Notice2026-17250
Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making
Primary source
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Published
August 24, 2026
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS or the Department), in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order of August 10, 2026, "Delivering Gold Standard Childhood Vaccine Recommendations for Americans," seeks public comment on whether the categories currently used in Federal vaccine recommendations are adequate. Those categories are routine (universal) recommendations, risk-based recommendations, and recommendations based on shared clinical decision-making, also referred to as individual-based decision-making. The Department seeks comment on these categories and whether additional or different categories should be adopted. The Department further seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor of individual autonomy and religious freedom, the downstream legal and programmatic consequences of category assignment, and the communication practices necessary to earn and maintain public trust.
Full Text
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[Federal Register Volume 91, Number 162 (Monday, August 24, 2026)]
[Notices]
[Pages 54724-54728]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17250]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Docket No. HHS-OS-2026-0332]
RIN: 0991-ZA62
Request for Information: Categories Used in Federal Vaccine
Recommendations and the Role of Shared Clinical Decision-Making
AGENCY: Office of the Secretary, Department of Health and Human
Services (HHS).
ACTION: Notice; request for information.
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SUMMARY: The Department of Health and Human Services (HHS or the
Department), in support of the Task Force on Safer Childhood Vaccines
and in furtherance of the Executive Order of August 10, 2026,
``Delivering Gold Standard Childhood Vaccine Recommendations for
Americans,'' seeks public comment on whether the categories currently
used in Federal vaccine recommendations are adequate. Those categories
are routine (universal) recommendations, risk-based recommendations,
and recommendations based on shared clinical decision-making, also
referred to as individual-based decision-making. The Department seeks
comment on these categories and whether additional or different
categories should be adopted. The Department further seeks comment on
the considerations that should be relied upon in setting vaccine
recommendations, including the availability and strength of available
scientific evidence, the appropriate approach when randomized
controlled trial evidence is limited or absent, a presumption in favor
of individual autonomy and religious freedom, the downstream legal and
programmatic consequences of category assignment, and the communication
practices necessary to earn and maintain public trust.
DATES: To be assured consideration, comments must be received at the
address provided below no later than September 20, 2026.
ADDRESSES: Interested persons are invited to submit written comments
identified by Docket No. HHS-OS-2026-0332 by either of the following
methods: (1) Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments; or (2) Mail: Cynthia
Goss, 200 Independence Ave SW, Washington, DC 20201. All submissions
received must include the agency name and docket number. Comments
received will be posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
including any personal information provided.
FOR FURTHER INFORMATION CONTACT: Cynthia Goss, Deputy Assistant
Secretary for Planning and Evaluation (Health Policy), Performing the
Delegable Duties of the Assistant Secretary for Planning and
Evaluation, Office of the Secretary, Department of Health and Human
Services, (202) 690-7858 or by email at: <a href="/cdn-cgi/l/email-protection#147b67756764717d7a727b547c7c673a737b62"><span class="__cf_email__" data-cfemail="8fe0fceefcffeae6e1e9e0cfe7e7fca1e8e0f9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Federal Vaccine Recommendation Framework and its Categories
Federal vaccine recommendations are developed principally through
the Centers for Disease Control and Prevention (CDC) and its Advisory
Committee on Immunization Practices (ACIP), and are reflected in the
child and adolescent and adult immunization schedules. Current
recommendations fall into three principal categories. Under a routine
(universal) recommendation, the default is to vaccinate all persons in
an age group absent contraindications. A risk-based recommendation is
directed to persons with specified medical, occupational, behavioral,
or other risk factors. A recommendation based on shared clinical
decision-making (SCDM) is individually based and informed by a decision
process between the health care provider and the patient or parent/
guardian. CDC guidance explains that
[[Page 54725]]
for routine, catch-up, and risk-based recommendations ``the default
decision should be to vaccinate,'' whereas for SCDM recommendations
``there is no default''; the decision turns on the individual's
characteristics, the best available scientific evidence, the clinical
discretion of the provider, and the values and preferences of the
patient or parent.\1\ Since 2025, the Department and ACIP have also
used the term individual-based decision-making for this category.\2\
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\1\ Ctrs. for Disease Control & Prevention, ACIP Shared Clinical
Decision-Making Recommendations (page updated Jan. 7, 2025), <a href="https://www.cdc.gov/acip/vaccine-recommendations/shared-clinical-decision-making.html">https://www.cdc.gov/acip/vaccine-recommendations/shared-clinical-decision-making.html</a>.
