hpv tor 508

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Advisory Committee on Immunization Practices  (ACIP)
Centers for Disease Control and Prevention (CDC)
Human Papillomavirus (HPV ) Vaccine Workgroup
Terms of R eference
UPDATED:  December 18 , 2025

PURPOSE

This document defines the activities, membership, and administrative requirements associated
with the establishment of a Human Papillomavirus (HPV ) Vaccine Workgroup  under the
Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention (ACIP, CDC).   ACIP utilizes subgroups of the Committee, known as Workgroups (WGs), to
review relevant published and unpublished data , and clinical and scientific knowledge, and
develop options for presentation to the full ACIP  parent committee  during its public meetings to
facilitate discussion, deliberation , and development of recommendations.  ACIP WGs are
intended to augment the effectiveness of ACIP.  The direction, focus, and pace of both ACIP and the individual WGs are guided by CDC and HHS policies and priorities,  as well as the need for
expert input to inform development of CDC immunization policy.  ACIP WGs play a key
scientific role supporting immunization  recommendations.  The HPV Vaccines  WG has been
specifically established  to review data , as well as clinical and scientific knowledge on HPV
vaccine s and their role in preventing infection and cancer and their effect on prevalence and
carcinogencity of subtypes, to help develop HPV immunization policy options  for ACIP
consideratio n to formulate recommendations to the Director of the CDC.

For purposes of this document, “ Immunization ” refers to vaccines and other antibody protective
products  used to prevent disease such as immunoglobulins .

BACKGROUND

HPV is a common virus spread through intimate skin- to-skin contact. Although most HPV
infections become undetectable within two  years, some HPV infections will persist and can
cause cancers in women and men.  In the United States, HPV vaccination is currently
recommended in early adolescence to protect against HPV infection. A 9 -valent HPV vaccine ,
9vHPV , is the only HPV vaccine currently available in the United States. This vaccine  targets
nine HPV types (HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) that  cause the majority of cervical
and other HPV -related  cancers and anogenital warts.
 An ACIP HPV Vaccine Work Group met almost continuously from 2005 through 2019 to address policy for new vaccines and new FDA indications.  The work of the  HPV Vaccine WG
was reconvened in July 2024 to review and discuss the number of vaccine doses in the recommended HPV vaccination series and the recommended  age for routine HPV vaccination.
The HPV Vaccine WG will continue this work and, per ACIP charter,  will also conduct a
comprehensive review of the cumulative data, knowledge , and evidence regarding the efficacy,
effectiveness and the safety of the HPV vaccine.

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 In accordance with the  21st Century Cures Act (PL 114-255), ACIP shall also , as appropriate,
consider new vaccines or new indications at its next regularly scheduled meeting after licensure;
if the Committee defers making a recommendation, it will provide an update on the status of its
review. Ad ditionally, ACIP shall make recommendations in a timely ma nner for vaccines that
are designated as breakthrough interventions or could be used in a public health emergency. In case of any new HPV immunizations, the ACIP parent committee requests that the HPV Vaccine WG include consideration of the new immunizations  to assist the parent committee in
implementing its 21
st Century Cures Act requirements.
 The purpose of this HPV Vaccine WG  is to review available data, as well as clinical and
scientific knowledge, to support the development of recommendations for ACIP consideratio n
that are used to advise the Director of the CDC.
 The HPV Vaccine WG will also assist and support the A CIP parent committee , in accordance
with Section 1928 of the Social Security Act (42 USC 1396s) , to be able to establish and
periodically review and, as appropriate, revise the list of immunization s for administration to
children and adolescents eligible to receive immunizations  through the Vaccines for Children
Program, along with schedules regarding the appropriate dose and dosing intervals , and
contraindications to administration of the pediatric immunization .

TOPICS UNDER DISCUSSION BY THE WORKGROUP

The following topics relevant to  a comprehensive review of the efficacy, effectiveness and safety
of the HPV vaccine, as well as to specific vaccination policies regarding the use of HPV vaccine
and effective control of HPV in fection and related disease in the population of the United States
will be under discussion in the HPV Vaccine WG in multi- year efforts and include , for
presentation to the parent committee for its deliberation and development of recommendations to
CDC, evaluation of:
1) HPV vaccination schedules with fewer  doses;

2) Wording of the age for routine HPV vaccination ; and

3) Draft p olicy recommendations following a comprehensive review of the cumulative
scientific and clinical data, knowledge, and evidence regarding the efficacy,
effectiveness, and the safety of the HPV vaccine. This includes assessment of the long
term effect s of HPV vaccination programs on population level incidence (per subtype),
morbidity and mortality of cervical cancer.

DESCRI PTION of WORKGROUP  ACTIVITIES
The following activities provide a framework for the HPV Vaccine  WG multi -year efforts , which
may involve data requests from other Federal and private partners , for development of
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 presentations to the parent ACIP for its deliberations as it develops recommendations to the CDC
Director:
1. Summarize and review the cumulative data on temporal trends in the U.S. and other countries
of HPV infection, precancers, cervical cancer incidence ; other HPV attributable outcomes;
and mortality per different age groups and how they potentially correlate with evolving
vaccination rates and screening policies.

2. Summarize and review , using existing systematic reviews, where possible, the cumulative
data and knowledge regarding vaccine efficacy and effectiveness in  relation  to cervical
cancer and surrogate outcomes, including a meta -analysis of clinical trials and observational
studies.

3. Summarize and review the cumulative data and knowledge regarding vaccine safety and related adverse events, including VAERS source and other safety data and meta -analysis of
clinical trials and observational studies.

4. Characterize the nature of the safety reports in men and women and timing of the report post vaccination with the first and second dose.

5. Summarize and review existing data and knowledge regarding the potential toxicity of HPV vaccine, adjuvants, and potential contaminants and/or impurities.

6. Summarize and review existing knowledge related to the efficacy, eff ectiveness and safety of
HPV vaccination when given to individuals with prior exposure to HPV infections.

7. Summarize and review the existing data on potential HPV type replacement (i.e., increase in
oncogenic types not targeted by HPV vaccine, after introduction of HPV vaccination
programs , as well as data and knowledge related to the potential impact of vaccination rates.
8. Review  and summarize existing  data, including published and as available and appropriate,
unpublished research, as well as clinical knowledge, related to the efficacy, effectiveness,
and immunogenicity of HPV vaccination with fewer than two doses in individuals aged 9
through 14 years.

9. Review and summarize existing data  including published and, as available and appropriate,
unpublished research, as well as clinical knowledge related to the efficacy, effectiveness, and
immunogenicity of HPV vaccination with fewer than three  doses in individuals to inform
vaccination recommendations for persons aged 15 years and older.

10. Review programmatic data on age at vaccination in the United States.

11. Develop HPV vaccination policy options for presentation to  and deliberation by, the ACIP
parent committee .
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 Overall, the HPV Vaccine WG will prepare information for the ACIP members to enable them
to:
• Advise on population groups and/or circumstances in which a vaccine or related agent is recommended.
• Provide recommendations on contraindications and precautions for use of the vaccine and
related agents and provide information on recognized adverse events.
• Provide recommendations that address the general use of vaccines and if applicable,
immune globulin preparations as a class of biologic agents, use of specific antibody products for prevention of infectious diseases, and special situations or populations that may warrant modification of the routine recommendations.
• Support committee deliberations on use of immunization to control disease including consideration of disease epidemiology and burden of disease, immunization safety, immunization efficacy and effectiveness, the quality of evidence reviewed, economic analys es, medical ethics, and implementation issues including informed consent
language.
• Revise or withdraw their recommendation(s) regarding a particular immunization should new information on disease epidemiology, immunization effectiveness or safety, economic considerations, or other data become available.

MEMBERSHIP

Workgroup Leadership:  The HPV Vaccine WG is  chaired by a member of ACIP committee . The
Workgroup Lead  (WG L) is a federal employee, identified  by the ACIP parent committee
Designated Federal O fficial (DFO) ( within the Immediate Office of the Director) in consultation
with the relevant CDC program s. The ACIP DFO will determine wh ich roles and responsibilities
will be further assigned, as appropriate, to the WGL, who will then be responsible for carrying
them out .  The WG Chair , in consultation with both the WG L and the DFO,  establishes the
WG’s membership , work priorities , and deliverables  for presentation to the full committee .

Workgroup Membership:  The HPV Vaccine  WG  is comp osed of experts who are appointed
based on their professional, scientific, technical, or other expertise.  They are experts who are
regarded as an authority or a practitioner of unique competence and skill by other individuals in
their profession or occupation. Upon request, HHS f ederal agencies name d in the ACIP charter
may also appoint members to serve on WGs. The HPV Vaccine  WG will be comp osed of
members  from a variety of disciplines. The HPV Vaccine WG will engage with the following
disciplines on WG activities :

• Public health science and practice ;
• Public health policy development, analysis, and implementation, including development and
execution of immunization programs for children and adults;
• Clinical and medical practice , and patient- care experience;
• Epidemiology;
• Immunology;
• Virology;
• Neurology;
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 • Oncology;
• Pathology;
• Toxicology;
• Drug  and vaccine safety;
• Medical ethics; and
• Consumer perspectives and/or social and community aspects of immunization programs

Due to the complexity and variability of information to be gathered, additional external subject
matter experts may also be invited to provide data and presentations to the HPV Vaccine WG
and answer questions during HPV Vaccine WG meetings on an ad hoc basis. Such additional
external subject matter experts will not be members of the HPV Vaccine WG  and will not
participate in any deliberations or HPV Vaccine WG  discussions.

