FAQ: What the RFI on Vaccine Categories Means for Pharmacists

On August 21, the US Department of Health and Human Services (HHS) explicitly released a request for information (RFI) regarding the 3 categories being used in the federal government’s vaccination schedule: routine or universal vaccines, risk-based, and the shared clinical decision-making model.

“Through the RFI, HHS seeks input on whether the 3 categories currently used in federal vaccine recommendations are adequate, clear, and well understood,” wrote the agency in a release.¹ “HHS also seeks input on whether it should adopt additional or different categories.”

In the latest rendition of frequently asked questions with Drug Topics, we welcomed on clinical pharmacist and educator Gretchen Garofoli, PharmD, BCACP, CTTS, FAPhA, to discuss what this RFI might uncover for the future of childhood schedules. Furthermore, Garofoli helps us understand why the request was announced in the first place and how these vaccine policy actions are causing disruptions in the pharmacy industry.

READ MORE: Worth a Shot: How ACIP Changes Are Reshaping US Vaccine Policy

What is the reasoning behind HHS releasing an RFI on vaccination categories in the first place?

There doesn’t seem to have been a published rationale for the release other than to gather input from the public and stakeholders. Putting out the request for information when there is currently an injunction that is pausing the revisions to the federal vaccine policies that occurred between May 2025 and March 2026 shows that the administration is still making changes to vaccine policies a priority. This request for information came out not long after our president signed the executive order for the “Gold Standard Childhood Vaccine Recommendations.”

What are the 3 vaccination categories and what factors make a vaccine part of a particular category?

There are 3 categories, which mostly apply to the pediatric vaccination schedule. [They] include routine vaccinations for all patients in that age category; risk-based, where vaccines are recommended to patients who have certain risk factors; and shared clinical decision-making.

There have been no studies published that support moving vaccines to these categories, but when they were first released, the vaccine policies of other countries were cited.

What are the pros and cons of the shared clinical decision-making category?

Prior to this announcement, there were already vaccines that fell into the shared clinical decision-making category. This method should be utilized when vaccines are likely to benefit an individual patient yet not have a profound or substantiated population-level impact.

Discussions should be had with patients to best understand any risk factors they may have for certain diseases along with discussing risk versus benefit with them prior to making a decision together on whether or not the patient receives the vaccine. The risk of shifting vaccines to this category without the data to support such a move is that additional patients who would benefit from vaccination would then be at risk for contracting a vaccine-preventable illness.

How do new or shifting vaccination categories impact the daily administration of immunizations at community pharmacies?

Due to the current federal injunction, vaccine practices in community pharmacies should, for the most part, remain the same as they were in 2025. However, when patients and members of the health care team hear announcements of these proposed changes, it adds confusion and perpetuates a potential increased vaccine hesitancy in some of our patients.

What can the pharmacy industry expect following HHS’ retrieval of the information they’ve sought out?

The public comment period is open until September 20, 2026. Once that timeframe passes, one can foresee a report of the results along with a corresponding plan from the administration.

READ MORE: How Pharmacies Are Powering Vaccinations Ahead of Cold and Flu Season

REFERENCE

HHS seeks public input on federal vaccine recommendation categories and shared clinical decision-making. US Department of Health and Human Services. News Release. August 21, 2026. Accessed August 31, 2026. https://www.hhs.gov/press-room/hhs-seeks-public-input-federal-vaccine-recommendations.html