ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES: 

WORK GROUPS

Standard Operating Procedures: August 2018

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 ..... 3

II. Work Group Membership ........................................................................................ 4

III. Conflicts of Interest ................................................................................................... 6

IV. Roles and Responsibilities....................................................................................... 10

V. Work Group Teleconferences and Meetings......................................................... 11

VI. Confidentiality ......................................................................................................... 13

VII. Pharmaceutical Companies and Work Groups .................................................... 14

VIII. Work Group Resources .......................................................................................... 15

IX. Preparing for ACIP Meeting Presentations .......................................................... 16

Submitting Agenda Items for ACIP Meetings ...................................................................... 16

ACIP Briefing Documents ...................................................................................................... 17

ACIP Background Materials .................................................................................................. 17

ACIP Presentations ................................................................................................................. 18

X. Evidence-Based Decision and Cost-effectiveness Analyses .................................. 19

XI. Preparing MMWR Reports .................................................................................... 20

XII. Termination of Work Groups ................................................................................ 21

XIII. Appendices ............................................................................................................... 22

Appendix 1: Annual Membership Agreement and Conflict of Interest Forms .................. 22

Appendix 2: Additional Information for FDA, ISO, and ISD Representatives to 

ACIP WGs................................................................................................................................ 29
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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 development 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 

WGs are guided by CDC and HHS priorities, and by the perceived need for expert advice to 

inform development 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. 

Four WGs—the Adult Immunization, General Recommendations, Child/Adolescent 

Immunization, and Influenza WGs—are permanent. The remaining WGs are task oriented; 

such task-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 time 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. 

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In general, WGs should begin reviewing data 12-18 months prior to a 

potential decision on licensure; the length 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 exists. 

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 available or under consideration. 
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• 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 recommendations. 

Each WG operates under specific Terms of Reference (TORs) determined by the 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 TORs annually. TORs 

should be formalized annually to provide documentation of the WG priorities for each 

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. Additionally, 

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 of 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 changes; 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 matter 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 
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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 

representatives 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 

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 concurrence 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 United 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 person 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 
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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. 

• 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 an alternate. When determining the organizations and ex officio liaisons to 

include, the existing size of and the relevance of the organization to the WG TORs 

should be considered. There should be an FDA liaison for each WG where a new 

vaccine or indication is under consideration by the WG.

• The WG Lead should extend requests for 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), consultants 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. Conflicts of Interest

ACIP WGs serve a key scientific role in support of vaccine policy development by ACIP. 

Because WGs do not vote on policy recommendations, do not include a quorum of voting 

ACIP members, and report findings to ACIP rather than the government, procedural 

requirements of the Federal Advisory Committee Act (FACA) do not apply to WG meetings. 

Though FACA procedural requirements do not apply to ACIP WGs, CDC is sensitive to the 

possibility that conflicts of interest could interfere with the effective functioning of a WG. 
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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 establishment of 

the 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 

WG Chairs and WG Leads with the collection of conflict of interest forms (Appendix 1); 

screening of the conflict of interest forms will be conducted by the WG Chair and WG Lead 

in conjunction with the ACIP Secretariat. 

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 pharmaceutical 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 Chair and WG Lead about any 

possible conflict of interest that may impact perception of impartial and fair activities of 

WG members and (2) to identify 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 constitutes a conflict of interest. 

When a possible conflict of interest is reported by a WG member, the WG Chair or 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 imputed financial 

interests or potentially bias his/her approach to development of options for 

recommendations for use of that vaccine, or of a competing vaccine. Regardless of the 

level of financial involvement or other conflict of interest, if the participant feels unable to 

provide objective advice, he/she must recuse him/herself from the WG activities under 

consideration. The ACIP WG process relies on the integrity of each participant 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. 
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The following guidance and definitions will assist in determining whether a conflict 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 include:

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 holds stock in a vaccine/product 

manufacturer or its parent company in excess of the OGE de minimus amounts 

(https://ethics.od.nih.gov/topics/deminimis.htm). 