MEETINGS, ADMINISTRATION, and TIMELINES

1. Administrative Oversight:  The WG L will work with the WG Chair to arrange meetings, and
document meeting proceedings  and may provide presentations about the WG activities and
findings to the ACIP.  Staff from WG L’s program may be assigned to assist with some of the
WG’s administrative activities including notetaking and required record keeping.

2. Meeting frequency and location :  The HPV Vaccine  WG will meet  on an as needed basis as
determined by the WG Chair and WGL. All HPV Vaccine  WG meetings are convened virtual ly
via teleconference.

3. Meeting structure :  In addition to the WGL, at least two ACIP parent committee members  (one
of whom serves as the HPV Vaccine WG  Chair) must be present at each meeting for a quorum.
An agenda, relevant publications, and background documents will be circulated as read ahead
material prior to each meeting.

4. Conflicts of Interest :  HPV Vaccine WG  members will complete an  ACIP WG  Agreement and
Conflict of I nterest Certification  process prior to participation on the HPV Vaccine WG.  The
WGL will screen for conflict- of-interest declarations and share any conflicts that need to be
elevated to the DFO/ACIP Secretariat.   The ACIP parent committee DFO in collaboration with
the WGL  will work with the Office of Strategic Business Initiatives, Federal Advisory
Committee Act Program and the Office of the General Counsel (OGC) as needed, to mitigate any conflicts identifie d.  HPV Vaccine WG members will consent to abide by guiding principles and
disclose interests (e.g., employment, special interests, grants, or contracts) that a reasonable person could view as conflicts or potential conflicts of interest with their HPV Vaccine  WG
participation.  Members will also disclose any potential conflicts of interest before each meeting.  If an HPV Vaccine  WG member indicates a potential or actual conflict of interest, the DFO will
review and make a determination as to  whether the individual must recuse themselves from
participating  in HPV Vaccine WG discussions that implicate such a conflict -of-interest concern.

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 5. Confidentiality :  The discussions of the HPV Vaccine  WG  may include information that is
unpublished, protected, privileged, or confidential . HPV Vaccine W G deliberations, including
policy options  under consideration by the HPV Vaccine WG , are also considered confidential .
Information of this nature must not be disseminated, distributed, or copied to persons not
authorized to receive such information.  When these types of information are distributed, the person/s presenting will identify the information as such, so all members are duly informed; and written materials shall be clearly marked as such.   Unlike ACIP parent committee meetings,
which are open to the public, HPV Vaccine  WG teleconferences are not subject to the open
meeting requirements  of the Federal Advisory Committee Act or the GSA Final Rule ; data
presented during these meetings/teleconferences are often proprietary and should not be distributed to people other than approved HPV Vaccines WG members.

6. CDC Staff Involvement:   CDC staff do not serve as members of the HPV Vaccine  WG  but may
provide administrative support and technical expertise to ACIP WG, bringing subject matter expertise and current professional focus in areas relevant to the goal s of the HPV Vaccine WG.
Consultation or information al presentations by CDC staff will be transparent and evident to
minimize the risk of, or the appearance of, undue influence that would compromise the independence of the WG.  The ACIP , CDC parent committee DFO and WG L of the HPV
Vaccine WG, in consultation with the Chair of the HPV Vaccine  WG, will monitor the
interaction between the WG and the agency staff  to ensure that the WG  activities and work
products are appropriate and that there is not undue influence by the CDC or by any special interest group on the activities  or work products  of the  WG .

7. Timelines :  ACIP WGs are established when needed and terminated once the activities and work
products stated in the terms of reference have been completed  and the  WG ’s charge has been
fulfilled .

8. Subject content:  Findings and opinions of the HPV Vaccine  WG members will be discussed at
meetings.  The HPV Vaccine  WG’s findings will be presented to the ACIP  parent committee  for
consideration for action (discussion, deliberation and decision , and recommendations ).

9. Workgroup Meeting Summaries:  Meeting minutes will be created to capture the information
gathered during each HPV Vaccine  WG meeting and teleconference.

10. Workgroup findings : The HPV Vaccine  WG will present findings (briefing documents,
background materials, presentations) to the ACIP  parent committee  for consideration and
deliberation in a public meeting. Final versions of all slides presented at the ACIP parent committee meeting will be posted on the ACIP website following the meeting and included in
the committee’s official records.

11. Workgroup Record Keeping: All CDC FACA committees, subcommittees, and WGs are subject
to the Federal Records Act. All records will be uploaded in the Federal Advisory Committee Management Portal. The summary report of WG meeting activities and other WG documents will become part of the ACIP’s official records as required by GENERAL RECORDS SCHEDULE 6.2: Federal Advisory Committee Records .

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 RECORDKEEPING and REPORTING

The WG  Chair and WG L, WG members and other experts will present
findings/outcomes/observations to the ACIP  parent committee  for discussion, deliberations,
further development of recommendations, and vote in an open public forum. Approved ACIP
recommendations adopted by the CDC Director wil l be posted on CDC’s ACIP website and also
published in the Morbidity and Mortality Weekly Report (MMWR).  In addition, approved ACIP recommendations will be included in the ACIP meeting minutes  and annual report.

Summary: Page 1 of 7     Advisory Committee on Immunization Practices  (ACIP)   Centers for Disease Control and Prevention (CDC)   Human Papillomavirus (HPV ) Vaccine Workgroup    Terms of R eference   UPDATED:  December 18 , 2025    PURPOSE     This document defines the activities, membership, and administrative requirements associated  with the establishment of a Human Papillomavirus (HPV ) Vaccine Workgroup  under the  Advisory Committee on Immunization Practices, Centers for Disease Control and…


influenza tor 508

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 Advisory Committee on Immunization Practices  (ACIP)
Centers for Disease Control and Prevention (CDC)
Influenza  Immunization Workgroup
Terms of R eference
DRAFT: December 18 , 2025

PURPOSE
 This document defines the activities, membership, and administrative requirements associated with the establishment of a n Influenza  Immunization Workgroup  under the Advisory
Committee on Immunization Practices, Centers for Disease Control and Prevention (ACIP, CDC).   ACIP utilizes subgroups of the Committee, known as Workgroups (WGs), to review
relevant published and unpublished data , and clinical and scientific knowledge, and develop
options for presentation to the full ACIP  parent committee  during its public meetings to facilitate
discussion, deliberation and development of recommendations.  ACIP WGs are intended to enhance the effectiveness of ACIP.  The d irection, focus, and pace of both ACIP and the
individual WGs are guided by CDC and HHS policies and priorities, and by the need for expert input to inform development of CDC immunization policy. ACIP WGs serve a key scientific
role in support of immunization  recommendations.  The Influenza Immunization  WG has been
specifically established  to review data , as well as clinical and scientific knowledge on existing
and developmental- stage influenza immunization s, to help develop influenza  immunization
policy options for ACIP consideratio n to formulate recommendations to the Director of the CDC.
 For purposes of this document, “i mmunization ” refers to vaccines and other antibody protective
products to prevent disease, e.g., immunoglobulins.

