The Claim:
HHS is asking if the current vaccine recommendation system should change. It is considering new types of recommendations, changes to when some vaccines are given, and more decisions made by families and health care providers together. HHS also wants to consider personal choice, religious freedom, public trust, and how strong the scientific evidence is when deciding how vaccines should be recommended.
The Facts:
- HHS is considering major changes to how vaccines are recommended, including timing, recommendation categories, and more individual decision-making.
- The strongest path forward is to keep vaccine recommendations based mainly on disease risk, safety, effectiveness, and the full body of scientific evidence.
- Questions about trust, consent, religious freedom, and mandates matter, but they should be handled separately from the scientific question of whether a vaccine is medically recommended
For many years, federal vaccine recommendations have followed a standard process. Experts look at how common and serious a disease is, how well a vaccine works, what side effects are known, and who is most likely to benefit. The Advisory Committee on Immunization Practices, or ACIP, reviews this evidence and recommends who should get each vaccine and when. These recommendations are then added to the federal vaccine schedules.
Most vaccine recommendations fit into one of three groups:
- Routine recommendation: The vaccine is recommended for almost everyone in a certain age group, unless there is a medical reason not to get it.
- Risk-based recommendation: The vaccine is recommended for people who have a certain health condition, job, travel plan, or other risk.
- Shared clinical decision-making: There is not one answer that fits everyone. The patient or parent and health care provider talk about the person’s situation and decide together.
A vaccine recommendation is not the same as a vaccine requirement. Federal health agencies recommend vaccines. Requirements, such as vaccines needed to attend school, are usually set by states. Patients and parents still make decisions about vaccination and give consent, no matter which type of recommendation applies.
The U.S. Department of Health and Human Services, or HHS, is now asking whether this system should change. HHS is considering new types of recommendations, changes to when vaccines are given, and more use of individual decision-making. It is also asking whether issues such as personal choice, religious freedom, public trust, and different kinds of scientific evidence should play a larger role.
Some changes could make the system better. For example, recommendations could be easier to understand, and health officials could be clearer when there is uncertainty. But other changes could weaken vaccine recommendations that are supported by strong evidence if concerns that are not based on medical science are used to decide what doctors should recommend.
One proposed new category is “recommended, but not during infancy.” Many vaccines are given during infancy for an important reason: babies can become very sick from these infections. A vaccine should be delayed only when evidence about that vaccine and disease shows that waiting is safer or more helpful. Infancy by itself should not be a reason to delay a vaccine.
HHS has also raised concerns that not every vaccine has been studied using a randomized controlled trial, or RCT. In an RCT, people are randomly placed into different groups so researchers can compare what happens. This administration often calls RCTs the “gold standard” of research. RCTs are very useful, especially when a vaccine is first being studied. But they are not the best or most ethical study design for every question.
For example, once researchers know that a vaccine protects people from a serious disease, it may be unethical to purposely leave some people unprotected just to create a comparison group. Scientists can still study vaccines using large health databases, studies that follow people in the real world, disease tracking, vaccine safety monitoring, and other strong forms of evidence. RCTs should continue to be used when they are appropriate.
People can send comments to HHS until September 20, 2026. Comments should mention Docket No. HHS–OS–2026–0332. They can be submitted online following the instructions for public comments.
Comments can also be mailed to:
Cynthia Goss
200 Independence Ave. SW
Washington, DC 20201
HHS says comments submitted through the public docket will be posted online. This may include personal information included in the comment. People should avoid sharing anything they do not want made public.