CIDRAP Op-Ed: HHS is asking what to call vaccine recommendations. You have 4 days to weigh in.

On a Monday in late August, two weeks after the executive order on childhood vaccines, the Department of Health and Human Services (HHS) published a request for information in the Federal Register. It runs five pages and asks 18 questions, most of them about the categories themselves: what to call the categories of federal vaccine recommendations, whether there should be more of them, and whether “shared clinical decision-making” should become “conditional recommendation.” 

It gave the public 27 days to respond, including Labor Day weekend, and it says in the text that HHS will not respond to anyone individually. Comments close this Sunday, September 20.

The notice exists because of the executive order. The order gave the Task Force on Safer Childhood Vaccines 90 days to hand President Donald Trump its plans for the childhood schedule, which puts the deadline in early November, and the notice was issued to gather public input for that work. Comments submitted by Sunday go into the public record that HHS says will inform those plans. 

The people with the most to say, the pediatricians and pharmacists and labor and delivery nurses who work inside these categories every day, are the ones least likely to know they can say it.

A question about words

Federal vaccine recommendations come in three kinds. “Routine” means the default is to vaccinate everyone in an age-group. “Risk-based” means the recommendation applies to people with a particular condition or exposure. “Shared clinical decision-making,” which HHS now also calls individual-based decision-making, means there is no default; the decision is made one person at a time, between a clinician and a patient or parent.

That third category is the one the notice is built around, and it helps to know what “no default” does in a clinic, because it does more than the phrase suggests.

A routine recommendation works while nobody is looking. It shows up in the chart on its own, because the clinical decision support logic used by the Centers for Disease Control and Prevention (CDC) encodes routine recommendations, and the forecasting software in electronic records acts on them. A nurse or a pharmacist can give the vaccine under a standing order. The visit begins from the assumption that the child is due, and the clinician can say so, which is the approach the communication research most consistently ties to vaccine acceptance.

Shared clinical decision-making takes the default away. Nothing about the category forbids reminders or standing orders, and the conversation does not need a physician; the CDC’s page lists nurses and pharmacists among the people who can have it. But the prompts and the orders were built for a schedule with defaults, and rebuilding them for a category that means “no default” is work that mostly has not been done. 

More than four in ten adults read ‘shared decision-making’ to mean it was up to them whether to talk to a clinician at all.

A national survey of family physicians and internists found that 90% to 95% said these recommendations take more time than routine ones, that fewer than half knew the vaccines were covered by insurance, and that many saw their electronic records display the recommendations wrong or not at all. Patients understand the phrase even less. In two Annenberg surveys last year, more than four in ten adults read “shared decision-making” to mean it was up to them whether to talk to a clinician at all.

The results are what you would expect. In the 2025 National Immunization Survey-Teen, out this month, 90.8% of 17-year-olds had received the routinely recommended meningococcal ACWY vaccine. For meningococcal B, which has sat in the permissive category since 2015 and under shared clinical decision-making since 2019, the figure was 36.3%, and just 12.5% had received at least two doses. The two vaccines cover different strains, so it is not a controlled experiment. It is a decade of results, against a disease that kills roughly one in 10 of the people it infects and can leave survivors with permanent disabilities, including limb loss.

In a busy clinic, no default is a default.

What the notice leaves out

The Federal Register notice lays out the survey evidence above and presents it fairly. The trouble is in the gaps, and there are four of them.

It cites the CDC’s reconstituted vaccine advisory committee’s September and December 2025 votes, on COVID-19 vaccination and the hepatitis B birth dose, as examples of the individual-based decision-making category. It does not mention that a federal district court stayed those votes in March, along with the January memo that moved five vaccines off the routine schedule and the appointments of the members who cast them. 

The ruling was preliminary and the case goes on. A reader of the notice would not know there was a case.

None of the 18 questions asks whether the vaccines moved in January belong where they were put. The notice asks what the boxes should be called, how many there should be, and what should go into deciding which box a vaccine belongs in. Where the vaccines sit today is treated as settled.

The notice mentions disease severity and epidemiology once, in a list of considerations in question 14, and then analyzes none of it. It mentions measles once, to observe that the first dose can be given anywhere from 12 to 15 months. As of September 11 the United States had counted 3,294 confirmed measles cases this year, the most since 1991, 95% of them in people who were unvaccinated or whose status nobody knew. Kindergarten exemptions hit 4.2% in the school year that just started, the highest ever recorded.

