The Vaccine Intelligence Report: December 3-9

The Vaccine Intelligence Report—brought to you by Vaccinate Your Family—provides clear, fact-based updates on vaccine policy, research, and public health each week. This report is part of Viral Truths, a resource designed to cut through the noise, offering concise information to help navigate the evolving immunization landscape.

THIS WEEK AT A GLANCE

  • At last week’s meeting, ACIP (the federal vaccine advisory committee) voted to change its longstanding recommendation that all children receive the hepatitis B vaccination at birth 
  • For children born to mothers who test negative for hepatitis B, the committee now recommends parents consult with their doctor regarding vaccination—vaccination at birth is still recommended for all children born to mothers who test positive for the infection or whose status is unknown 
  • The move has drawn widespread criticism from medical societies, public health organizations, clinical experts, and elected officials, as this decision was made without any evidence of new safety concerns from hepatitis B vaccination and is likely to lead to harm from increases in hepatitis B cases  
  • An additional ACIP presentation and subsequent directive from President Trump also indicate broader changes to the childhood vaccine schedule are under consideration 
  • A dozen former FDA commissioners condemned CBER Director Prasad’s leaked plan to change the vaccine regulatory system—Prasad defended his proposal and FDA Commissioner Makary expressed his support 
  • Leadership changes at HHS continue as the FDA and CDC experience ongoing instability  

ACIP INSIGHTS

ACIP Modifies Longstanding Hepatitis B Birth Dose Recommendation 

  • On Friday (December 5), the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to revise its longstanding recommendation for universal vaccination against hepatitis B at birth. According to an HHS press release, ACIP now recommends “individual-based decision-making” for infants born to mothers who test negative for hepatitis B—meaning parents should make the choice in consultation with their clinician. 
    • If an infant does not receive the birth dose, ACIP suggests that the first dose should not be given before two months of age.
    • The Committee continues to recommend that all infants born to mothers who test positive for hepatitis B—or whose status is unknown—still receive a birth dose. 
    • “Individual-based decision-making” is another term for “shared clinical decision-making,” in which families weigh benefits, risks, and timing in partnership with healthcare providers. 
  • This marks a change from ACIP’s prior universal birth dose recommendation, in place since 1991, which advised vaccination within 12 hours of birth. The change was not prompted by new evidence; research continues to show that hepatitis B vaccination at birth is safe, effective, and lifesaving. 
    • The universal recommendation contributed to a 99% decline in hepatitis B infections among children and adolescents. 
    • Multiple studies have found that there is no safety benefit associated with delaying the initial hepatitis B shot past birth.
  • It’s important to clarify that ACIP’s prior guidance was not a vaccine mandate. Parents, in tandem with providers, have always had—and still have—the final say about whether their child receives the hepatitis B vaccine or any other routine immunization. 
    • While most states require hepatitis B vaccination for school or daycare entry, all allow medical exemptions and most permit religious or personal belief exemptions. 
  • Hepatitis B is a serious viral infection that can cause chronic liver damage, liver cancer, and death. Infants are particularly vulnerable: 90% of babiesinfected in their first year develop chronic hepatitis B, which carries lifelong health risks.
    • Transmission can occur at birth (vertical transmission) or after birth through contact with infected blood or bodily fluids (horizontal transmission)—even from individuals who show no symptoms. The hepatitis B virus can live on surfaces for extended periods of time, heightening the risk of exposure through shared personal items (e.g., toothbrushes) or contact with infected bodily fluids through bites or scratches. 
  • Although all pregnant women are recommended to be screened, gaps in testing occur. Some people lack consistent prenatal care, some acquire the infection later in pregnancy, and false-negative test results can occur. 
    • The universal birth dose served as a safety net, protecting infants whose mothers’ infections went undetected and guarding against early horizontal transmission. 
  • If CDC Acting Director Jim O’Neill adopts ACIP’s recommendation, insurance coverage for the hepatitis B vaccine is not expected to change. 
    • HHS notes that vaccines under shared clinical decision-making are generally required to be covered without cost-sharing. 
    • In addition, most private insurers have pledgedto cover all vaccines recommended by ACIP as of September 1, 2025, with no cost-sharing through 2026.    

Major Organizations, Experts, and Officials Respond to ACIP’s Hepatitis B Decision

  • ACIP’s vote to end the longstanding universal recommendation for hepatitis B vaccination at birth drew widespread criticism from medical societies, public health organizations, clinical experts, and elected officials.  
  • Many, including some members of the committee itself, emphasized that the decision was not supported by new evidence and could undermine protection for newborns. 

