The Advisory Committee on Immunization Practices (ACIP), an independent U.S. scientific body within the Centers for Disease Control and Prevention (CDC) that provides official recommendations on vaccine use, decided by an 8-3 vote to end the general recommendation that all newborns be vaccinated against hepatitis B within the first hours of life. The new policy maintains the indication for neonatal vaccination only for children whose mothers test positive for the infection or have unknown status.

For mothers who test negative, the committee ruled they should discuss with their doctor and decide for themselves when to vaccinate their infant, recommending no vaccination before two months of age. This decision closes a 30-year chapter in American public health and will only take effect if it receives final approval from the CDC.

The change represents a victory for those who have been challenging this policy for years, but it has drawn sharp criticism. Joseph Hibbeln, an ACIP member who voted against it, warned: “This has the potential to cause great harm, and I simply hope the committee will take responsibility when that harm is caused. ”

Louisiana Senator Bill Cassidy, a physician, also called on the acting CDC director to reject the recommendation, predicting that “ending the recommendation for newborns increases the likelihood that the number of cases will begin to rise again. ”

Why Eliminate the Rule? 30 Years of Unjustified Hypotheses

The most detailed analysis of the arguments for elimination comes from an article published in the Brownstone Institute, written by Yaffa Shir-Raz, PhD, a risk communication researcher and professor at the University of Haifa and Reichman University, who supervised the ACIP’s work. According to this account, the discussion revealed “significant scientific gaps in a universal vaccination policy [in the US] that has been in place for over thirty years.”

One of the central arguments concerns the actual effectiveness of the dose at birth. For decades, the official narrative has held that universal newborn vaccination has dramatically reduced hepatitis B transmission in the United States. But the data presented at ACIP tell a different story. The most significant decline in incidence occurred between 1990 and 2007 among adults aged 20 to 49, not among infants. Among young children, rates were already extremely low, making it difficult to attribute any reduction to the birth vaccine. Furthermore, the downward trend had begun before the introduction of universal vaccination in 1991.

The data seem to confirm this statement. In fact, from an online search I conducted, I found that the peak of hepatitis B prevalence occurred in 1983, a full eight years before universal vaccination began in 1991. After that peak, the curve began its downward phase. The tables below, taken from Sage Journals, demonstrate this:

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As Professor Retsef Levi, a professor at MIT and a member of ACIP recognized in the academic community for the rigor of his analyses and for the application of quantitative models to real-world problems, observed, “The narrative that policy does not need to be changed because it has been successful is simply not supported by the data.” And: “As a father and a scientist, I don’t understand how we can have the courage to ask parents to vaccinate a healthy newborn at birth, when the risk to the child is so low and the evidence is so scant. I honestly don’t know where this courage comes from,” said Professor Levi.

More Relevant Factors Than the Birth Dose

According to the presentation, several factors contributed to the decline of hepatitis B much more significantly than universal neonatal vaccination:

• Prenatal screening and targeted intervention: when a pregnant woman is identified as positive, targeted prophylaxis almost completely prevents transmission
• Behavioral changes among high-risk groups
• Improving blood screening protocols
• Vaccination during childhood or adolescence: most people were vaccinated later, not at birth

Many countries that do not administer the dose at birth, including Italy (see below), show incidence rates similar to or even lower than those in the United States, a finding that further undermines the narrative of the necessity of universal newborn vaccination.

A Policy Created to Address System Shortcomings

Perhaps the most controversial aspect that emerged is that the universal policy arose not from a clinical need, but administrative concerns. In the 1990s, the CDC feared that prenatal screening might not be performed properly, that some women might not be tested, or that results might not be reported in a timely manner. Dr. Evelyn Griffin, a pediatrician and member of the committee, summed it up: “These are problems that adults have to solve. We can’t ask newborns to solve them for us.” Instead of strengthening the health care system, the choice was made to circumvent its weaknesses by universally vaccinating all newborns.

The Informed Consent that Never Existed

Another point raised concerns on the lack of true informed consent. Griffin emphasized that women in labor, experiencing physical pain and stress, are asked to sign numerous documents. Genuine discussions about interventions on newborns rarely occur.

Professor Levi gave personal testimony: “Four of my children were born here in the United States and 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. ”

Inadequate Safety Studies

As Dr. Tracy Beth Hoeg, a clinical researcher and senior FDA official, summarized: “These are studies that wouldn’t even meet the minimum threshold for approving a vaccine for infants today.” The problem, Hoeg explained, goes far beyond the lack of placebo controls. To detect an adverse event that occurs at a rate of 1 in 1,000 requires a study with tens of thousands of infants. In practice, no study comes close to meeting that requirement. When Dr. Robert Malone asked if there were data that could detect even a 1-in-100 risk, Hoeg replied: “We don’t have any randomized, placebo-controlled trials. We don’t have a single randomized trial that would allow us to detect a signal like that.”

The implication is clear: most of the potential safety risks could never have been identified because the studies were never designed to detect them.

Despite these shortcomings, not a single independent, controlled, or methodologically adequate study has been conducted in the decades since. Without adequate 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 evaluate it. Studies without placebos, without long-term follow-ups, and with non-comparable groups simply cannot detect safety signals. The absence of results is not proof of safety, but rather proof that the right questions were never asked.

