Are the Changes to the Vax Schedule Finished?

Cutting through the noise and propaganda, just the facts

The opinions expressed in this essay are those of the author, and do not necessarily represent the views of US Department of Health and Human Services, the Centers for Disease Control and Prevention, or the Advisory Committee on Immunization Practices.

Are the Changes to the Vax Schedule Finished?

Context

On January 5, 2026, the U.S. Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr., announced a significant update to the CDC’s childhood and adolescent immunization schedule. This followed a December 5, 2025, Presidential Memorandum directing a review of U.S. practices compared to peer developed nations (e.g., Denmark, Japan, Germany) to align with international best practices while preserving vaccine access.

The primary change reduces routine (recommended for all children) vaccines from approximately 17–18 to 11, focusing on those with strong international consensus and clear broad benefits: measles, mumps, rubella (MMR), polio, pertussis (whooping cough), tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV; now single-dose recommendation), and varicella (chickenpox). Vaccines for other diseases—including influenza (flu), rotavirus, hepatitis A, hepatitis B, meningococcal disease, respiratory syncytial virus (RSV), and COVID-19, are reclassified to:

• High-risk groups (targeted recommendations), or

• Shared clinical decision-making (decided individually between parents/guardians and healthcare providers).

All vaccines previously recommended as of December 31, 2025, remain fully available and covered without out-of-pocket costs under insurance (including ACA plans), Medicaid, CHIP, and the Vaccines for Children program. Regarding vaccine clinical trials and research, the policy explicitly commits HHS to strengthening vaccine science with “gold standard” methods:

• Double-blind, placebo-controlled randomized trials (where appropriate and ethical) for individual vaccines, combinations, timing, and the overall schedule.

• Expanded long-term observational studies to assess benefits, risks, chronic conditions, and interactions.

• Agencies, including NIH, CDC, and FDA, are directed to fund, initiate, and conduct this research, with ongoing reassessment of recommendations based on emerging data.

• The policy builds on earlier 2025 statements requiring all new vaccines to undergo safety testing in placebo-controlled trials prior to licensure, a described “radical departure” from past practices for certain updates (e.g., annual flu or COVID boosters, which historically relied on immunogenicity data against prior versions rather than full placebo trials).

This builds on an earlier 2025 HHS policy requiring placebo-controlled safety testing for all new vaccines prior to licensure (a shift described as a “radical departure” from some prior practices, such as annual flu/COVID booster approvals that relied on immunogenicity data rather than full new placebo trials).

The announcement emphasizes restoring public trust through transparency, rigorous evidence, and respect for parental informed consent amid declining vaccination rates and trust post-2020. HHS officials have reiterated this commitment in follow-up statements, including recent comments from Deputy Chief of Staff Stefanie Spear highlighting plans for placebo-controlled randomized trials, long-term observational studies, and shorter-term studies at FDA/CDC.

The change has drawn sharp criticism from medical organizations (e.g., American Academy of Pediatrics, infectious disease experts), who argue it risks the resurgence of preventable diseases (e.g., flu-related child hospitalizations), undermines decades of evidence-based prevention, and that placebo trials can be unethical when effective vaccines exist (potentially exposing participants to harm). Supporters praise it as prioritizing “gold standard” science and parental choice. Implementation involves education for parents/providers, continued safety monitoring, and potential future updates as new research emerges. The policy focuses on recommendation categories rather than restricting availability.

Will there be Additional Changes?

I am often asked whether these decisions have made the ACIP irrelevant, and whether it will be asked to provide additional independent advice to CDC leadership regarding vaccine policies. Basically, has the ACIP been made irrelevant?