Medical and Public Health Organizations

  • More than 40 national medical, scientific, and public health organizations—including the AAP, American Medical Association (AMA), Infectious Diseases Society of America (IDSA), and Vaccinate Your Family—issued a joint letter on Friday warning that the revised guidance could complicate access to vaccination and place infants and families at avoidable risk. 
  • These groups stressed that the birth dose remains safe, effective, and a cornerstone of early-life hepatitis B prevention. 

Medical Experts and ACIP Members 

  • Current ACIP members who voted against the revised recommendation voiced concern about the absence of new scientific evidence supporting the change and its impact.
    • Dr. Cody Meissner, Professor of Pediatrics at Dartmouth, warned that the committee was “doing harm by changing this wording.” 
    • Dr. Joseph Hibbeln, former National Institutes of Health (NIH) section chief, called the decision “unconscionable” and said it “certainly wasn’t based on data.”  
  • Former committee members—including Dr. William Schaffner (Vanderbilt) and Dr. Noel Brewer (University of North Carolina)—also criticized the decision, noting that reducing early-life protection could leave more children vulnerable to chronic infection and liver disease.  
  • Vaccine law and infectious disease experts, such as Dorit Reiss (UC Law San Francisco) and Dr. Flor Munoz (Texas Children’s Hospital), echoed concerns about the lack of rationale and scientific justification.  

Current and Former Government and Agency Officials

  • Senator Bill Cassidy (R-LA) criticized the committee as “totally discredited” ahead of the vote, citing concerns about the inclusion of vaccine-skeptic perspectives in Friday’s presentations. After the vote, he urged CDC Acting Director Jim O’Neill to reject the recommendation, underscoring the vaccine’s safety and efficacy. 
  • Former CDC official Dr. Debra Houry described the meeting as “an all-time low” following months of organizational challenges at the agency. 
  • The Democratic Doctors Caucus issued a statement “unequivocally” opposing ACIP’s decision and reaffirming support for the birth dose.

State-Level Organizations 

  • State health departments, like Illinois and Maryland, also released statements reiterating the safety and efficacy of hepatitis B vaccines and encouraging continued adherence to the birth dose.  

ACIP Begins Broader Review of Childhood Vaccine Schedule with Trump’s Support

  • In addition to voting on new hepatitis B guidance, Friday’s ACIP meeting included early discussionsabout a broader review of the childhood and adolescent vaccine schedule.
    • The conversation followed the committee’s October formation of a new work group focused on evaluating several components of the schedule, including vaccine timing and spacing, co-administration of multiple vaccines, and vaccine ingredients such as adjuvants. 
  • As part of Friday’s agenda, ACIP heard a presentation from vaccine trial attorney Aaron Siri, who raised questions about the quality of clinical trial data supporting routine childhood vaccines, the safety of certain ingredients (including aluminum adjuvants), and the evidence base for vaccines’ effectiveness in reducing transmission and severe disease.
    • Siri, who has previously litigated against vaccine requirements and is an ally of HHS Secretary Kennedy, emphasized areas where he believes additional data or review may be warranted.  
    • It is important to note that the concerns Siri raised do not align with the extensive and robust clinical and real-world evidence that the longstanding childhood vaccine schedule is based on.  
    • Siri’s appearance was notable given the committee’s typical reliance on presentations from scientists, academic researchers, and professional medical organizations. 
  • Following the meeting, President Donald Trump directed Kennedy to review the U.S. schedule and consider how it compares with recommendations in “peer, developed countries.”
    • Public health experts note that while schedules differ across countries, most high-income nations recommend a similar set of childhood vaccines and use comparable approaches to timing and co-administration. 
    • Any differences in schedules are typically based on country-specific considerations such as varying disease patterns, health systems, and a variety of factors that influence how each country balances risk, benefits, and logistics—and is not a reflection of one schedule being safer or “less aggressive” than another.  
  • The work group has not yet proposed any specific changes to the schedule, and ACIP has not signaled a timeline for future recommendations. For now, Friday’s meeting indicates that ACIP’s evaluation of the childhood schedule is underway and likely to continue in the months ahead.
    • The committee’s next meeting is planned for February. Any revisions to existing recommendations would still require review and adoption by CDC leadership before taking effect.    

