Work Group Guidance 508

ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES :
WORK GROUPS
Standard Operating Procedures: August 201 8

Advisory Committee on Immunization Practices Secretariat
Centers for Disease Control and Prevention

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Contents
I. Overview of Advisory Committee on Immunization Practices Work Groups  ..... 2
II. Work Group Membership  ................................ ................................ ........................  4
III. Roles and Responsibilities ................................ ................................ .........................  6
IV. Work Group Teleconferences and Meetings ................................ ...........................  8
V. Confidentiality  ................................ ................................ ................................ ...........  9
VI. Pharmaceutical Companies and Work Groups  ................................ ....................  10
VII.  Work Group Resources  ................................ ................................ ..........................  12
VIII.  Preparing for ACIP Meeting Presentations  ................................ ..........................  13
Submitting Agenda Items for ACIP Meetings  ................................ ................................ ...... 13
ACIP Briefing Do cuments  ................................ ................................ ................................ ...... 13
ACIP Background Materials  ................................ ................................ ................................ .. 13
ACIP Presentations  ................................ ................................ ................................ .................  14
IX. Evidence -Based Decision and Cost -effectiveness Analyses  ................................ .. 15
X. Preparing MMWR Reports  ................................ ................................ ....................  16
XI. Termination of Work Groups  ................................ ................................ ................  17
XII.  Appendices  ................................ ................................ ................................ ...............  18
Appendix 1 : Additional Information for FDA, ISO, and ISD Representatives to
ACIP WGs ................................ ................................ ................................ ................................  18

I. Overview  of Advisory Committee on Immunization Practices
Work Groups
The role of the Advisory Committee on Immunization Practices (ACIP) is to assist the
Centers for Disease Control and Prevention (CDC) and the Department of Health and
Human Services (HHS) in developm ent of public policy related to immunization of the
civilian population in the United States. ACIP  utilizes subgroups of the Committee, known
as work groups (WGs), to review  relevant published and unpublished data and develop
recommendation options for  presentation  to the ACIP . ACIP WGs are intended to augment
the effectiveness of ACIP.  The direction, focus , and pace of both ACIP and the individual

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 WGs are guided by CDC and HHS priorities , and by the perceived need for expert advice to
inform  developmen t of immunization policy.
ACIP WGs  are responsible for collection, analysis , and preparation of information for
presentation, discussion, deliberation , and vote by the ACIP in an open public forum. WGs
review specific topics in detail and elucidate issues  in a manner that facilitates informed
and efficient decision making  by ACIP voting members .
Five WGs —the Adult Immunization, General Recommendations, Child/Adolescent
Immunization, Evidence Based Recommendations, and Influenza  WGs —are permanent .
The remaining WGs are task oriented ; such t ask-oriented WGs are developed in response
to specific needs and are disbanded when the task at hand has been completed. A list of
WGs that are currently active can be obtained from the ACIP Secretariat  or the ACIP
website .
Q.: When is the appropriate tim e to establish  an ACIP WG?
A.: ACIP WGs should be established  when :
•  Updates to existing recommendations are anticipated based on availability of new
data ( regarding safety, effectiveness, and/or programmatic  issues, e.g., vaccine
administration or storage ).
• Licensure of a new vaccine or new indications for existing vaccines are anticipated.
o In general, WGs should begin reviewing data 12 -18 months prior to a
potential decision on licensure ; the le ngth  of time required for the WG to
review data in anticipation of vaccine licensure will depend upon the
complexity of the topic, and the amount of available data  that exist s.
o Immunoglobulin therapies , monoclonal antibodies,  and/or antimicrobial
agents may be considered by ACIP only in relation to control of a disease for
which there is a vaccine av ailable or under consideration.
• Existing ACIP recommendations should be reviewed on a regular basis , at least
every 7 years, and either revised , renewed , or retired  with a vote  by ACIP.  The ACIP
Secretariat will establish a WG if review of the recommendations identifies a need
to revise  the recommendation s.
Each WG operates under specific Terms of Reference (TORs) determined by th e WG Chair
(see below ) and WG Lead  (see below ) at the time the WG is formed. The WG Chair and WG
Lead, in consultation with other CDC staff, should re-evaluate  the TOR s annually . TORs
should be formalized annually  to provide documentation of the WG priorities for each

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 year.  TORs will be included on the ACIP website along with a listing of current WG
members and will be updated annually.
TORs should be sent to potential WG members as the WG is being formed.  Addition ally,
TORs should be included in the WG Chair presentation to ACIP annually to ensure
transparency.  Examples of WG TORs can be obtained from the ACIP secretariat. TORs
should be brief (<1 page) and include  the following sections:
• Purpose o f the WG
• Policy Topics Under Consideration by the WG
• WG Activities
Q.: How frequently should WG TORs be evaluated and/or updated?
A.: TORs  should be re -evaluated when major tasks are completed ; when the WG Chair or
WG Lead change s; if new issues relevant to the WG arise ; when events result in shifts in
public heath priorities ; and annually  between the June and October ACIP meetings.
II. Work Group Membership
Each WG must include at least two voting members of ACIP , one of whom functions as WG
Chair . A CDC subject ma tter expert (SME) serves as WG Lead, and generally is selected by
the concerned CDC program . Other WG members may include ACIP ex-officio  members,
ACIP liaison representatives, and invited consultants. Most WGs should include a
representative from CDC’s Immunization Safety Office  and Immunization Services Division .
CDC staff may serve in a supportive or administrative function. During ACIP meeting
presentations, CDC staff should be listed on the WG membership slide separately from WG
members.
WGs  are encouraged to invite a consumer representative to join as an expert consultant .
An ideal consumer representative has experience or expertise relevant to the vaccine,
disease  or condition involved . It is desirable, though not required, that the individual  have
some degree of familiarity with vaccines. The WG should have a reasonable expectation
that the candidate will be able to engage in a dispassionate, unbiased review of data and
to comply strictly with the confidentiality requirements placed on all WG members. The
ACIP Secretariat can help identify potential consumer representatives.
In order to facilitate participatory discussion among all WG members, consideration should
be given to the overall number of WG members, including the invited liaison
repre sentatives and consultants serving on the WG , and the expertise each invited
consultant brings to the WG. The recommended size of a WG is <15 members, not

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 including CDC staff supporting the WG . WG members may change when the WG TORs
change  and should be reassessed annually .
Representatives of vaccine manufacturers may not serve as members of a WG but may , at
the discretion of the WG Chair and WG Lead, be invited  to make presentations to the
group and answer questions.  Experts  from the private sector who do not represent vaccine
manufacturers may be asked to make presentations to the WGs or to participate in
discussions at the discretion of the WG Chair and concur rence of WG Lead. Following these
presentations, non -WG members are asked to leave so that deliberations are limited to
members of the WG.
Participants in WGs are typically limited to U .S. residents , due to the increased cost of
international teleconferences, but exceptions occur when expertise is needed from
individuals living outside the U nited States .
Q.: How are WG members selected?
A.: The process for WG member selection is as follows.
• The ACIP Secretariat  will, in consultation with the WG Lead,  recruit one ACIP voting
member to serve as WG Chair , and at least one additional ACIP voting member.  The
ACIP secretariat will send an inquiry  to all current voting ACIP members to assess
interest.  The ACIP voting members and WG Chair will be determined based on
interest, need for expertise on the WG, and balancing ACIP members ’ available
time.
• As an ACIP voting member’s term expires, the perso n may continue to serve on the
WG in a consultant role at the discretion of the WG Chair and WG Lead.
• At the time new ACIP members begin their terms, the Secretariat will request a list
of the WGs they are interested in joining and balance these requests with the need
to fill voting member positions on WGs.  When feasible, the WG Chair will be
replaced by an ACIP voting member who has already been on the WG for a period of
time.  The WG Chair will be chosen by the WG Lead in consultation with the
outgoing WG Chair , but should be approved by the Secretariat in order to ensure
balance of workload among ACIP voting members.
• The WG Lead will be designated by the CDC Center, Institute, or Office  with
responsibility for the concerned program/vaccine to be considered.
• The WG Chair and the WG Lead, in consultation with the ACIP Secretariat , will
recruit additional members and consultants for the WG. The WG Chair and the WG
Lead should work closely together to determine priorities, process, direction , and
timeline for WG activities, again in consultation with the ACIP Secretariat .