\2\ See, for example, Ctrs. for Disease Control & Prevention
Newsroom, CDC Immunization Schedule Adopts Individual-Based
Decision-Making for COVID-19 and Standalone Vaccination for
Chickenpox in Toddlers (Oct. 6, 2025),<a href="https://www.cdc.gov/media/releases/2025/cdc-immunization-schedule-adopts-individual-based-decision.html">https://www.cdc.gov/media/releases/2025/cdc-immunization-schedule-adopts-individual-based-decision.html</a>; Dep't of Health & Hum. Servs. Press Release, ACIP
Recommends Individual-Based Decision-Making for Hepatitis B Vaccine
for Infants Born to Women Who Test Negative for the Virus (Dec. 5,
2025), <a href="https://www.hhs.gov/press-room/acip-recommends-individual-based-decision-making-hepatitis-b-vaccine-birth-dose-infants-born-women-test-negative-virus.html">https://www.hhs.gov/press-room/acip-recommends-individual-based-decision-making-hepatitis-b-vaccine-birth-dose-infants-born-women-test-negative-virus.html</a>.
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ACIP adopted the SCDM terminology in 2019, replacing the earlier
``Category A''/``Category B'' (permissive) framework. It applies the
category through an Evidence to Recommendations (EtR) framework,
adopted in 2018, that contemplates three outcomes: a recommendation for
all persons in an age or risk group; a recommendation for individuals
based on shared clinical decision-making; or no recommendation.\3\ The
EtR framework directs consideration of the public health importance of
the problem; the magnitude and balance of benefits and harms, and the
certainty of the evidence as assessed under the Grading of
Recommendations, Assessment, Development, and Evaluation (GRADE)
approach; the values and preferences of the affected population;
acceptability to stakeholders; feasibility; and resource use.\4\
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\3\ G. Lee & W. Carr, Adv. Comm. on Immunization Practices
Evidence-Based Recommendations Work Grp., Updated Framework for
Development of Evidence-Based Recommendations by the Advisory
Committee on Immunization Practices, 67 MMWR Morb. Mortal. Wkly.
Rep. 1271 (2018), available at <a href="https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a4.htm">https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a4.htm</a>; E. Meites et al., Human Papillomavirus Vaccination
for Adults: Updated Recommendations of the Advisory Committee on
Immunization Practices, 68 MMWR 698 (2019) (first recommendation
issued under the SCDM label).
\4\ Adv. Comm. on Immunization Practices, Evidence to
Recommendations Framework; Ctrs. for Disease Control & Prevention,
Evidence-Based Recommendations for ACIP (page updated Jan. 7, 2025),
<a href="https://www.cdc.gov/acip/evidence-based-recommendations/index.html">https://www.cdc.gov/acip/evidence-based-recommendations/index.html</a>.
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B. The Executive Order of August 10, 2026, and the Task Force on Safer
Childhood Vaccines
On August 14, 2025, the Secretary reinstated the Task Force on
Safer Childhood Vaccines, a statutory body established by the National
Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-27) and charged
with securing safer childhood vaccines and improved adverse-event
surveillance and research.\5\
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\5\ Dep't of Health & Hum. Servs. Press Release, HHS Revives
Task Force on Safer Childhood Vaccines (Aug. 14, 2025), <a href="https://www.hhs.gov/press-room/hhs-reinstates-task-force-on-safer-childhood-vaccines.html">https://www.hhs.gov/press-room/hhs-reinstates-task-force-on-safer-childhood-vaccines.html</a>.
