was postponed once again to refine the language of the recommendations. Yet what surfaced during the session may have been even more important than the vote itself: for the first time, the ACIP’s scientific staff presented, openly and systematically, the profound gap between the institutional narrative and the evidence base, or rather the lack of one, that underpinned an expansive policy for 30 years. They detailed how a major, far-reaching public health directive had been constructed on assumptions, theoretical frameworks, and partial datasets, absent rigorous foundational research.
Did the Birth Dose Reduce Hepatitis B Infection? The Data Say Otherwise
One of the central narratives used to justify the universal newborn hepatitis B vaccination policy was simple and compelling: the birth dose dramatically reduced hepatitis B transmission in the United States.
This narrative appeared repeatedly in CDC documents, official presentations, and public health communications.
But yesterday, perhaps for the first time so explicitly, data were presented that undermine this narrative at its core.
- The sharpest and most substantial decline in hepatitis B incidence occurred between 1990 and 2007 among adults aged 20 to 49, not among infants.
- Among infants and young children, case rates were extremely low to begin with, making it difficult to attribute any decline to the vaccine.
- Many countries without a birth dose show similar or even lower incidence rates than the United States.
- The populations that contributed most to the decline were high-risk adults, including people who inject drugs and individuals exposed via blood.
- The downward trend began before the universal birth dose was introduced in 1991.
What Did Contribute to the Decline?
Several factors were presented as far more significant than the birth dose:
- Prenatal screening and targeted intervention: When a pregnant woman is identified as hepatitis B–positive, targeted prophylaxis almost completely prevents neonatal transmission. This mechanism is evidence-based and far more effective than universal newborn vaccination.
- Behavioral change among high-risk groups: Increased public health campaigns, risk-reduction programs, and broader access to treatment significantly reduced primary sources of transmission.
- Improved blood screening protocols.
- Vaccination later in childhood or adolescence: Most individuals were vaccinated in early childhood or adolescence, not at birth. These doses are far more relevant for reducing adult infection risk, since immunity from a birth dose wanes precisely at the ages when exposure risk increases.
As Prof. Levi noted, “The narrative that the policy must not be touched because it has been successful is simply not supported by the data. Nor is the claim, made recently in the media, that we are now introducing ad hoc ideas to dismantle a thirty-year-old policy, supported by reality.”
The gap between the narrative and the evidence had never been presented to the public so plainly. When the entire rationale for a universal medical intervention rests on a claimed benefit to public health, but the data show that benefit to be minimal to nonexistent, the central question becomes unavoidable: Is it justified to continue vaccinating every healthy newborn within hours of birth when the demonstrated benefit to public health is almost zero?
Beyond this gap, Levi also addressed the tone of absolute confidence that has long surrounded the birth-dose policy. He noted that many countries that do not administer a universal birth dose “care about their children just as much as we do,” and that they are “potentially not convinced by the very confident arguments that you and others are making…about the safety and the need and the benefits of having a birth dose for babies born to mothers tested negative for Hep B.”
Levi went on to highlight a broader pattern. “The same speakers…were very adamant that the mRNA vaccines are very safe for children and young people,” he noted. “We heard recently some evidence that maybe that confidence was not necessarily correct.”
Why Vaccinate at Birth at all?
The mismatch between the data and the policy led to the most basic clinical question: Why is the hepatitis B vaccine given specifically at birth? What is the medical rationale for this timing?
Yesterday’s discussion revealed that the universal policy did not arise from a clinical need but from administrative concerns about system failures. The CDC’s reasoning in the 1990s centered on fears that prenatal screening might not be carried out properly, that some women would not be tested, that results would not be transmitted in time, or that recordkeeping errors would occur.
In other words, instead of fixing the weak points in the healthcare system, policymakers chose to bypass them through a blanket directive: vaccinate every newborn, regardless of maternal status.
Dr. Evelyn Griffin, a pediatrician and public health specialist on the committee, articulated this succinctly: the failures belonged to the system, not to families, and it was unreasonable to place the burden on newborns. “These are problems adults need to solve. We cannot ask newborns to solve them for us.”
Griffin also highlighted the gap between the policy’s assumptions and reality in delivery rooms. Women in labor face physical pain, stress, and are asked to sign multiple documents. In such circumstances, genuine discussion about newborn interventions rarely occurs. Most parents she interviewed were not even aware their infant had received the hepatitis B vaccine in the first hours of life.
In practice, a policy long presented as operating under informed consent had become one in which many infants were vaccinated contrary to parental wishes simply because the parents were never informed.
Prof. Levi added a personal account: “Four of my children were born here in the United States, and they received the hepatitis B vaccine at birth without any prior discussion with me or my wife. I can personally attest that there was no informed consent.”