BACKGROUND

Influenza  is a disease caused by the influenza A and B virus es. There are other upper respiratory
viruses and pathogens such as respiratory syncytial virus (RSV), rhinoviruses, mycoplasma,
Sarbecoviruses, beta coronaviruses , and human metapneumoviruses that are associated with
clinical signs and symptoms similar or identical to influenza. Both i nfluenza virus es and these
other pathogens contribute to the overall burden of influenza- like illness (ILI).  F or some
patients, influenza and other ILI can be severe, causing significant morbidity and mortality , and
are a frequent contributing cofactor to morbidity and mortality in some populations with
additional risk factors . Currently , there are multiple  vaccine manufacturers employing a wide
range of manufacturing, formulation , and adjuvant technologies to produce i nfluenza vaccines
for the United States .
The specific virus components for the 2025–2026 season include:
An A/Victoria/4897/2022 (H1N1)pdm09-like virus (for egg- based vaccines) or an
A/Wisconsin/67/2022 (H1N1)pdm09- like virus (for cell- or recombinant -based vaccines)
An A/Croatia/10136RV/2023 (H3N2)-like virus (for egg- based vaccines) or an A/District of
Columbia/27/2023 (H3N2)- like virus (for cell- or recombinant- based vaccines)
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 A B/Austria/1359417/2021 (B/Victoria lineage) -like virus
For those manufacturing platforms employing either chick embryo or mammalian cell -based
antigen production, the seed virus representing the annually selected influenza strain(s) requires
adaptation from the circulating version infecting humans to support efficient reproduction in the
relevant manufacturing platform supporting viral replication.  In some cases, this adaptation may
introduce partial antigenic mismatch relative to the parental human circulating viruses.  For other
platforms such as baculovirus- based manufacturing, it may be that this form of seed virus protein
sequence drift relative to parental strain is minimized, but these platforms may yield antigens
that diverge in criti cal glycosylation patter ns relative to parental human circulating viruses.  The
significance,  or lack thereof , of influenza antigens glycosylated with insect patterns rather than
mammalian patterns is not well characterized.
New formulations , compositions, or technologies  for use in influenza  vaccine s are actively being
developed, with a specific emphasis on a universal influenza vaccin e.  These may require
regulatory  (by the appropriate entities)  and ACIP safety and efficacy  and/or effectiveness review
in the foreseeable future.
According to the 21st Century Cures Act (PL 114- 255), ACIP shall also, as appropriate, consider
new vaccines or new indications at its next regularly scheduled meeting after licensure . If the
Committee defers making a recommendation, it will provide an update on the status of its
review. Ad ditionally, ACIP shall make recommendations in a timely ma nner for vaccines that
are designated as breakthrough interventions or could be used in a public health emergency.  The purpose of this WG  is to review available data, as well as clinical and scientific knowledge,
to support the development of vaccine and related product clinical use recommendations for ACIP parent committee consideratio n, which may then elect to advise  the Director of the CDC
concerning those recommendations .
 In accordance with the ACIP Charter, t he Influenza  Immunization WG will prepare information
for the ACIP  parent committee  members to enable them to:
• Advise on population groups and/or circumstances in which one or more influenza
vaccine s or related agent s are recommended.
• Provide recommendations on contraindications and precautions for the use of influenza
vaccine s and related agents , and provide information on recognized adverse events.
• Provide  recommendations that address the general use of influenza v accines and
immune -globulin preparations as a class of biologic agents, use of specific antibody
products for prevention of influenza infection- related infectious diseases, and special
situations or populations that may warrant modification of the routine recommendations.
• Support c ommittee deliberations on the use of immunization  to control disease , including
consideration of disease epidemiology and burden of disease, immunization  safety,
immunization  efficacy and effectiveness, the quality of evidence reviewed, economic
analyses, and implementation issues.
• Revise or withdraw , as warranted,  their recommendation(s) regarding a particular
influenza immunization  or related product as new information on disease epidemiology,
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 immunization  effectiveness or safety, economic considerations, or other data that
becomes available.
• Differentiate and provide differentiated data summaries regarding the use of specific
influenza vaccines in various risk groups, and facilitate modified use recommendations as appropriate or necessary concerning specific influenza vaccines or related products and technologies.
 The WG will also assist and support A CIP, i n accordance with Section 1928 of the Social
Security Act,  [42 U.S.C. Section 1396s ], to be able to establish and periodically review and, as
appropriate, revise the list of immunization s for administration to children and adolescents
eligible to receive immunizations  through the Vaccines for Children Program, along with
recommended schedules concerning the appropriate dose and dosing interval, and contraindications to administration of pediatric immunization s.
 The WG will engage external subject matter experts, as needed, to support  development of
materials for presentation to the WG and/or parent committee for its deliberations .

TOPICS UNDER DISCUSSION BY THE WORKGROUP

In accordance with the ACIP Charter and in a multi -year effort, the Influenza Immunization WG
members will work with expert consultants as appropriate and in accordance with FACA
statutory requirements and policies, to prepare information for presentation to and deliberation
by the parent ACIP committee in developing their recommendations . In particular, the following
topics and related activities relevant to  influenza immunization  for effective control of i nfluenza
A and/or B- related  disease in the civilian population of the United States will be considered  as a
framework  for and/or undertaken by the Influenza WG in multi -year effort s:
1) Conduct and/or review r isk-benefit and cost -benefit data for, and/or analyses of , existing and
newly -licensed  influenza vaccines, and their administration  schedules, to inform the parent
committee’s deliberations on vaccine use recommendations according to age-group, major
risk factors , and health status.
2) Identify critical gaps in  existing scientific  and clinical  knowledge and CDC monitoring
methods related to the safety , efficacy /effectiveness,  immunogenicity, and long- term immune
system impacts  of influenza vaccines  to inform the parent committee’s deliberations on
development of policy recommendations and to identify further analyses and research to be
recommended to  CDC for its consideration and CDC potential advice to other federal
agencies and the scientific community  to conduct.
3) Review and summarize data, clinical and scientific knowledge related to short and long- term
adverse events associated with influenza vaccines  to present to the parent committee for its
deliberations in  identify ing precautions and contraindications recommendations.
4) Review and summarize data for presentation to the parent committee on the long- term
immunological effects of repeated annual influenza vaccination as a function of risk group
and strain variability or type (drift/shift).
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DESCRI PTION of WORKGROUP  ACTIVITIES
The following activities provide a framework for the Influenza Immunization WG multi- year
efforts , which may involve data requests from the FDA and other f ederal agencies and private
partners , for development of presentations to the parent ACIP for its deliberations as it develops
recommendations to the CDC Director:
1. Review  and summarize existing  data including published and unpublished research and
clinical knowledge related to the safety, effectiveness, and immunogenicity of influenza
vaccines authorized or approved in the U nited S tates.
2. Summarize literature review s of the epidemiology of influenza disease and infection .
3. Assess the benefit -risk balance for administration  of influenza immunization products co -
administered with other vaccinations.
4. Identify areas where additional data and research  are needed to inform influenza
immunization recommendations to be developed by ACIP.
5. Annually review and develop updat es of U.S. seasonal influenza  immunization  policy
recommendations.
6. Review and summarize the existing clinical and scientific information concerning the role of
innate, adaptive innate, adaptive cellular , and adaptive humoral immune responses associated
with different influenza vaccines, adjuvants, and correlates of protection associated with
influenza vaccination.
7. Review and  summarize the existing clinical and scientific information , and gaps in the
existing knowledge, including from the FDA and other federal agencies, as well as academic
studies, concerning the impact of repeated influenza vaccination including immunological
effects such as immune imprinting, “ original antigenic sin ,” and related phenomena.
8. Review and s ummarize the existing clinical and scientific information , and  identify and
address gaps in the existing knowledge regarding both antigenic sequence mismatch , as well
as glycosylation mismatch , in existing immunization products and their health impacts  to
inform immunization recommendations.
9. Review and summarize  the existing scientific knowledge and gaps, regarding the cumulative
short- and long- term impact of repeated annual seasonal influenza vaccination  (including
boosting in young children’s first season), including non- specific effects (e.g., IgG4 class
switching, immune imprinting, viral evolution under leaky immunizations ) to help inform
immunization recommendations.
10. Examin e the impact of Influenza A and B immunization  on influenza  and all-cause deaths,
hospitalizations, and disability to inform immunization recommendations .
11. Analyze existing data and scientific knowledge regarding cardiovascular, thrombotic,
neurological , immunological, and othe r serious adverse events potentially caused  and averted
by influenza  immunization .
12. Review, analyze, and summarize available data concerning the safety and effectiveness of influenza immunization of the elderly , including the interaction between influenza vaccines
and immunosenescence, and both innate and adaptive immunity.
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 13. Review and s ummarize available data, information , and gaps regarding long- term repeated
Influenza vaccination  effects from scientific literature  and clinical experi ence associated with
influenza  immunization products and influenza  infection  to inform policy  recommendations.
14. Map existing influenza  immunization  policies in countries around the world and how they
compare to U .S. vaccine policy.
15. Analyze existing data and scientific knowledge related to the safety of influenza
immunization  during pregnancy, including both potential teratogenic effects and potential
beneficial effects for the newborn .

MEMBERSHIP

Workgroup Leadership:  The Influenza  Immunization  WG is  chaired by one of the ACIP, CDC
parent committee members appointed to serve as Special Government Employees. The
Workgroup Lead (WGL ) is a federal employee, identified  by the Immediate Office of the
Director in consultation with  the appropriate CDC program . The WG Chair , in consultation with
the WGL, ACIP  CDC Designated Federal Offi cial (DFO), determine s the WG ’s membership and
work priorities and deliverables to the full committee . The DFO may further assign  some of the
DFO- related roles and responsibilities , as appropriate,  to the WGL.

Workgroup Membership:  The Influenza Immunization  WG is comp osed of  experts who are
appointed based on their professional, scientific, technical, or other expertise.  They are  experts
who are regarded as an authority or a practitioner of unique competence and skill by other
persons in the ir profession, or occupation. Upon request, HHS f ederal agencies name d in the
ACIP charter may  also appoint members to serve on WG s. The Influenza  Immunization WG will
be composed of members from a variety of disciplines. The WG will engage with the following
disciplines on WG activities :

• Public health science and practice ;
• Public health policy development, analysis, and implementation, including development and
execution of immunization programs for children and adults;
• Clinical and medical practice , and patien t-care experience;
• Epidemiology;
• Molecular biology;
• Immunology;
• Virology;
• Diagnostics and correlates of protection;
• Drug  and vaccine safety;
• Bioethics; and
• Consumer perspectives and/or social and community aspects of immunization programs

Due to the complexity and variability of the information to be gathered, additional external
subject matter experts may also be invited to provide data and presentations to the WG and
answer questions during Influenza  Immunization WG  meetings on an ad -hoc basis. Such
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 additional external subject matter experts will not be members of the WG  and will not participate
in any deliberations or WG discussions.