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On August 10, 2026, the President signed the Executive Order
``Delivering Gold Standard Childhood Vaccine Recommendations for
Americans.'' \6\ The Executive Order states that the policy of the
United States is that core childhood vaccine recommendations should be
aligned with scientific evidence and best practices of peer nations, as
well as that Federal programs should support parental choice consistent
with personal autonomy and informed consent. It directs the Secretary,
working through the Task Force on Safer Childhood Vaccines, to present
plans within 90 days addressing, among other subjects, the timing and
sequencing of the Federal immunization schedule and the continuous
evaluation of the risk-benefit profile of recommended vaccines. This
request for information is issued in furtherance of the Executive Order
and in support of the Task Force's work. Public input received in
response to this notice will help inform consideration by the
Department and the Task Force of whether the current category structure
adequately serves the goals of scientific rigor, informed choice, and
public trust.
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\6\ Executive Order No. 14,420, Delivering Gold Standard
Childhood Vaccine Recommendations for Americans, 91 FR 53,173 (Aug.
14, 2026), available at <a href="https://www.whitehouse.gov/presidential-actions/2026/08/delivering-gold-standard-childhood-vaccine-recommendations-for-americans">https://www.whitehouse.gov/presidential-actions/2026/08/delivering-gold-standard-childhood-vaccine-recommendations-for-americans</a>.
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C. Experience With Shared Clinical Decision-Making
The SCDM category was created to clarify the intent of the former
permissive ``Category B'' recommendations, which survey evidence
indicated were poorly understood. In a 2018 national survey of
pediatric primary care providers, only 24 percent could accurately
define a Category B recommendation; a majority did not know that such
vaccines are covered by private insurance or the Vaccines for Children
program; and providers were divided on whether the permissive category
should be retained, with 39 percent valuing the leeway it provided and
22 percent favoring its elimination.\7\
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\7\ A. Kempe et al., Knowledge and Attitudes Regarding Category
B ACIP Recommendations Among Primary Care Providers for Children, 18
Acad. Pediatr. 763 (2018).
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Experience with SCDM since 2019 has been mixed, and the Department
is aware of both criticisms and defenses of the category. In a national
survey of physicians published in 2021, approximately 90 to 95 percent
reported that implementing SCDM recommendations requires more time than
routine recommendations; fewer than half knew that SCDM vaccines are
covered by insurance; many reported that electronic health record and
immunization forecasting tools displayed SCDM recommendations
inaccurately or not at all; and most agreed that SCDM recommendations
create confusion for patients.\8\ Some evidence suggests uptake of
vaccines recommended under SCDM has been lower than uptake of routinely
recommended vaccines.\9\
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\8\ A. Kempe et al., Shared Clinical Decision-Making
Recommendations for Adult Immunization: What Do Physicians Think?,
36 J. Gen. Intern. Med. 2283 (2021), <a href="https://link.springer.com/article/10.1007/s11606-020-06456-z">https://link.springer.com/article/10.1007/s11606-020-06456-z</a>.
\9\ See, for example, J. Vietri et al., Pneumococcal Vaccine
Uptake Among Medicare Beneficiaries Aged <ls-thn-eq>=65 Years
Following the Shared Clinical Decision-Making Recommendation for 13-
Valent Pneumococcal Conjugate Vaccine in 2019, 41 Vaccine 5211
(2023).
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At the same time, surveyed physicians have expressed support for
the existence of an SCDM category for appropriate vaccines, and
commenters have defended SCDM as sound, patient-centered clinical
practice for vaccines whose benefit-risk balance varies meaningfully
with individual circumstances, whose population-level benefit is less
clear, or for which the evidence base is limited or evolving.\10\ On
this view, an intermediate category permits the Federal Government to
avoid a binary choice between a universal recommendation and no
recommendation at all. This allows for an additional opportunity
between patient and provider to discuss the state of the evidence and
gives weight to the values and preferences of patients and parents/
guardians, including considerations of personal autonomy, informed
consent, and religious conviction. These principles apply across all
vaccine recommendations, including routine ones. SCDM is
[[Page 54726]]
distinct in that the Federal recommendation provides no default--not
because patient or parent decision-making is confined to that category.