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 • In consultation with the WG Lead and WG Chair, the ACIP Secretariat  will extend
invitations to those ex officio and liaison organizations  requested by the WG
Chair/ WG Lead for representation on the WG.  The organization or ex  officio agency
will designate the individual to represent the organization and agency and can
request a n alternate . When determining the organizati ons and ex officio liaisons to
include, the existing size of and the  relevance of the organization or ex officio
background to the WG TOR s. There should be an FDA liaison for each WG where a
new vaccine or indication is under consideration by the WG.
• The W G Lead should  extend requests fo r subject matter experts to serve as
consultants to participate on  a WG  to ensure there is adequate expertise on the WG
to provide evidence -based  information to support ACIP deliberations . Consultants
should serve as a resource to offer expertise on clinical, programmatic and basic
scientific aspects of the vaccine -preventable disease and vaccine, and other factors .
If these individuals do not have a conflict of interest (see below), consult ants may
participate in all discussions and deliberations. If a subject matter expert has a
conflict of interest, he/she may participate in scientific discussions but may not
participate in policy deliberations.
• A temporary consultant can be included in a WG to deal  with an important but
limited  policy topic (i.e., involving interpretation of information and policy
discussion over a period of months) .
III. Roles and Responsibilities
WG Chair
• Signs annual membership agreement form  (see A ppendix  1).
• Attends and participates in  WG meetings on a regular basis.
• Completes timely review of materials as requested.
• Works with the WG Lead to identify potential WG members .
• Reviews WG membership to ensure necessary expertise  is represented .
• Works with the WG L ead to set an agenda for WG meet ings and for timelines of
presentations at the full ACIP meetings.
• Provides overview presentation of WG topics at ACIP meetings , and other
presentations if needed .
• Co-authors  Morbidity and Mortality Weekly Report (MMWR)  Policy Notes and
Recommendations and Reports  (comprehensive ACIP recommendation document) .
ACIP Member (s)

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 • Signs annual membership agreement .
• Attends and participates in  WG meetings on a regular basis.
• Completes timely review of materials as requested.
• Co-authors  MMWR  Policy Notes and Recommendations and Reports  if authorship
criteria are met .
CDC WG Lead
• Works with WG Chair to identify potential WG members .
• Works with the WG Chair to set an agenda for WG meetings and for timelines of
presentations at ACIP meetings .
• Coordinates WG meeting s, documents roll call, takes minutes or designates
another person on the WG (e.g., other CDC staff member) to do so (see Work
Group Teleconferences and Meetings , below ).
• Coordinates developing agenda proposals, background and briefing documents,
and presentations on behalf of the WG for ACIP meeting s.
• Leads development of MMWR Policy Notes and Recommendations and Reports
documents.
• Attends and participates in monthly WG Lead meetings, routinely uploads
documents to the ACIP SharePoint site, completes a timely review of materials , and
responds to requests from the ACIP Secretariat.
• Works with the Adult Immunization and Child/Adolescent Immunization WG Lead
to rev iew immunization schedule footnotes annual ly.
Liaison Representatives and Ex-Officio  Members
• Signs annual membership agreement  and conflict of interest  form s.
• Attend s and participates in WG meetings on a regular basis .
• Completes  timely review of materials as requested .
• Communicate s the perspective  of the organization or agency  they  represent at WG
meetings .
• Additional information for FDA representatives to ACIP WGs can be found in
Appendix 2.
Consultants
• Signs annual membership agreement  and conflict of interest  form s.
• Attend s and participates in WG meetings on a regular basis .
• Completes  timely review of materials as requested .
• Serve s as a subject matter expert  during  WG meetings and calls .

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 CDC Staff
• Provide administrative support and technical expertise to ACIP WGs.
o CDC staff on WGs bring subject matter expertise and current professional
focus in areas relevant to the goals of the WG. CDC staff are aware of
agency priorities, and of current and antici pated policy issues that may arise
in association with the focus of each WG and are responsible for working
with the WG L ead to ensure that the focus, direction , and timing of WG
efforts remain compatible with the needs of CDC and HHS.
• As needed, p erform,  coordinate, or identify scientific studies and outbreak
investigations to address questions that arise regarding vaccine policy decisions;
conduct analysis of data addressing efficacy, effectiveness, safety, feasibility, and
economic aspec ts of immunizati on policy ; and participate in evaluation of quality of
the evidence, e.g. GRADE review .
• Additional information for ISO and ISD representatives to ACIP WGs can be found in
Appendix 2.
IV. Work Group Teleconferences and Meetings
WGs accomplish most of their work  through teleconferences. When the group is active, a
set day and time for routine monthly teleconferences (e.g., 2 PM EST on the last Friday of
the month) is usually established. This allows standing teleconferences to be arranged and
WG members to anticipate and reserve time for these teleconferences. The frequency of
WG teleconferences may change depending on the urgency of the issue (s) being
considered by the group.  Most WGs meet once per month, but some WGs meet twice
monthly, particularly in the time period leading up to an ACIP meeting when the WG may
need to meet more frequently.
Most WG teleconferences are held using a call -in number or Skype business
teleconfer ence  software , and are not operator assisted.  The same number may be used for
all teleconferences for a particular WG.  Teleconferences should not be recorded .
The development of a brief (1 -2 page) summary of each WG meeting will facilitate the
function of  the WG; the taking of minutes is best accomplished by a WG member other
than the WG Chair or the WG Lead , in order to allow the WG Chair and WG Lead to lead
and manage the meeting effectively. WG meeting minutes are confidential and may be
shared by the W G Chair/ WG Lead  with WG members.
Minutes and slides from each WG teleconference should be uploaded to the ACIP
SharePoint sites by the WG Lead on a regular basis (e.g., monthly or quarterly).

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 When needed, an in -person WG meeting may be arranged either immediately before or
after a full ACIP meeting.  The Secretariat cannot support these meetings  financially , but
may be able to reserve a room in the G lobal Conference Center  if a need is identified early.
In-person meetings should be used with discr etion : ACIP  voting members should primarily
focus on the public meeting discussions.  Please consult with the Secretariat prior to
scheduling an in -person WG meeting during an ACIP meeting.
Q.: Are there special considerations for WG meetings in relation to  FACA requirements?
A.: Yes. To be able to operate in closed meetings , ACIP WGs must observe certain guidelines
that allow them to function exempt from FACA requirements. ACIP WGs function in a fact -
finding role, do not include a quorum of voting ACIP memb ers, and do not vote on policy ;
they are therefore exempt from FACA requirements.
As FACA -exempt groups, ACIP WGs are not allowed to render consensus advice or
recommendations directly to the Federal government. ACIP WG Chairs, other WG
representatives, or the WGs per se are not empowered to speak on behalf of ACIP. Rather,
they are uti lized by ACIP  to gather and organize information upon which ACIP  can
deliberate and act.  Thus, while ACIP WGs can and should examine specific topics  in detail
and define the issues, including development of options for recommendations, the actual
processes  of group deliberation terminating in development of immunization
recommendations must occur in the open public forum of ACIP meetings in compliance with
FACA requirements.
Q.: How are “straw poll s” used during WG meetings?
A.: When there are several diff erent opinions about an issue expressed during a WG
meeting or the WG Chair and WG Lead  want to ensure all members ’ perspectives are
considered, a “straw poll” can be conducted.  A straw poll is not a vote on policy  and the
goal is not to come to consensus,  but rather to document the different opinions of the WG
members and help with continued deliberations.  Results of straw polls should be kept
within the WG, but  can be summarized during a presentation at the public ACIP meeting.
ACIP voting members, liaison representatives, and consultants with no conflicts of interest
should be included in straw polls. Federal employees should not be included. These polls can
be done over email or during teleconferences.
V. Confidentiality
Unlike ACIP meetings, which are open to the public, WG meetings/teleconferences are not
public meetings ; data presented during these meetings/teleconferences are often

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 proprietary and should not b e distributed to people other than approved WG members. To
ensure  confidentiali ty of data, the following guidelines  should be i mplemen ted by  all WGs.
1. Roll call by  the WG Lead  should be taken at the start of each WG teleco nference  to
document n ames of members who are pa rticipa ting; the roll call of participants
should be inco rporated into  brief meeting minutes, which  may be compiled by  the
WG Lead  or someone de signated to do so  by her/him.
2. At the beginning of each  WG meeting/teleco nference where any material that is
not already publically available is being discussed , the WG Lead  shou ld state that
the meetings are closed  and i nformation  discuss ed is co nfidential and sh ould not
be dis tributed or used in  presentation s.
3. Only WG members and i nvited consul tants should  participa te in WG meetings.
4. If the parent organization of a liaison representative wishes to obtain information
about WG proceedings, the organization should contact the WG Lead to request a
presentation. Liaison representatives serving on WGs should not share WG
proceedings, discuss ion, or slides with the parent organization unless permission is
granted by the person who presented this information to the WG.
5. Slides  distributed at WG meetings or sho wn du ring teleco nferences  should  be
marked as co nfidential and shou ld not be sh ared with pe ople who are  not WG
members.
6. To minimize the possibil ity that slides may be e xtracted  or used  outside the WG
meeting, PowerPoint  present ations should be sa ved and d istributed as .PDF
(Portable Docume nt Format) files.
7. WG members should not  discu ss WG deliberations with an yone representi ng or
employed by a vaccine manufacturer.
VI. Pharmaceutical Companies and Work Groups
Presentations given by pharmaceutical companies to ACIP provide critical information on
clinical trials and other studies assessing the safety and efficacy of vaccine products.
Guidance for WGs includes:
• If a company and or lobbyist  reaches out to a WG member  to discuss WG
proceedings, the WG member should inform the WG lead  immediately .
• When feasible, WGs should provide oppo rtunities for companies with plans to
submit a biologics licensing  application (BLA) to FDA  for a vaccine product  to
update the WG if new data are available.  Relevant updates from companies with
products already licensed should be considered when new produ cts are under
consideration for use by the WG.