In this context, Hoeg emphasized that the implementation of a universal policy of control at birth in a population whose vast majority presents an extremely low baseline risk was carried out without the scientific data necessary to adequately assess safety. The closing question to the committee was directed: If no randomized, placebo-controlled trial has ever examined the safety of birth dosing, on what basis can we confidently assert that this policy is necessary for every newborn?

Despite the lack of fundamental safety research, monitoring systems like VSD and VAERS have repeatedly shown consistent patterns over the years: increased neuromotor disorders, developmental delays, tics, and emotional or behavioral changes. Some reports have even indicated precocious puberty. Effect sizes often ranged from 1.5 to 1.8, sometimes even higher. None of these signs have ever been the subject of a controlled follow-up study.

The FDA is the U.S. federal agency responsible for regulating and overseeing food, pharmaceuticals, medical devices, and other products to protect public health. The agency approves new drugs and evaluates their safety and effectiveness, and companies intending to distribute these products in the United States must register with the FDA.

Why Force the Vaccine? A Necessary Safety Net

Supporters of maintaining universal vaccination at birth, as seen in a Politico article, mainly emphasize the precautionary principle and the historical results of vaccination policy. Cody Meissner, a professor of pediatrics at Dartmouth and the only remaining member of the old committee, voted against the change, saying, “There is evidence of benefits… and there is no evidence of harm.” This statement, however, must be compared with the news reported above regarding the lack of studies conducted with rigorous scientific criteria.

A Safety Net against False Negative Tests

American public health officials argue that birth vaccination is a necessary safety net that can prevent a devastating disease in several scenarios:

• False negative tests of mothers
• Mothers who contract hepatitis B late in pregnancy
• Transmission through casual contact with family members or caregivers who may not know they are infected

The hepatitis B virus is highly transmissible and newborns can contract it even outside of mother-to-child transmission during birth.

The Risk of Inappropriate Comparisons

American public health experts caution against comparing U.S. vaccination policies with those of European countries, where universal vaccination against hepatitis B is not available at birth, and where socialized healthcare systems are capable of comprehensively tracking patient records. This latter statement, at least for Italy, does not appear to be accurate.

The United States had moved to universal infant vaccination after adopting a risk-based approach in the 1980s that had not significantly affected disease transmission.

Concerns about the Decision-Making Process

Daniel Jernigan, who resigned from the CDC in August, criticized the pro-elimination presentations, saying they placed “too much emphasis on the potential risks while ignoring the vaccine’s benefits demonstrated over decades.”

Several ACIP members asked opponents of birth vaccination to provide documented examples of the risks associated with the birth dose, which they were unable to provide. Hibbeln sarcastically commented: “Speculation and limited evidence… OK! Got it. ” This statement by Hibbeln, however, clashes with the senior FDA official Hoeg’s claim, cited above, that the studies underlying universal vaccination at birth “would not even meet the minimum threshold for approval of a vaccine for infants today.”

A Politicized Committee

Paul Offit, a vaccine expert who declined to attend the meeting, said: “This is a political committee, not a scientific committee. This group will continue to provide dangerous and misleading advice to parents of children in this country.” It’s important to note, however, that “prior to the vote on hepatitis B, no CDC expert presented his opinion on the vaccine. In his opening statement Friday, Vice President Robert Malone said that scientists Paul Offit and Peter Hotez, vaccine experts, had also been invited to attend the meeting but declined. Offit said he didn’t remember the invitation, but that “it’s possible” he was asked to attend. Jason Goldman, a senior fellow at the American College of Physicians, called the meeting “political theater,” lamenting the lack of scientific rigor and the waste of taxpayer money.

The Italian Model: A Proven Alternative

The American decision brings the United States closer to the European and Italian models, where universal vaccination at birth has never been adopted. The Italian case is particularly significant because it demonstrates that a targeted approach can be equally effective.

According to the Italian vaccination schedule, hepatitis B vaccination at birth is mandatory and recommended only for infants born to mothers who are HBsAg-positive. In these specific cases, the first dose is administered within the first 12–24 hours of life, along with specific immunoglobulins.

For the vast majority of newborns, those of mothers who test negative, universal hepatitis B vaccination begins at three months of age, as part of the hexavalent vaccine. The complete series includes three doses at 3, 5, and 11-12 months. HBsAg screening during pregnancy is mandatory in Italy, allowing for the precise identification of risk situations and targeted intervention. This approach has proven effective without having to indiscriminately vaccinate all newborns in the first hours of life.

It is important to note that the prevalence of hepatitis B in Italy began to decline, dramatically among 15-24 year-olds, well before 1991, the year the aforementioned schedule came into force.

Towards a New Balance of Prevention and Informed Choice

The December 5 U.S. vote potentially represents a turning point in American vaccination policy, although its implementation is far from guaranteed. The final decision, as mentioned, rests with the CDC, and political pressures from both directions are evident.

What clearly emerges is that after 30 years of automatic application, vaccination policy is finally facing critical scrutiny based on real data rather than, at best, studies that apparently fail to meet rigorous scientific standards and, at worst, are based on hypotheses and theoretical models. Comparison with the experience of Italy and other European countries demonstrates that effective alternatives to universal neonatal vaccination exist.

The challenge will be to find a balance between the necessary protection of at-risk newborns and respect for the principle of informed parental consent, overcoming both an overly paternalistic approach, to put it mildly, and an overly skeptical one toward vaccines. The Italian example, like that of other European countries, suggests such balance is possible. The case of the United States may require far more far-reaching reforms than simply closing a vaccination recommendation.