3. A person is a holder of, or otherwise is entitled to royalties or other compensation 

for, a patent on a vaccine/product or process, immunologic agent, adjuvant, or 

preservative that can be used for a vaccine that is under the purview of the WG and

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/products under the purview of the WG 

(including as a principal/co-principal investigator, or a site principal investigator for 

an industry sponsored clinical trial even when funding goes to the 

institution/program). A person must agree to forego such paid consultation or 

membership during his/her tenure on the ACIP WG. Participation in conducting 

research studies (except as a principal/co-principal investigator, or a site principal 

investigator for an industry sponsored clinical trial) funded by a pharmaceutical 

companies is not prohibited but must be declared as a potential conflict of interest 

(see below). 

5. WG members should agree that they will not serve on data safety monitoring 

boards (paid or unpaid) for a vaccine or manufacturer under the purview of the 

WG.

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.
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Potential conflicts of interest that should be disclosed but do not limit participation of 

the individual on the WG include: 

1. WG members are required to disclose participation in conducting research studies 

funded by pharmaceutical companies. 

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. 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.

Activities not considered a potential conflict of interest include:

1. WG members may receive travel reimbursement, and/or honoraria 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 Chair and 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. 

Q.: How should conflicts of interest be declared during ACIP WG discussions?

A.: There are two procedures for declaration of conflicts of interest:

• Annually, through an annual disclosure form. All WG members, including federal 

staff who do not file an OGE450 form, should complete this form, except for voting 

ACIP members whose potential conflicts are reviewed regularly. An individual who 

participates in more than one WG can submit one disclosure form.

• Prior to each WG meeting: during roll call any potential conflict of interest should be 

declared.
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IV. Roles and Responsibilities 

WG Chair

• 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 Lead to set an agenda for WG meetings 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)

• 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 meetings, 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 meetings. 

• 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 review immunization schedule footnotes annually.
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Liaison Representatives and Ex-Officio Members

• Signs annual membership agreement and conflict of interest forms.

• Attends and participates in WG meetings on a regular basis. 

• Completes timely review of materials as requested. 

• Communicates 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 forms. 

• Attends and participates in WG meetings on a regular basis. 

• Completes timely review of materials as requested. 

• Serves as a subject matter expert during WG meetings and calls. 

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 anticipated policy issues that may arise 

in association with the focus of each WG and are responsible for working 

with the WG Lead to ensure that the focus, direction, and timing of WG 

efforts remain compatible with the needs of CDC and HHS. 

• As needed, perform, 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 aspects of immunization 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.

V. 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 
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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 

teleconference 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 WG 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).

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 Global Conference Center if a need is identified early.

In-person meetings should be used with discretion: 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 factfinding role, do not include a quorum of voting ACIP members, 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 utilized 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. 
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Q.: How are “straw polls” used during WG meetings?

A.: When there are several different 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.

VI. 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 

proprietary and should not be distributed to people other than approved WG members. To

ensure confidentiality of data, the following guidelines should be implemented by all WGs. 

1. Roll call by the WG Lead should be taken at the start of each WG teleconference to 

document names of members who are participating; the roll call of participants 

should be incorporated into brief meeting minutes, which may be compiled by the 

WG Lead or someone designated to do so by her/him. 

2. At the beginning of each WG meeting/teleconference where any material that is 

not already publically available is being discussed, the WG Lead should state that 

the meetings are closed and information discussed is confidential and should not

be distributed or used in presentations. 

3. Only WG members and invited consultants should participate 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, discussion, 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 shown during teleconferences should be

marked as confidential and should not be shared with people who are not WG 

members. 

6. To minimize the possibility that slides may be extracted or used outside the WG 

meeting, PowerPoint presentations should be saved and distributed as .PDF 

(Portable Document Format) files.
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7. WG members should not discuss WG deliberations with anyone representing or 

employed by a vaccine manufacturer. 

VII. 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 opportunities 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 products are under 

consideration for use by the WG. 