NEED TO KNOW

Former FDA Chief’s Proposed FDA Shift Could Undermine Vaccine Safety Framework

  • An internal memo leaked in late November revealed that the director of the FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad, alleged—without providing evidence—that Covid vaccines caused “at least 10” child deaths and outlined plans for sweeping changes to vaccine regulation.
    • HHS confirmed the FDA is conducting “a thorough investigation” of the issue but has not provided details on what this includes, nor has CBER released any findings from its ongoing Covid vaccine review. 
  • In response, 12 former FDA commissioners authored a New England Journal of Medicine articlewarning that Prasad’s proposals would “undermine a regulatory model designed to ensure vaccine safety, effectiveness, and availability.”
    • The authors span nearly every FDA commissioner since 1990, representing both Republican and Democratic administrations. 
    • They rejected Prasad’s conclusions, stating that his claims about vaccine-related child deaths and his suggested regulatory changes lack scientific basis. They also reaffirmed that “substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents.” 
  • On Thursday (December 4), Prasad defended his proposal at a conference, and current FDA Commissioner Dr. Marty Makary signaled his support for the CBER Director in an interview.
    • Makary also alleged that the Biden administration withheld data on myocarditis risks from mRNA Covid vaccines—a claim contradicted by senior officials who served at the agency during that period.  
    • The CDC has monitored myocarditis (inflammation of the heart) closely since 2021, and Covid vaccines have undergone the most extensive safety surveillance in U.S. history, with hundreds of millions of doses administered domestically and over 13 billion administered worldwide. 
    • While mRNA vaccines are associated with a small increased risk of myocarditis, Covid infection poses a far greater risk: a meta-analysis of nearly 60 million vaccinated and unvaccinated individuals found Covid infection carries more than seven times the risk of myocarditis compared to vaccination.    

Latest Federal Health Leadership Changes Add to Growing Concerns about Agency Stability and Independence

  • In recent weeks there have been several changesto FDA and CDC leadership positions that oversee and influence vaccine policy. Like many recent appointments across FDA and CDC, these changes have been controversial, raised concerns among public health experts, and highlight ongoing instability.  
  • Last week, Dr. Tracy Beth Høeg—a physician and epidemiologist with a background in sports medicine and interventional spine medicine—was named Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER), becoming the fifth person to hold the role in 2025. 
    • Høeg has no prior experience overseeing drug approvals or long-term clinical trials, prompting concern among current and former FDA officials about potential politicization of the process.  
    • Her appointment follows current Director Dr. Richard Pazdur’s abrupt decision to retire at the end of December after holding the role for less than a month. 
  • Just before last week’s ACIP meeting it was announced that Cynthia Nevison—a climate researcher with ties to anti-vaccine groups—had been brought on by the CDC as a contractor to assist ACIP’s hepatitis B work group.
    • At the ACIP meeting, Nevison’s presentation on hepatitis B burden was widely criticized for misrepresenting evidence—including downplaying risks to U.S. infants, introducing unsupported racial and immigration framing, and suggesting waning vaccine protection based on antibody counts alone.  
    • Experts directly corrected these points, noting that hepatitis B is highly contagious in household settings and that infant vaccination provides long-lasting immunity through immune memory, not captured by antibody counts. 
  • Additionally, HHS announced on December 1 that Dr. Kirk Milhoan, a pediatric cardiologist who has been publicly critical of Covid vaccines, had been named ACIP Chair—replacing Martin Kulldorff, who recently moved to a role within HHS.
    • Milhoan participated in the December 4-5 meeting virtually, leaving Vice Chair Robert Malone to run the session while Milhoan reportedly dialed in from the airport.  
    • During a break in the session—and immediately after the committee voted to end the universal hepatitis B birth dose recommendation—Milhoan was overheard telling another member that he felt ACIP members were “puppets on a string,” raising concerns about the committee’s independence. 

New Surveys Reveal Public Confusion and Trust Gaps in U.S. Vaccine Guidance

  • The National Foundation for Infectious Diseases (NFID) released findings from its November 2025 annual survey, which assessed U.S. adults’ vaccination behaviors, perceptions, barriers, and trusted information sources related to influenza (flu), Covid, respiratory syncytial virus (RSV), and pneumococcal disease. Key insights include:
    • Nearly half (45%) of respondents reported receiving at least one respiratory vaccine since September 2025. Uptake was highest for flu (34%) and Covid (25%), and lowest for pneumococcal (8%) and RSV (6%). 
    • One in four said they could not access Covid vaccines in their area. 
    • 44% of respondents reported confusion about respiratory vaccine guidance. 
    • Healthcare professionals were the most trusted information source (44%), followed by the CDC (13%); among adults 18–28, social media ranked second (15%). 
    • The most frequently cited reasons for not getting vaccinated were concerns about side effects, lack of a provider recommendation, doubts about vaccine effectiveness, and fear of becoming sick from the vaccine. 
  • A separate University of Pennsylvania study found similar trends in public trust and perception.
    • Nearly half (48%) of respondents said they are not confident that the CDC is providing trustworthy vaccine information to the public.  
    • 35% said they would be more likely to follow the American Medical Association’s (AMA) recommendation if the AMA and CDC disagreed on vaccine safety. 
    • When asked about the perceived link between vaccines and autism, a majority (52%) agreed that there is no association.  