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 • All information, data, and slides presented during WG calls are confidential.
However, all documents related to WGs are subject to FOIA  requests.  In the event
that WG Lead receives a FOIA for materials from some or all WG meetings, the WG
Lead will be requested to review and provide all such materials; in consultation
with the CDC FOIA Office, the WG Lead may identify items that need to be
redacted , e.g. proprietary information ( http://intranet.cdc.gov/ocio/about/foia/ ).
• After pharmaceutical presentations to the WG and time for questions, the
company should ex it the call.  The WG should discuss the implications of the data
presented and the importance of presenting the data to ACIP  only when company
representatives have left .
• All presentation topics by pharmaceutical companies on the ACIP agenda must be
present ed to the WG prior to presentation at meetings of ACIP .
• The final presentation for ACIP will be more concise , and should be reviewed and
approved by the ACIP WG Chair and WG Lead (with consultation from the FDA ex
officio  member serving on the WG, when needed ) prior to the ACIP  meeting .
• The WG lead (or other CDC staff member serving on the WG) should present a
summary of the WG’s interpretation of the data presented by the company during
the same ACIP session , if appropriate.
Guidance for pharmaceutical companies includes:
• Representatives of vaccine manufacturers should not contact any ACIP WG
member for the purpose of promoting a product scheduled for presentation at an
ACIP meeting or to suggest recommendations for consideration  by ACIP.
• Representatives of vaccine manufacturers should contact the WG Lead when they
have data they would like to present to the ACIP WG. Vaccine manufacturers also
may be solicited by WG Leads for  presentation on  specific topics of interest.
• Data that can be proposed for presentation may  include data on products under
consideration for licensure or post -licensure data on a product that may inform
current discussions of the WG.
• The time allocation for the ACIP presentation should be approximately 15 minu tes,
with an additional 5 minutes for questions.  Longer or shorter presentations may be
needed ; final time allocation s will be determined by the WG Lead and the ACIP
steering committee during agenda development.
• Presentations must be submitted to the WG Lead 3 weeks prior to the ACIP
meeting for review and approval.  This provides time for review and incorporation
of feedback.  If changes are requested, the final presentation should be reviewed by
the WG Lead . The d eadline for final submission for printing of slides is the
Wednesday 1 week prior to the ACIP meeting.

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 • Any slide outlining the measures used in the studies presented should include  the
study population, comparison groups, and outcome measures.
• A strengths and limitations slide should be included in the conclusion section of the
talk.
VII. Work Group Resources
The most significant internal resources available to ACIP WGs are the expertise and energy
of WG Leads and other CDC staff . In addition, the Secr etariat is  dedicated to support the
work of ACIP  WGs  including l ogistic s, oversight of issues of science and policy , day-to-day
oversight of WGs , and interactions with ACIP  membership.
The ACIP Executive Secretary, or “Designated Federal Official,” (DFO) is a senior consultant
to the Director  at the National Center for Immunization and Respiratory Diseases (NCIRD).
The DFO is responsible for the committee's overall management and compliance with
FACA law.
Additional resources at CDC (e.g. , the Office of General Counsel, Federal Advisory
Committee Management Branch/Management Analysis and Services Office) are available
and can be accessed through the ACIP Secretariat , as well as support for GRADE and cost -
effectiveness evaluations.
A monthl y meeting of WG Leads is organized by the Secretariat to get input from WG
Leads on issues related to ACIP processes and to discuss any challenges or questions
specific to a WG among the WG Leads.  The Secretariat also provides support to the WG
Leads for t he ACIP SharePoint site and coordinates annual membership agreement  and
conflict of interest  paperwork.
Funds for support of ACIP activities are limited. Requests for specific support for additional
expenses that will enhance ACIP functioning (e.g., extra meeting rooms, equipment, travel
of additional persons to ACIP meetings) will be considered by the ACIP Secretariat . CDC
routinely supports travel costs for the duration of ACIP meetings for ACIP voting members
only. CDC rarely may support travel for invit ed speakers making presentations during the
ACIP meeting, or may agree to provide funding for an additional night for ACIP members.
Such requests should be brought to the ACIP Secretariat  for consideration on a case -by-
case basis, with justification for th e increased costs.  In some instances, it may be necessary
to deny reasonable requests for financial support.

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 VIII. Preparing for ACIP Meeting Presentations
Submitting Agenda Items for ACIP Meetings
Topics for inclusion in the agenda for an upcoming ACIP meeting  are solicited by the ACIP
Secretariat approximately 3 months  before the ACIP meeting, and  are due 2 weeks later.
Requests for agenda proposals are sent to voting ACIP members, WG leads and ACIP
Steering Committee members. A standard template form is used, and includes the
following items:
• Justification for inclusion of topic
• Proposed presentat ions, including topic, presenter, question(s) to be addressed by
the ACIP
• Any additional pertinent information
Following compilation of all agenda proposals, the ACIP Steering Committee meets to
prepare a detailed agenda,  which is then sent back to WG L eads and any others who have
submitted proposals. The ACIP secretariat finalizes the draft agenda within 1 -2 days of the
Steering Committee meeting, and distributes and posts on the ACIP web site. The draft
meeting agenda may be modified as needed up to the w eek of the ACIP meeting.
ACIP Briefing Documents
In advance of each ACIP meeting, a briefing book will be prepared for the CDC Director that
includes information on the topics being presented at ACIP and items on which a vote will
be taken. The ACIP Secret ariat will request briefing documents from WG Leads after the
draft agenda has been distributed. Briefing documents will be due 3 weeks prior to the
ACIP meeting. A standard template form is used (not to exceed two pages), and includes
the following items:
• Topic
• Statement of status of the vaccine or topic and key issues
• Background
• Reason topic is being presented to ACIP: information, discussion, vote, VFC vote (if
applicable)
• Policy options
• Consensus of ACIP WG
• Implications of ACIP decision
ACIP Background Materials
In order to prepare voting ACIP members, ex -officio members, and liaison representatives
for the issues to be discussed during each ACIP meeting, b ackground materials  are

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 prepared and distribut ed in advance of each meeting. Background materials  can be
submitted for all topics on an ACIP agenda, but are required for major issues and items  on
which a vote will be taken.  Background materials will be requested from WG Leads
approximately six weeks prior to each ACIP meeting, and will be due  two weeks in advance
of the meeting.
A cover letter should be prepared that highlight s the information that is most important
for the members to read. Examples of cover letters may be requested from the ACIP
Secretariat, and will be circulated when backg round materials are requested. The
background materials can includ e key WG summaries, draft MMWR P olicy Notes or
Recommendations and Reports , key articles or studies, or a summary of key issues.
Background materials are not considered to be confidential an d may be shared in a limited
fashion (e.g., by liaisons within their organizations).  If confidential information needs to be
shared with the voting ACIP members, the WG lead should reach out to the ACIP
Secretariat to facilitate that process.
ACIP Prese ntations
WG Leads should collect meeting presentation files for meeting handouts from all presenters in
your session. Approximately 2 -3 weeks before each ACIP meeting the ACIP Secretariat will
request presentation files for printing. The ACIP Secretariat can assist with printing needs up to
one week prior to the meeting. If there are files that should go to ACIP members only (ACIP, ex -
officio, liaison representatives) or voting members only, please indicate that in the file name. For
any presentations that  are not received electronically by one week in advance of the meeting,
the WG Lead will be responsible for coordinating printing, photocopying, and delivery of hard
copy per the instructions below.
• Compile your presentations in sets  with handouts in chronological order;  ready to be
slipped straight into meeting binders (e.g., if you have five individual handouts, put them in
sets with handouts #1 , 2, 3, 4, 5 in order ).
• For ACIP membership:  25 sets as handouts, 6 slides/page, 3 inch ho le punch, collated and
stapled; black/ white unless you need them to be in color (e.g., child/adolescent and adult
immunization schedules).
• For public:  200 sets as handouts, six slides/ page, regular paper, collated and stapled.
• Delivered in labeled boxes to the Global Communications Center  (Building 19 ) marked  with
ACIP meeting, name of session and session date .
All presentation files will be converted to PDFs and shared with ACIP members, ex -officio,
and liaison representatives via ShareFile prior to the meeting.  These files do not have to
be the final presentations and can be the same files that are used for pr inting.  Recipients
will be instructed that the meeting slides should not be shared or used in presentations

