Infectious Disease Regulatory Watch: January Highlights

This is our new monthly column looking at federal regulatory topics including recent decisions, personnel changes, and news related to the agencies and infectious disease.

Last month, the Department of Health and Human Services (HHS) Deputy Secretary of HHS Jim O’Neill, who was serving as acting director of the Centers for Disease Control and Prevention (CDC) up until recently, signed a decision memorandum formally adopting the recommendations of childhood vaccines for 11 diseases, downsizing immunization protection from the previous list of 18 diseases.¹

“After reviewing the evidence, I signed a decision memorandum accepting the assessment’s recommendations,” O’Neill said in a statement.¹

Under the updated framework, the CDC said it will continue organizing vaccines into 3 categories, which must all be covered by insurance without cost sharing. The categories include:

Vaccines recommended for all children. Vaccines in this category will include those protecting against measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type b, pneumococcal disease, human papillomavirus, and varicella.²

Vaccines for specific high-risk groups. The immunizations recommended for this group are the RSV, hepatitis A, hepatitis B, dengue, meningococcal ACWY, and meningococcal B vaccines.²

Vaccines offered through shared clinical decision-making. The immunizations in this category are for rotavirus, COVID-19, influenza, meningococcal disease, hepatitis A, and hepatitis B.²

Whereas this last category was part of recommended federal guidance, this new shared clinical decision-making category suggests these vaccines may not be required or needed for everyone.

HHS and the CDC will work with state health agencies, physician organizations, and other partners to implement the updated schedule and educate clinicians and families nationwide.

AAP’s Response

In response to this action, the American Academy of Pediatrics (AAP) published its own recommended 2026 childhood and adolescent immunization schedule.

The 2026 AAP recommendations remain largely unchanged from prior AAP guidance released in August 2025, but they differ from a schedule recently issued by the CDC. The AAP formerly partnered with the CDC to create a unified set of vaccine recommendations, but recent changes to the CDC immunization schedule depart from longstanding medical evidence and no longer offer the optimal way to prevent illnesses in children. By contrast, the AAP childhood and adolescent immunization schedules continue to recommend immunizations based on the specific disease risks and health care delivery in the United States.³

“AAP recommends immunizations that have been designed to teach the immune system to recognize and resist serious diseases,” Sean O’Leary, MD, MPH, FAAP, chair of the AAP Committee on Infectious Diseases, said in a statement. “They are carefully tested and monitored over time. The pacing and combination of vaccines are based on what we know about when your child’s immune system is ready to learn and respond best.” ³

At the time of this posting, it was still up in the air if the CDC’s Advisory Committee on Immunization Practices (ACIP) was going to conduct its first meeting for 2026, which was schedule for February 25-27. Regardless of when the next meeting does occur, more changes around American public health policy and immunizations are to be expected.

References

1. CDC acts on presidential memorandum to update childhood immunization schedule. News release. US Department of Health and Human Services. January 5, 2026. Accessed February 19, 2026.
https://www.hhs.gov/press-room/cdc-acts-presidential-memorandum-update-childhood-immunization-schedule.html

2.Fact sheet: CDC childhood immunization recommendations. US Department of Health and Human Services. Updated January 5, 2026. Accessed February 19, 2026.
https://www.hhs.gov/press-room/fact-sheet-cdc-childhood-immunization-recommendations.html

3.American Academy of Pediatrics Issues Recommended Childhood and Adolescent Immunization Schedule for 2026. AAP press release. January 26, 2026. Accessed February 19, 2026.
https://www.aap.org/en/news-room/news-releases/aap/2025/american-academy-of-pediatric-issues-recommended-childhood-and-adolescent-immunization-schedule-for-2026/