For decades, vaccines were categorized as routine or preventative. Under this system, most children were expected to receive a standard set of vaccines at specific ages unless contraindicated.
On Jan 5, the Centers for Disease Control and Prevention (CDC) and the Health and Human Services (HHS) replaced this framework, one of many changes in the new United States childhood immunization practices. Under the new guidelines, vaccines are categorized as “recommended for all children,” “recommended for certain high-risk groups/populations” and “based on shared clinical decision-making.” The last category involves an individualized discussion between the clinician and the patient about individual risk and preferences.
“The biggest practical difference is what the ‘default’ is,” said Dr. Katherine Dobbs, a staff physician in the Pediatric Infectious Diseases Unit at Cleveland Clinic. “Routine recommendations tell families what most children should get. Shared clinical decision-making shifts the default to ‘it depends,’ which changes messaging and can change uptake.”
While shared clinical decision-making has always existed, it was not the dominant organizing principle for vaccine recommendations.
The updated schedule retains universal recommendations for protection against diseases, including but not limited to measles, mumps, pneumococcal disease, varicella and human papillomavirus (HPV). On the other hand, several vaccines that were previously routine, such as those for influenza, COVID-19, rotavirus, hepatitis A and B, meningococcal disease and respiratory syncytial virus, have been moved into high-risk or shared decision-making categories, with officials citing currently low incident rates as part of the rationale. However, Dobbs also noted that these diseases are now uncommon because routine vaccination has been effective. These seven vaccines had been recommended routinely in earlier schedules because they prevent severe illness, hospitalization and outbreaks, even when individual risk is unpredictable.
“[This change] will likely lead to confusion and lower uptake, as families may assume that since a recommendation is no longer routine it is less important,” Dobbs said.
According to the CDC, these revisions were partly intended to align U.S. vaccine policy with those of other high-income countries. However, Dobbs believes that vaccine policies are not automatically transferable, as a country’s vaccine policy must take into account disease epidemiology, healthcare access and infrastructure.
“The change [in the vaccine schedule] was not based on any new scientific evidence and was made without the usual careful scientific review and public meeting to allow for feedback from medical specialists and the community,” Dobbs stated.
The revision also includes a change to the HPV vaccine, reducing the recommended dose from two to one. While emerging research from the World Health Organization (WHO) suggests a single dose may provide substantial protection, organizations such as the American Academy of Pediatrics (AAP) continue to recommend a two-dose schedule pending further evidence.
The CDC and HHS stated that vaccines will remain covered without out-of-pocket costs through the Affordable Care Act plans and Vaccines for Children Program, and insurance companies have signaled continued coverage through at least 2026.
However, on March 16, a federal judge in Massachusetts temporarily paused these federal vaccination changes following a lawsuit filed by the AAP. Amid these ongoing developments, Dobbs emphasized that pediatricians continue to remain a trusted source for families navigating vaccine decisions by using the most reliable evidence and medical reasoning available.