RFI: Categories Used in Federal Vaccine Recommendations and the of Role Shared Clinical Decision-Making

September 18, 2026 

Cynthia Goss 
Deputy Assistant Secretary for Planning and Evaluation, Health Policy 
U.S. Department of Health and Human Services 
200 Independence Avenue, S.W. 
Washington, DC 20201 

Re: Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making (Docket No. HHS-OS-2026-0332), 91 Fed. Reg. 54,724 (Aug. 24, 2026) 

Dear Ms. Goss: 

The U.S. Chamber of Commerce (“the Chamber”) appreciates the opportunity to respond to the Department of Health and Human Services' (“HHS”) Request for Information on the categories used in federal vaccine recommendations and the role of shared clinical decision-making. The Chamber is the world’s largest business federation, representing businesses of all sizes, sectors, and regions, including employers that provide health coverage to millions of American workers and their families. 

The Chamber shares the Administration's goal of ensuring Americans have access to safe, effective, and innovative vaccines with no out-of-pocket costs. Vaccines are among the most cost-effective public health tools available, and employer-sponsored health coverage depends on a stable, predictable, and evidence-based federal vaccine recommendation framework. Any changes to that framework carry significant consequences not only for public health, but also for employers, insurers, manufacturers, and the millions of working Americans who rely on employer-provided coverage. 

i. The Importance of Evidence-Based Review 

The Chamber strongly believes that any potential changes to federal vaccine recommendations—including changes to the categories used to classify those recommendations—must be firmly grounded in evidence-based science and conducted through longstanding, credible review processes such as the ACIP's Evidence to Recommendations (EtR) and GRADE frameworks. These processes exist precisely to ensure that recommendations reflect the best available scientific evidence, are transparent about the certainty of that evidence, and are developed with meaningful input from clinicians, researchers, manufacturers, and other stakeholders. The use of an evidence review framework for vaccine recommendation development provides a critical structure for translating a complex and evolving body of research into guidance for health care providers, patients, families, caregivers, health systems, payers, and other stakeholders. Providers serve as critical translators and facilitators of the informed decision-making process and rely on the independent synthesis of evidence to support patient care and decisions. Recommendation categories should be informed by the rigorous and objective review of the totality of available evidence. 

The Chamber is concerned that changes to vaccine recommendation categories made outside of these established processes reduce transparency and increase confusion among clinicians, patients, and employers about what vaccines are available, recommended, and covered. Such confusion undermines the predictability that employers and insurers depend on to design benefit packages, and that manufacturers depend on to make long-term investment decisions in vaccine research, development, and production. Consideration of any potential changes to the longstanding recommendation development infrastructure should be grounded in a balanced review of the full evidentiary record and clearly communicated to prevent erosion of public trust. Acknowledging the benefits of vaccines to help protect against infectious diseases and integrating key stakeholder perspectives ensures a smooth implementation process and sustained access and coverage for patients. 

Before considering modification of an existing recommendation category or creation of a new one, HHS should clearly identify specific evidence, implementation challenges, or communication gaps the proposed change would address. The Department should also explain why the identified issue cannot be addressed through provider education, clearer communication, decision-support tools, or implementation guidance within the current framework.  

Potential changes to recommendation categories should be considered extremely carefully, acknowledging that they may affect clinical workflows, provider confidence, vaccine purchasing and stocking, coverage and reimbursement, and patient access. Even if some potential changes to recommendation categories may seem straightforward, implementation may prove far more challenging. Ensuring that potential new recommendations are clear to health care providers and the public—while preserving access to vaccinations and the associated public and private health insurance coverage for informed and consenting individuals who choose to be vaccinated—would require considerable effort and engagement. 

ii. Preserving Coverage and Access 

Federal vaccine recommendations have direct downstream consequences for access and coverage requirements under the Affordable Care Act, the Vaccines for Children program, Medicaid, and employer-sponsored health plans. The Chamber urges HHS to carefully evaluate the potential unintended coverage implications of any proposed changes to recommendation categories. 

This coverage framework is statutorily anchored. Section 2713 of the Public Health Service Act requires no-cost coverage specifically for vaccines recommended by ACIP and adopted by the CDC Director, and the Vaccines for Children program ties covered vaccines to ACIP’s recommendations. Changes made outside of this established process create uncertainty as to whether the legal basis for existing coverage and funding obligations remain intact. 