MEETINGS, ADMINISTRATION, and TIMELINES
1. Administrative Oversight:  The WGL  will work with the WG Chair to arrange meetings,
document meeting proceedings, and report to the ACIP on the Influenza  Immunization WG’s
activities and  findings.
2. Meeting frequency and location :  The Influenza  Immunization WG will meet on an as needed
basis as determined by the WG Chair and WGL . All Influenza Immunization WG meetings are
convened virtual ly via teleconference.
3. Meeting structure :  In addition to the WGL,  at least two ACIP parent committee  member s (one
of whom serves as the Influenza  Immunization WG  Chair) must be present at each meeting for a
quorum.  An agenda, relevant publications, and background documents will be circulated as
read-ahead mat erial before each meeting.
4. Conflicts of Interest :  WG  members will complete an ACIP WG  Agreement and C onflict of
Interest Certification  process before  participation on the WG.  The WGL will screen for conflict
of interest declarations and share any conflicts with the ACIP Secretariat.  The ACIP Secretariat /DFO, in collaboration with WGL will work with the Office of Business Initiatives
(OSBI)  ethics officials and the Office of General Counsel (OGC), as needed, to resolve any
conflicts  that the WGL  identifie d.  WG members  will consent to abide by several guiding
principles and disclose interests (e.g., employment, special interests, grants, or contracts) that a
reasonable person could view as conflicts or potential conflicts of interest with their Influenza
Immunization  WG participation.  Members will also disclose any potential conflicts of interest
before each meeting.  If an Influenza Immunization  WG member indicates a potential or actual
conflict of interest to the WGL , the WGL or designee will  forward  any conflicts to the DFO to
determine  whether the individual must  recuse themselves from participating  in WG discussions
that implicate such a conflict -of-interest concern. If needed, the DFO will engage OSBI and
OGC to assist with making COI determination.
5. Confidentiality : The discussions by the Influenza  Immunization  WG  may include information
that is unpublished, protected, privileged, proprietary, or confidential. WG deliberations, including policy options under consideration by the WG , are also considered confidential.
Information of this nature must not be disseminated, distributed, or copied to, and/ or described or
discussed with,  persons not authorized to receive such information.  When these types of
information are distributed, the person/s presenting will identify the information as such, so all members are duly informed; and written materials shall be clearly marked as such.   Unlike ACIP
parent committee  meetings, which are open to the public, Influenza Immunization WG
teleconferences are not subject to the open meeting requirements of the Federal Advisory Committee Act or the GSA Final Rule; data presented during these meetings/teleconferences are often proprietary and should not be distributed to people other than approved Influenza Immunization  WG members.
6. CDC Staff Involvement:  CDC staff do not serve as members of the Influenza Immunization  WG
but may provide administrative support and technical expertise to ACIP WGs, bringing subject matter expertise and current professional focus in areas relevant to the goal s of the Influenza
Immunization  WG.  C onsultation or information al presentations by CDC staff will be transparent
and evident to minimize the risk of, or the appearance of, undue influence that would
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 compromise the independence of the WG .  The DFO , and WGL of Influenza Immunization  WG,
in consultation with the Chair of the Influenza Immunization  WG, will monitor the interaction
between the WG  and the agency staff  to ensure that the WG  activities and work products are
appropriate and that there is not undue influence by the CDC or by any special interest group on
the activities  or work products of the WG .
7. Timelines:  ACIP WGs are established when needed and terminated once the activities and work
products stated in the terms of reference have been completed  and the WG ’s charge has been
fulfilled .
8. Workgroup Meeting Summaries:  Meeting minutes will be created to capture the information
gathered during each Influenza Immunization  WG meeting and teleconference.
9. Workgroup findings : The Influenza Immunization  WG will present findings (briefing
documents, background materials, and presentations) to ACIP parent committee  for
consideration and deliberation in a public meeting.  Final versions of all slides presented at the ACIP  parent committee meeting will be posted on the ACIP website following the meeting and
included in the committee’s official records.
10. Workgroup Record Keeping: All CDC FACA committees, subcommittees, and WGs are subject
to the Federal Records Act.  All records will be uploaded to  the Federal Advisory Committee
Management Portal.  The summary report and other WG documents will become part of the ACIP’s official records as required by GENERAL RECORDS SCHEDULE 6.2: Federal Advisory Committee Records.
RECORDKEEPING and REPORTING

The WG  Chair and /or WG L will present findings/outcomes/observations to the ACIP  parent
committee  for discussion, deliberations, further development of recommendations, and vote in an
open public forum .  Approved ACIP recommendations adopted by the CDC Director wil l be
posted on CDC’s ACIP website and also published in the Morbidity and Mortality Weekly Report (MMWR).  In addition, approved ACIP recommendations will be included in the ACIP meeting minutes  and annual report.

Summary: Page 1 of 7   Advisory Committee on Immunization Practices  (ACIP)   Centers for Disease Control and Prevention (CDC)   Influenza  Immunization Workgroup    Terms of R eference   DRAFT: December 18 , 2025    PURPOSE    This document defines the activities, membership, and administrative requirements associated with the establishment of a n Influenza  Immunization Workgroup  under the Advisory  Committee on Immunization Practices, Centers for Disease Control and Prevention (ACIP, CDC).   ACIP…


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 Advisory Committee on Immunization Practices ,
Centers for Disease Control and Prevention (ACIP, CDC)
Meeting Administration  and Planning  Workg roup
Terms of Reference
UPDATED:  January 21, 2026

PURPOSE

This document defines the activities, membership, and administrative requirements associated
with the establishment of a Meeting Administration and Planning Workgroup (WG)  under
the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention
(ACIP, CDC).   ACIP utilizes subgroups of the Committee, known as WGs, to develop options
for presentation to the full ACIP  parent committee  during its public meetings to facilitate
discussion, deliberation , and development of recommendations.  ACIP WGs are intended to
augment the effectiveness of ACIP.  The direction, focus, and pace of both ACIP and the
individual WGs are guided by CDC and HHS policies and priorities, a s well as the need for
expert input to inform development of  CDC  immunization policy.

DESCRI PTION of WG ACTIVITIES
The Meeting Administration and Planning W G will support the Designated Federal Officer
(DFO) with ACIP meeting preparation and planning.  The WG’s activities may involve input
from other Federal and private partners:
• Provide input to  the DFO regarding  the d evelop ment  and coordination of  ACIP meeting
agendas , schedules, and critical  materials to prepare members for the meetings .
• Provide suggestions to the DFO on needed s upport  for orderly discussion s and time
management  for ACIP meetings .

The WG will provide information  and suggestions  to the D FO for consideration.  The D FO
welcomes this input, together with input from other relevant stakeholders and sources, and
determines its application as appropriate .  For example, t he DF O will consider several  factors
including operational/logistical (data availability, time needed for analyses, FDA vaccine
licensing timing, vaccine safety and efficacy data, etc.) and priorities (current administration,
HHS, CDC Director, and CDC programs) that inform  agenda topic selection for an ACIP
meeting.

MEMBERSHIP

The Meeting Administration and Planning W G is chaired by a member of the ACIP committee .
The ACIP DFO or a designee from the ACIP Secretariat will serve as the WG Lead (WGL) .  The
WG Chair , in consultation with both the WGL and the ACIP  DFO,  determines  the WG’s
membership , work priorities , and deliverables .  Other federal staff (e.g., HHS leadership) and
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 members of liaison representatives may be invited to join WG meetings for expertise as needed
but will not serve as WG members or  participate in any deliberations or WG discussions .

WG Membership : The Meeting Administration and Planning WG is comp osed of  a WG Chair
and up  to 5 additional ACIP voting members  given their professional, scientific, and technical
expertise ; and vested interest in ensuring the success of the ACIP meetings.   They are experts
who are regarded as an authority or a practitioner of unique competence and skill by other
persons in their profession or occupation.  Upon request, HHS federal agencies named in the
ACIP charter may also appoint members to serve on WGs.   The ACIP Chair may recommend
and DFO will select the WG members.

MEETINGS, ADMINISTRATION, and TIMELINES
1. Administrative Oversight : The  WGL will work with the WG Chair to arrange meetings,
document meeting proceedings , and may provide presentations about the WG activities and
findings to the ACIP .

2. Meeting frequency  and location : The  Meeting Administration and Planning WG will meet  on an
as needed basis as determined by the WG Chair , WGL, and DFO .  All Meeting Administration
and Planning WG meetings are convened virtual ly via teleconference.

3. Meeting structure : In addition to the WGL, at least two ACIP parent committee members (one of
whom serves as  the Meeting Administration and Planning WG Chair)  must be present at each
meeting for a quorum .  An agenda, relevant publications, and background documents will be
circulated as read ahead mat erial prior to each meeting.

4. Conflicts of Interest : N/A.

5. Confidentiality : The discussions of the Meeting Administration and Planning WG may include
information that is unpublished, protected, privileged, or confidential .  Discussions within the
WG will be kept confidential.   Information of this nature must not be disseminated, distributed,
or copied to persons not authorized to receive such information.   When these types of
information are distributed, the person/s presenting will identify the information as such, so all
members are duly informed; and written materials shall be clearly marked as such.   Unlike ACIP
parent committee meetings , which are open to the public, Meeting Administration and Planning
WG teleconferences are not subject to the open meeting requirements  of the Federal Advisory
Committee Act or the GSA Final Rule ; data presented during these meetings/teleconferences are
often proprietary and should not be distributed to people other than approved WG members.