Yes, additional changes to the CDC’s childhood and adolescent immunization recommendations are likely in the coming months and years. The January 5, 2026, overhaul, which reduced routine (universal) recommendations from ~17 to 11 diseases while shifting others (e.g., flu, rotavirus, hepatitis A/B, meningococcal, COVID-19) to high-risk groups or shared clinical decision-making, was explicitly framed as part of an ongoing process rather than a final endpoint. Key indicators from official HHS/CDC statements and related coverage include:

• Commitment to “gold standard” research and reassessment: The policy directs HHS agencies (CDC, FDA, NIH) to fund and conduct double-blind, placebo-controlled randomized trials (where ethical), long-term observational studies, and evaluations of individual vaccines, combinations, timing, and the overall schedule. Officials have stated that trials are already underway, with results expected to inform future updates. This reflects recognition of “evidence gaps” and the need for better data on benefits, risks, chronic conditions, and interactions.

• Ongoing role of advisory processes: Acting CDC Director Jim O’Neill’s announcement noted that the CDC will continue to ask the Advisory Committee on Immunization Practices (ACIP), now reconstituted under the current administration, to review emerging evidence and make updated recommendations as new data becomes available.

• Explicit language on future evolution: The changes stem from a “comprehensive scientific assessment” comparing U.S. practices to peer nations (e.g., Denmark, Japan, Germany), but HHS emphasized that this is about rebuilding trust through transparency and rigorous science. Statements highlight that recommendations will be reassessed based on new studies, implying iterative adjustments rather than a one-time fix.

• No new announcements since January 5: As of January 10, 2026, HHS and CDC sites show no further press releases or schedule modifications beyond the January 5 update (last reviewed/issued that date). Implementation focuses on education for parents/providers, continued insurance coverage for all prior vaccines, and monitoring uptake/safety.

Critics (e.g., American Academy of Pediatrics, infectious disease experts) argue the initial change was unprecedented (bypassing typical ACIP processes), risks disease resurgence, and could lead to confusion. Supporters view it as a step toward evidence-based refinement and parental choice.

While the current schedule is effective immediately, HHS has positioned further changes as probable, driven by new research findings, ongoing reviews, and the explicit goal of continuous improvement based on “better science.” Expect potential tweaks beginning with the next ACIP meeting in 2026, and continuing for a decade or more as placebo trials and observational data emerge.

In my opinion, many of the planned trials are likely to be managed by the US CDC, either using in-house staff, commercial clinical research organizations under contract, or academic institutions. One example of such clinical trials involves a US-backed study of the hepatitis B (Hep B) vaccine in Guinea-Bissau, a randomized controlled trial funded by the Centers for Disease Control and Prevention (CDC), part of the US Department of Health and Human Services (HHS).

Announced in December 2025 via the Federal Register and beginning enrollment in early January 2026 (as of January 10, 2026, the trial has reportedly started), the study awards approximately $1.6 million over five years (through 2031) to the University of Southern Denmark (SDU) and the Bandim Health Project. This group is led by researchers Christine Stabell Benn and Peter Aaby, known for their work on “non-specific effects” (NSEs) of vaccines—claims that vaccines can influence overall health outcomes beyond their targeted disease, sometimes controversially.

Study Design and Objectives

• Participants: A planned enrollment of over 14,000 newborns in Guinea-Bissau, a low-income West African country with high Hep B prevalence (around 13–18% of the population infected, leading to risks of chronic liver disease, cirrhosis, and liver cancer, especially if infected early in life).

• Intervention: Single-blind, multicenter, phase IV randomized controlled trial.

  • One group receives the monovalent Hep B vaccine at birth (aligning with future national policy and WHO recommendations).

  • The control group follows Guinea-Bissau’s current standard (no Hep B at birth; first dose at ~6 weeks of age, alongside other routine vaccines like BCG and oral polio).

• Primary focus: Assessing effects of neonatal Hep B vaccination (at birth) on all-cause early-life mortality, severe morbidity (e.g., hospitalizations), and long-term neurodevelopmental outcomes. It also examines potential sex-specific differences.

• Rationale from funders/researchers: To evaluate broader “non-specific” health effects of the Hep B birth dose (beyond preventing Hep B infection), as evidence on NSEs for this vaccine is limited compared to others like BCG or oral polio. The trial leverages a “unique window of opportunity” before Guinea-Bissau implements universal birth dosing in 2027/2028. All infants receive other recommended vaccines regardless of group.