• 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 request 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 exit 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 

presented 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. 
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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.

• Presentations given to WGs should be submitted to the CDC WG lead 5 business 

days prior to the presentation to allow the WG lead to distribute to the members. 

• The time allocation for the ACIP presentation should be approximately 15 minutes, 

with an additional 5 minutes for questions. Longer or shorter presentations may be 

needed; final time allocations 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 deadline for final submission for printing of slides is the 

Wednesday 1 week prior to the ACIP meeting. 

• Presentations should have the company name and/or logo on the title page and in 

the header/footer of each slide.

• 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. Additionally, a slide should be included that describes data on race and 

ethnicity, and pregnant women if available, or indicate that data are not available.

• Companies are responsible for including alt text and completing the properties to 

support 508 compliance prior to posting on the ACIP website. 

VIII. 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 Secretariat is dedicated to support the 

work of ACIP WGs including logistics, oversight of issues of science and policy, day-to-day 

oversight of WGs, and interactions with ACIP membership. 
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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 costeffectiveness evaluations.

A monthly meeting of WG Leads is organized by the Secretariat to gather 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 the 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 invited 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-bycase basis, with justification for the increased costs. In some instances, it may be necessary 

to deny reasonable requests for financial support. 

IX. 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 presentations, including topic, presenter, question(s) to be addressed by 

the ACIP

• Any additional pertinent information
17 

Following compilation of all agenda proposals, the ACIP Steering Committee meets to 

prepare a detailed agenda, which is then sent back to WG Leads 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 week 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. Briefing documents will be 

requested by the ACIP Secretariat for all major issues on the agenda, and for items on 

which a vote will be taken. The ACIP Secretariat 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, background materials are 

prepared and distributed 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 highlights 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 background materials are requested. The 

background materials can include key WG summaries, draft MMWR Policy Notes or 

Recommendations and Reports, key articles or studies, or a summary of key issues. 

Background materials are not considered to be confidential and may be shared in a limited 
18 

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 Presentations 

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, exofficio, 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 hole 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 presentation slides, they can be the same file versions that are used for 

printing. Recipients will be instructed that the meeting slides should not be shared or used 

in presentations without permission from the Work Group Lead. Final versions of all slides 

presented at the meeting will be posted on the ACIP website following the 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:
19 

• 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.

X. 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 under 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 documented. The ACIP Secretariat is available to assist with 

questions about GRADE. 

Additionally, In February 2018 the ACIP adopted use of an evidence to recommendations 

framework. Information about the framework will be added here and on the ACIP website

when available. 

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 quality.
20 

XI. 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 upon 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 Recommendations and Reports (comprehensive summary 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/CDCPolicy-Notes-Development-and-Reporting-Checklist.docx). The WG Lead should also meet 

with MMWR prior to developing 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.

After clearance and prior to publication, sections of the MMWR that discuss a particular 

product should be shared with the company that manufactures that product to ensure 

there are no factual errors or literature that was not included. At the time where 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 schedule and general 

guidance documents). This is for awareness purposes only and edits can be made only if 

factual errors are identified.
21 

XII. Termination of Work Groups

Four ACIP WGs are designated “permanent” WGs, since recurring tasks occur annually 

(influenza, child/adolescent immunization, and adult immunization) or approximately 

every 3-5 years (general recommendations). The remaining WGs are designated “taskoriented,” and are established when needed (Section I), and disbanded once the stated 

terms of reference have been completed. It is often the case that the WG has completed 

its terms of reference, but an ACIP recommendation statement (Policy 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 Lead may disband the 

WG, and the draft recommendations 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 and completes its TORs, 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 Lead agree that it is reasonable to disband the WG, the 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.
22 

XIII.Appendices

Appendix 1: Annual Membership Agreement and Conflict of Interest Forms 
23 

ACIP Work Group Member Agreement

Your name: 

Please list each of the work group(s) which you are a member of: 

Thank you for your generous contribution of time and expertise as a member of an 

Advisory Committee on Immunization Practices (ACIP) work group (WG). Serving as an 

ACIP WG member is an important responsibility. Work groups are responsible for 

collection, analysis, and preparation of information for presentation, discussion, 

deliberation, and vote by ACIP. Work Groups review specific topics to facilitate informed 

and efficient decision making by ACIP voting members. 