6. CDC Staff Involvement : The CDC staff engaged in the ACIP M eeting Administration and
Planning WG include the ACIP DFO and ACIP Secretariat staff .  Consultation or information al
presentations by CDC staff may be requested by the WG .  CDC staff do not serve as members of
the Meeting Administration and Planning  WG but may be asked to provide administrative
support and technical expertise to ACIP WGs, bringing subject matter expertise and current
professional focus in areas relevant to the goa ls of the WG.  Consultation or informational
presentations by CDC staff will be transparent and evident to minimize  the risk of, or the
appearance of, undue influence that would compromise the independence of the WG.  The ACIP,
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 CDC DFO and WGL of the Meeting Administration and Planning WG, in consultation with the
Chair of the Meeting Administration and Planning  WG, will monitor the interaction between the
WG and the agency staff to ensure that the WG activities and work products are appropriate and
that there is not undue influence by the CDC or by any special interest group on the activities or
work products of  the WG.

7. Subject content : Findings  and opinions of the Meeting Administration and Planning WG
members may be discussed at ACIP meetings.  Where applicable, t he Meeting Administration
and Planning WG’s findings will be presented to the ACIP  parent committee  for consideration
for action (discussion, deliberation and decision , and recommendations ).

8. WG Meeting Summaries : Meeting  minutes will be created to capture the information gathered
during each Meeting Administration and Planning WG meeting and teleconference.

9. WG finding s: The Meeting Administration and Planning WG will present any products to the
ACIP  DFO and at the ACIP meeting, as applicable .  Final versions of any products that may be
produced and  presented at the ACIP parent committee meeting will be included in the
committee’s official records.

10. WG Record Keeping : All CDC FACA committees, subcommittees, and WGs are subject to the
Federal Records Act.  All records will be uploaded in the Federal Advisory Committee
Management Portal.  The summary report of WG meeting activities and other WG documents
will become part of the ACIP’s official records as required by GENERAL RECORDS
SCHEDULE 6.2: Federal Advisory Committee Records .

RECORDKEEPING and REPORTING

The WG will share approved products with the ACIP DFO and at ACIP meeting , if applicable.

Summary: Page 1 of 3   Advisory Committee on Immunization Practices ,  Centers for Disease Control and Prevention (ACIP, CDC)   Meeting Administration  and Planning  Workg roup   Terms of Reference   UPDATED:  January 21, 2026       PURPOSE     This document defines the activities, membership, and administrative requirements associated  with the establishment of a Meeting Administration and Planning Workgroup (WG)  under  the Advisory Committee on Immunization Practices, Centers for Disease Control and…


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 Advisory Committee on Immunization Practices ,
Centers for Disease Control and Prevention (ACIP, CDC)
Recommendation Methodology Review Workgroup
Terms of Reference
UPDATED:  January  21, 2026

PURPOSE

This document defines the activities, membership, and administrative requirements associated
with the establishment of a Recommendation Methodology Review Workgroup  under the
Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention
(ACIP, CDC).   ACIP utilizes subgroups of the Committee, known as Workgroups (WGs), to
develop options for presentation to the full ACIP  parent committee  during its public meetings to
facilitate discussion, deliberation , and development of recommendations.  ACIP WGs are
intended to augment the effectiveness of ACIP.  The direction, focus, and pace of both ACIP and
the individual WGs are guided by CDC and HHS policies and priorities, a s well as the need for
expert input to inform development of  CDC  immunization policy.

BACKGROUND

ACIP and its WGs  address a wide range of issues related to U.S. immunization policies and
practices.  Their work has primarily focused on three areas:  (1) recommendations for specific
populations regarding the use or non -use of immunization products for particular infections or
diseases (target indications); (2) recommendations on the optimal timing, dosing, and intervals of
immunization products; and (3 ) recommendations on the coordinated use of multiple licensed
immunization products across different target indications within the overall immunization
schedule.

ACIP provides evidence -based recommendations to the CDC Director on immunization policy.
A critical initial step in ACIP WG activities and committee deliberations is the prospective
formulation of clear, well -defined policy questions and related hypotheses.  Doing so requires
the use of an optimal and consistent framework to guide evidence review and decision -making.

TOPICS UNDER DISCUSSION
The WG will discuss  topics that will address  historical use and potential revisions to  ACIP
frameworks ; policy questions and evidence assessment  formulation ; vaccine timing, dosing and
scheduling considerations; implementation , economic , and resource considerations; uncertainty,
assumptions, and evidence gaps; and transparency and documentation.

DESCRI PTION of WORKGROUP  ACTIVITIES
The following activities provide a framework for the Recommendation Methodology Review
Workgroup multi -year efforts , which may involve input  from other Federal and private partners:
Page 2 of 4
 • Assess the manner and the consistency of the use of existing frameworks that have been
adopted and used by ACIP  and its workgroups  to facilitate evidence assessment,
decision -making and recommendations  – including Grading of Recommendations,
Assessment, Development and Evaluation ( GRADE ); and Evidence to Recommend ations
(EtR).
• Define Scope and Criteria – Establish decision criteria for evaluating processes for
developing discussion and presenting framing models that capture considerations related
to benefits, risks, uncertainties and ethics (to include rigor, transparency, usability,
adaptability, relevance, scalability, resource needs).
• Identify Relevant Models  – Compile a comprehensive inventory of nationally and
internationally used evidence frameworks , as well as models and frameworks to assess
benefits,  effectiveness, risk, safety , and uncertainty . This will include review of other
framework s used in public and private organizations responsible for high consequence
decision making (e.g., impacting lives and health of people)
• Conduct Systematic Evidence Scan  – Review literature, guidelines, and organizational
methodologies to gather detailed information on each identified model.
• Assess Each Model Components  – Evaluate (i) structure ; (ii) the way benefits, risks and
uncertainties are analyzed and presented; (iii) evidence appraisal methods ; (iv)  discussion
and decision framing;  (v) transparency ; (vi)  reproducibility ; (vii)  stakeholder -engagement
mechanisms, and other considerations.
• Engage Subject Matter Experts  – Consult with internal and external experts for input on
findings and capture practical insights on model implementation.
• Identify Strengths, Limitations , and Gaps  – Summarize benefits, constraints, and
contextual considerations for each model, including resource implications.
• Determine Ideal or Hybrid Model  – Present the model (or combination of components
from multiple models) that best aligns with ACIP needs and broader system goals.
• Develop Summary Report  – Prepare a concise report outlining methods, findings,
comparisons, and the final options .
• Present Findings  – Deliver a briefing with options/findings , rationale, and proposed next
steps for adoption or further refinement  at an upcoming ACIP meeting .

MEMBERSHIP

The Recommendation Methodology Review Workgroup is chaired by one of the ACIP members
appointed to serve as a Special Government Employee.   The ACIP DFO or a designee will serve
as the Workgroup Lead (WGL) .  The WGL and the ACIP DFO , in consultation with WG Chair ,
determine  the WG’s membership , work priorities , and deliverables  for presentation to the full
committee .  Other federal staff (e.g., HHS leadership) and members of liaison representatives ,
and additional external subject matter experts may be invited to join workgroup meetings on an
ad hoc basis, to provide expertise as needed but will not participate as members of the
workgroup  or participate  in any deliberations or WG discussions .

Workgroup Membership : The Recommendation Methodology Review Workgroup  is comp osed
of a WG Chair and up  to 5 additional ACIP voting members  given their professional, scientific,
and technical  expertise ; and vested interest in ensuring the success of the ACIP meetings.   They
are experts who are regarded as an authority or a practitioner of unique competence and skill by
Page 3 of 4
 other persons in their profession or occupation.  Upon request, HHS federal agencies named in
the ACIP charter may also appoint members to serve on WGs.

MEETINGS, ADMINISTRATION, and TIMELINES
1. Administrative Oversight : The  WGL will work with the WG Chair to arrange meetings,
document meeting proceedings , and may provide presentations about the WG activities and
findings to the ACIP .

2. Meeting frequency  and location : The  Recommendation Methodology Review Workgroup  will
meet  on an as needed basis as determined by the WG Chair , WGL, and ACIP DFO . All
Recommendation Methodology Review Workgroup  meetings are convened virtual ly via
teleconference.

3. Meeting structure : In addition to the WGL, at least two ACIP parent committee members (one of
whom serves as  the Recommendation Methodology Review Workgroup  Chair)  must be present
at each meeting for a quorum .  An agenda, relevant publications, and background documents  will
be circulated as read ahead mat erial prior to each meeting.

4. Conflicts of Interest : N/A.

5. Confidentiality : The discussions of the Recommendation Methodology Review Workgroup  may
include information that is unpublished, protected, privileged, or confidential .  Discussions
within the workgroup will be kept confidential.   Information of this nature must not be
disseminated, distributed, or copied to persons not authorized to receive such information.   When
these types of information are distributed, the person/s presenting will identify the information as
such, so all members are duly informed; and written materials shall be clearly marked as such.
Unlike ACIP parent committee meetings, which are open to the public, Recommendation
Methodology Review Workgroup  teleconferences are not subject to the open meeting
requirements  of the Federal Advisory Committee Act or the GSA Final Rule ; data presented
during these meetings/teleconferences are often proprietary and should not be distributed to
people other than approved workgroup  members.