Studies like this typically require 1 - 2 years for the CDC to plan, design, solicit, and award contracts. Study performance periods will vary depending on design, required follow-up periods (up to five years if long-term adverse events are to be rigorously assessed), and enrollment objectives. It is likely that many of the envisioned studies will take up to a decade to design, enroll, complete, and analyze. Therefore, it is reasonable to assume that there will be shorter-term adjustments in ACIP recommendations and CDC-recommended childhood vaccine schedules in the near term based on existing data, intermediate-term changes based on data from current epidemiological, physician/scientist reports, and clinical research studies, and longer-term changes reflecting data obtained from larger randomized and fully controlled clinical trials.

Based on my decades of working with or for the Federal Government and supporting vaccine clinical research, the most likely and efficient agency to manage such studies will be the US CDC. The NIH typically requires up to five years from concept to even being able to award a new contract or grant. FDA does not have the contracting infrastructure to handle such large projects. BARDA has the capabilities necessary to expedite and manage this type of contract work, but it is outside of the scope of this branch.

The problem with the CDC handling contracting management is that the organization's historic pro-vaccine bias may introduce bias into study design, performance, and interpretation. Internal CDC capabilities could be employed to directly manage the work, but once again, the pro-vaccine bias, combined with the hollowing out of CDC personnel and capabilities, creates obstacles to efficient and objective performance.

In Conclusion

On January 5, 2026, the U.S. Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy Jr., announced a major revision to the CDC’s childhood and adolescent immunization schedule, following a 2025 Presidential Memorandum directing alignment with international best practices. The reform reduces the number of universally recommended (routine) vaccines from roughly 17–18 to 11, focusing on those with clear, globally accepted benefits such as MMR, polio, pertussis, tetanus, diphtheria, Hib, pneumococcal disease, HPV (now single‑dose), and varicella. Other vaccines, including influenza, hepatitis A/B, rotavirus, COVID‑19, and RSV, are now recommended only for high‑risk groups or based on shared clinical decision‑making between parents and providers. All previously available vaccines remain accessible and covered under public and private insurance programs.

HHS simultaneously directed agencies to strengthen scientific rigor through double‑blind, placebo‑controlled clinical trials and expanded long‑term observational studies assessing safety, chronic outcomes, and timing effects. This new approach reflects a “gold‑standard” commitment to evidence‑based policy and informed parental consent amid eroding public confidence in vaccination policies since 2020. Supporters hail it as a historic correction toward transparency and scientific integrity, while critics, particularly within pediatric and infectious‑disease organizations, warn it risks resurgence of preventable illnesses and could expose participants in placebo trials to unnecessary harm.

Further changes to the schedule are explicitly anticipated. The HHS plan references ongoing research, reconstituted ACIP advisory roles, and continuous reassessment as new data emerge. Early examples include the 2026 U.S.‑backed hepatitis B birth‑dose trial in Guinea‑Bissau, run by the University of Southern Denmark and the Bandim Health Project under CDC contract, which explores broader health outcomes beyond infection prevention. This and similar studies are expected to take years to produce results, implying an evolving, data‑driven policy environment rather than a fixed endpoint. While the CDC is the logical choice to manage most contracts, its historical pro‑vaccine bias and diminished internal capacity may compromise neutrality, raising concerns about whether the process will fulfill its promise of transparency.

The January 2026 immunization schedule overhaul marks the beginning, not the end, of an extended re‑evaluation of U.S. vaccine policy. HHS has positioned the new framework as part of a long‑term transformation toward rigorous, ethically sound, and truly independent vaccine science. Although the reforms have triggered intense debate between public‑health traditionalists and advocates for deeper safety scrutiny, the guiding theme is continuous improvement based on stronger evidence rather than automatic institutional trust. With numerous randomized and observational studies underway, incremental updates to ACIP recommendations are expected over the next decade. The ultimate outcome will depend on whether government agencies can conduct this unprecedented wave of trials objectively and whether transparency can restore the public confidence that decades of opaque policymaking have eroded.

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