Due to the high public health significance of this work, it is imperative that all WG 

members understand and consent to abide by several guiding principles. Please initial 

each principle below to indicate that you understand it and agree to abide by it in your 

role as a WG member. Typed initials are acceptable. 

Nature of the advisory role. ACIP assists the Centers for Disease Control and 

Prevention (CDC) and the Department of Health and Human Services (HHS) in 

development of public policy related to immunization of the civilian population in the 

United States. ACIP utilizes WGs to review relevant published and unpublished data and 

develop recommendation options for presentation to the ACIP. ACIP WGs serve a key 

scientific role in support of vaccine policy development by ACIP, including development of 

policy options for presentation to ACIP and written ACIP policy statements. However, WGs

do not formulate policy or vote on policy recommendations. 

Participation. WGs accomplish most of their work through teleconferences; 

participants communicate the perspective of the organization or agency they represent, 

and serve as subject matter experts when appropriate. Active WGs have a set day and time 

for routine monthly teleconferences, which allows standing teleconferences to be 

arranged and WG members to anticipate and reserve time for these teleconferences. Work 

group members must agree to make a best effort to attend all calls, and over the course of 

a year must attend at least 75% of calls.
24 

Confidentiality. Unlike ACIP meetings, WG meetings/teleconferences are not 

public; data presented during these meetings are often proprietary and should not be 

distributed to people other than approved WG members. Only WG members and invited 

consultants should participate. WG proceedings should not be discussed in any personal or 

professional setting. Liaison representatives serving on WGs should not share proceedings, 

discussion, or slides with the parent organization unless permission is granted by the 

person who presented this information. Slides distributed at WG meetings or 

teleconferences should be marked as confidential and should not be shared with people 

who are not WG members. Work Group members should be especially sensitive about not 

discussing WG deliberations with anyone representing or employed by a vaccine 

manufacturer.

Disclosure of conflicts of interest. A participant who has a potential conflict of 

interest for a vaccine under the purview of each ACIP WG on which a person serves, or 

with the manufacturer of such a vaccine, should disclose the potential conflict to the WG 

Chair or WG Lead. Regardless of the level of financial involvement or other interest, if the 

participant feels unable to provide objective advice, he/she must recuse him/herself from 

the WG activities under consideration. The ACIP WG process relies on the integrity of each 

participant to disclose to the WG Chair or WG Lead any real or perceived conflicts of 

interest that are likely to bias the reviewer’s evaluation of an application or proposal. 

Because ACIP WG members are most familiar with their own situations, they must (1) to 

alert the WG Chair and WG Lead about any possible conflict of interest that may impact 

perception of impartial and fair activities of WG members and (2) to identify 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 constitutes a conflict of interest.

Please sign below to indicate that you have read and consented to abide by all guiding 

principles listed above. A typed signature is acceptable.

Signature

Date
25 

Conflict of Interest Disclosure for Participants in ACIP Work Groups

ACIP WGs serve a key scientific role in support of vaccine policy development by ACIP. 

Because WGs do not vote on policy recommendations, do not include a quorum of voting 

ACIP members, and report findings to ACIP rather than the government, procedural 

requirements of the Federal Advisory Committee Act (FACA) do not apply to WG meetings. 

Though FACA procedural requirements do not apply to ACIP WGs, CDC is sensitive to the 

possibility that conflicts of interest could interfere with the effective functioning of a WG. 

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 establishment of 

the 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 

WG Chairs and WG Leads with the collection of conflict of interest forms; screening of the 

conflict of interest forms will be conducted by the WG Chair and WG Lead in conjunction 

with the ACIP Secretariat. 