This disconnect underscores how far the policy drifted from the core ethical principle of informed choice. Levi noted that the one-size-fits-all approach ignored the wide diversity of parental preferences, medical risk profiles, and responsible decision-making.
For years, this issue remained outside public discourse. The problem was not only the lack of scientific justification, but that the policy created a long-standing medical practice incompatible with transparency, informed decision-making, and individualized care.
Thirty Years of Unquestioned Assumptions: What Did We Really Know About the Safety of the Birth Dose?
For three decades, the universal birth dose of the hepatitis B vaccine has rested on an assumption that gradually solidified into a medical axiom: the practice is safe, and it is a self-evident preventive measure for all newborns, regardless of their actual risk of infection. Yesterday’s ACIP discussion exposed a profound gap between this narrative and the scientific foundation that has underpinned the policy since the early 1990s.
The original documents used to license Engerix-B and Recombivax did not include a single placebo-controlled trial in newborns. The studies were extremely short, with follow-up periods of only a few days, and the control groups received another vaccine rather than a placebo. Several studies were observational and funded by the manufacturers themselves. No long-term trials were conducted that could capture neurological, developmental, or autoimmune effects emerging over the first years of life.
Added to these limitations was the “healthy vaccinee bias:” infants who were not vaccinated at all were typically preterm, low-birth-weight, or medically fragile, and therefore ineligible for vaccination. In effect, safety assessments compared healthy infants to particularly vulnerable ones, creating the illusion of safety rather than a clean evaluation of true risk.
As Dr. Tracy Beth Hoeg, a clinical researcher and senior FDA official, summarized: “These are studies that would not meet even the minimal threshold for approval of a newborn vaccine today.” The problem, Hoeg clarified, extends far beyond the absence of placebo controls. Detecting an adverse event occurring at a rate of 1 in 1,000 requires a trial with tens of thousands of infants. In practice, not a single study approaches that requirement. When Dr. Robert Malone asked whether any data exist that could detect even a 1 in 100 risk, Hoeg replied: “We have no placebo-controlled randomized trials. We don’t have a single randomized trial that would allow us to detect a signal like that.”
The implication is stark: a large share of potential safety risks could never have been identified, because the trials were never designed to detect them.
Despite these gaps, not a single independent, controlled, or methodologically adequate study has been conducted in the decades since. In the absence of proper research, the claim that “there is no evidence of harm” becomes meaningless. As Levi emphasized, safety cannot be separated from the quality of the studies designed to assess it. Trials without placebos, without long-term follow-up, and with incomparable groups simply cannot detect safety signals. The absence of findings is not evidence of safety, but evidence that the right questions were never asked.
Against this backdrop, Hoeg stressed that implementing a universal birth-dose policy in a population whose overwhelming majority is at extremely low baseline risk was done without the scientific data required to adequately evaluate safety. Her concluding question to the committee was direct:
If not a single randomized, placebo-controlled trial has ever examined the safety of the birth dose, on what basis can we confidently assert that this policy is necessary for every newborn?
Risk Signals Emerged but Were Never Studied
Despite the lack of foundational safety research, monitoring systems such as VSD and VAERS repeatedly showed consistent patterns over the years: increases in neuro-motor disorders, developmental delays, tics, and emotional or behavioral changes. Some reports also noted precocious puberty. Effect sizes often ranged from 1.5 to 1.8, sometimes higher. None of these signals was ever subjected to a follow-up controlled study.
In the case of neonatal mortality and SIDS, for example, the Eriksen study found deaths only in the vaccinated group. But because of healthy vaccinee bias and unequal cohort composition, the signal was dismissed rather than investigated. Again, structural issues prevailed: data pointed in a direction, yet no research was conducted to determine whether that direction reflected an underlying biological mechanism.
A Turning Point in Newborn Vaccination Policy
Yesterday’s discussion marked a turning point far beyond the hepatitis B vaccine. For the first time since universal newborn vaccination was introduced in the 1990s, the foundational assumption behind such policies is being reexamined: whether it is justified to administer a vaccine to every newborn regardless of individual risk and without prior discussion with parents.
If policy changes are ultimately recommended, they may set an important precedent for other vaccination decisions, particularly in cases where individual risk is low and strong evidence is required to justify universal intervention. The message that emerged from the session was unambiguous: vaccination policy cannot continue to rely on inherited assumptions and historical models. It requires reexamination, full transparency, and recognition that public trust begins with presenting all the evidence, even when it raises difficult questions.
Against this backdrop, Levi offered a closing reflection on the tone that should guide future deliberations. “Maybe we’ll be a little bit more humble and less confident…and not present the discussion as something that has to do with being evil or being irresponsible,” he said, adding that such framing “is not the basis for a scientific discussion.”
Join the conversation:
Published under a Creative Commons Attribution 4.0 International License
For reprints, please set the canonical link back to the original Brownstone Institute Article and Author.