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\10\ A. Kempe et al., supra note 8 (majority support for
retaining SCDM for certain vaccines); M. Hogue et al., Shared
clinical decision making on vaccines: Nothing has really changed for
pharmacists, 60 J. Am. Pharm. Assoc. e91 (2020).
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The Department seeks information on how the category is understood
and applied in practice, whether its risks and benefits have been
adequately characterized, and how it could be improved.
D. Considerations in Setting Vaccine Recommendations: Evidence,
Freedom, and Trust
The durability of any vaccine recommendation framework depends on
the public's trust in the process that produces it. Trust is essential
both to public health objectives and to effective, informed individual
choice. Several bodies of evidence inform the Department's thinking.
Calibration of recommendations to the strength of the evidence. The
GRADE approach used by ACIP recognizes that the certainty of evidence
varies, from randomized controlled trials to observational and post-
licensure data, and the EtR framework calls for transparency about that
certainty.\11\ Commentators, including current and former Federal
officials, have cautioned that recommendations extending beyond the
strength of the underlying evidence can carry costs to institutional
credibility.
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\11\ ACIP, Evidence to Recommendations Framework, supra note 4.
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The Federal COVID-19 vaccination effort shows both the value of
calibrating recommendations to the underlying evidence and the cost of
departing from that calibration. Operation Warp Speed produced safe and
effective vaccines in record time, with first doses administered in
December 2020, less than a year after the virus was sequenced.
Executive Order 13962 directed that Americans have priority access to
those vaccines and framed vaccination as available to ``all Americans
who choose to be vaccinated,'' and the initial allocation framework
directed limited early supply to those at highest risk of severe
disease and exposure.\12\ Federal policy thereafter shifted toward
progressively broader, population-wide recommendations. That shift drew
criticism from within the scientific mainstream. In 2021, an
international group of scientists that included senior Food and Drug
Administration vaccine officials publicly argued that available
evidence did not support COVID-19 booster doses for the general
population, and warned that premature deployment could carry risks for
vaccine confidence.\13\ A 2023 commentary in the New England Journal of
Medicine described the broad, all-ages recommendation of the bivalent
COVID-19 booster on the basis of limited human data as ``a cautionary
tale.'' \14\ A 2025 New England Journal of Medicine article by Food and
Drug Administration leadership advanced a risk-stratified alternative
to universal COVID-19 vaccination recommendations, applying different
evidentiary expectations to high-risk and low-risk populations.\15\ The
Department notes that these positions are contested within the
scientific community. That contestation is itself relevant to the
questions posed below.
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\12\ Exec. Order No. 13,962, Ensuring Access to United States
Government COVID-19 Vaccines, 85 FR 79,777 (Dec. 11, 2020); K.
Dooling et al., The Advisory Committee on Immunization Practices'
Updated Interim Recommendation for Allocation of COVID-19 Vaccine--
United States, December 2020, 69 MMWR Morb. Mortal. Wkly. Rep. 1657
(2021).
\13\ P.R. Krause et al., Considerations in boosting COVID-19
vaccine immune responses, 398 The Lancet 1377 (2021).
\14\ P.A. Offit, Bivalent Covid-19 Vaccines--A Cautionary Tale,
388 New Eng. J. Med. 481 (2023).
\15\ V. Prasad & M.A. Makary, An Evidence-Based Approach to
Covid-19 Vaccination, 392 New Eng. J. Med. 2484 (2025).
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The process by which recommendations are finalized matters as well.
