Changes to Childhood Vaccine Recommendations Threaten Public Health

The White House recently signed an executive order that reduces the vaccines recommended for all U.S. children from 18 immunizations against vaccine-preventable diseases to 11, reclassifies several vaccines for use in “high-risk groups” and others in “shared clinical decision-making” categories, and directs that combination vaccines such as MMR be administered as separate individual vaccinations given at separate visits.

Current vaccine schedules are based on rigorous safety and efficacy testing with each vaccine's timing set to protect children at the ages when they are most vulnerable to the diseases. ECRI is concerned that this latest directive was issued without a transparent, evidence-based review process and is not supported by new scientific evidence.

The current scientific consensus, backed by decades of epidemiologic research, continues to affirm that the existing pediatric immunization schedule is safe and effective, and that vaccination is not associated with autism. Altering a proven schedule without credible new evidence fuels confusion that could threaten patient safety and undermine public health.

There have been studies testing the current vaccine schedule. The most authoritative and frequently-cited 2013 study concluded that available evidence supports that the current vaccine schedule is safe, that any vaccine schedule that delays vaccines is less safe than the approved schedule, and that it would not be appropriate to conduct studies of alternate schedules that delayed vaccines, because doing so would place children at risk of acquiring vaccine-preventable disease for a longer period. More recent studies supporting the current schedule's safety have followed, including Maglione et al. 2014, Glanz et al. 2018, and Glanz et al. 2021. These studies complement findings of the Evidence to Recommendation framework that was traditionally used to review and evaluate the evidence for vaccines and develop the existing pediatric immunization schedule. However, since the June 2025 change of ACIP committee members, the committee has exhibited a lack of transparency in their decision-making process and has not disclosed methodology or framework details to justify the changes in the vaccine schedule.

Fewer Shots Spaced Out is not Evidence-Based

The Executive Order states: "To the maximum extent feasible, all childhood immunizations should be administered at separate medical visits.” However, there’s no safety evidence supporting spacing out the shots. Requiring more doctor visits is more than just an inconvenience to the family: it extends the window in which a child is susceptible to a vaccine-preventable disease; and it presents more opportunities for disruptions that could result in children with incomplete vaccinations. The risks include:

• Increases disease risk: Children under-vaccinated by multiple doses of DTaP were found to be up to 18 to 28 times more likely to develop pertussis than children vaccinated on schedule.
• Extends the vulnerability window: A population-based cohort study of over 316,000 children found under-vaccination was associated with 3.2 to 4.8 times higher pertussis risk across different booster stages, confirming that delay leaves children unprotected for longer.
• Lowers overall vaccine schedule completion rates: Children on delayed schedules are less likely to ever complete the full recommended series, leaving lasting immunity gaps.
• Increases febrile seizure risk: Rather than reducing side effects, delaying the first MMR dose past 15 months doubles the risk of a febrile seizure (from roughly 1 in 3,000 doses to 1 in 1,500 doses).

No Single-Shot Option to Replace Combination Shots

The Executive Order directs that MMR be given as three separate single-antigen shots, rather than a combined MMR shot. However, there's currently no such FDA-approved vaccine product available on the market in the U.S. The only licensed products are combination shots. To bring three standalone vaccine products to the market will not only reduce likelihood of completion of the three vaccinations but will also require new clinical trials, reconfigured manufacturing, and other processes that could take several years to complete.

Published Clinical Evidence

The following is a sampling of the many comprehensive reviews summarizing the state of the evidence on childhood immunization, which continue to point to the same conclusion – the current vaccine schedule is safe and effective, and vaccination is not associated with autism.

• Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-analysis
• The vaccine–autism connection: No link, still debate, and we are failing to learn the lessons - Sheffali Gulati, Indar Kumar Sharawat, Prateek Kumar Panda, Sanjeev V Kothare, 2025
• Vaccines for measles, mumps, rubella, and varicella in children - PubMed
• Literature Reviews on Autism and Vaccines from the Autism Science Foundation

Expert Insights 

“At ECRI, our responsibility is to follow the evidence,” said Marcus Schabacker, President and CEO of ECRI. “We are dedicated to advancing evidence-based medicine and upholding the highest standards of scientific integrity. We examine the facts, apply rigorous analysis, and communicate what we find. It sometimes means challenging strongly held beliefs, but we must remain steadfast in our commitment to objectivity and scientific rigor. The world needs institutions willing to stand behind the facts. That is what ECRI has done throughout its history, and that is what we will continue to do. We support the healthcare professionals, researchers, patients, and families who rely on accurate and trustworthy medical information to keep themselves safe and healthy.”

Consensus from Medical Experts

ECRI’s position is shared by a broad range of the nation’s leading medical societies, which have publicly opposed this executive order in the days since it was signed, including the American Academy of Pediatrics (AAP); American Medical Association (AMA); and the American College of Physicians (ACP). ECRI stands with these and other medical societies and healthcare associations nationwide in their shared concern that injecting doubt into settled science, absent credible new evidence, has serious implications for patients, families, and public health.
 
Learn more about ECRI’s Clinical Evidence Assessments.

Media Contact: 
Yvonne Rhodes, ECRI Director of Strategic Communications & Operations, YRhodes@ECRI.org