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ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES:
WORK GROUPS
Conflict of Interest Policy : December 2023
Advisory Committee on Immunization Practices Secretariat
Centers for Disease Control and Prevention
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ACIP W ork Group s (WG) serve a key scientific role in support of vaccine policy development by
ACIP. In order to avoid undue influence or the appearance /perception of a conflict of interest in
WG discussions, screening for potential conflicts will be conducted upon establi shment of a WG
and annual updates will be collected from WG members to ensure that financial or other conflicts
are not present and/or have not changed. The ACIP Secretariat will assist with the collection of
conflict of interest disclosures ; screening of the conflict of interest declarations will be conducted
by the WG Lead in conjunction with the ACIP Secretariat.
The ACIP Secretariat will consider issuance of waivers to this conflict of interest policy in limited
situations. Waivers may be issued if it is determined that an individual’s subject matter expertise
is necessary for work group deliberations and another expert is not available who could fulfill this
role. In situations where a waiver is granted, the conflict of interest (or perceived conflic t of
interest) should be regularly announced to the WG.
Note: The conflict of interest policy for ACIP WG members outlined here applies to vaccines or
related products under the purview of each ACIP WG on which a person serves, as well as the
pharmaceutica l company(s) that manufactures the vaccines or related products under the
purview of each ACIP WG on which a person serves.
Because WG members are most familiar with their own situations, their personal responsibilities
include the following: (1) to alert the WG Lead about any possible conflict of interest that may
impact perception of impartial and fair activities of WG members and (2) to ident ify and certify on
an annual conflict of interest screening form (a) any aspect of the work of the ACIP WG where a
conflict of interest exists, and (b) that there will not be, and has not been, involvement in the
efforts of the WG where participation const itutes a conflict of interest.
When a possible conflict of interest is reported by a WG member, t he WG Lead will consult with
the ACIP Executive Secretary (and legal counsel if necessary), to determine whether the particular
situation involves a conflict of interest or an appearance /perception of a conflict of interest which
1) requires that the WG member not be involved in the ACIP WG process , or 2) the potential
conflict of interest must be disclosed to the WG, but participation in the ACIP WG process is
allowed .
A conflict of interest exists when a participant has a financial interest in a vaccine product , related
product (e.g., monoclonal antibody), or pharmaceutical company that manufactures vaccines (or
related products ) that may affect his/her imput ed financial interests or potentially bias his/her
approach to development of options for recommendations for use of that vaccine, or of a
competing vaccine.
In addition, WG member s who feel they might be unable to provide impartial advice on the matter
at issue for any reason, or who have made public statements (written or oral) that would indicate
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to an observer that you have taken a position on the products or issue under consideration should
disclose this as a potential conflict of interest .
Regardless of the level of financial involvement or other conflict of interest, if the participant feels
unable to provide objective advice, they must recuse themsel f from the WG activities under
consideration. The ACIP WG process relies on the integrity of each par ticipant to disclose to the
WG Chair or WG Lead any real or apparent conflicts of interest that are likely to bias the
reviewer’s evaluation of an application or proposal.
The following guidance and definitions will assist in determining whether a conflic t of interest
exists. This guidance applies to vaccines or related products under the purview of each ACIP WG
on which a person serves and the pharmaceutical company(s) that manufactures the vaccines or
related products under the purview of each ACIP WG on which a person serves . This guidance is
not all -inclusive, due to the variety of possible conflicts of interest and the potential for
appearance of conflicts of interest.
Situations where a conflict of interest exists and the individual should not serve as a WG
member includ e:
1. A person or a member of their immediate family is employed directly by a vaccine /product
manufacturer or its parent company. A member of the immediate family includes spouse ,
domestic partner , or child .
2. A person or a member of their immediate family hol ds stock in a vaccine/product
manufacturer or its parent company in excess of the OGE de minimus amounts
(https://ethics.od.nih.gov/waiver ).
3. A person is a holder of, or otherwise is entitled to royalties or other compensation for, a
patent (planned, issued, or pending) on a vaccine/product or process, immunologic agent,
adjuvant, or preservative that can be used for a vaccine that may come before ACIP for
review/discussion during the anticipated term of the concerned WG.
4. A person holds a paid advisory or consulting role with a manufacturer to perform work
related to vaccines /products expected to be considered by the WG or companies that
manufacture vaccines/p roducts under the purview of the WG . A person must agree to
forego such paid consultation or membership during his/her tenure on the ACIP WG
(except participation in research studies or service on data monitoring boards – see
below ).
5. A person is a 1) princ ipal investigator, 2) co-principal investigator, or 3) a site principal
investigator for an industry sponsored clinical trial involving a vaccine or manufacturer
under the purview of the WG (even when funding goes to the institution/program).
6. WG members should agree that they will not serve as a paid litigation consultant or expert
witness in litigation involving a vaccine or manufacturer under the purview of the WG .
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Potential conflicts of interest that should be disclosed but do not limit1 part icipation of the
individual on the WG include:
1. WG members are required to disclose participation in conducting research studies funded
by pharmaceutical companies and service on data monitoring boards (paid or unpaid) .
2. WG members should disclose any uncompensated single time participation in advisory
boards, or lectures on behalf of a pharmaceutical company that occurred in the prior 6
months . Participation in these activities should cease during tenure on the WG.
3. WG members sh ould disclose any honoraria received for continuing medical education
(CME) presentations that occurred i n the prior 6 months where the source of funding was
an unrestricted grant to the CME provider by a vaccine manufacturer and where all CME
rules and regulations are followed. Participation in these activities should cease during
tenure on the WG.
4. Non-financial conflicts (e.g. uncompensated participation in vaccine development, or a
researcher identified with a particular scientific perspective in a controversial area), should
also be disclosed and considered prior to participation.
5. WG members should disclose any potential reaso ns th ey might be unable to provide
impartial advi ce, or any reason that their impartiality in the matter might be questioned.
In addition, public statements (written or oral) that would indicate to an observer that the
WG member has taken a position on th e products or issue under consideration should be
disclosed.
Activities not considered a potential conflict of interest include:
1. WG members may receive travel reimbursement for continuing medical education (CME)
presentations where the source of funding is an unrestricted grant to the CME provider by
a vaccine manufacturer and where all CME rules and regulations are followed.
2. Discussions with pharmaceutical representatives in regards to purchasing vaccines for a
clinical practice.
WG members have an ongoing obligation to bring any new information regarding potential
conflict(s) of interest to the attention of the WG Lead. In addition, WG members must inform the
WG Lead if they are contacted directly by a representative of a vaccine manufacturer regarding a
vaccine /product under consideration by the WG on which they serve; the WG Lead will then
inform the ACIP Secretariat of any such contact.
1 Waivers may be issued by the Secretariat in consultation with the work group lead.