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 without permission from the Work Group Lead.   Final versions of all slides presented at the
meeting will be posted on the ACIP website following th e meeting.
 Electronic presentation files  will be loaded on a laptop computer in the meeting room for
presentation at the ACIP meeting. Presentation files may be updated before the meeting
starts, or at breaks, on meeting days, brought to us in person on a  flash drive by the WG
Lead only . We cannot accommodate several people updating their files, all for the same
session.
WG Leads should  send the presentation files for your session to  Stephanie  Thomas
(hkp4@cdc.gov ), as a group.  Please use the following naming format to ensure that the person
operating the meeting computer can pull them up easily and in the proper order. For example:
• 01 HPV introduction Kempe
• 02 HPV review Markowitz
• 03 HPV  proposed recommendations Meites
• 04 HPV recommendation vote Meites
• 05 HPV VFC Santoli
• Often the manufacturers provide their files to you as PDF files; if possible,  we prefer PPT.
IX. Evidence -Based Decision and Cost -effectiveness Analyses
CDC vaccine recommendations are developed using an explicit evidence -based method
based on the Grading of Recommendations, Assessment, Development and Evaluation
(GRADE) approach. Key factors considered in development of recommendations include
the balance of benefits  and harms, type or quality of evidence, values and preferences of
the people affected, and health economic analyses . More information about GRADE can be
found in the ACIP’s GRADE handbook
(https://www.cdc.gov/vaccines/acip/recs/grade/downloads/handbook.pdf ).
Most issues that ACIP will vote upon require a GRADE evaluation of the evidence.
However, a “when to GRADE” algorithm is currently un der development and once it is
finalized a link will be added here. A summary of the GRADE evidence should be included
in the MMWR Policy Note, and the GRADE evidence tables are published on the ACIP
website ( https://www.cdc.gov/vaccines/acip/recs/grade/table -refs.html ). If it is
determined that a GRADE evaluation is not needed, the rationale for why GRADE is not
being done should be clearly documen ted. The ACIP Secretariat is available to assist with
questions about GRADE.

16
 Additionally, In February 2018 the ACIP adopt ed use  of an evidence to recommendations
framework. Information abo ut the framework will be added here and on the ACIP website
when a vailable.
The ACIP also provides guidance for the development of health economics studies
(https://www.cdc.gov/vaccines/acip/committee/guidance/economic -studies.html ). These
procedures should be followed for economic analyses to be presented to the ACIP to
ensure that economic data presented to the ACIP and its WGs are uniform in presentation,
understandable, and of the highest quali ty.
X. Preparing MMWR Reports
Following approval by the CDC Director, ACIP ’s recommendations are published in MMWR
as a Policy Note  whereby they become official policy . The MMWR Policy Note and
Recommendations and Reports documents summarize both the ACIP recommendations
(language voted upon by ACIP; e.g., the vaccine should be used for outbreak response) and
guidance for use (CDC’s guidance for use which is not voted upo n by ACIP; e.g., how to
determine when an outbreak is occurring, dose spacing, etc.).
Development of the Policy Note is led by the WG Lead. The WG Chair and other ACIP (or
WG) members who meet authorship criteria should be included  as co -authors on each
Policy Note . The Secretariat encourages WG Leads to approach ACIP members to be
included as co-authors early in the process of developing the Policy Note  to allow for
participation and co -authorship . The WG Lead also is responsible for developing the
MMWR Re commendations and Reports (comprehensive summar y of ACIP
recommendations).
The WG Lead should meet  with OADS prior  to drafting each  Policy Note  and the OADS
Checklist should be followed  (http://intranet.cdc.gov/od/oads/osq/guide_rec/docs/CDC -
Policy -Notes -Development -and-Reporting -Checklist.docx ). The WG Lead should also meet
with MMWR prior to developi ng a Recommendations and Reports  document .
A Policy Note should be drafted before an ACIP vote  is requested  and the draft Policy Note
should be distributed to ACIP members in the background materials for the session in
which the vote is requested . The ACIP  Secretariat will preschedule each Policy Note with
MMWR to ensure prompt publication  once the recommendation is approved by the CDC
Director.  Similarly, a Recommendations and Reports document should be drafted and
distributed to ACIP members before a vote  is requested.

17
 After clearance and prior to publication, sections of the MMWR that discuss a particular
product should be shared with the company making that product to ensure there are no
factual errors or literature that was not included. At the time whe re there are proofs, the
embargoed document should be shared with any pharmaceutical company that has a
vaccine named in the document (with the exception of the schedul e and general guidance
documents). This is for awareness purposes only and edits can be made only if factual
errors are identified.
XI. Termination of W ork Groups
Five ACIP WGs are designated “permanent” WGs, since recurring tasks occur annually
(influenza, child/adolescent immunization, adult immunization , and evidence based
recommendations ) or approximately every 3 -5 years (general recommendations). The
remaining WGs are designated “task -oriented,” and are established when needed (Section
I), and disbanded once the stated terms of reference ha ve been completed. It is often the
case that the WG has completed its terms of reference, but an ACIP recommendation
statement (P olicy Note or Recommendations & Reports for publication in MMWR) is still in
progress. If there is not a need to have ongoing, regular WG discussion, the WG Chair and
WG L ead may disband the WG, and the draft recommendation s can be circulated to WG
members for review and comment until a final draft is ready to put into CDC clearance.
It may happen that and ACIP WG is established a nd completes its T ORs, and is then
disbanded but at a later date new information becomes available that necessitates
regrouping the WG, e.g. new safety data, a new vaccine, etc. This has occurred, for
example, with the Rotavirus Vaccine WG. Therefore, a WG  does not need to stay in
existence “in case” a future need arises, but can be disbanded and reestablished as
required, with the original WG members and/or with new WG members. When the WG
Chair and WG L ead agree that it is reasonable to disband the WG, th e WG Lead sends out
an email to WG members thanking them for their service and contributions, and informing
them of any next steps, e.g. ACIP recommendation review and publication plans.

18
 XII. Appen dices
Appendix 1: Additional Information for  FDA, ISO, and ISD Representatives to
ACIP WGs

FDA Representatives to ACIP Work Groups
In most circumstances, the ACI P considers vaccines once they have been licensed by the
FDA.   While ACIP reviews the safety and efficacy data available to them during
deliberations, they rely on FDA to conduct a review of all data submitted for
licensure.    Therefore, the FDA representa tive to the ACIP Work Group provides expertise
in the licensure, indications, and package insert of vaccines under consideration.   While
information being reviewed by FDA is confidential during the pre -decisional phase, the FDA
makes available on its websi te its reviews of the biologic license application within 30 days
of the approval.   While the FDA representative cannot discuss trade secrets, confidential
commercial or financial information from the applicant, he/she can still provide guidance
and perspe ctive to inform ACIP Work Group discussions based on publicly available
information, including all information made available to the public that is not available
elsewhere.
• Open lines of communication between the Work Group Lead and FDA
representative are important to ensure ACIP Work Group deliberations and
proposed recommendations are appropriate and in line with licensure
considerations and information made available to th e public by FDA upon approval
of the vaccine.
• When recommendations are proposed that are not aligned with the licensed
indications, it is important to ensure any concerns from FDA are communicated to
the CDC Work Group Lead.
• Given that the FDA represent ative is often in the middle of the review for the
vaccine under consideration, FDA representatives are prohibited from providing
certain information in the ongoing review until an approval decision has been
made.
• When there are scientific or policy concer ns (i.e., differences between FDA and the
Work Group’s interpretation of data and/or proposed recommendations) that are
challenging to resolve within the Work Group, both the FDA representative and the
CDC Work Group Lead should communicate these concerns to leadership for
further collaborative discussion.