OUTBREAK OUTLOOK

Measles Cases Climb as Respiratory Illness Activity Begins to Rise Nationwide

  • The CDC reports that overall respiratory illnessremains low but is beginning to rise across the country. 
    • RSV activity is increasing across several regions of the U.S., with hospitalizations and emergency department visits concentrated among children 0-4 years old. 
    • Flu activity is also climbing, largely in the Northeast and Mountain West. 
    • Covid activity remains very low nationwide. 
  • Much of U.S. flu activity is being driven by subclade K, a mutation of the influenza A virus first identified in August 2025 that has fueled surges in Canada and the U.K. 
    • Although the 2025–26 flu vaccine—finalized before the emergence of this strain—is not a perfect match, CDC underscores that vaccination remains the strongest protection against severe flu, hospitalization, and death, regardless of which strain is circulating. 

REALITY CHECK

These fact checks respond to several recent claims made by different groups and individuals.

For more on the December 4–5 ACIP meeting, this resource from the Evidence Collective includes many additional fact checks.

CLAIM: ACIP, the federal vaccine advisory committee, limited the hepatitis B vaccine only to babies whose mothers are infected with the virus.

  • REALITY: This claim is false. Although ACIP votedon December 5 to revise its longstanding universal recommendation for a hepatitis B vaccine at birth, the committee did not restrict the vaccine only to infants born to mothers with hepatitis B. 
  • Access to the hepatitis B vaccine has not changed:  
    • The shift in recommendation does not affect eligibility or insurance coverage. Babies born to mothers who test negative can still receive the hepatitis B vaccine at birth.  
    • It remains available, recommended by major medical organizations, and should be coveredfor families who choose it.  
  • Leading medical organizations continue to recommend the birth dose because the evidence has not changed:
    • Newborns remain at risk even without known maternal risk factors. Hepatitis B can survive on surfaces for up to a week and can be transmitted by undiagnosed caregivers (the majority of people living with hepatitis B in the U.S. do not know they are infected) or through accidental exposures in households, health care settings, or early childhood environments, such as bites or scratches at daycare. 
    • Most infected infants develop chronic disease. About 90% of babies infected in their first year of life will develop chronic hepatitis B, which can lead to liver failure, liver cancer, or death. 
    • The birth dose has been extraordinarily effective. Since the universal birth dose recommendation began in 1991, hepatitis B infections among children and teens have dropped by 99%—from roughly 20,000 casesper year to virtually none.

CLAIM: The evidence for the hepatitis B vaccine isn’t very strong—there are questions about its safety in infants and how long its protection lasts.

  • REALITY: This claim is false. Suggestions that the hepatitis B vaccine has not been rigorously evaluated or that it was only studied for “4–5 days” are incorrect and misrepresent the scientific record. 
  • What the evidence actually shows:
    • The hepatitis B vaccine is supported by decades of extensive research, including large clinical trials, long-term observational studies, and real-world data from more than 1 billion doses administered worldwide. 
    • Together, this evidence overwhelmingly demonstrates that the vaccine is both safe and highly effective, including when given at birth. 
    • The safety, benefits, and risks associated with the vaccine have been evaluated over decades, not days. Over the last 50 years, more than 1 billion doses of the vaccine having been administered worldwide, making the hepatitis B vaccine one of the most well-studied vaccines in history. 
    • Claims that the vaccine was only studied for “4–5 days” misrepresent the data: The short period being cited is just listed in package inserts (which are legal documents, not clinical trial reports) and refers just to monitoring minor, non-serious injection-site reactions (like redness or swelling) for the five days following vaccination.  
    • Serious adverse events and other safety and efficacy indicators are monitored for the duration of all trials and continue to be tracked extensively through long-term safety monitoring.  
  • A strong, longstanding safety record: 
    • Decades of safety monitoring show extremely low rates of serious adverse reactions. 
    • Claims linking the hepatitis B vaccine to infant death, severe illness, neurological disorders, or immune conditions have been thoroughly investigated and found to have no crediblesupporting evidence. 
    • Medical and scientific organizations worldwide continue to affirm the vaccine’s excellent safety profile. 
  • High effectiveness and durable protection:
    • Among healthy infants who complete the full vaccine series (birth dose plus follow-up doses), 98% achieve full protection against hepatitis B. 
    • Protection lasts for decades. Long-term follow-up studies confirm that the immune system retains “immune memory” even if antibody levels naturally decline—meaning individuals remain protected well into adulthood without needing routine booster doses. 
  • The hepatitis B vaccine is one of the most extensively studied and safest vaccines ever developed, and its long-lasting protection has played a central role in preventing chronic liver disease, liver cancer, and deaths worldwide.

