Federal Health Officials Announce Major Revisions to Childhood Vaccine Schedule
Federal health officials in the United States have announced revisions to the routine childhood vaccine schedule, reducing the number of universally recommended immunizations from 17 to 11. Implemented by the Department of Health and Human Services (HHS) under Secretary Robert F. Kennedy Jr., following a directive from President Donald Trump, the changes reclassify several vaccines for high-risk individuals or shared clinical decision-making.
The new schedule, which officials state aligns the U.S. with some international counterparts, has drawn significant concern and legal challenges from numerous medical and public health organizations.
The revised guidelines were announced on January 5, 2026, by federal health officials and became effective immediately. These changes mark a significant adjustment to the U.S. vaccine schedule, which had maintained a basic structure since a unified national standard was first issued in 1995.
Details of the Revised Schedule
Under the updated guidelines, the Centers for Disease Control and Prevention (CDC) will now universally recommend 11 vaccines for all children. Six additional vaccines will be recommended for children identified as high-risk, while a third group will be available through shared clinical decision-making with medical providers.
Universally Recommended Vaccines (11 diseases):
- Diphtheria
- Tetanus
- Pertussis
- Haemophilus influenzae type B (Hib)
- Pneumococcal disease
- Polio
- Measles
- Mumps
- Rubella
- Human papillomavirus (HPV)
- Varicella (chickenpox)
High-Risk Individuals Only
Vaccines for hepatitis A, Respiratory Syncytial Virus (RSV), hepatitis B, dengue, meningococcal ACWY, and meningococcus B are now designated for high-risk individuals. The announcement did not define or clarify what constitutes a "high-risk individual." Examples provided for meningococcal vaccination include individuals with specific medical conditions, those traveling to high-disease-rate areas, and first-year college students in dorms. The dengue vaccine remains recommended only for children with a previous dengue infection living in high-risk areas.
Shared Clinical Decision-Making
Vaccines falling under this category include rotavirus, Covid-19, influenza, meningococcal disease, hepatitis A, and hepatitis B. This category typically requires a doctor's recommendation and necessitates physician involvement in each vaccination decision.
Dosage Changes
The CDC now recommends a single dose of the HPV vaccine, a reduction from the previous recommendation of two or three doses based on the child's age at initial vaccination.
Other Specific Changes
- In December 2025, the CDC withdrew its long-standing recommendation for hepatitis B vaccination in all newborns.
- Under the reconstituted Advisory Committee on Immunization Practices (ACIP), members have also voted to cease recommending certain flu vaccines containing thimerosal.
- The combined measles, mumps, rubella, and varicella (MMRV) shot will now be split into separate MMR and varicella shots.
Official Justification and Procedural Context
Officials stated that the new schedule aims to align U.S. recommendations with those in other developed nations and enhance public trust in the health system. The revisions followed a directive from President Donald Trump in December, which called for HHS to align the U.S. vaccination schedule with "peer, developed countries." Secretary Kennedy stated the decision followed "an exhaustive review of the evidence," intended to align the U.S. childhood vaccine schedule with international consensus while "strengthening transparency and informed consent."
Senior health officials involved in the decision cited that the previous childhood vaccine schedule had contributed to declining vaccination rates and public trust. They also stated that "unknown risks" of vaccination and limited safety data informed their decision.
A 34-page review by Tracy Beth Høeg (acting director of the FDA’s Center for Drug Evaluation and Research) and Martin Kulldorff (chief science and data officer for HHS’ Assistant Secretary for Planning and Evaluation) was released to justify the changes. This report highlights comparisons to other nations, states that peer nations often achieve high voluntary vaccination rates without mandates, and links declining public health trust to vaccine mandates. Both Høeg and Kulldorff had previously expressed views opposing vaccine mandates and advocating for a reduced U.S. childhood vaccine schedule.
Kirk Milhoan, the newly appointed chair of ACIP, stated in a podcast interview that the committee's objective is to "return individual autonomy to the first order, not public health, but individual autonomy to the first order." Milhoan suggested reconsidering polio vaccine use and questioned established vaccine science, implying that policy goals, rather than new research, were influencing recent changes. He argued that modern sanitation and reduced crowding might bring diseases like polio and measles under control without vaccines.
Reactions and Concerns from Medical and Public Health Experts
The revisions have prompted immediate and significant concern from public health experts, medical organizations, and former government officials. Critics argue that the Trump administration bypassed the standard process for updating vaccine schedules, which typically involves input from scientific experts, public health leaders, and stakeholder groups like ACIP. They noted that ACIP was not consulted and no new scientific evidence was presented to support the changes.
Statements from experts and organizations include:
- Paul Offit, an infectious diseases physician, stated the changes effectively make vaccines optional.
- Peter Hotez, dean for the National School of Tropical Medicine at Baylor College of Medicine, characterized the changes as a "systematic attempt" to diminish public confidence in childhood vaccines.
- Dorit Reiss, a vaccine law expert, highlighted that the decision was not transparent and could lead to confusion and decreased vaccine coverage.
- Dr. Jason M. Goldman, president of the American College of Physicians, stated, "Abandoning the U.S. evidence-based process is a dangerous and potentially deadly decision for Americans."
- The American Academy of Pediatrics (AAP) opposes the new schedule, calling the changes "dangerous and unnecessary," and has not altered its own childhood vaccination recommendations. Many pediatricians and family doctors have indicated their intent to continue following AAP guidance.
- Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, characterized the decision as "radical and dangerous," citing a lack of public discussion or transparent review of supporting data.
- Daniel Jernigan, former director of the National Center for Emerging Zoonotic Infectious Diseases, called the decision "astounding," stating it was made without scientific evidence or public input and projecting it will worsen vaccine access and increase disease outbreaks.
- The World Health Organization (WHO)'s director of immunization, Kate O’Brien, stated she was unaware of any other country significantly reducing its childhood vaccine schedule without serious safety concerns or a public process.
- The American Medical Association (AMA) criticized the change, stating that altering longstanding recommendations without an evidence-based process "undermines public trust and puts children at unnecessary risk."
Concerns have also been raised about the composition of the ACIP. Secretary Kennedy removed previous ACIP members and the CDC director before appointing new advisors, some of whom have expressed skepticism regarding vaccines. For example, Dr. Kimberly Biss has described herself as "anti-vaccine," and Dr. Adam Urato has stated that "the science is not 'long-settled' regarding vaccines."
International Comparisons and U.S. Healthcare Context
Officials stated that the adjustments are intended to align the U.S. closer to "peer, developed countries." The revised schedule bears similarities to Denmark's vaccination protocol, often cited as an outlier with a more limited schedule. Most other high-income countries currently maintain vaccine schedules similar to the previous U.S. recommendations, with 13 to 16 vaccines for all children, including universal childhood recommendations for influenza, rotavirus, and hepatitis B in many nations. Canada, for instance, recommends 16 vaccines.
Experts highlight that the U.S. healthcare system differs significantly from countries like Denmark, which offers universal healthcare, reliable prenatal care, consistent medical follow-up, and a national health registry. In contrast, the U.S. operates a decentralized health system across a large geography and diverse population, with approximately one-third of the population lacking access to primary care. Limited healthcare access and the absence of paid sick leave in the U.S. are associated with diseases potentially spreading further before individuals seek care, factors that may influence disease transmission differently than in nations with more comprehensive social safety nets.
Japan's historical experience with vaccine policy shifts, such as discontinuing mandatory influenza vaccination for schoolchildren, was associated with subsequent declines in vaccination rates, increased transmission, and a rise in deaths.
Historical Context and Public Health Implications
The U.S. vaccine schedule evolved over decades, influenced by disease outbreaks and scientific advancements. For example, the addition of hepatitis B vaccination at birth in 1991 contributed to a 99% decrease in infections among American children, while the rotavirus vaccine (introduced in 2006) significantly reduced child hospitalizations due to severe diarrhea and vomiting. Rubella was eliminated from the Americas by 2015 due to widespread vaccination.
Historical data indicates recent public health challenges in the U.S., including a significant measles outbreak, an increase in tetanus cases, and a rise in pertussis deaths over the past decade. Last year, nearly 300 children died from influenza.
Concerns have been raised that these changes could lead to an increase in vaccine-preventable diseases and hospitalizations. Arguments regarding a potential overload of children’s immune systems due to an increased number of recommended vaccines have been countered by observations that despite an increase in the number of recommended vaccines, the total number of immune-stimulating molecules (antigens) has decreased significantly since the 1980s due to advancements in vaccine technology.
A study published in the journal Annals of Internal Medicine indicated that nearly half of the public health databases regularly updated by the CDC have been paused without explanation since March and April 2025. Nearly 90% of these paused databases contained vaccination information, raising concerns about the availability of data needed to monitor public health.
Financial Coverage and Legal Challenges
Officials stated that vaccines no longer universally recommended would continue to be covered by federal health insurance programs, including Medicaid, the Children’s Health Insurance Program, and the Vaccines for Children program. Affordable Care Act plans will also cover these shots. Previously, officials also indicated that vaccines under shared clinical decision-making would qualify for the National Vaccine Injury Compensation Program (VICP), though legal uncertainty regarding this coverage has been noted.
The legality of the policy change is under scrutiny, with critics arguing that the administration bypassed the standard rule-making procedures mandated by the Administrative Procedures Act (APA). Seven prominent medical associations, including the American Academy of Pediatrics, the American College of Physicians, and the American Public Health Association, have filed a lawsuit in U.S. District Court in Massachusetts. The lawsuit describes the revised vaccine schedule as “egregious, reckless, and dangerous” and requests it be declared unlawful, seeking to restore the vaccine schedule to its status prior to the HHS changes and to prevent the current ACIP panel from convening. HHS spokesperson Andrew Nixon described the lawsuit as “baseless.”
The federal government does not mandate vaccines for children; these decisions are made at the state and local levels. There are concerns about potential political pressure on states to remove recommended vaccines from school mandates, which could lead to a varied landscape of vaccine regulations across states.
Ongoing Developments and Future Outlook
The American Academy of Pediatrics (AAP), representing a majority of the nation’s pediatricians, has released its own immunization guidelines, which now differ substantially from the federal government’s, advocating for routine vaccination against 18 diseases. States such as California, New York, and Illinois have indicated they will continue to follow established guidelines rather than the new federal recommendations.
The AMA will collaborate with the Vaccine Integrity Project to review the safety and effectiveness of respiratory vaccines, addressing a perceived gap in guidance left by federal health agencies. This initiative aims to provide evidence-based recommendations for influenza, Covid-19, and RSV vaccines.
The practical impact of changes to categories like "shared clinical decision-making" may create logistical challenges for healthcare providers, potentially reducing vaccine uptake, particularly for individuals without consistent access to primary care.