19
 Roles and Responsibilities
• Signs annual membership agreement.
• If the FDA representative has not signed an OGE 450 through FDA, they should
complete the ACIP Work Group member conflict of interest form.
• Attends and participates in Work Group meetings on a regular basis (attends more
than 75% of meetings).
• Completes timely review of materials as requested, including pre -clearance review
of policy notes and Recommendations and Reports.
• Communicates either d uring the call or follows -up with the Work Group lead if
there are concerns related to interpretation of data or potential conflicts between
recommendations and language in the package insert, as permitted under its
regulations
• As able to, provides updates  to Work Group Lead about potential changes to a
vaccine’s indications.
• Known or approximate distribution dates for Healthcare Provider letters indicating
changes to prescribing information relevant to work group deliberations should be
communicated to the  CDC Work Group Lead by the FDA representatives.
• Respond to communications from the Work Group Lead via email or phone.   If they
are unable to communicate a concern due to confidentiality restrictions, the FDA
representative should inform their leadershi p of potential issues.

ISO Representatives to ACIP Work Groups
The ISO representatives to the ACIP Work Groups plays a key role ensuring that vaccine
safety issues related to proposed new recommendations, changes to recommendations,
new vaccine safety fin dings, and potential vaccine safety issues of concern are identified
and considered during Work Group deliberations.
• Vaccine safety is a key component of the review of the evidence supporting
proposed recommendations.
• There may be vaccine safety issues f or special populations that may not be
recognized by the ACIP Work Group, such as vaccination of pregnant women, or
immunocompromised populations.
• There may be vaccine safety findings from routine surveillance, epidemiologic
studies, or new issues of conce rn from provider groups, health officials or the
general public for which the ACIP Work Group should be made aware.

20
 • When recommendations are proposed for which there are potential vaccine safety
concerns, it is important that these concerns are communicat ed to the CDC Work
Group Lead.
• When there are vaccine safety or policy concerns (i.e., differences between ISO and
the Work Group’s interpretation of data and/or proposed recommendations) that
are challenging to resolve within the Work Group, both the ISO representative and
the CDC Work Group Lead should communicate these concerns to their leadership
for further collaborative discussion.
Roles and Responsibilities
• Signs annual membership agreement.
• If the ISO representative has not signed an OGE 450 through CDC, they should
complete the ACIP Work Group member conflict of interest form.
• Attends and participates in Work Group meetings on a regular basis (attends more
than 75% of meetings).
• When neede d, the ISO representative should pull available data, review literature,
and conduct analyses to support ACIP Work Group deliberations.
• Completes timely review of materials as requested, focusing on vaccine safety and
the safety studies supporting licensur e.  The ISO representative may be requested
to co -author policy notes or recommendations and reports depending on the
content.
• Communicates either during the call or follows -up with the Work Group Lead if
there are concerns related to implementation issues .
• Presents related vaccine safety updates at ACIP meetings, as needed.

ISD Representatives to ACIP Work Groups
The ISD representative to the ACIP Work Groups plays a key role ensuring that
implementation issues related to proposed new recommendations or changes to
recommendations are identified and considered during Work Group deliberations.
• Implementations issue s are considered as one piece of the evidence supporting
proposed recommendations.
• While the scientific evidence should drive ACIP recommendations, implementation
issues can help refine potential policy options supported by the evidence.
• Understanding impl ementation issues can also help how recommendations are
framed.

21
 • Clinical decision support is a key part of implementation of vaccine
recommendations.   Projecting how recommendations are translated into clinical
decision support can also help refine potenti al policy options and clinical guidance.
• When recommendations are proposed for which there are implementation
concerns, it is important that these concerns are communicated to the CDC Work
Group Lead.
• When there are implementation or policy concerns (i.e.,  differences between ISD
and the Work Group’s interpretation of data and/or proposed recommendations)
that are challenging to resolve within the Work Group, both the ISD representative
and the CDC Work Group Lead should communicate these concerns to their
leadership for further collaborative discussion.
Roles and Responsibilities
• Signs annual membership agreement.
• If the ISD representative has not signed an OGE 450 through CDC, they should
complete the ACIP Work Group member conflict of interest form.
• Attends and participates in Work Group meetings on a regular basis (attends more
than 75% of meetings).
• When needed, the ISD representative should pull available data, review literature,
and conduct analyses around implementation issues to support ACIP Work  Group
deliberations.
• Completes timely review of materials as requested, focusing on implementation
issues including language, how recommendations will be communicated, and how
they will be incorporated into clinical decision support.
Communicates either d uring the call or follows -up with the Work Group Lead if
there are concerns related to implementation issues.

Summary: ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES :  WORK GROUPS   Standard Operating Procedures: August 201 8                                      Advisory Committee on Immunization Practices Secretariat   Centers for Disease Control and Prevention     2     Contents   I. Overview of Advisory Committee on Immunization Practices Work Groups  ..... 2  II. Work Group Membership  ................................ ................................ ........................  4  III. Roles and…


ACIP conflicts interest policy

ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES:
WORK GROUPS
Conflict of Interest Policy : December 2023

Advisory Committee on Immunization Practices Secretariat
Centers for Disease Control and Prevention
2
 ACIP W ork Group s (WG)  serve a key scientific role in support of vaccine policy development by
ACIP. In order to avoid undue influence or the appearance /perception  of a conflict of interest in
WG discussions, screening for potential conflicts  will be conducted  upon establi shment of a WG
and annual updates  will be collected  from WG members to ensure that financial or other conflicts
are not present and/or have not changed.  The ACIP Secretariat will assist with the collection of
conflict of interest disclosures ; screening of the conflict of interest declarations  will be conducted
by the WG Lead in conjunction with the ACIP Secretariat.
The ACIP Secretariat will consider issuance of waivers to this conflict of interest policy in limited
situations.  Waivers may be issued  if it is determined that an individual’s subject matter expertise
is necessary for work group deliberations and another expert is not available who could fulfill this
role.  In situations where a waiver is granted, the conflict of interest (or perceived conflic t of
interest) should be regularly announced to the WG.
Note: The conflict of interest policy for ACIP WG members outlined here applies to vaccines or
related products under the purview of each ACIP WG on which a person serves, as well as the
pharmaceutica l company(s) that manufactures  the vaccines or related products under the
purview of each ACIP WG on which a person serves.
Because WG members  are most familiar with their own situations, their personal responsibilities
include the following: (1) to alert the WG Lead about any possible conflict of interest that may
impact perception of impartial and fair activities of WG members and (2) to ident ify and certify on
an annual conflict of interest screening form  (a) any aspect of the work of the ACIP WG where a
conflict of interest exists, and (b) that there will not be, and has not been, involvement in the
efforts of the WG where participation const itutes a conflict of interest.
When a possible conflict of interest is reported by a WG member, t he WG Lead will consult with
the ACIP Executive Secretary (and legal counsel if necessary), to determine whether the  particular
situation involves a conflict of interest or an appearance /perception  of a conflict of interest which
1) requires that the WG member  not be involved in the ACIP WG process , or 2) the potential
conflict of interest must be disclosed to the WG, but participation in the ACIP WG process is
allowed .
A conflict of interest exists when a participant has a  financial  interest in a vaccine product , related
product (e.g., monoclonal antibody),  or pharmaceutical company that manufactures vaccines (or
related products ) that may affect his/her imput ed financial interests or potentially bias his/her
approach to development of options for recommendations for use of that vaccine, or of a
competing vaccine.
In addition, WG member s who feel they might be unable to provide impartial advice on the matter
at issue for any reason, or who have made public statements (written or oral) that would indicate
3
 to an observer that you have taken a position on the products or issue under consideration should
disclose this as a potential conflict of interest .
Regardless  of the level of financial involvement or other conflict of interest, if the participant feels
unable to provide objective advice, they  must recuse themsel f from the WG activities under
consideration. The ACIP WG process relies on the integrity of each par ticipant to disclose to the
WG Chair or WG Lead any real or apparent conflicts of interest that are likely to bias the
reviewer’s evaluation of an application or proposal.
The following guidance and definitions will assist in determining whether a conflic t of interest
exists.  This guidance applies to vaccines or related products under the purview of each ACIP WG
on which a person serves and the pharmaceutical company(s) that manufactures  the vaccines or
related products under the purview of each ACIP WG on which a person serves .  This guidance is
not all -inclusive, due to the variety of possible conflicts of interest and the potential for
appearance of conflicts of interest.
Situations where a conflict of interest exists and the individual should not serve as a WG
member includ e:
1. A person or a member of their immediate family is employed directly by a vaccine /product
manufacturer or its parent company. A member of the immediate family includes spouse ,
domestic partner , or child .
2. A person or a member of their immediate family hol ds stock in a vaccine/product
manufacturer or its parent company in excess of the OGE de minimus amounts
(https://ethics.od.nih.gov/waiver ).
3. A person  is a holder of, or otherwise is entitled to royalties or other compensation for, a
patent (planned, issued, or pending) on a vaccine/product or process, immunologic agent,
adjuvant, or preservative that can be used for a vaccine that may come before ACIP for
review/discussion during the anticipated term of the concerned WG.
4. A person holds a paid advisory or  consulting role  with a manufacturer  to perform work
related to vaccines /products  expected to be considered by the WG or companies that
manufacture vaccines/p roducts under the purview of the WG . A person must agree  to
forego such paid consultation or membership during his/her tenure on the ACIP WG
(except participation in research studies  or service on data monitoring boards  – see
below ).
5. A person is a 1) princ ipal investigator, 2) co-principal investigator, or 3) a site principal
investigator for an industry sponsored clinical trial involving a vaccine  or manufacturer
under the purview of the WG  (even when funding goes to the institution/program).
6. WG members should agree that they  will not serve as a paid litigation consultant or expert
witness in litigation involving a vaccine  or manufacturer  under the purview of the WG .
4
 Potential conflicts of interest  that  should be disclosed but do not limit1 part icipation of the
individual on the WG include:
1. WG members are required to disclose participation in  conducting  research studies funded
by pharmaceutical companies  and service on data monitoring boards  (paid or unpaid) .
2. WG members  should disclose any uncompensated single time participation in advisory
boards, or lectures on behalf of a pharmaceutical company that occurred in the prior 6
months .  Participation in these activities should cease during tenure on the WG.
3. WG members sh ould disclose any honoraria  received  for continuing medical education
(CME) presentations that occurred i n the prior 6 months where the source of funding was
an unrestricted grant to the CME provider by a vaccine manufacturer and where all CME
rules and  regulations are followed.   Participation in these activities should cease during
tenure on the WG.
4. Non-financial conflicts  (e.g. uncompensated participation in vaccine development, or a
researcher identified with  a particular scientific perspective in a controversial area),  should
also be disclosed and considered prior to participation.
5. WG members should disclose any potential reaso ns th ey might be unable to provide
impartial advi ce, or any reason that their impartiality in the matter might be questioned.
In addition, public statements (written or oral) that would indicate to an observer that the
WG member has taken a position on th e products or issue under consideration should be
disclosed.
Activities not considered a potential conflict of interest include:
1. WG members may  receive travel reimbursement for continuing medical education (CME)
presentations where the source of funding is  an unrestricted grant to the CME provider by
a vaccine manufacturer and where all CME rules and regulations are followed.
2. Discussions with pharmaceutical representatives in regards to purchasing vaccines for a
clinical practice.
WG members have an ongoing  obligation to bring any new information regarding potential
conflict(s) of interest to the attention of the  WG Lead. In addition, WG members must inform the
WG Lead if they are contacted directly by a representative of a vaccine manufacturer regarding a
vaccine /product  under consideration by the WG on which they serve; the WG Lead will then
inform the ACIP Secretariat of any such contact.

