U.S. Revises Childhood Vaccine Schedule: A Major Shift in Public Health Policy

The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) have revised routine childhood vaccine recommendations, reducing the number of universally advised vaccines for children from 17 to 11. Six vaccines previously recommended for all children are now categorized for individuals at high risk or require "shared clinical decision-making" in consultation with a healthcare provider.

This change, following a presidential directive to compare U.S. vaccine policy with that of other developed nations, has elicited varied reactions from medical experts and organizations. Some states and professional bodies have moved to adopt an alternative vaccine schedule.

Revised Childhood Vaccine Schedule

On January 5, federal health agencies issued new guidance, shifting six previously universal childhood immunizations to categories requiring specific risk assessment or joint consultation. The vaccines no longer routinely recommended for all children include those for Hepatitis A, Hepatitis B, Rotavirus, Respiratory Syncytial Virus (RSV), Meningococcal disease, Influenza (Flu), and COVID. Additionally, the recommendation for all newborns to receive a hepatitis B vaccine at birth was removed. The guidance also noted an alteration to the recommendation for Human Papillomavirus (HPV).

The CDC maintained its universal recommendations for 11 childhood vaccines, covering diseases such as measles, mumps, rubella (MMR); whooping cough, tetanus, diphtheria (DTaP); bacterial disease Hib; pneumonia; polio; and chickenpox.

"Shared clinical decision-making" is defined as a process where families consult with a healthcare provider to assess a vaccine's appropriateness by discussing risks and benefits for the individual child. This approach was previously utilized for limited situations, such as HPV vaccination in specific contexts.

Administration's Stated Rationale

The changes follow a December 5 presidential memorandum that directed HHS and the CDC to compare U.S. childhood vaccine recommendations with those of "peer, developed countries." Health Secretary Robert F. Kennedy Jr. stated the administration's intent to adjust the immunization schedule, citing a presidential directive to examine how other developed nations protect children.

"After an exhaustive review of the evidence, we are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent."

HHS officials indicated the changes resulted from a "comprehensive scientific assessment" that compared U.S. policy with that of 20 other countries. This assessment, authored by Martin Kulldorf, chief science officer at an HHS unit, and Tracy Beth Høeg, acting director of the FDA's Center for Drug Evaluation and Research, concluded that the United States' previous recommendations for both the number of vaccinations and doses were an "outlier." Officials also cited "a drop in vaccine uptake of routine vaccinations for children," including declining measles vaccination rates, as indicators of reduced public trust in vaccines, stating that the revisions were intended to increase public confidence.

Process and Implementation

Officials confirmed that the changes to the schedule were implemented without formal public comment or input from vaccine manufacturers. This deviates from the typical process, which involves input from various stakeholders, including the CDC's Advisory Committee on Immunization Practices (ACIP), regarding vaccine schedule modifications.

The January 5th schedule overhaul occurred without consultation from ACIP.

Reactions from Medical Experts and Organizations

The policy changes have drawn criticism and concern from medical experts and organizations. Michael Osterholm, an epidemiologist with the Vaccine Integrity Project and director of the University of Minnesota's Center for Infectious Disease Research and Policy, stated that eliminating vital U.S. childhood vaccine recommendations without public discussion or a transparent review of data is a "radical and dangerous decision" that could "sow further doubt and confusion among parents and put children's lives at risk." He also suggested it could lead to increased hospitalizations and preventable deaths.

Experts in childhood diseases expressed confusion regarding the updated guidance. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, highlighted the past effectiveness of U.S. vaccination against rotavirus. Public health officials cautioned that the new guidance places increased responsibility on parents to research and comprehend vaccine importance.

Lori Handy, a pediatric infectious disease specialist, noted that the new approach might not align with established science due to the proven protective benefits of these vaccines for the general population. Pediatrician Eric Ball expressed concern that the change could confuse parents, leading them to question vaccine safety, despite "shared clinical decision-making" not being related to safety concerns. Wendy Parmet, a health care policy researcher, noted that shared clinical decision-making is typically reserved for complex medical decisions where outcomes are less clear, rather than for routine vaccines with established safety and efficacy. Jake Scott, an infectious disease researcher, stated that these vaccines have clear benefits for all children and that the reclassification introduces uncertainty. Dr. Lainie Friedman Ross, a pediatrician and bioethicist, highlighted that implying both vaccination and non-vaccination are equally valid choices is inaccurate, as not vaccinating poses risks to the child and community.

In response to the federal changes, the American Academy of Pediatrics (AAP) released its own 2026 schedule on January 26, which recommends vaccines against 18 diseases, including COVID-19. This schedule was endorsed by twelve major medical organizations.

The AAP stated that the CDC schedule "no longer offers the optimal way to prevent illnesses in children."

Potential Implications for Access and Insurance

HHS officials clarified that no vaccines were removed from the schedule but rather reclassified. They stated that vaccines would remain free and accessible to individuals who choose them, with insurance coverage facilitated through shared clinical decision-making. Officials also stated that the overhaul would not result in families losing access or insurance coverage for vaccines.

