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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
([email protected] ), 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.
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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.
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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.
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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.
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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.
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• 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.
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• 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.