1 Waivers may be issued by the Secretariat  in consultation with the work group lead.

Summary: ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES:  WORK GROUPS   Conflict of Interest Policy : December 2023                                       Advisory Committee on Immunization Practices Secretariat   Centers for Disease Control and Prevention   2   ACIP W ork Group s (WG)  serve a key scientific role in support of vaccine policy development by  ACIP. In order to avoid undue influence or the appearance /perception  of a conflict of interest in  WG discussions, screening for potential…


child schedule tor 508

Page 1 of 7
 Advisory Committee on Immunization Practices  (ACIP) ,
Centers for Disease Control and Prevention (CDC)
Childhood and Adolescent  Immunization Schedule Workgroup
Terms of R eference
UPDATED: October 8 , 2025

PUR
POSE

Thi
s document defines the activities, membership, and administrative requirements
associated with the establishment of a C hildhood and Adolescent Immunization
Schedule  Workgroup under the Advisory Committee on Immunization Practices
(ACIP) , Centers for Disease Control and Prevention (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  to the CDC Director .
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, and by the  need for expert input to inform development of  CDC immunization
policy. ACIP WGs are task oriented and convene in response to specific policy needs.
WGs  serve a key role in providing expertise for the use of  immunizations in support of
the full committee  deliberations and recommendations. Each WG operates under
specific terms of reference and disbands  when current WG  activities are completed.
The Childhood and Adolescent  Immunization Schedule WG has been specifically
established to review data, as well as clinical and scientific knowledge related to the
childhood and adolescent  immunization schedule to help develop childhood and
adolescent  immunization schedule policy options  for ACIP consideration to formulate
recommendations to the Director of the CDC.

For
 the purposes of this document, i mmunization refers to vaccines and other antibody
protective products , to prevent disease, e.g., immunoglobulins .

BACKGRO
UND

Whi
le many vaccines are universally recommended worldwide, different countries have
different vaccine schedules  for a variety of rea sons , both in terms of the collection of
vaccines given and the timing and order of the vaccines.  These reasons can include
implementation considerations ( differen ces in  healthcare systems , and variance in
practices related to pediatric medicine practice) and concerns about vaccine safety and
adverse events .  As part of ACIP ’s core mission  to develop recommendations on the
use of vaccines in the civilian population of the United States, the  committee is standing
up a WG  focused on assessing  the safety  and effectiveness  of the childhood and
adolescent  schedule. The rationale for this WG  includes considerations such as  the use
of new  vaccine technologies and ingredients , and the rise of vaccine hesitancy . These
Page 2 of 7
 activities  should not only be based on past research but also future vaccine studies . If
such studies reveal unexpected but scientifically  validated concerns, the schedule
should be adjusted  accordingly .

In 2
002, the Institute of Medicine (IOM), now the National Academy of Medicine ,
published Immunization Safety Review: Multiple Immunizations and Immune
Dysfunction1 and noted that :

“
The committee was unable to address the concern of some that repeated
exposure of a susceptible or fragile child to multiple vaccines over the
developmental period may also produce atypical or nonspecific immune or nervous system injury that could lead to severe disability or death...There are no
epidemiological studies that address this, either in terms of exposure or outcome. That is, there is no study that compares an unvaccinated control group with children exposed to the complete immunization schedule, or are there any studies that looked at health outcomes other than those classically defined, such as infections, allergy, or diabetes. Thus the committee recognizes with some discomfort that this report addresses only part of the overall set of concerns  of
some who are most wary about the safety of childhood vaccines. ” (page 36)

T
he report also noted that one- quarter of parents expressed concern about the number
of immunizations children were receiving and concluded that,
“Concern about multiple immunizations has been, and could continue to be, of
societal significance in terms of parental worries, potential health burdens, and future challenges for immunization policy making.” (pages 104- 105)

O
ver a  decade later, in 2013, the IOM published The Childhood Immunization Schedule
and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies ,2 the report
of an expert committee that had been tasked with reviewing “scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule,” and identifying “ potential research approaches, methodologies, and study
designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them. ” (page 3) The committee noted:

 “
Few studies have comprehensively assessed the association between the
entire immunization schedule or variations in the overall schedule and categories of health outcomes, and no study has directly.”...“Studies designed to examine the long- term effects of  the cumulative number of vaccines or other aspects of
the immunization schedule have not been conducted. Nevertheless, and its literature review, the committee found useful designs for studies to measure exposures and outcomes and identified strategies f or expanding or adapting
conventional study designs to clearly address whether any adverse health outcomes are associated with the overall immunization schedule.” (page 5- 6)

Page 3 of 7
 To assess the feasibility of studying the vaccine schedule, the IOM solicited a report
from Dr. Martin Kulldorff , a biostatistician and epidemiologist  at Harvard Medical School .
He concluded that “ a wide variety of different vaccine schedule components can be
studied”, including “ the timing of individual vaccines, the timing between doses of the
same vaccine, the interaction effect between vaccines and concurrent health conditions or pharmaceutical medications, the interaction effects of different vaccines given on the same day, the ordering of different vaccines, and the effect of cumulative summary metrics such as the total number of vaccines or the total amount of some vaccine ingredient ”. He also outlined possible “study designs for the comparative evaluation of
one or more complete schedules” , considering methods “both for adverse events with
an early onset, which are the easiest to study, and for adverse events with a late onset, including serious chronic conditions” .