In September 2021, ACIP voted against recommending COVID-19 booster
doses for adults aged 18 to 64 on the basis of occupational or
institutional exposure. Members opposing the recommendation argued that
such decisions were better left to individual benefit-risk judgment.
The CDC Director set that vote aside and extended the recommendation to
the occupational group, a departure from the committee's judgment that
was widely reported as extraordinary.\16\ In the Department's view,
episodes in which the deliberative advisory process reaches a narrower
conclusion that is then overridden in favor of a broader, top-down
recommendation contribute to public doubt about whether Federal
recommendations in fact reflect the process created to produce them,
and thereby to mistrust of the system as a whole.
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\16\ See, for example, CNBC, The leader of CDC just made a rare
call to allow Covid booster shots for more people (Sept. 24, 2021),
<a href="https://www.cnbc.com/2021/09/23/covid-booster-shots-cdc-panel-endorses-third-pfizer-doses-for-millions.html">https://www.cnbc.com/2021/09/23/covid-booster-shots-cdc-panel-endorses-third-pfizer-doses-for-millions.html</a>.
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Trust and the effects of mandates. A substantial body of research
indicates that top-down mandates and coercive measures can sow distrust
and provoke psychological reactance, particularly among persons whose
trust in government is already low. A study published in the
Proceedings of the National Academy of Sciences found that enforcement
can crowd out voluntary support for public health measures, especially
where trust in government is weak.\17\ Research in Germany and the
United States found that mandatory vaccination policies triggered
reactance, an anger-driven motivation to reassert restricted freedom,
associated with reduced vaccination intentions and increased anti-
policy activism.\18\ A large United Kingdom survey and modeling study
found that the introduction of vaccine passports would likely lower
inclination to be vaccinated among some groups.\19\ Scholars writing in
BMJ Global Health argued that COVID-19-era mandates, passports, and
restrictions risked amplifying distrust and proving counterproductive,
and urged a return to trust-based public health approaches.\20\
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\17\ K. Schmelz, Enforcement may crowd out voluntary support for
COVID-19 policies, especially where trust in government is weak and
in a liberal society, 118 Proc. Nat'l Acad. Sci. e2016385118 (2021).
\18\ P. Sprengholz et al., Vaccination policy reactance:
Predictors, consequences, and countermeasures, 27 J. Health Psychol.
1394 (2022).
\19\ A. de Figueiredo et al., The potential impact of vaccine
passports on inclination to accept COVID-19 vaccinations in the
United Kingdom: evidence from a large cross-sectional survey and
modeling study, 40 EClinicalMedicine 101109 (2021).
\20\ K. Bardosh et al., The unintended consequences of COVID-19
vaccine policy: why mandates, passports and restrictions may cause
more harm than good, 7 BMJ Global Health e008684 (2022).
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The Department notes that the empirical literature is mixed. Other
rigorous studies found that mandate and certification policies
measurably increased vaccine uptake in several countries, particularly
where baseline uptake was low, and one multi-study United States
analysis found that requirements strengthened rather than weakened
vaccination intentions.\21\ The Department observes, however, that much
of the evidence on the effectiveness of compulsory approaches comes
from peer countries whose baseline levels of institutional trust differ
from those in the United States. The Department acknowledges those
differences. But trust is not fixed. It is built, and forfeited, over
time through the conduct of institutions. The Department's view is that
a
[[Page 54727]]
recommendation framework should accordingly be judged not only by its
immediate effect on uptake but by whether the framework itself builds
durable trust. Global guidance on mandatory vaccination counsels that
policymakers ``have a duty to carefully consider the effect that
mandating vaccination could have on public confidence and public
trust,'' and that mandates are not ethically justified where public
health goals can be achieved through less coercive means.\22\ In the
United States, vaccination requirements have historically been
creatures of State law within constitutional limits,\23\ and Federal
recommendations are recommendations, not mandates. The Department
believes that distinction should be preserved and made legible to the
public.