6. CDC Staff Involvement :  The CDC staff engaged in the ACIP Recommendation Methodology
Review Workgroup  include the ACIP DFO and designee .  Consultation or information al
presentations by CDC staff may be requested by the WG .  CDC staff do not serve as members of
the Recommendation Methodology Review WG but may be asked to provide administrative
support and technical expertise to ACIP WGs, bringing subject matter expertise and current
professional focus in areas relevant to the goa ls of the WG.   Consultation or informational
presentations by CDC staff will be transparent and evident to minimize the risk of, or the
appearance of, undue influence that would compromise the independence of the WG.  The
ACIPDFO and WGL of the Recommen dation Methodology Review WG, in consultation with
the WG Chair, will monitor the interaction between the WG and the agency staff to ensure that
the WG activities and work products are appropriate and that there is not undue influence by the
CDC or by any special interest group on the activities or work products of the WG.

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 7. Timelines : ACIP WGs are established when needed and  terminated once the activities and work
products stated in the terms of reference have been completed  and the  WG’s charge has been
fulfilled .

8. Subject content : Findings  and opinions of the Recommendation Methodology Review
Workgroup  members will be discussed at ACIP meetings.  Where applicable, t he
Recommendation Methodology Review Workgroup’s  findings will be presented to the ACIP
parent committee  for consideration for action (discussion, deliberation and decision , and
formulations of recommendations ).

9. Workgroup Meeting Summaries : Meeting  minutes will be created to capture the information
gathered during each Recommendation Methodology Review Workgroup  meeting and
teleconference.

10. Workgroup finding s: The Recommendation Methodology Review Workgroup  will present
briefing documents, background materials, presentations to the ACIP parent committee for
consideration and deliberation in a public meeting.  Final versions of all products /slides
presented at the ACIP parent committee meeting will be included in the committee’s official
records  and uploaded into the Federal Advisory Committee Management Portal .

11. Workgroup Record Keeping : All CDC FACA committees, subcommittees, and WGs are subject
to the Federal Records Act.  All records will be uploaded in the Federal Advisory Committee
Management Portal.  The summary report of WG meeting activities and other WG documents
will become part of the ACIP’s official records as required by GENERAL RECORDS
SCHEDULE 6.2: Federal Advisory Committee Records .

RECORDKEEPING and REPORTING

The Workgroup will present findings/outcomes/observations to the ACIP parent committee for
discussion, deliberation, and potential adoption  in an open public forum.

Summary: Page 1 of 4   Advisory Committee on Immunization Practices ,  Centers for Disease Control and Prevention (ACIP, CDC)   Recommendation Methodology Review Workgroup    Terms of Reference   UPDATED:  January  21, 2026    PURPOSE     This document defines the activities, membership, and administrative requirements associated  with the establishment of a Recommendation Methodology Review Workgroup  under the  Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention …


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Advisory Committee on Immunization Practices  (ACIP)
Centers for Disease Control and Prevention (CDC)
Respiratory Syncytial Virus (R SV) Immunization Workgroup, Materna l, Infant, Adult
Terms of Reference
UPDATED: December  18, 2025

PURPOSE
This document defines the activities, membership, and administrative requirements associated
with the establishment of a  Respirat ory Sync ytial Virus  (RSV)  Immunization Workgroup for
patients of all ages under the Advisory Committee on Immunization Practices, Centers for
Disease Control and Prevention (ACIP, CDC).  ACIP utilizes subgroups of the Committee, known
as Workgroups (WGs), to review relevant published and unpublished data, and clinical and
scientific knowledge, and develop options for presentation to the full ACIP parent committee during its public meetings  to facilitate discussion, deliberation and development of
recommendations. ACIP WGs are intend ed to enhance the effectiveness of ACIP.  The direction,
focus and pace of both ACIP and the individual WG’s are guided by CDC and HHS priorities, and by the need for expert advice to inform development of immunization policy. ACIP WGs
serve a key scientific role in support of immunization recommendations.
 The RSV Immunization WG has been established to review data as well as scientific and clinical knowledge on RSV vaccine products and monoclonal antibodies currently in use or under
consideration for the prevention of severe RSV infection in both the infant  and at -risk adult
population. These findings will be presented to the full ACIP  parent committee  in a public forum
and will be considered in the formulation of recommendations regarding the use of these
products to the Director of the CDC.
  BACKGROUND
RSV is a viral illness primarily affecting infants , but older children and adults with certain co -
morbidities  or of older age  are also at risk of serious disease. Infants who get RSV almost always
have symptomatic disease. While the majority of RSV infections are mild —70% -- and localized
to the upper airway , RSV can also cause severe illness such as bronchiolitis (inflammation of the
small airways in the lungs) and pneumonia (infection of the lungs).  Before the introduction of universal RSV immunization recommendations for infants in 2023, RSV was the leading cause of hospitalization among U.S. infants (aged <12 months): an estimated one ( 1)%–three ( 3)% of
infants w ere hospitalized for RSV each year , accounting for the largest non- birth hospital ization
health care expenditures in the US for children under five (5 ).  Adults, unlike infants, may not
always show symptoms after infection with RSV . However, some  adults , including those with
certain medical conditions, especially those associated with respiratory compromise and immune compromise, are at risk of severe disease including pneumonia, exacerbation of underlying chronic conditions such as heart failure and chro nic obstructive pulmonary disease (COPD), and
death. Older adults are also at increased risk of severe RSV disease and at increased risk of
declining functional status after RSV infection.

CDC recommends several U.S. Food and Drug Administration (FDA) -approved products to
provide active or passive immunity to the at -risk populations . One such product is a recombinant
protein subunit vaccine with ASO1E adjuvant approved by FDA on May 3, 2023 for adults 60
years of age and older  for the prevention of lower respiratory tract disease (LRTD) caused by
RSV. In July 2025 FDA announced the agency  also accepted an application to review use of this
same product for  adults  aged  18-49 years at increased risk of LRTD caused by RSV .
 A second product is  a bivalent recombinant protein subunit vaccine with no adjuvant, approved
by FDA  on:

• May 31,2023 for adults 60 years of age and older  for the prevention of LRTD ;

• August 21, 2023 for maternal vaccination at 32- 36 weeks ’ gestation  for prevention of
LRTD in infants through 6 months of age ; and approved

• October 22, 2024 for adults ages 18 -59 with risk factors  for the prevention of LRTD .

Both protein subunit vaccines target sites on the pre- fusion F (preF) protein on the surface of the
RSV virus .
 A third product  is an mRNA -based vaccine approved  by FDA  on May 31, 2024,  fo r adults  60
years of age and older  for the prevention of LRTD caused by RSV , and approved by FDA  on
June 12, 2025 for those age d 18- 59 years at increased risk of LRTD caused by RSV .  This
product also targets the preF protein.
 For the indication of protection of adults, two of the products have shown significant efficacy in
randomized clinical trials  against preventing lower respiratory tract illness (LRTI) and
effectiveness in post -licensure observational studies  against hospitalization.  For the indication of
maternal use of RSV vaccine to protect infants after birth, randomized clinical trials for one of
these products have also demonstrated efficacy  and a postmarketing real world effectiveness
study also showed the vaccine to be effective .
 Two of the available products  have been associated with rare but significant adverse reactions in
older adults , notably Guilla in-Barrè Syndrome . There was also an imbalance of atrial fibrillation
in the clinical trials for the use of these vaccines in adults 60 and older, but no signal has emerged in post -marketing studies to date, though safety surveillance is ongoing. No cases of
Guillain -Barrè Syndrome have been reported in pregnant women after RSV vaccination.
 One product has  also shown significant efficacy in preventing L RTI in randomized clinical trials .
Because approval of this product was more recent than for  other available products  and uptake of
this product has been lower, there are not yet post -licensure observational studies of vaccine
effectiveness available.
 In addition to vaccines there are three  monoclonal antibody products now available for newborn
infants  and some older children, each providing long- term passive immunity (One product was
approved by FDA  in 2023 for use in infants born during or entering their first RSV season and
children up to 24 months of age who remain vulnerable to severe RSV disease through their
second RSV season . A second product clesrovimab was approved by FDA in June 2025 for
infants born during or entering their first RSV season. CDC recommends e ither product  for
infants younger than 8 months born during or entering their first RSV season; for children ages 8 through 19 months who are at  increased risk of severe RSV disease and entering their second
RSV season, only one is recommended.  A third product, was  first approved in the United States
on June 19, 1998 and will be available until the end of December, 2025.  Two of the products
have  both shown significant efficacy in randomized clinical trials against preventing RSV -
associated medically attended lower respiratory tract illness (RSV MA -LRTI)  and RSV MA -
LRTI with hospitalization. P ost-licensure observational studies  have demonstrated that one
product  is effective in preventing RSV -associated  hospitalization .
 The WG will engage external subject matter experts, as needed, to support presentations to the WG members and development of materials for presentation  to the parent committee for its
deliberations.
 TOPICS FOR DISCUSSION BY THE WORKGROUP
The topics for discussion by the RSV immunization workgroup can be most efficiently described
by breaking them into two groups: 1)  adult populations (18 -49 with risk factors, 50 and older
with risk factors, and those 75 and above) ; and 2) the maternal -infant group  (for which there is
currently a recommendation for all newborns), as well as use of a monoclonal antibody product in the second RSV season for  young children susceptible to serious RSV disease, including
groups such as all American Indian /Alaska Native infants.  The WG will work on questions and
topics described below and prepare deliverables for the ACIP parent committee to consider.
 Adults :
Ages 18- 49 years.  The CDC is being asked to consider a recommendation for vaccination of
persons in this age cohort with ‘risk factors’ making them susceptible to severe RSV infection.  This raises several questions for the WG , for example:
• What is the scope of the problem?  How many patients in this cohort are admitted to the
hospital annually for RSV LRTI.  What are the outcomes data?  What is the total number
of hospitalizations for LRTI of all causes in this group?
• What are the specific risk factors that have been identified as being significant?
• How are these risk -factors measured for severity?
• What are the critical values, (i.e. FEV1 in the case of obstructive airway disease, cardiac
output for those with congestive heart failure, A1C for diabetics, Creatinine levels for
chronic renal failure patients , psychiatric assessments for patients with psychoses, etc.).
• What congenital or other anatomic abnormalities are of concern ?
• What living situations , in addition to a nursing home environment , are considered to be
high risk?  This information is essential for both patients a nd for the physicians caring for
them responsible for providing adequate education for informed consent  (noting that
informed consent is a matter under state law).
• Will boosters be necessary, and if so, how often?
• What are the results of o ngoing monitoring of post -licensure safety and adverse events ?