A r
ecommendation of the  IOM committee was:

“that
 the Department of Health and Human Services incorporate study of the
safety of the overall childhood immunization schedule into its processes for setting priorities for research, recognizing stakeholder concerns, and establishing the priorities on the  basis of epidemiological evidence, biological plausibility, and
feasibility.”  (page 132)

In ac
cordance with the ACIP Charter, t he Childhood and Adolescent Immunization
Schedule WG and its members  will prepare information for the ACIP members to
enable them to  make recommendations that consider :

• T
he timing and order of different vaccines.
• The concurrent administration of various vaccines.
• The safety of ingredients that are present in multiple different vaccines.
• The efficacy and safety of different vaccine schedules used in different countries.
• Implementation considerations , including burden on healthcare  and payor
systems, economic impact, and acceptability and feasibility with input from pediatric healthcare providers and parents .

Th
e WG will also consider these issues for particular subgroups  of children, such as
children born pre- maturely, children with immune deficiencies, or children with cancer .

Th
e WG will engage external subject matter experts, as needed, to support
implementation of key activities.

TOPICS UNDER DISCUSSION BY THE WORKGROUP

In accordance with the ACIP Charter and in a multi- year effort, the Childhood and Adolescent
Immunization Schedule WG  members  will work with expert consultants as appropriate and in
accordance with FACA statutory requirements and policies, to prepare information for the ACIP
members to enable them to make recommendations on:
Page 4 of 7
 • The timing and order of different vaccines.  For example, should the last toddler
dose of the non- live DTaP vaccine be given before, on the same day , or after the
MMR vaccine?
• The concurrent administration of various vaccines  and other immunizing products
such as monoclonal antibodies . For example, does the risk of post -vaccination
febrile seizures increase or decrease  with concom itant administration?
• The safety of ingredients that are present in multiple different vaccines.  For
example, do either of the two different aluminum adjuvants increase the risk of
asthma?
• The efficacy and safety of different vaccine schedules used in different countries.
For example, are there differences in efficacy or safety between the U .S. and
Danish childhood vaccine schedules?

DES
CRIPTION OF  WORKGROUP  ACTIVITIES
The following activities provide a framework for the Childhood and Adolescent
Immunization Schedule WG  multi -year efforts , which may involve data requests  from
other Federal and non-Federal  entities : Review and summarize existing knowledge from
published and unpublished research and safety surveillance systems . This work may
include the following three multi -faceted tasks , which may be completed in sequence or
in parallel :
• Identify gaps in and collaborate accordingly to address new research studies  that
ascertain important aspects of the vaccine schedule, particularly  from CDC’s
Vaccine Safety Datalink (VSD), from F ood and D rug Administration’s Biologics
Efficacy and Safety System (BEST), and the National Institute s of Health through
their extramural grant awards program.
• Based on the highest quality studies, determine whether a change in the vaccine
schedule may be warranted, outline various options, and vote on which option to recommend to the full ACIP for consideration .
• Communicate the deliberations and recommendations to the full ACIP, for them to review and vote on. Together with the WG majority views, minority views will
also be communicated to the full ACIP, with rationales for the different opinions.

MEMBERSHIP

Work group Leadership:  The Childhood and Adolescent Immunization Schedule WG  is
chaired by one of the ACIP  members appointed to serve as  a Special Government
Employee.  The Workgroup Lead (WGL ) is a WG designated federal employee (DFO),
identified  by the Immediate Office of the Director  (IOD)  in consultation with the
appropriate CDC program . The WG Chair , in consultation with the WGL, ACIP  DFO ,
Page 5 of 7
 and CDC IOD, determines the WG ’s membership and work priorities  and deliverables  to
the full ACIP committee .

Workgroup Membership:  The Childhood and Adolescent Immunization Schedule WG  is
compo sed of  experts from a variety of disciplines who are appointed based on their
professional, scientific, technical, or other expertise . The y 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 name d in the ACIP
charter may  also appoint members to serve on WG s. 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 adolescents ;
• Clinical and medical practice, and patient- care experience ;
• Epidemiology;
• Biostatistics
• Molecular biology;
• Immunology;
• Virology;
• Toxicology
• Drug  and vaccine  safety; and
• C onsumer 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 WG
and answer questions during Childhood and Adolescent Immunization Schedule WG
meetings on an ad 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 Childhood and
Adolescent Immunization Schedule WG ’s activities and  findings.

2. Meet
ing frequency  and location: The Childhood and Adolescent Immunization Schedule
WG will meet  on an as needed basis as determined by the WG Chair and WGL . All
Childhood and Adolescent Immunization Schedule WG  meetings are convened virtual ly
via teleconference.

3. Meet
ing structure : In addition to the WGL,  at least two ACIP Special Government
Employee member s (one of whom serves as  the Childhood and Adolescent
Page 6 of 7
 Immunization Schedule 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. C
onflicts of Interest : WG members will complete an ACIP WG Agreement and Conflict
of Interest Certification  process  prior to participation on the WG. The WGL or designee
will screen for conflict of interest declarations and share any conflicts with the ACIP
DFO . The ACIP DFO in collaboration with the WGL will work with the CDC Ethics  and
Integrity  Office within the Office of Strategic Business Initiatives (OSBI) and the Office of
General Counsel (OGC), as needed, to resolve any conflicts . 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 Childhood and Adolescent Immunization Schedule WG participation. Members will also disclose any potential conflicts of interest before each meeting. If a Childhood and Adolescent Immunization Schedule WG
member indicates a potential or actual conflict of interest t o the WGL , the WGL or a
delegate will review and bring up any conflicts to the ACIP DFO  to determi ne whether
the individual must  recuse themselves from participating  in WG discussions that
implicate such a conflict -of-interest concern. If needed, the ACIP DFO will engage OSBI
and OGC to assist with making COI determination.

5. Co
nfidentiality : The discussions of the Childhood and Adolescent Immunization
Schedule WG may include information that is unpublished, protected, privileged, or confidential . WG deliberations, including, as appropriate,  policy options  under
consideration by the 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 meetings, which are
open to the public, Childhood and Adolescent Immunization Schedule 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 Childhood and Adolescent Immunization Schedule WG members.

6. CDC S
taff Involvement : CDC staff do not serve as members of the Childhood and
Adolescent Immunization Schedule 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 Childhood and Adolescent
Immunization Schedule 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 DFO
and WGL of Childhood and Adolescent Immunization Schedule WG, in consultation with
the WG Chair of the Childhood and Adolescent Immunization Schedule WG , will
monitor the interaction between the WG and the agency  staff to ensure that the WG
Page 7 of 7
 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. Time
lines: 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. Work
group Meeting Summaries:  Meeting minutes will be created by the WGL or WGL’s
delegate to capture the information gathered during each Childhood and Adolescent
Immunization Schedule WG  meeting and teleconference.

9. Work
group findings : The Childhood and Adolescent Immunization Schedule WG  will
present findings (briefing documents, background materials, presentations) to ACIP for consideration and deliberation in a public meeting.  Final versions of all slides presented at the ACIP meeting will be posted on the ACIP website following the meeting and included in the committee’s official records.

10. Work
group 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 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. WGL or the WGL’s delegate is
responsible for ensuring WG record keeping.

RECORDKEEPING and REPORTING

The WG Chair and /or WGL will present  findings  / outcomes  / observations  /
recommendations  to the ACIP  parent committee for discussion, d eliberations, further
development of recommendations  and vote in an open public forum . Approved ACIP
recommendations adopted by the CDC Director will be 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.

REFERENCES

1. Immunization Safety Review: Multiple Immunizations and Immune Dysfunction.
National Academies Press; 2002. doi:10.17226/10306
2. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific
Evidence, and Future Studies . National Academies Press; 2013. doi:10.17226/13563

Summary: Page 1 of 7   Advisory Committee on Immunization Practices  (ACIP) ,  Centers for Disease Control and Prevention (CDC)   Childhood and Adolescent  Immunization Schedule Workgroup   Terms of R eference   UPDATED: October 8 , 2025       PUR POSE     Thi s document defines the activities, membership, and administrative requirements  associated with the establishment of a C hildhood and Adolescent Immunization  Schedule  Workgroup under the Advisory Committee on Immunization Practices   (ACIP) ,…


COVID19 TOR 508

Page 1 of 6

Ad
visory Committee on Immunization Practices ,
Centers for Disease Control and Prevention (ACIP, CDC)
COVID-19 Immunization Workgroup
Terms of R eference
UPDATED:  August 20, 2025

P
URPOSE

T
his document defines the activities, membership, and administrative requirements associated
with the establishment of a COVID-19 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 augment the effectiveness of ACIP.  The direction, focus, and pace of both ACIP and the individual WGs are guided by CDC and HH S 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 COVID -19 Immunization  WG has been
specifically established  to review data, as well as clinical and scientific knowledge on COVID -
19 immunization s, to help develop COVID -19 immunization  policy options for ACIP
consideratio n to formulate recommendations to the Director of the CDC.