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\21\ A. Karaivanov et al., COVID-19 vaccination mandates and
vaccine uptake, 6 Nature Hum. Behav. 1615 (2022); M.C. Mills & T.
R[uuml]ttenauer, The effect of mandatory COVID-19 certificates on
vaccine uptake: synthetic-control modelling of six countries, 7
Lancet Pub. Health e15 (2022); D. Albarrac[iacute]n et al., Rather
than inducing psychological reactance, requiring vaccination
strengthens intentions to vaccinate in US populations, 11 Sci. Rep.
20796 (2021).
\22\ World Health Organization, COVID-19 and mandatory
vaccination: ethical considerations (policy brief, May 30, 2022),
<a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2022.1">https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2022.1</a>.
\23\ See Jacobson v. Massachusetts, 197 U.S. 11 (1905); CDC,
State Vaccination Requirements, <a href="https://www.cdc.gov/vaccines/php/requirements-laws/state-vaccination-requirements.html">https://www.cdc.gov/vaccines/php/requirements-laws/state-vaccination-requirements.html</a> (last visited
August 17, 2026).
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Trust after COVID-19. Public trust in Federal public health
agencies declined measurably during and after the COVID-19 pandemic. In
a national survey published in Health Affairs, among adults reporting
lower trust in CDC, the most commonly cited reasons were beliefs that
recommendations were influenced by politics and that the agency had
issued too many conflicting recommendations.\24\ Polling has documented
declining shares of Americans expressing trust in CDC and other health
agencies, a marked partisan divergence,\25\ and declining confidence in
scientists relative to the early-pandemic peak.\26\ Over the same
period, routine kindergarten vaccination coverage fell below pre-
pandemic levels while exemptions rose to the highest levels
reported.\27\ In 2022, the CDC Director publicly acknowledged, in
announcing an agency reorganization, that the agency was ``responsible
for some pretty dramatic, pretty public mistakes, from testing, to
data, to communications'' during the COVID-19 response.\28\ The
Department's working premise is that recommendations perceived as
premature, overconfident, or insulated from candor about uncertainty,
as many Americans perceived certain COVID-19-era recommendations to be,
impose lasting costs on the credibility of all Federal vaccine
recommendations, including those resting on the strongest evidence.
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\24\ G.K. SteelFisher et al., Trust In US Federal, State, And
Local Public Health Agencies During COVID-19: Responses And Policy
Implications, 42 Health Affairs 328 (2023).
\25\ Kaiser Family Found., Tracking Poll on Health Information
and Trust: January 2025 (Jan. 2025), <a href="https://www.kff.org/health-information-trust/kff-tracking-poll-on-health-information-and-trust-january-2025/">https://www.kff.org/health-information-trust/kff-tracking-poll-on-health-information-and-trust-january-2025/</a>.
\26\ Pew Rsch. Ctr., Americans' Trust in Scientists, Positive
Views of Science Continue to Decline (Nov. 14, 2023), <a href="https://www.pewresearch.org/science/2023/11/14/americans-trust-in-scientists-positive-views-of-science-continue-to-decline/">https://www.pewresearch.org/science/2023/11/14/americans-trust-in-scientists-positive-views-of-science-continue-to-decline/</a>.
\27\ R. Seither et al., Coverage with Selected Vaccines and
Exemption Rates Among Children in Kindergarten--United States, 2023-
24 School Year, 73 MMWR Morb. Mortal. Wkly. Rep. 925 (2024); CDC
SchoolVaxView, 2024-25 school year data (released July 31, 2025),
<a href="https://www.cdc.gov/schoolvaxview/data/index.html">https://www.cdc.gov/schoolvaxview/data/index.html</a>.
\28\ See, for example, CBS News, CDC director Rochelle Walensky
announces shake-up, citing COVID mistakes (Aug. 19, 2022), <a href="https://www.cbsnews.com/news/cdc-director-rochelle-walensky-announces-organization-shake-up-aimed-at-speed">https://www.cbsnews.com/news/cdc-director-rochelle-walensky-announces-organization-shake-up-aimed-at-speed</a> (quoting CDC Director Rochelle
Walensky).
