Comments to the Advisory Committee on Immunization Practices (ACIP)

November 25, 2025

The Partnership to Fight Infectious Disease (PFID) appreciates the opportunity to comment on the agenda items for the Advisory Committee on Immunization Practices (ACIP) meeting scheduled for December 4-5, 2025.

The need to uphold a strong, evidence-based childhood vaccination schedule could not be clearer: the U.S. faces the real possibility of losing of its measles elimination status amid more than 1,700 confirmed cases and counting this year,  whooping cough infections continue to rise, and there are early signs that we will face another severe flu season.¹ We strongly urge ACIP to maintain the current childhood vaccination schedule and to rely only on scientifically and medically rigorous, peer-reviewed evidence when making decisions that directly impact people’s lives. To do otherwise would not only needlessly confuse the American public but would undermine their access to safe and effective vaccines.

We remain deeply concerned that the abrupt dismissal and replacement of ACIP members earlier this year combined with a host of other changes to the committee’s procedures have undermined longstanding practices of scientific integrity, transparency, and independence in the immunization policy process. In that vein, we offer the comments below concerning the ACIP discussions around hepatitis B, childhood vaccination schedule, and vaccine adjuvants.

The Importance of a Stable, Evidence-Based ACIP

For more than six decades, ACIP has been widely regarded as the global gold standard for evidence-based vaccine decision-making, built on rigorous scientific review, conflict-of-interest safeguards, and robust engagement with clinical and public health experts.

Departures from this tradition – including compressed timelines, diminished reliance on longstanding workgroup processes, limited transparency regarding the development of agenda items, and lack of detail in agenda notices – raise serious doubts about whether current ACIP deliberations and recommendations meet the high bar that has historically characterized ACIP’s work. The committee’s credibility rests not only on outcomes, but on a process that is clearly independent, methodologically sound, and open to public scrutiny.

The December agenda includes:

• “CDC Vaccine Risk Monitoring Evaluation”

• “Childhood/adolescent immunization schedule”

• “Adjuvants and contaminants”

• "Hepatitis B vaccine recommendations”

These topics are central to the health of infants, children, and families nationwide and impact their ability to choose to vaccinate and access vaccines. Amid process concerns, PFID urges ACIP to avoid abrupt departures from established recommendations and consistently apply rigorous evidence of synthesis using the GRADE and Evidence-to-Recommendation (EtR) frameworks. Deviations from these methods, such as unclear member selection, altered use of working groups, and limited expert involvement, undermine committee independence and public trust. Adhering to transparent, evidence-based procedures is vital to ensuring recommendations reflect the best science – as well as securing and maintaining Americans’ confidence in those recommendations.

Preserve Recommendations on Hepatitis B Birth Dose

PFID is especially concerned that ACIP will revisit longstanding recommendations for the universal hepatitis B birth dose and early-life protection against vaccine-preventable diseases.² For more than three decades, the birth dose has been a cornerstone of the U.S. hepatitis B elimination strategy, contributing to steep declines in perinatal and early childhood infection, preventing future cirrhosis, liver failure, and hepatocellular carcinoma. Instituting universal birth dose recommendations in 1991 has prevented more than 500,000 childhood infections, reduced infant hepatitis B cases by 95%, and prevented more than 90,000 childhood deaths.^3,4  As ACIP members consider policy around this issue, it is vital to ground deliberations in rigorous evidence – not in personal beliefs or anecdotal concerns – because these decisions shape public health for all Americans.

The hepatitis B universal birth dose recommendation reflects the realities of clinical care in the U.S. Not all pregnant women are screened on time, test results can be missed, and new infections can occur late in pregnancy or postpartum. People in areas already facing barriers to prenatal care, hospital access, and follow-up visits are especially vulnerable. The recommendation also reflects the reality that exposure can come from others living in the household, childcare, many other pathways. More than 2 million people in the U.S. live with hepatitis B, but 1.4 million of them aren’t aware. Moreover, hepatitis B virus can survive on surfaces for up to seven days – even in dried blood – which makes childhood and childcare settings a significant risk if proper precautions are not taken.⁵ Hepatitis B is not only transmitted sexually, but also through bites, exposure to blood or open wounds, and shared personal items like toothbrushes and nail clippers.  Relying solely on perfect screening and follow-up will leave some newborns unprotected when hepatitis B infection can do the most harm. The long-standing ACIP recommendations of the birth dose are just that: recommendations – not mandates – that give parents the choice to protect their infants, prevent avoidable illness, and receive coverage of associated costs.