Age 50 and older with risk factors :
• What is the scope of the problem?
• What are the defined risk  factors, how they are measured, and the critical values?
• Will boosters be needed?  The duration of immunity in this cohort is currently unknown.

Age 75 and older :
• Currently this is a universal recommendation.  The WG should provide updates on
hospitalization rates of those vaccinated and unvaccinated, outcomes, and deaths attributed to RSV infection.  How many admissions for LRTI for any etiology are there in this cohort?
• The WG should provide updates  on the incidence of serious adverse events for all who
have been vaccinated, broken down by specific vaccine.  This cohort is particularly
susceptible.

Maternal -Infant and young children with risk factors :
• What is the uptake of the maternal vaccine and how does it compare with administration
of monoclonal antibodies to newborns?
• The WG should provide updates on rates of RSV -associated hospitalization in infants
who do not receive protection from either maternal vaccination or a monoclonal antibody,
in infants born to mothers that received maternal vaccination, and in infants that have received monoclona l antibodies only.
• What is the number needed to treat to prevent a hospital admission, an ICU admission, or death?  How does that compare with the number needed to vaccinate to see a significant adverse event for each product?
• The WG should provide a  thorough review of the data presented at the last ACIP meeting
in June 2025 regarding the safety of relevant RS V products .  This would include the
study design, the original description of the study groups. and a reanalysis of the safety data using more sophisticated methodologies.
• The WG should review all raw data on the RCTs including  data from  the ongoing trials of
RSV products.
• The WG should address a ny significant aberration or discrepancy between what was
presented in June and what is found on re -analysis that may  trigger  a review of the  ACIP
recommendation regarding other RSV products ?What  are the results of o n-going review s
of post -marketing surveillance  of the immunization products?
  MEMBERSHIP  AND LEADERSHIP
  Workgroup Leadership:  The RSV Immunization WG is chaired by one of the ACIP, CDC parent
committee members. The Workgroup Lead (WGL) is a federal employee, identified by the
Immediate Office of the Director in consultation with the appropriate CDC program. The WG Chair, in consultation with the WGL, and ACIP CDC Designated F ederal O fficial (DFO),
determines the WG’s membership and work priorities and deliverables to the full committee.   The DFO may further assign  some of the  DFO -related roles and responsibilities , as
appropriate, to the WGL.

Workgroup Membership:  The RSV Immunization WG is composed of experts who are appointed
based on their professional, scientific, technical, or other expertise.  They are experts who are
regarded as an authority or a practitioner of unique competence and skill by other persons i n their
profession, or occupation. Upon request, HHS federal agencies named in the ACIP charter may
also appoint members to serve on WGs. The RSV Immunization WG will be composed of members from a variety of disciplines. The WG will en gage with the following disciplines on
WG activities:

• Public health science and practice;
• Public health policy development, analysis, and implementation, including development and execution of immunization programs for children and adults;
• Clinical and medical practice, and patient- care experience;
• Epidemiology;
• Molecular biology;
• Immunology;
• Virology;
• Diagnostics and correlates of protection;
• Drug and vaccine safety;
• Bioethics; and
• Consumer perspectives and/or social and community aspects of immunization programs
  Due to the complexity and variability of the information to be gathered, additional external subject matter experts may also be invited to provide data and presentations to the WG and answer questions during RSV Immunization WG meetings on an a d-hoc basis. Such additional
external subject matter experts will not be members of the WG and will not participate in any
deliberations or WG discussions.

 MEETINGS, ADMINISTRATION, and TIMELINES

1. Administrative Oversight: The  WGL will work with the WG Chair to arrange meetings,
document meeting proceedings, and report to the ACIP on the RSV  Immunization WG’s
activities and findings.
2. Meeting frequency and location : The  RSV Immunization WG will meet on an as needed
basis as determined by the WG Chair and WGL. All RSV  Immunization WG meetings
are convened virtually via teleconference.
3. Meeting structure : In addition to the WGL, at least two ACIP parent  committee members
(one of whom serves as the RSV  Immunization WG Chair) must be present at each
meeting for a quorum.  An agenda, relevant publications, and background documents will
be circulated as read -ahead material before each meeting.
4. Conflicts of Interest : WG  members will complete an ACIP WG Agreement and Conflict
of Interest Certification process before participation on the WG.   The WGL  will screen
for conflict -of-interest  declarations and share any conflicts that need to be elevated to the
DFO/ACIP Secretariat .  The ACIP Secretariat and DFO , in collaboration with the WGL
will work with Ethics office within the Office of Strategy Business Initiatives (OSBI) and
the Office of General Counsel (OGC), as needed, to resolve any conflicts th at the WGL
identifie d.  WG members will consent to abide by guiding principles and disclose
interests (e.g., employment, special interests, grants, or contracts) that a reasonable
person could view as conflicts or potential conflicts of interest with their RSV
Immunization WG participation.   Members will also disclose any potential conflicts of
interest before each meeting.   If an  RSV Immunization WG member indicates a potential
or actual conflict of interest to the WGL, the WGL or a delegate will  forward  any
conflicts to the DFO to determine whether the individual must recuse themselves from participating in WG discussions that implicate such a conflict -of-interest concern.   If
needed, the  DFO will engage OSBI and OGC to assist with making COI determination.
5. Confidentiality : The discussions by the RSV Immunization WG may include information
that is unpublished, protected, privileged, or confidential. WG deliberations, including policy options under consideration by the WG, are also considered confidential.   Information of this nature must not b e disseminated, distributed, or copied
to persons not authorized to receive such information.  When these types of information
are distributed, the person  presenting will identify the information as such, so all
members a re duly informed; and written materials shall be clearly marked as
such.  Unlike ACIP  parent committee  meetings, which are open to the public, RSV
Immunization WG teleconferences are not subject to the open meeting requirements of the Federal Advisory Committee Act or the GSA Final Rule; data presented during these meetings/teleconferences are often proprietary and should not be distributed to peopl e
other than approved RSV  Immunization WG members.
6. CDC Staff Involvement: CDC staff do not serve as members of the RSV Immunization
WG but may provide administrative support and technical expertise to ACIP WGs, as appropriate, bringing subject matter expertise and current professional focus in areas
relevant to the goals of the RSV Immunization WG.  Consultation or informational
presentations by CDC staff will be transparent and evident to minimize the risk of, or the
appearance of, undue influence that would compromise the independence of the
WG.   The DFO a nd WGL of the RSV Immunization WG, in consultation with the Chair
of the RSV Immunization WG, will monitor the interaction between the WG and the agency staff to ensure that the WG activities and work products are appropriate and that there is no undue influence by the CDC or by any special interest group on the activities or work products of the WG.
7. Timelines : ACIP  WGs are established when needed and terminated once the activities
and work products stated in the terms of reference have been completed and the WG’s charge has been fulfilled.
8. Workgroup Meeting Summaries:  Meeting minutes will be created to capture the
information gathered during each RSV  Immunization WG meeting and teleconference.
9. Workgroup findings : The RSV Immunization WG will present findings (briefing
documents, background materials, and presentations) to the ACIP  parent committee for
consideration and deliberation in a public meeting.  Final versions of all slides presented at the ACIP  parent committee  meeting will be posted on the ACIP website following the
meeting and included in the committee’s official records.
10. Workgroup Record Keeping: All CDC FACA committees, subcommittees, and WGs are
subject to the Federal Records Act.   All records will be uploaded to the Federal Advisory
Committee Management Portal.  The summary report  of WG meeting activities  and other
WG documents will become part of the ACIP’s official records as required by GENERAL RECORDS SCHEDULE 6.2: Federal Advisory Committee Records .

RECORDKEEPING and REPORTING
The WG Chair and WGL will present  findings/outcomes/observations/recommendations to the
ACIP parent committee for discussion, deliberations, further development of recommendations, and vote in an open public forum. Approved ACIP recommendations adopted by the CDC Director will be posted on CDC’s ACIP website and al so published in the Morbidity and
Mortality Weekly Report (MMWR). In addition, approved ACIP recommendations will be included in the ACIP meeting minutes and annual report.

