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Federal health officials today outlined sweeping changes to the U.S. childhood immunization schedule.
The changes create a new framework that keeps all currently recommended vaccines available and fully covered while moving several vaccines into a category designed to emphasize shared decision-making between families and clinicians.
The new recommendations reduce the number of vaccines recommended as routine for all children to 11 from 17, a move The New York Times called a “seismic shift” in federal vaccine policy.
Mary Holland, CEO of Children’s Health Defense, called the change “the most significant change in U.S. vaccination policy in recent history.”
HHS said the change follows a directive from President Donald Trump, who issued a presidential memorandum on Dec. 5, 2025, instructing the agency and the Centers for Disease Control and Prevention (CDC) to review whether other developed nations protect children more effectively.
After what HHS described as a “comprehensive, evidence-based assessment,” the department concluded that the U.S. recommends more routine childhood vaccine doses than peer countries without achieving higher vaccination rates or greater public trust.
“This decision modernizes the U.S. childhood immunization schedule, protects children from serious disease, and rebuilds trust in public health,” HHS said.
“President Trump directed us to examine how other developed nations protect their children and to take action if they are doing better,” U.S. Health Secretary Robert F. Kennedy Jr. said. “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.”
“This decision protects children, respects families, and rebuilds trust in public health.”
What’s changing — and what’s not
Federal health officials emphasized that no vaccine is being banned or removed, and that families will not lose access to any immunizations. Every vaccine currently recommended by the CDC will remain available and fully covered by insurance without cost sharing, the agency said.
Instead, the childhood schedule will now be structured into three categories:
- Immunizations recommended for all children.
- Immunizations recommended for certain high-risk groups or populations.
- Immunizations based on shared clinical decision-making.
Under the updated schedule, vaccines protecting against what HHS called the “most serious childhood diseases” will remain recommended for all children. These include vaccines for measles-mumps-rubella (MMR), polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV) and varicella (chickenpox).
Recommendations for high-risk groups will remain unchanged, officials said.
The biggest change involves vaccines that fall under shared clinical decision-making.
HHS said four vaccines — hepatitis A, influenza, meningococcal ACWF and rotavirus — have been added to that category, bringing the total number to seven. Three vaccines were already listed in the shared clinical decision-making category: hepatitis B, COVID-19, and meningococcal B.
Shared decision-making “strengthens — not weakens — vaccination,” according to HHS, which said:
“Shared clinical decision-making doesn’t leave parents on their own. It strengthens the doctor-patient relationship, respects informed consent, and allows recommendations to reflect individual risk — while preserving access to every vaccine.”
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‘Unknown risks,’ limited safety data led to updated recommendations
The announcement cited concerns about public trust in healthcare institutions between 2020 and 2024, along with declining childhood vaccination rates and the increased risk of vaccine-preventable diseases.
From the 2019-2020 to 2023-2024 school years, national coverage for the MMR vaccine dropped from 95.2% to 92.7%, according to HHS. Sixteen states now report MMR coverage below 90%.
The agency contrasted the U.S. policy of mandating a higher number of vaccines with policies of other developed nations, which “maintain high vaccination rates through public trust and education rather than mandates,” according to the press release.
In 2024, the U.S. recommended more childhood vaccines than any peer nation, and more than twice as many doses as some European nations.
“Public health works only when people trust it,” U.S. Food and Drug Commissioner Marty Makary said. “That trust depends on transparency, rigorous science, and respect for families. This decision recommits HHS to all three.”
Senior health officials said in a call with reporters that “unknown risks” of vaccination and limited safety data on vaccination informed their decision, STAT reported.
HHS pointed to gaps in “gold standard” vaccine evidence, including placebo-controlled randomized trials and long-term observational studies to better characterize vaccine benefits, risks and outcomes.
“Vaccines are effective public-health tools, but no medical intervention is risk-free,” the agency said. Placebo-controlled trials have “rarely been conducted” for vaccines intended for universal childhood use, and post-licensure surveillance systems can detect serious adverse events, but have limitations for long-term safety evaluation.
The department said the overall childhood schedule has “never been comprehensively evaluated as a whole,” despite repeated calls from the Institute of Medicine to do so.
HHS said it will fund and conduct research, including placebo-controlled randomized clinical trials and long-term observational cohort studies. The agency plans to publish the findings, and the CDC advisory committee will reassess recommendations as evidence emerges.
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