The hepatitis B vaccine has been extensively tested for safety and efficacy in newborns. Large studies and continuous monitoring by the CDC have found no evidence of increased risk for serious health problems, such as fever, sepsis, allergies, or neurological issues, following the birth dose.⁶ Changes to those recommendations will lead to delayed access and more risks of infections without any beneficial offset.

In keeping with ACIP’s long history of evidence-based policymaking, any consideration of changes to the hepatitis B recommendation should be grounded in comprehensive epidemiologic data, real-world implementation evidence, and meaningful engagement with hepatology, pediatrics, obstetrics, and public health experts – as well as communities disproportionately affected by hepatitis B. Until and unless such a transparent process clearly demonstrates that altering the universal birth-dose policy will not increase the risk of infection or exacerbate existing disparities, PFID strongly urges the committee to reaffirm the universal hepatitis B birth dose recommendation to maintain access, decision-making freedom, and coverage. Weakening these protections now would send a dangerous signal and risk validating misinformation at a time when clear, stable guidance is urgently necessary.

Further, we strongly urge ACIP to maintain Vaccines for Children program coverage of the hepatitis B vaccine at birth to protect families’ ability to protect their children from hepatitis B and the liver diseases that can develop from infection.

Maintain U.S. Childhood Vaccine Schedule

The current U.S. childhood vaccine schedule represents the best science and medicine can offer to protect the country’s children. The CDC estimates that vaccinating children born between 1994-2023 will prevent approximately 508 million illnesses, 32 million hospitalizations, and 1.13 million deaths – resulting in $540 billion in direct savings and $2.7 trillion in societal costs.⁷ Each additional vaccine underwent rigorous testing and addressed a real public health need.

Long-standing childhood recommendations were analyzed, developed, and adopted through critical reviews of high-quality studies, rating of the evidence using the GRADE framework, and following the evidence to recommendation framework. This process facilitated public input, transparency, and inclusion of expertise from scientific and medical experts – facilitating accountability, which the current ACIP approach lacks. This ACIP’s exclusion of CDC experts and third-party medical and stakeholder liaisons in the working group examining the childhood vaccine schedule is unprecedented, dangerous, and completely undermines the credibility of any new recommendations or changes to existing ones.⁸  These actions do not reflect gold standard science or radical transparency. Excluding CDC and liaison experts confirms concerns that ACIP, and this working group specifically, is engaged in a search for data to fit a desired conclusion, rather than objectively and critically evaluating the evidence.

Moreover, any comparisons of the U.S. vaccine schedule with the vaccine schedules of other countries lack validity without including a comparison of the nation’s health systems, childcare systems, and risk-benefit tradeoffs that different societies choose to make. For example, Denmark, Sweden, and Norway have generous family leave policies that result in very few children under age 1 attending daycare. In comparison, almost half of all U.S. children under age 1 receive childcare outside the home. Those social differences can lead to greater exposures to infectious illnesses. Other nations also have socialized medical systems with budgetary limitations that factor into vaccine access and coverage policies – differing significantly from U.S. vaccine coverage and risk-benefit decisions. Different does not mean better, and context matters. The U.S. schedule has served the children of America well for decades and has represented the gold standard for children's health.

Reject Pseudoscience on Adjuvants, Aluminum, and Vaccine Safety

PFID is also concerned that the scheduled discussion of adjuvants and “contaminants” could be used to cast doubt on the safety of aluminum-containing vaccines, despite decades of data supporting their safe and effective use.⁹

Aluminum is the most abundant metal in the Earth’s crust, and is present in air, food, and water. Babies are exposed to more aluminum from breast milk or formula in the first six months of life than from all vaccines in the childhood schedule combined.¹⁰

Aluminum salts have been used safely as adjuvants in vaccines for nearly a century and remain essential for generating robust, long-lasting immune responses to several pediatric and adult vaccines. Regulatory agencies, including the U.S. Food and Drug Administration and the World Health Organization’s Global Advisory Committee on Vaccine Safety, have repeatedly evaluated aluminum adjuvants and concluded that they have a strong safety record when used at the doses present in vaccines.¹¹ Large epidemiologic studies, including long-term population-based analyses, have found no association between aluminum-containing vaccines and chronic neurologic or autoimmune conditions.