CLAIM: The U.S. is an outlier in recommending universal vaccination against hepatitis B at birth—other high-income countries don’t do this.

  • REALITY: This claim is false: the U.S. is not an outlier. In fact, the majority of countries worldwide recommend a universal hepatitis B birth dose. 
  • The global reality:  
    • Of the 194 WHO-recognized countries, 116 recommend that all newborns receive a hepatitis B vaccine at birth. 
    • Many countries considered higher-income or industrialized—including Australia, South Korea, parts of Canada, and several European countries—recommend administering the birth dose within 24 hours. 
    • Other high-income countries, including  Japan, New Zealand, the U.K., France, Germany, and several other European countries, have universal infant hepatitis B vaccination, though their schedules begin slightly later in infancy. 
  • Why some high-income countries have different recommendations:  
    • In some high-income countries—such as those in Scandinavia—a universal birth dose is not recommended. 
    • This reflects country-specific cost-benefit and cost-effectiveness assessments, epidemiological profile, and considerations related to access to healthcare and screenings—and is not a broad assessment on whether the birth dose is valuable or not. 
    • Selective (or risk-based) birth dose strategies may be deemed most effective in countries that have:  
      • Smaller size and population and low hepatitis B prevalence, making the likelihood of perinatal transmission very small. 
      • Consistently high rates of prenatal hepatitis B screening, with reliable follow-up to ensure infected mothers are reliably identified before delivery. 
      • Universal, no-cost prenatal care and strong national registries that minimize gaps in screening or follow-up care. 
  • How the U.S. differs from countries using selective strategies: 
    • An estimated 2.4 million people are living with chronic hepatitis B, and most do not know they are infected. 
    • About 15% of pregnant women, or an estimated half a million people, do not receive the recommended hepatitis B screening during pregnancy. 
    • 37% of pregnant women receive fewer than the recommended number of prenatal visits, and 1 in 4  begin prenatal care later than the first trimester (the optimal window). 
  • Because the U.S. has a higher hepatitis B prevalence, more frequent gaps in prenatal care and screening, and greater population mobility from regions with high hepatitis B rates, a universal birth dose strategy is the safest and most effective approach to protect infants from a potentially life-long infection. 

CLAIM: Babies really only get hepatitis B from their mothers during childbirth, while transmission from anyone else outside of childbirth is rare.    

  • REALITY: This claim is misleading. While infants and young children most commonly acquire hepatitis B from their mother (known as perinatal or vertical transmission), they can also be infected through other ways, like exposure to the blood or bodily fluids of an infected person other than their mother (known as horizontal transmission). 
  • Why routes of exposure matter: 
    • Prior to 1991, the U.S. relied on a selective birth dose strategy, meaning only babies born to mothers who tested positive were vaccinated. 
    • Even with this approach, 20,000 childrenbecame infected each year, showing that selective vaccination alone could not prevent early childhood infections. 
    • After the U.S. adopted a universal birth dose recommendation, hepatitis B infections in infants and children fell by 99%, underscoring how critical early protection is. 
  • The real risk of horizontal transmission: 
    • Hepatitis B is a highly resilient virus that can live up to 7 days outside of the body and is up to 100 times more infectious than HIV. 
    • Infants can be infected through every day, often unavoidable, exposures including: 
      • Bites, scratches, or even a nosebleed from an infected person 
      • Contact with open cuts or sores 
      • Accidental contact with personal items such as toothbrushes or razors  
    • Because about half of people with hepatitis B in the U.S. don’t know they’re infected, infants may be exposed by caregivers or household members whose status is unknown. 
  • Approximately 90% of newborns infected with hepatitis B within their first year of life will develop chronic hepatitis B, which can lead to serious health issues later in life, including liver damage, liver cancer, liver failure, and even death.  
  • Vaccinating at birth provides strong, reliable protection during the period when infants are most vulnerable.  

Vaccinate Your Family is a nonpartisan organization dedicated to protecting people of all ages from vaccine-preventable diseases. To learn more, visit us at: vaccinateyourfamily.org

If additional members of your team would benefit from receiving this newsletter, please reply to this email with their information so they can be added to the newsletter distribution list.