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Communication science. Risk-communication research bears directly
on how recommendation categories are named, explained, and implemented.
CDC's Crisis and Emergency Risk Communication framework counsels
transparency and candor: tell the public ``what you know when you know
it, tell them what you don't know, and tell them if you will know
relevant information later.'' \29\ Experimental research indicates that
communicating uncertainty transparently imposes at most small costs to
trust.\30\ Transparent communication about negative or uncertain
features of vaccines may reduce acceptance in the short term but
increases trust in health authorities, whereas vague reassurance fails
to increase acceptance and reduces trust.\31\ A global behavioral and
social drivers framework likewise identifies confidence in vaccines,
providers, and institutions as a central determinant of uptake.\32\ The
names of recommendation categories are themselves communication. As the
survey and provider-experience evidence discussed above indicates,
categories whose meaning is unclear to clinicians and the public
generate confusion about safety, efficacy, coverage, and intent.
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\29\ B. Reynolds, Ctrs. for Disease Control & Prevention, Zika
Crisis and Emergency Communication (CERC) Discussion (June 14,
2016), <a href="https://stacks.cdc.gov/view/cdc/39966">https://stacks.cdc.gov/view/cdc/39966</a>; see also Ctrs. for
Disease Control & Prevention, Crisis and Emergency Risk
Communication (CERC) Manual (2014 ed.), available at <a href="https://www.cdc.gov/cerc/php/cerc-manual/index.html">https://www.cdc.gov/cerc/php/cerc-manual/index.html</a>.
\30\ A.M. van der Bles et al., The effects of communicating
uncertainty on public trust in facts and numbers, 117 Proc. Nat'l
Acad. Sci. 7672 (2020).
\31\ M.B. Petersen et al., Transparent communication about
negative features of COVID-19 vaccines decreases acceptance but
increases trust, 118 Proc. Nat'l Acad. Sci. e2024597118 (2021).
\32\ World Health Org., Understanding the behavioural and social
drivers of vaccine uptake: WHO position paper--May 2022, 97 Wkly.
Epidemiological Rec. 209 (2022); see also NE MacDonald & SAGE
Working Group on Vaccine Hesitancy, Vaccine hesitancy: Definition,
scope and determinants, 33 Vaccine 4161 (2015).
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II. Request for Information
The Department seeks comment from the public, including parents and
patients; clinicians, nurses, pharmacists, and other immunization
providers; State, Tribal, local, and territorial health officials;
health plans and issuers; researchers in medicine, public health,
ethics, law, communication science, and decision science; faith
communities; manufacturers; and professional, civil-society, and
community-based organizations. Commenters need not address every
question. Supporting data, citations, and concrete examples are
encouraged.
A. Adequacy of the Current Categories
1. Are the current categories (routine, risk-based, and shared
clinical decision-making/individual-based decision-making) adequate,
clear, and well understood by clinicians, patients, and parents? What
evidence bears on how each category is understood in practice?
2. Do the current categories convey meaningful differences in the
strength of the evidence, the magnitude of individual and population
benefit, and the room left for individual circumstances and values? If
not, how should those differences be conveyed?
3. Do the current categories unintentionally imply that parental
permission, individual consent, or meaningful clinical discussion
applies only to shared clinical decision-making recommendations? Should
the framework expressly distinguish the strength of a Federal
recommendation from the consent, parental-permission, and assent
processes involved in administering a vaccine?
B. Potential Additional or Modified Categories and Timing and Frequency
Recommendations
4. Should additional or different categories be adopted, such as
``recommended, but not during infancy'' (or otherwise age-de-emphasized
recommendations); ``recommended with qualification''; or ``shared
clinical decision-making with qualification''? For any proposed
category, describe its definition, its default (if any), its
evidentiary basis, and its intended downstream consequences.