F
or the purposes of this document, Immunization refers to vaccines and other antibody protective
products, to prevent disease, e.g., immunoglobulins.

B
ACKGROUND

C
OVID-19 is a disease caused by the SARS-CoV-2 virus. F or some patients, COVID -19 can  be
severe, causing significant morbidity and mortality. Currently there are three vaccine manufacturers (Moderna, Novavax, and Pfizer) with a combined four COVID -19 vaccines
authorized or approved for use in the United States. As the SARS-CoV-2 virus evolves, new formulations of the COVID-19 vaccine have been developed to better approximate currently
circulating strains.

T
he COVID -19 WG was established in 2020 and met frequently to discuss immunization
recommendations as the COVID -19 pandemic evolved. ACIP  has three scheduled meetings per
year, and as needed, to provide recommendations on existing and/or newly developed vaccines .

A
ccording 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.

Page 2 of 6
 The purpose of this WG is to review available data, as well as clinical and scientific knowledge,
to support the development of recommendations for ACIP consideration that are used to advise the Director of the CDC.

In
 accordance with the ACIP Charter, the COVID -19 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 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 modifi cation
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
analyses, and implementation issues.
• Revise or withdraw their recommendation(s) regarding a particular immunization  as new
information on disease epidemiology, immunization  effectiveness or safety, economic
considerations, or other data that becomes available.

T
he WG will also assist and support A CIP, i n accordance with Section 1928 of the Social
Security Act, to be able to establish and periodically review and, as appropriate, revise the list of immunization  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 interval, and contraindications to administration of the pediatric immunization .

TOPICS UNDER DISCUSSION BY THE WORKGROUP

The following topics relevant to  COVID- 19 immunization  for effective control of COVID -19
disease in the civilian population of the United States  will be under discussion in the WG in
multi- year effort s.
1) Risk-benefit and cost-benefit analyses of existing and newly FDA-authorized mRNA and
other COVID -19 immunizations , and immunization  schedules as it relates to COVID -19
immunization  to inform use recommendations, personalized per age-group, major risk factors
and health status.

2) T
o identify critical gaps in the existing scientific  and clinical  knowledge and methodologies
related to the safety and efficacy of the COVID -19 immunizations , to inform the
development of policy recommendations and further analyses and research by the CDC,
other related federal agencies , and the scientific community.

Page 3 of 6
 3) To review and summarize data, clinical and scientific knowledge related to adverse events
associated with COVID -19 immunizations  to inform immunization recommendations in
terms of precautions and contraindications to receipt of immunization .

DE
SCRI PTION of WORKGROUP  ACTIVITIES
The following activities provide a framework for the COVID-19 immunization WG multi- year
efforts which may involve data requests from other Federal and private partners:
1. Review  and summarize existing  data and published and unpublished research and clinical
knowledge related to the safety, effectiveness, and immunogenicity of COVID -19
immunizations  authorized  or approved in the United S tates.
2. Summarize literature r eview s of the epidemiology of COVID-19 disease and SARS -CoV-2
virus.
3. Assess the benefit -risk balance for administration  of COVID -19 immunization products at
the same time as other immunization s.
4. Identify areas where additional data and research  are needed to inform COVID-19
immunization  recommendations.
5. Develop COVID-19 immunization  recommendations .
6. R eview and  summarize the existing clinical and scientific information available ; and gaps in
the existing knowledge, including from other federal agencies like the FDA , where
appropriate relating to bio distribution, pharmacokinetics and persistence of the spike protein,
mRNA, and lipid nanoparticles to inform immunization recommendations .
7. Review and s ummarize the existing clinical and scientific information (including from
federal agencies like the FDA , where appropriate); gaps in the existing knowledge regarding
potential impurities  (e.g., DNA contamination and endotoxins) in existing  immunization
products and the ir health impacts to inform immunization recommendations.
8. Review and summarize the existing scientific knowledge, and gaps, regarding the cumulative
short- and long-term impact of repeated boosting immunization  including non- specific
effects (e.g., IgG4 class switching, immune imprinting, viral evolution under leaky immunizations ) to help inform immunization recommendations.
9. Examin e the impact of COVID -19 immunization  on COVID-19 and all cause deaths,
hospitalizations , and disability  to inform immunization recommendations.
10. Analyze existing data and scientific knowledge regarding cardiovascular, thrombotic, neurological, immunological and othe r serious adverse events potentially caused by COVID-
19 immunization .
11. Review and s ummarize available data, information , and gaps regarding long-term Covid
effects from scientific literature  and clinical experience associated with COVID -19
immunization products and COVID-19 infection to inform policy recommendations.
12. Map existing COVID-19 immunization  policies in countries around the world and how they
compared to the US.
Page 4 of 6
 13. Analyze existing data and scientific knowledge related to the safety of COVID -19
immunization  during pregnancy.

MEMBERSHIP

Work group Leadership: The COVID -19 Immunization s WG is  chaired by one of the ACIP, CDC
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 DFO,
determine s the WG ’s membership and work priorities and deliverables  to the full committee .

Workgroup Membership:  The COVID -19 Immunizations  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 named in the
ACIP charter may  also appoint members to serve on WGs. The COVID -19 Immunization s WG
will be comp osed of members from a variety of disciplines . The WG will engage with the
following disciplines on WG activities to :

• 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 patience -care experience;
• Epidemiology;
• Molecular biology;
• Immunology;
• Virology;
• Drug  and vaccine safety ; 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 WG and answer
questions during COVID -19 Immunization WG  meetings on an ad 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 COVID -19 Immunization WG’s
activities and  findings.
Page 5 of 6
 2. Meeting frequency  and location:  The COVID -19 Immunization  WG will meet on an as needed
basis as determined by the WG Chair and WGL . All COVID -19 Immunization WG meetings are
convened virtual ly via teleconference.
3. M eeting structure :  In addition to the WGL,  at least two ACIP Special Government Employee
member s (one of whom serves as the COVID -19 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 prior to each meeting.
4. C onflicts of Interest :  WG  members will complete an  ACIP WG  Agreement and Conflict of
Interest Certification  process  prior to participation on the WG.  They 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 COVID -19 Immunization  WG participation.  Members will also disclose any potential
conflicts of interest before each meeting.  If a COVID -19 Immunization s WG member indicates
a potential or actual conflict of interest, the ACIP , CDC DFO  in consultation with the WGL  will
review and make a determination as to  whether the individual must recuse themselves from
participating  in WG discussions that implicate such a conflict -of-interest concern.
5. C
onfidentiality :  The discussions of the COVID -19 Immunization s 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 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 meetings, which are open to the public, COVID-19
Immunizations 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 COVID -19 Immunizations WG members.
6. C
DC Staff Involvement:  CDC staff do not serve as members of the COVID -19 Immunization s
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 goas of the COVID-19 Immunizations  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 , CDC  DFO and WGL of COVID -
19 Immunizations  WG, in consultation with the Chair of the COVID -19 Immunizations 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. T
imelines:  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. S ubject content: Findings and opinions of the COVID -19 Immunizations  WG members will be
discussed at meetings.  The COVID -19 Immunizations  WG’s findings will be presented to ACIP
for consideration for action (discussion, deliberation and decision).
9. W orkgroup Meeting Summaries: Meeting minutes will be created to capture the information
gathered during each COVID -19 Immunizations  WG meeting and teleconference.
Page 6 of 6
 10. Workgroup findings : The COVID-19 Immunizations  WG will present findings (briefing
documents, background materials, presentations) to ACIP for consideration and deliberation in a
public meeting.  Final versions of all slides presented at the ACIP 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 and other WG documents will become part of the ACIP’s official re cords as required by GENERAL RECORDS SCHEDULE 6.2: Federal
Advisory Committee Records

RECORDKEEPING and REPORTING

The WG  Chair and WG L 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 wil l be published in the Morbidity and Mortality Weekly Report (MMWR).  In addition,
approved AC IP recommendations will be included in the AC IP meeting minutes and annual
report.

Summary: Page 1 of 6     Ad visory Committee on Immunization Practices ,  Centers for Disease Control and Prevention (ACIP, CDC)   COVID-19 Immunization Workgroup    Terms of R eference   UPDATED:  August 20, 2025    P URPOSE     T his document defines the activities, membership, and administrative requirements associated  with the establishment of a COVID-19 Immunization Workgroup  under the Advisory  Committee on Immunization Practices, Centers for Disease Control and Prevention (ACIP,  CDC).   ACIP…