None of the 18 questions asks whether the vaccines moved in January belong where they were put.

And the notice describes shared clinical decision-making as a category with no default, cites evidence that uptake has been lower for vaccines recommended that way, and then asks whether to build more categories like it.

HHS has been here before. The category was called “Category B” until 2019, when the advisory committee renamed it because a survey found that only 24% of pediatric providers could define it. The 2021 survey above was conducted after the rename. The confusion survived it. 

The notice now asks whether to rename the category again. The first rename did not end the confusion, and the notice offers no evidence that another one would.

The category with no vaccine in it

Among the new categories the notice floats is “recommended, but not during infancy.” It does not say which vaccine would go there.

There is one recommendation on the schedule that exists specifically for the first days of life, and it is the hepatitis B birth dose, the same dose the reconstituted committee voted in December to move out of the routine category for infants of mothers who test negative. The birth dose is a safety net, and the failures it catches are not hypothetical. 

On December 14, 1999, an infant was admitted to a Michigan hospital with jaundice and acute liver failure from hepatitis B. She died three days later. Her mother had tested positive at her first prenatal visit and attended ten appointments. The record that reached the delivery hospital said she tested negative for hepatitis B. The Immunization Action Coalition documented more than 500 transmissions like it from 1999 to 2002: results not reported, results lost, results transcribed wrong.

The country had already learned this lesson once. It tried risk-based screening of pregnant women in the 1980s and gave it up after studies found the approach missed 35% to 65% of infected women. An infant infected at birth has about a 90% chance of chronic infection, and roughly a quarter of those infected in infancy or early childhood die prematurely of cirrhosis or liver cancer. Infants of mothers whose status is unknown at delivery still get the dose within 12 hours, under the December change as before. 

The country had already learned this lesson once.

The change is for infants whose mothers’ results say negative. The Michigan infant’s mother’s result said negative. At 2:00 a.m. on a labor floor, nobody can tell which negative result is wrong, and that is why the dose was the default. If that dose is the target of the new category, HHS should say so, and people who work in labor and delivery should ask it to.

For rotavirus the category cannot exist. The first dose must be given by 14 weeks and six days of age and the last by eight months, so a recommendation to wait past infancy is a recommendation not to vaccinate, against a disease that put 55,000 to 70,000 American children in the hospital every year before the vaccine existed. Where delay has been studied carefully, it has had a cost. A first measles-containing dose given at 16 to 23 months carries roughly twice the risk of a fever-related seizure as the same dose at 12 to 15 months.

How to answer

Go to regulations.gov and search for docket HHS-OS-2026-0332, or comment directly here. Comments are due by the end of the day on Sunday, September 20. Include the docket number. Everything you write, including your name, will be posted publicly, so leave out anything you would not want there.

You do not have to answer all 18 questions; the notice says so. Pick the two or three you can answer from your own work and write a few paragraphs.

• If you run a pediatric practice, questions 1, 7, and 11 are yours: whether the categories are clear to you and your patients, what changing the timing or the number of visits would do in your office, and what shared clinical decision-making costs you in time and your patients in doses. 
• If you work in labor and delivery, question 4 belongs to you more than to anyone at HHS. 
• If you are a pharmacist, the notice names you in its list of who it wants to hear from, and questions 11 through 13 ask about the time, the coverage confusion, and the tools you deal with. 
• If you run a health department, questions 6, 16, and 18 ask what a category change does to coverage and state law, what the evidence says about mandates and trust, and how anyone would know whether the framework is working. 
• If you are a parent, question 3 asks whether the categories make consent and real discussion seem unique to shared decision-making, and question 10 asks what value you see in autonomy, informed consent, and a clinician’s individual judgment.

Say what you think, plainly. Cite one thing if you have one. Describe one patient if you have one. A comment that reads “I gave the birth dose to an infant whose mother’s result was lost between the clinic and the hospital, and here is what would have happened without it” is worth more on the record than anything I can write.

HHS has asked what the categories should be called. Whatever it decides will be written into the schedule your patients live under, and the schedule your children live under. The question is about words. The answer is not.

Dr. Scott is a clinical associate professor of infectious diseases at Stanford University School of Medicine, and a coauthor of “Updated evidence for COVID-19, RSV, and Influenza Vaccines for 2025-2026” in the New England Journal of Medicine.

The opinions voiced in CIDRAP Op-Ed pieces are the authors’ own and do not necessarily represent the official position of CIDRAP.