5. What can be learned from the recommendation structures of peer
bodies abroad, such as global or
[[Page 54728]]
international health bodies of peer regulatory bodies?
6. If new categories were adopted, what is needed to preserve
access to vaccines currently available to Americans and ensure
predictable and consistent treatment under coverage requirements,
program eligibility rules, the injury-compensation programs, and State
law?
7. If categories remain the same, what modifications to timing and
frequency of vaccine administration (for example, clearer presentation
of flexible age ranges such as the 12-through-15-month window for the
first dose of measles-containing vaccine) or guidance on administering
vaccines individually versus at a single visit would help parents and
clinicians understand that a vaccine is recommended while affording
flexibility in timing of administration?
C. Shared Clinical Decision-Making: Meaning, Risks, and Benefits
8. What does, or what should, ``shared clinical decision-making''
mean in the vaccination context? How, if at all, does ``individual-
based decision-making'' differ?
9. Does the term ``shared clinical decision-making'' create an
unintended contrast with routine recommendations? Since shared
decision-making describes a clinical process applicable to all vaccine
decisions, should the Department reserve that phrase for use across all
categories and instead adopt ``conditional recommendation'' or
``recommendation based on individualized assessment'' for
recommendations whose expected benefit varies materially among
individuals?
10. What are the benefits of an SCDM category, including respect
for autonomy, informed consent, religious conviction, and
individualized clinical judgment, and what evidence supports them?
11. What are the risks of an SCDM category, including confusion,
reduced access or uptake, and time burdens in practice, and what
evidence supports them?
12. An SCDM recommendation, once adopted by the CDC Director,
triggers the same coverage requirements as a routine recommendation,
including coverage without cost-sharing under the Affordable Care Act
and availability through the Vaccines for Children program. Given
evidence that patients and even providers may not understand this, what
steps should the Department take to educate the public and the provider
community that SCDM-recommended vaccines are covered? What
communication formats would most effectively ensure that an SCDM
designation is not misread as a lapse in coverage or a signal that a
vaccine is unavailable?
13. What supports would make SCDM work as intended, such as
decision aids, provider training, documentation standards, coverage
clarifications, or category-specific communication materials, and who
should develop them?
D. Considerations in Setting Recommendations
14. What considerations should be relied upon in establishing
vaccine recommendations and assigning categories, and under what
conditions should each predominate? Commenters are specifically invited
to address the availability, quality, and strength of evidence; the
appropriate approach where randomized controlled trial evidence is
absent, infeasible, or unethical to obtain; disease severity and
epidemiology; individual versus population benefit; a presumption in
favor of individual autonomy, informed consent, and religious freedom;
and feasibility and programmatic consequences.
15. When evidence is limited, uncertain, or evolving, how should
that uncertainty be reflected in the recommendation itself, whether
through category assignment, qualifying language, sunset or re-review
provisions, or explicit statements of evidentiary certainty, rather
than resolved silently in favor of either a universal recommendation or
no recommendation?
E. Trust and Communication
16. What does the evidence show about the effects of mandates and
other compulsory or high-pressure approaches on public trust, vaccine
confidence, and long-run vaccination behavior? How should Federal
recommendation policy account for those effects, consistent with the
principle that Federal recommendations are not mandates?
17. What communication practices should accompany vaccine
recommendations so that they earn and keep public trust, and what
lessons from COVID-19-era communication should inform them?
18. How should the Department measure whether a recommendation
framework is succeeding, and what data should be collected and
published for that purpose?
III. Scope and Effect of This Notice
This request for information does not constitute a rule, a proposed
rule, or a recommendation, and it does not alter any existing vaccine
recommendation, coverage requirement, or program obligation. The
Department will not respond individually to comments but will consider
them in the work described above.
Robert F. Kennedy, Jr.,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2026-17250 Filed 8-21-26; 8:45 am]
BILLING CODE P
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