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 pharmaceutical 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 Chair and WG Lead about any 

possible conflict of interest that may impact perception of impartial and fair activities of 

WG members and (2) to identify 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 constitutes a conflict of interest. 

When a possible conflict of interest is reported by a WG member, the WG Chair or 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 imputed financial 

interests or potentially bias his/her approach to development of options for 
26 

recommendations for use of that vaccine, or of a competing vaccine. Regardless of the 

level of financial involvement or other conflict of interest, if the participant feels unable to 

provide objective advice, he/she must recuse him/herself from the WG activities under 

consideration. The ACIP WG process relies on the integrity of each participant 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 conflict 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 include:

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 holds stock in a vaccine/product 

manufacturer or its parent company in excess of the OGE de minimus amounts 

(https://ethics.od.nih.gov/topics/deminimis.htm). 

3. A person is a holder of, or otherwise is entitled to royalties or other compensation 

for, a patent on a vaccine/product or process, immunologic agent, adjuvant, or 

preservative that can be used for a vaccine that is under the purview of the WG and

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/products under the purview of the WG 

(including as a principal/co-principal investigator, or a site principal investigator for 

an industry sponsored clinical trial even when funding goes to the 

institution/program). A person must agree to forego such paid consultation or 

membership during his/her tenure on the ACIP WG. Participation in conducting 

research studies (except as a principal/co-principal investigator, or a site principal 

investigator for an industry sponsored clinical trial) funded by pharmaceutical 

companies is not prohibited, but must be declared as a potential conflict of interest 

(see below). 
27 

5. WG members should agree that they will not serve on data safety monitoring 

boards (paid or unpaid) for a vaccine or manufacturer under the purview of the 

WG.

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.

Potential conflicts of interest that should be disclosed but do not limit participation of 

the individual on the WG include: 

1. WG members are required to disclose participation in conducting research studies 

funded by pharmaceutical companies. 

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. 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.

Activities not considered a potential conflict of interest include:

1. WG members may receive travel reimbursement, and/or honoraria 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 Chair and 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. 

There are two procedures for declaration of conflicts of interest:

1. Annually, through an annual disclosure form. All WG members, including federal 

staff who do not file an OGE450 form, should complete this form, except for voting 

ACIP members whose potential conflicts are reviewed regularly. An individual who 

participates in more than one WG can submit one disclosure form.
28 

2. Prior to each WG meeting: during roll call any conflict of interest should be 

declared. 

CERTIFICATION

All ACIP WG members must certify that they have read these guidelines and that, to the 

best of his/her knowledge, he/she has disclosed all conflicts of interest that he/she may 

have with the vaccines under the purview of each ACIP WG on which they serve, and with 

the manufacturers of those vaccines or of competing vaccines under the purview of each 

WG on which they serve.

Member Name: 

Work Group (s): 

Potential Conflicts of Interest to Disclose:

Please initial next to the following statement:

I certify that I have read the guidance on Conflict of Interest Disclosure for 

Participants of ACIP WGs and disclosed any existing or potential conflicts of 

interest with any vaccines under the purview of each ACIP WG on which I 

serve, and with the manufacturers of those vaccines or of competing vaccines

under the purview of each WG on which I serve.
29 

Appendix 2: Additional Information for FDA, ISO, and ISD Representatives to 

ACIP WGs

FDA Representatives to ACIP Work Groups

In most circumstances, the ACIP 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 representative 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 website 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 perspective 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 the 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 representative 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 concerns (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.

Roles and Responsibilities

• Signs annual membership agreement.
30 

• 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 during 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 leadership 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 findings, 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 for 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 concern from provider groups, health officials or the 

general public for which the ACIP Work Group should be made aware. 
31 

• When recommendations are proposed for which there are potential vaccine safety 

concerns, it is important that these concerns are communicated 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 needed, 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 licensure. 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 issues 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 implementation issues can also help how recommendations are 

framed.
32 

• 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 potential 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 during the call or follows-up with the Work Group Lead if

there are concerns related to implementation issues.