In fact, these adjuvants allow for less antigen to be used in vaccines to provoke a sufficient protective immune response.³

It is critical that ACIP’s discussion reflects the extensive safety literature and avoids elevating flawed, retracted, or methodologically unsound analyses that could mislead the public or fuel conspiracy narratives.¹² Moreover, the scientists at the FDA – not ACIP – have the statutory responsibility for assessing the safety and efficacy of vaccine ingredients. The FDA continues to support their use. ACIP overreach to reopen settled science about aluminum will disrupt vaccine supply, increase provider confusion, and create barriers to access at a moment when Americans need more, not fewer, tools to combat infectious disease threats. PFID urges ACIP to center its deliberations on high-quality, peer-reviewed evidence and to leave vaccine recommendations, including those involving aluminum-containing vaccines, in place.

Adhere to Process Integrity, GRADE and EtR frameworks, and Legal Obligations

Finally, PFID remains troubled by reports that the current ACIP has not consistently followed established GRADE and EtR process, including transparent rating of evidence, public documentation of analytic choices, and clear articulation of how benefits, risks, equity, and feasibility are weighed in reaching recommendations.¹³ These frameworks are critical not only for scientific rigor, but also for ensuring that recommendations are evidence-based and medically sound. Deviations from these methods, especially in the context of concerns about how new members were appointed and how working groups are being used compared to past practices, risk undermining both the perceived and actual independence of the committee members.^7,14,15 Similarly, the exclusion of scientific and medical experts from the CDC and liaison organizations in the working groups and discussions completely undermines the integrity of the ACIP deliberations and contradicts claims of pursuing “gold standard science” and reflecting “radical transparency.”

PFID urges ACIP, CDC, and the Department of Health and Human Services to restore full adherence to established procedures for member vetting, conflict-of-interest management, and evidence review. Reinstating a transparent, merit-based appointment process; ensuring that workgroups are populated with diverse, independent experts; sharing advance details on ACIP meetings to allow for more rigorous public comment processes; and providing the public with clear documentation of evidence assessments are essential steps to rebuild trust. Any ongoing or future litigation challenging the committee’s structure or recommendations underscores how vital it is for ACIP to demonstrate procedural integrity beyond reproach.

Conclusion

Traditionally, ACIP has served as a source of stability and fact-based guidance, making recommendations that carry the weight of expertise and public confidence. However, the committee’s recent actions and the agenda for the upcoming December meeting raise serious concerns about ACIP’s credibility, which in turn puts the health of millions of Americans at risk. PFID remains committed to working alongside federal, state, and local partners to reduce the burden of infectious diseases and to ensure that all communities benefit from the full promise of safe, effective vaccines.

Submitted respectfully, The Partnership to Fight Infectious Disease (PFID)

¹ Measles cases and outbreaks in the US: https://www.cdc.gov/measles/data-research/index.html

² Hepatitis B perinatal vaccine information: https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/vaccine-administration.html

³ Hepatitis B and its impact on reduced risk of infection: https://www.aap.org/en/news-room/fact-checked/fact-checked-hepatitis-b-vaccine-given-to-newborns-reduces-risk-of-chronic-infection/

⁴ Reduction of hepatitis B cases in infants: https://www.nfid.org/why-we-give-hepatitis-b-vaccines-to-infants/

⁵ Life cycle of hepatitis B virus on surfaces: https://www.healthline.com/health/how-long-does-hep-b-live-outside-the-body

⁶ CDC on lack of evidence of risk for serious health problems from vaccines: https://www.nbcnews.com/health/kids-health/rfk-jr-cdc-vaccine-panel-hep-b-babies-data-rcna232394

⁷ CDC health and economic benefits of routine childhood immunizations: https://www.cdc.gov/mmwr/volumes/73/wr/mm7331a2.htm

⁸ ACIP exclusion of CDC experts and medical experts in working group: https://www.cdc.gov/acip/downloads/child-schedule-tor-508.pdf

 ⁹ Aluminum as a vaccine ingredient: https://www.chop.edu/vaccine-education-center/vaccine-safety/vaccine-ingredients/aluminum

¹⁰ Facts on aluminum in vaccines: https://vaccineresourcehub.org/resource/factsheet-three-important-things-know-about-aluminum-and-vaccines

¹¹ WHO on aluminum adjuvants: https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/adjuvants

¹² Safety profile of adjuvants in vaccines: https://pmc.ncbi.nlm.nih.gov/articles/PMC10871092/

¹³ Definition of GRADE and EtR frameworks: http://cdc.gov/acip/evidence-based-recommendations/index.html

¹⁴ Deviations of ACIP members from standard practices: https://www.cidrap.umn.edu/adult-non-flu-vaccines/quality-decisions-made-cdc-vaccine-advisers-has-nose-dived-former-voting

¹⁵ History on ACIP procedures: https://www.congress.gov/crs-product/IF12317