Summary: Advisory Committee on Immunization Practices  (ACIP)   Centers for Disease Control and Prevention (CDC)   Respiratory Syncytial Virus (R SV) Immunization Workgroup, Materna l, Infant, Adult   Terms of Reference   UPDATED: December  18, 2025      PURPOSE   This document defines the activities, membership, and administrative requirements associated  with the establishment of a  Respirat ory Sync ytial Virus  (RSV)  Immunization Workgroup for  patients of all ages under the Advisory Committee on…


ACIP Evidence to Recommendations Framework cdc

ACIP Evidence to Recommendations Framework

Question: Overarching policy question to be answered by the guideline panel (ACIP)  using the Evidence to Recommendations (EtR) frame work.
The quest ion shou ld be precise and ident ify the specific interv ention, compar ison, and outcome, as w ell as the tar get popul ation and t he setting
(specific s ubpopul ations) in PICO format.
Popula tion: Target popul ation  for vaccine (e.g., a ge range, se x, immune sta tus, pregnancy )
Intervention: Vaccination (if appl icable, dosag e and sc hedul e)
Compa rison(s): No Vaccination/S tandard  of care/An existing vaccine/O ther prevention option
Outcome : Outcome(s) associated with vaccination  (e.g., prevention outcomes or adverse effects)

Background: The addressed PICO question should be described in detail, and important background information for understanding the questio n
and why a recommendation or decision is needed should be briefly provided.  If a recommendation is preferential or represents off-label use,
this should be indicated.
Include sample language: Additional background information supporting the ACIP recommendations on the use of xxx vaccine can be found in
the relevant publication of the recommendation referenced on the ACIP website .

 WORK GROUP  JUDGMENTS  EVIDENCE  ADDITIONAL INFORMATION  PROBLEM  Is the problem of public health importance?

○ No
○ Probably no
○ Probably yes
○ Yes

○ Varies
○ Don't know  Provide available  scientific evidence on
burden of  disease, preferably within the
target population for the
recommendation.

If no published evidence is available,
provide expert judgment on the  public
health priority  considerations.  Identify any additional public health
priority  considerations, including
consideration of disparities.

WORK GROUP JUDGMENTS  EVIDENCE  ADDITIONAL INFORMATION  BENEFITS & HARMS  How substantial are the desirable
anticipated effects?
○Minimal
○S
mall
○M
oderate
○L
arge
○Va
ries
○D
on't knowDescribe the magnitude of the  beneficial
effects of vaccination  on individual
(vaccine  effectiveness, duration of
protection) and population  (herd
immunity) levels.   Take into consideration:
Is the baseline benefit similar across
subgroups (by age, sex,  pregnancy or
lactation s tatus, occupation [ i.e., healthcare
workers], immune s tatus, r ace, S ES, and
other gr oups)?
Are there indirect ef fects that should b e
considered ( e.g.,  herd i mmunity)?
How substantial are the undesirable
anticipated effects?
○Minimal
○S
mall
○M
oderate
○L
arge
○Va
ries
○D
on't knowAre there undesirable effects of the
vaccine, either on the individual (e.g.,
adverse events following immunization) or population (e .g., age -shift of disease,
serotype replacement) levels?  Take into consideration:
Is the baseline risk for harm similar across subgroups (see above)?
S
hould there be separate recommendations
for subgroups based on harms?
Do the desirable effects outweigh the
undesirable effects?
○Favors interventionl
○F
avors comparison
○F
avors both
○F
avors neither
○Va
ries
○D
on't knowDescribe the balance of benefits of the
vaccine with possible harms (individual and population level).

 WORK GROUP JUDGMENTS  EVIDENCE  ADDITIONAL INFORMATION
 What is the overall certainty of this
evidence for the critical outcomes ?

Effectiveness of the intervention
○ No  studies found
○ 4 (very low)
○ 3 (low)
○ 2 (moderate)
○ 1 (high)

Safety of the intervention
○ No studies found
○ 4 (very low)
○ 3 (low)
○ 2 (moderate)
○ 1 (high)
 Please refer to GRADE evidence profiles  for
detailed assessment of the certainty of the
evidence. For more information, please see the
 ACIP Handbook for Developing Evidence -
Based Recommendations.   If GRADE was n ot used to evaluate the
certainty of evidence, please provide
justification and the method and outcome of any other tools used to evaluate the body of evidence relevant to the critical outcomes.  VALUES  Does the target population feel that the
desirable effects are large relative to
undesirable effects?

○ No
○ Probably no
○ Probably yes
○ Yes

○ Varies
○ Don't know  Provide any available evidence on target
population values & preferences related to
vaccination and comparative health benefits
and risks. Describe the source of these estimates.  Are values and preferences for relevant
outcomes measured?  Are the benefits,
harms and costs of vaccination valued
differently by different subgroups?
  If the target group doesn’t value the intervention, or attributes little value to the
harms and benefits, consider whether potential education measures are needed.

 WORK GROUP JUDGMENTS  EVIDENCE  ADDITIONAL INFORMATION
Is there important uncertainty about or
variability in how much people value the
main outcomes?

○ Important uncertainty or variability
○ Probably important uncertainty or variability
○ Probabl not important uncertainty or variability
○ No important uncertainty or variability
○ No known undesireable outcomes
 Please provide available data used to
determine the relative importance that the
target population attributes to the desirable
and the undesirable outcomes related to the
intervention as well as the comparison.  Describe the source of variability, if any.

Are there methods for determining values
satisfactory for this recommendation?

If not, systematic assessment of values and
preferences of target group may be
considered.  ACCEPTABILITY  Is the intervention acceptable to key
stakeholders?

○ No
○ Probably no
○ Probably yes
○ Yes

○ Varies
○ Don't know
 Provide assessment of whether intervention
would be acceptable to stakeholders
(ethically, programmatically, financially, etc.)   RESOURCE USE  Is the intervention a reasonable and
efficient allocation of resources?

○ No
○ Probably no
○ Probably yes
○ Yes

○ Varies
○ Don't know
 Provide summary of cost -effectiveness
analyses (CEAs) of the vaccine in the target
population. Include base case results and a
sensitivity range. Include any other notable
findings, for example, specific policy -
relevant scenario s.  Overall findings: Summarize the findings
from available CEAs, including major
differences in baseline assumptions.

Uncertainty: Does the analysis capture the
full range of uncertainty? For example, are
the findings from the uncertainty of
evidence ana lysis, identified earlier in this
document (the EtR Framework),
appropriately represented in the methods of
the CEAs?

Multiple assessments: Are there multiple
CEAs? If so, what are the major differences
in methods and results?

 WORK GROUP JUDGMENTS  EVIDENCE  ADDITIONAL INFORMATION  EQUITY  What would be the impact on health
equity?

○ Reduced
○ Probably reduced
○ Probably no impact
○ Probably increased
○ Increased

○ Varies
○ Don't know
 Summarize the findings from a review of the
literature addressing issues of health inequities or groups who may be disadvantaged.  Consider from the evidence or guideline
panel:
• Are there any groups or settings that might be disadvantaged in relation to
the problem or options that are
considered?
• Are there plausible reasons for
anticipating differences in the relative effectiveness of the option for disadvantaged groups or settings?
• Are there different baseline conditions across groups or settings that affect the
absolute effectiveness of the option o r
the importance of the problem for
disadvantaged groups or settings?
• Are there important considerations
that should be made when implementing the intervention (option) in order to ensure that
inequities are reduced, if possible,
and that they are not incr eased?  FEASIBILITY  Is the intervention feasible to implement?

○ No
○ Probably no
○ Probably yes
○ Yes

○ Varies
○ Don't know
 Are there any barriers to implementation?
 Please refer to the Implementation
Considerations checklist.
Balance of
consequences  Undesirable
consequences
clearly outweigh
desirable
consequences
in most settings  Undesirable
consequences
probably outweigh
desirable
consequences
in most settings  The balance
between
desirable and
undesirable
consequences
is closely balanced
or uncertain
 Desirable
consequences
probably outweigh
undesirable
consequences
in most settings  Desirable
consequences
clearly outweigh
undesirable
consequences
in most settings  There is
insufficient
evidence to
determine the
balance of
consequences
 ○ ○ ○ ○ ○ ○
Is there sufficient information to move forward with a recommendation?
Yes   ○                                              No   ○

Policy options for
ACIP consideration
ACIP does not recommend the
intervention*
*Intervention may be used within
FDA licensed indications

ACIP recommends the intervention
for individuals based on shared
clinical decision -making
ACIP recommends the intervention
 ○ ○ ○

Draft
recommendation
(text)  Please provide the draft recommendations proposed to ACIP.

Additional
considerations
(optional)  Please outline any significant additional considerations (e.g., aspects related to implementation, monitoring and
evaluation, research priorities, etc.).

Final deliberation and decision by the ACIP

Final ACIP
recommendation

ACIP does not recommend the
intervention*
*Intervention may be used within FDA
licensed indications

ACIP recommends the intervention for
individuals based on shared clinical
decision -making
ACIP recommends the intervention

 ○ ○ ○
Additional ACIP
considerations
 Wording as accepted in the guide

Summary: ACIP Evidence to Recommendations Framework     Question: Overarching policy question to be answered by the guideline panel (ACIP)  using the Evidence to Recommendations (EtR) frame work.  The quest ion shou ld be precise and ident ify the specific interv ention, compar ison, and outcome, as w ell as the tar get popul ation and t he setting  (specific s ubpopul ations) in PICO format.   Popula tion: Target popul ation  for vaccine (e.g., a ge range, se x, immune sta tus, pregnancy )    …