However, legal experts like Dorit Reiss of UC Law San Francisco indicated that insurance coverage may not be guaranteed, as private insurers could challenge coverage, arguing the vaccines are no longer universally recommended. Changes in policy could also create practical hurdles for vaccine administration, such as the deletion of automatic electronic medical record alerts for due vaccinations and the cancellation of standing orders allowing nurses and pharmacists to administer vaccines without direct physician involvement.

Related Federal Initiatives and Legal Actions

HHS officials announced upcoming placebo-controlled trials designed to investigate the timing and long-term effects of vaccines. These trials have commenced at the CDC and are being initiated at the FDA and the National Institutes of Health, with follow-up indicated over "many, many years."

On January 13, Secretary Kennedy appointed two new members to the Advisory Committee on Immunization Practices (ACIP): Dr. Adam Urato and Dr. Kimberly Biss. The new Kennedy-appointed ACIP chair, Kirk Milhoan, stated in interviews that the committee is "reevaluating all of the vaccine products" and suggested current measles outbreaks could be an "opportunity to observe" the effects on unvaccinated individuals.

The American Academy of Pediatrics and other medical organizations filed a lawsuit last summer, AAP v. Kennedy, arguing that the administration overstepped its authority in rewriting vaccine recommendations and replacing ACIP experts. A federal judge denied the government's attempt to dismiss the case in January, allowing it to proceed.

Senators Warren, Markey, Blumenthal, and Alsobrooks sent a letter to Secretary Kennedy regarding his reported ties to Wisner Baum, a law firm suing Merck over the HPV vaccine Gardasil. Kennedy had reportedly referred vaccine injury cases to the firm since 2018, entitling him to a 10% share of successful judgments, which he later transferred to his son. Kennedy has refused to recuse himself from HHS decisions involving the vaccine.

Concerns have also been raised regarding the Vaccine Injury Compensation Program (VICP). Congress established the VICP in 1986 to manage rare vaccine injury cases. Kennedy has reportedly fired at least half of the VICP's advisory panel members. Concerns were raised that altering the panel's composition could lead to adding conditions like autism to the vaccine injury table, despite a lack of scientific evidence connecting vaccines to autism. Experts warn this could exhaust the program's $4 billion reserve, potentially pushing cases into civil court and threatening the vaccine supply. The advisory panel met only once in 2025, consolidating four required quarterly meetings, and has no meetings scheduled for 2026.

State-Level Responses and Public Health Context

Following the AAP's release of its 2026 schedule, a group of 15 Democratic governors, and subsequently a majority of U.S. states, formally adopted the AAP's recommended vaccine schedule. This has led to a public split between the medical establishment and the federal government on childhood vaccine protection, with pediatricians nationwide continuing to follow AAP guidance as the professional standard of care. State vaccination laws are not affected by these HHS changes, allowing medical practitioners to continue recommending vaccines based on professional guidelines and evidence.

Federal schedule changes have been cited by some groups as an argument against state vaccine requirements. A Stateline analysis indicated that at least 33 states are now below herd immunity thresholds for kindergartners.

Specific State Actions

• Texas: The Attorney General launched an investigation into pediatricians who vaccinate children, alleging an illegal financial incentive scheme. This follows a measles outbreak in the state that resulted in two deaths and a decline in Dallas County's kindergarten vaccination coverage.
• Florida: A bill to expand vaccine exemptions narrowly passed committee, retaining MMR, DTaP, and polio requirements but adding "conscience" as an opt-out reason. Separately, the health department is moving to drop requirements for chickenpox, hepatitis B, Hib, and pneumococcal vaccines through rulemaking. Three measles cases have been reported in the state this year.
• New Hampshire: A public hearing was held on a bill that would eliminate mandatory vaccinations for school and daycare, along with companion bills to restrict school-based clinics and ban state spending on vaccine outreach.
• Idaho: The state has banned schools from enforcing vaccine requirements and has the lowest kindergarten vaccination rate in the country at approximately 80%.
• Iowa: House lawmakers advanced a bill that would remove all vaccine requirements for school entry.
• Mississippi and West Virginia: Both states, which previously had high kindergarten vaccination rates, now allow religious exemptions (Mississippi by court order, West Virginia by executive action) and are experiencing declining rates. Mississippi is observing its highest whooping cough numbers in a decade, including a recent death.

The Medical Freedom Act Coalition, which includes Kennedy’s Children’s Health Defense, is collaborating with lawmakers in nearly a dozen states and plans to expand to all 50, with the stated aim of eliminating vaccine mandates at the state level.

These developments occur amidst a reported surge in measles cases (588 reported this year), a severe flu season with at least 52 pediatric deaths, and three measles-related child deaths in the past year. A recent JAMA Pediatrics study indicated that states maintaining vaccine requirements generally sustained higher vaccination rates during periods of increased hesitancy, suggesting the effectiveness of these requirements.