HHS Announces Major Updates to Childhood Immunization Schedule
Mandy Cohen, Julian Polaris, and Katie Rubinger, Manatt Health
On January 5, the Centers for Disease Control and Prevention (CDC) Acting Director Jim O’Neill released a decision memorandum overhauling the CDC’s Childhood and Adolescent Immunization Schedule. Notably, and as with several other preceding actions, this memorandum was issued by the United States Department of Health and Human Services (HHS) unilaterally, without public comment, and without initial review of the evidence by designated advisory bodies.
The decision follows a December 5 Presidential Memorandum directing the CDC—and HHS writ large—to review the U.S. childhood vaccine schedule and consider aligning U.S. vaccine recommendations with those in countries such as Denmark. Specifically, the directive:
- Decreases from 17 to 11 the number of diseases for which the CDC recommends vaccination as a default—so-called recommendations for “routine use.”
- Modifies the other six recommendations by narrowing them to patients deemed “high-risk” or designating them as recommendations for “shared clinical decision-making”—as the CDC already did last year for COVID-19 and certain other vaccines.
These changes, further described here, were made to allow “for more flexibility and choice, with less coercion,” as stated by the HHS fact sheet. In its accompanying announcement, HHS underscores that all vaccines recommended as of December 31, 2025, will continue to be covered by Affordable Care Act plans and federal health insurance programs, including Medicaid, the Children’s Health Insurance Program (CHIP), and the Vaccines for Children (VFC) program.
However, continuing a trend from last year’s vaccine policy shifts, these new recommendations will likely create operational challenges for states and clinicians, increase vaccine access challenges for families, and further sow confusion and erode public trust in the safety and efficacy of vaccines.
Background on the Administration’s Actions Preceding the January 5 Updates
Since his swearing in, HHS Secretary Robert F. Kennedy has: terminated all 17 sitting members of the CDC’s Advisory Committee on Immunization Practices (ACIP) and appointed several notable anti-vaccine activists; modified the CDC website to imply that vaccines may cause autism, even though numerous scientific studies have consistently found no such connection; spurred the termination or resignation of several high-level CDC and Food and Drug Administration (FDA) officials, including the CDC Director Susan Monarez less than a month after her confirmation; unilaterally announced, without input from ACIP, that the COVID-19 vaccine was no longer recommended for healthy children and pregnant individuals; and approved several controversial updates to FDA labels for vaccines.
President Trump’s December memo to HHS and the CDC was issued in conjunction with the December ACIP meeting, during which ACIP voted to rescind the universal recommendation for the hepatitis B vaccine birth dose for infants born to mothers who test negative for the virus. The memo called for an assessment of “best practices from peer, developed countries,” specifically noting the disparities between American recommendations and those in Denmark, Japan, and Germany.
The 25-page assessment released by HHS on January 2 calls the U.S. “a global outlier among peer nations in the number of target diseases included in its childhood vaccination schedule and in the total number of recommended vaccine doses.” Throughout the report, the authors—Tracy Beth Høeg, the Acting Director of FDA’s Center for Drug Evaluation and Research, and Martin Kulldorff, the Chief Science and Data Officer for the HHS Assistant Secretary for Planning and Evaluation—reference data from Denmark, which vaccinates against only 10 diseases with a total of 30 doses and is at the “lower end” of vaccines recommended for all children in peer nations. The report urges CDC to adopt a revised childhood immunization schedule that:
- Limits “routine use” recommendations to “vaccines for which there is consensus among peer nations.”
- For “non-consensus vaccines,” limits the recommendation to high-risk groups and/or downgrades the recommendation to “shared clinical decision-making” to “[allow] for more flexibility and choice, with less coercion.”
- Ensures that all diseases covered by the prior immunization schedule would “still be available to anyone who wants through their private health insurance, Medicaid, [CHIP], and/or the [VFC] program.”
- Is accompanied by “strengthening of vaccine research, including those to evaluate long-term effects of individual vaccines and the vaccine schedule.”
The CDC’s Changes to the Childhood Immunization Schedule
The January 5 CDC memo adopts these recommendations by reorganizing the childhood immunization schedule as follows:
- Immunizations Recommended for All Children (i.e., routine use). This category previously included vaccines against 17 diseases but is now reduced to vaccines against the following 11 diseases: measles, mumps, rubella, polio, pertussis, diphtheria, tetanus, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV), and varicella (chickenpox). While noting that “the safety/risk profile is not fully understood, and in need of further study,” these are immunizations that the CDC deems “important for all children to receive” and “for which there is nearly unanimous peer nation agreement.”[1] As to HPV, the CDC now recommends only a single dose, down from the previously recommended two doses.
