US government overhauls the childhood vaccine schedule in unprecedented move

The U.S. federal government has rewritten its childhood vaccine schedule, reducing the number of shots universally recommended to kids 18 and under from around 17 to 11.

This policy change effectively downgrades the recommendations for several shots, such as those against rotavirus, the flu and hepatitis A. Rather than being recommended to all children by default, those vaccines will now be recommended to only certain "high-risk" groups or will be accessible through "shared clinical decision-making" between parents and providers.

The concept of shared clinical decision-making emphasizes that, if a child's caregivers wish to give them a routine vaccine, they should first consult with a medical provider. While that idea may sound benign, it could sow confusion around which vaccines are considered effective and medically necessary, Dr. Daniel Jernigan, former director of the Centers for Disease Control and Prevention's (CDC) National Center for Emerging and Zoonotic Infectious Diseases, told STAT. And it could introduce logistical hurdles to accessing vaccines.

"By making these vaccines a shared clinical decision making, it introduces one more barrier that prevents a child from getting a life-saving vaccine," Jernigan said.

The new recommendations

The new recommendations group vaccines and immunizations into three categories:

• Those recommended for all children
• Those recommended for certain high-risk groups
• Those that can be given based on "shared clinical decision-making"

Federal guidance still recommends that all children receive shots against 11 diseases: measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, varicella (chickenpox), and human papillomavirus (HPV). However, HHS is recommending only one dose of HPV vaccine instead of the usual two, STAT reported.

Certain "high-risk" populations are recommended to be immunized for RSV, hepatitis A, hepatitis B, dengue, and two types of meningococcal disease. (Note that immunizations against respiratory syncytial virus, or RSV, include a prenatal vaccine given to mothers and antibody drugs given to kids. There is no RSV vaccine available for children.)

Vaccines against meningococcal disease and hepatitis A and B are also listed under the "shared decision-making" category, as are shots against rotavirus, COVID-19 and the flu.

"Abandoning recommendations for vaccines that prevent influenza, hepatitis and rotavirus, and changing the recommendation for HPV without a public process to weigh the risks and benefits, will lead to more hospitalizations and preventable deaths among American children," Michael Osterholm of the University of Minnesota's Center for Infectious Disease Research and Policy, told The Associated Press.

'Dangerous and unnecessary' changes

Stakeholders had been bracing for this policy change for several weeks by the time it was announced Monday (Jan. 5).

In early December, President Donald Trump called on federal officials to compare the U.S. childhood vaccine schedule to that of "peer nations," implying that other countries have superior policies. In mid-December, Politico reported that Robert F. Kennedy Jr., the head of the Department of Health and Human Services (HHS), had intended to make the U.S. vaccine schedule more like that of Denmark — which recommends shots against only 11 diseases in its schedule.

Comparable countries often recommend vaccines and immunizations against about 12 to 15 pathogens, while Austria and the U.S. have historically sat on the high end at around 17.

Experts have emphasized that the United States' vaccine schedule has been rigorously tested and that the decision to change it was not made using new data on its safety or effectiveness. They also noted that the policies of Denmark — a small country of roughly 6 million people with universal health care and a fairly homogenous population — may not serve the U.S. population, given that it's much larger and contends with a splintered health care system and greater health inequities. (The U.S. population is roughly 340 million.)

"The truth is that while vaccine guidance is largely similar across developed countries, it may differ by country due to different disease threats, population demographics, health systems, costs, government structures, vaccine availability, and programs for vaccine delivery," the American Academy of Pediatrics (AAP) noted.

These location-specific factors weigh upon which vaccines health officials recommend to a given country's children. But despite the differences between America and Denmark, federal officials are now claiming that Denmark's approach is the superior one regardless of context.

Officials had already been shifting away from giving full-throated recommendations of routine vaccines. For example, HHS previously recommended "shared clinical-decision making" for giving COVID-19 vaccines to kids and providing hepatitis B vaccines to infants of mothers who test negative for the virus.

Various stakeholders are expected to break with the CDC's new recommendations. For instance, medical societies, city and state health departments, and regional health alliances have rejected the CDC's other vaccine policy changes, and the AAP has sued HHS for allegedly violating established rules around vaccine regulatory changes when the agency tweaked its COVID-19 vaccine guidance.

"Today's announcement by federal health officials to arbitrarily stop recommending numerous routine childhood immunizations is dangerous and unnecessary," AAP president Dr. Andrew Racine, said in a statement, according to the clinical news source Contemporary Pediatrics.

"The longstanding, evidence-based approach that has guided the U.S. immunization review and recommendation process remains the best way to keep children healthy," Racine said, "and protect against health complications and hospitalizations."