In particular, the Chamber is concerned that the introduction of new or modified categories, or changes to the timing and sequencing of existing recommendations, could inadvertently disrupt vaccine access and coverage obligations, create ambiguity for health plans and employers, and result in increased out-of-pocket costs for families. Any new category framework must not only preserve timely and no-cost access to all currently recommended vaccines, but must also provide clear, consistent guidance to health plans, employers, and state regulators about coverage requirements. 

iii. Feasibility and Market Considerations 

The Chamber urges HHS to carefully assess the feasibility and market implications of potential changes to vaccine recommendations, particularly those that would require the development of new vaccine products or formulations. For example, there are currently no single-antigen MMR products approved in the United States. Developing such products would require significant new investment, clinical trials, regulatory review, manufacturing changes, and adjustments to distribution and supply chains—a process that could take up to 10 years to complete. Furthermore, there is no clear scientific basis for such a change, especially considering the decades of real-world data demonstrating that the current MMR combination vaccines are safe and effective. 

Changes of this magnitude should not be pursued without a clear scientific and market basis for doing so. The Chamber encourages HHS to engage closely with manufacturers, insurers, and employers to fully assess all considerations relevant to any proposed or potential changes, including economic and operational implications. 

iv. Impact of Changed Recommendations on the Workforce and Employers 

Employers have a direct stake in maintaining the stability and predictability of the federal vaccine recommendation framework. Vaccines reduce absenteeism, improve workforce productivity, and lower long-term health care costs—all of which benefit employers, employees, families, and the broader economy. 

Changes to vaccine recommendations that require more frequent or additional medical visits would impose real costs on working families and their employers. For employers, more frequently required visits would mean increased absenteeism as working parents take time away from work to accompany their children to additional appointments, reducing workforce productivity and adding to the broader economic burden already imposed by rising health care costs. Additionally, to the extent that vaccinations are missed because of more burdensome vaccination schedules, potential increases in childhood illnesses could result in further absenteeism, with even more impactful consequences as described above. The Chamber urges HHS to account for these workforce impacts when evaluating potential changes to the immunization schedule. 

v. Trust, Communication, and Stability 

The Chamber agrees with HHS that public trust in the federal vaccine recommendations and the evidence-based framework is essential to both public health objectives and the stability of the markets that depend on that framework. Trust is built through transparent, evidence-based processes and clear, consistent communication. It is undermined by changes that are not clearly supported by relevant scientific evidence, or that are made without adequate, thorough engagement with the clinicians, researchers, manufacturers, and other stakeholders who implement recommendations in practice. In addition, such changes could contribute to confusion among states and lead to inconsistent or conflicting state-level requirements and guidance, resulting in significant adverse impacts on manufacturers, employees, patients, and employers. 

The Chamber encourages HHS to engage trusted immunization experts under longstanding, credible review processes like the ACIP's EtR and GRADE approaches, and to work closely with physicians, researchers, employers, manufacturers, insurers, and other stakeholders to fully assess the scientific, economic, and operational implications of any proposed or potential changes. Transparent expert review and consistent explanations can help the public understand that changes to recommendations result from an established scientific process and are intended to support informed decision-making. Any changes to federal vaccine policy should preserve Americans' timely and no-cost access to vaccines, help strengthen public trust in immunizations, and provide the predictability necessary to support continued investment and innovation in the United States. 

vi. Conclusion 

The Chamber appreciates HHS's willingness to engage stakeholders on these important questions. We recommend that HHS retain a vaccine recommendation framework like EtR and GRADE that is scientifically rigorous, transparent, practical to implement, and designed to preserve access and coverage. Any proposed changes to existing categories should be supported by a clearly articulated need, defined evidentiary and operational criteria, and meaningful stakeholder engagement and should be tested with individuals, medical societies, and immunization experts. We encourage the Department to ensure that any potential changes to the federal vaccine recommendation framework are grounded in rigorous scientific review and thorough deliberation; preserve existing coverage and access; account for the feasibility and market implications of proposed changes; and provide the stability that employers, manufacturers, and health plans need to continue investing in the health of American workers and their families. 

The Chamber stands ready to work with HHS and the Task Force on Safer Childhood Vaccines to advance these shared goals. 

Sincerely, 
Lexi Branson
Vice President, Health Policy
U.S. Chamber of Commerce 

About the author

Lexi Branson

Lexi Branson serves as Vice President of Health Policy at the U.S. Chamber of Commerce, where she leads the Chamber’s Health Policy Division.

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