- Immunizations Recommend for Certain High-Risk Groups or Populations. For six additional vaccines—respiratory syncytial virus (RSV), hepatitis A, hepatitis B, dengue, meningococcal ACWY and meningococcal B—the CDC recommends routine vaccination only for children at higher risk, such as those with underlying comorbidities, those who may have “unusual exposure to the disease” (e.g., due to international travel to an endemic area), or those with risk of disease transmission to others. As an example, consistent with ACIP’s December vote, the hepatitis B vaccine is recommended only for infants whose mother tests positive or whose status is unknown.
- Immunizations Based on Shared Clinical Decision-Making. In addition to COVID-19, this category now includes the annual influenza vaccine, as well as the following vaccines for children who are not at high risk: meningococcal disease, hepatitis A, and hepatitis B. For these vaccines, the CDC advises parents and physicians to consider factors like likelihood of exposure to the disease, risks of morbidity or mortality if the disease is contracted, likelihood of benefitting from the vaccine, likelihood of vaccine adverse reactions, as well as “family preferences, beliefs, and knowledge, including when a patient presents specific information regarding the pre-and-post licensure safety data of a vaccine.”
Looking Ahead
These recommendations represent a significant shift in vaccine policy—one taken unilaterally and without public comment or review of the evidence by designated advisory. These updates do not have immediate implications for health coverage of vaccines, but the CDC’s recommendations have significant ripple effects in state policy, professional practice, and the public consciousness, as described below.
No impact on federal requirements for vaccine coverage. With respect to health coverage, the CDC emphasizes that all vaccines in all three categories will continue to be available “for anyone who wants them and will be covered” by Medicaid, CHIP, the VFC program, and private health insurance. These public programs and private insurers must cover all CDC-recommended vaccines, including recommendations for high-risk groups and shared clinical decision-making.
Operational issues for providers and access barriers for families. The CDC’s recommendations play a role in federal and state policies on liability protections for vaccinations and have historically been incorporated into many states’ laws defining which vaccines can be administered by pharmacists, nurses, and medical assistants. Depending on the state and the policy, there may be different implications for a CDC recommendation for shared clinical decision-making versus routine use.
In the wake of the CDC’s narrowed recommendations for COVID-19 and varicella last fall, many states began reexamining those policies to identify risks and preserve vaccine access. To avoid any disruption in access, states can update scope-of-practice laws and standing orders to preserve flexibility for vaccine administration and delivery capacity. For additional discussion of these and other state vaccine policies, see the state vaccine toolkit that Manatt prepared with support from the State Health & Value Strategies program.
Confusion and vaccine skepticism. As detailed in a recent New England Journal of Medicine article, the CDC’s recommendation to vaccinate based on shared clinical decision-making “does not meaningfully change the clinical interaction [between patient and provider] but rather serves to mislead and introduce more paperwork and perceived clinician liability into an already complex system.” By introducing the concept that these vaccines are “optional,” it implies that they are less safe or important than vaccines recommended for routine use. This may, in turn, heighten vaccine skepticism among the public and generate provider confusion about which vaccines to recommend or how to communicate about them.[2]
Vaccine supply issues. Manufacturers produce supplies of vaccines based on the existing immunization schedule. This currently includes several combination vaccines that rely on the full recommended schedule. As such, the vaccine supply chain may be disrupted, potentially leading to shortages or higher prices for providers, which could further hinder vaccine access for children and families.
Disruption of school and childcare vaccine requirements. As with liability and pharmacist vaccination authority, many states have incorporated the CDC’s recommendations into their vaccination requirements for schools and daycares. State action may be needed to clarify or amend those requirements for vaccines recommended for shared clinical decision-making.
[1] Despite finding a lack of international consensus as to varicella, the CDC nonetheless preserved the recommendation for routine use based on the changing epidemiology of varicella in an environment of historical immunization.
[2] An October 2025 Kaiser Family Foundation (KFF) Tracking Poll found that, amid various Trump administration changes to vaccine policy and “increasingly mixed messaging on vaccine recommendations from a variety of authorities, groups and individuals,” public trust in the CDC is now at “its lowest level since the beginning of the COVID-19 pandemic.” Fewer than half of adults report trusting health agencies and officials for reliable vaccine information a “great deal” when asked specifically about the CDC, their state government officials, or Secretary Kennedy. Further, a September 2025 KFF-Washington Post Tracking Poll found that more than one-third of parents believe vaccines do not undergo sufficient safety testing before being recommended to children; and about one quarter say that the CDC recommends too many childhood vaccines. These attitudes coincide with declines in recent years in routine and seasonal vaccination rates among children.