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  1. Vaccines and Related Biological Products Advisory Committee

Charter of the Vaccines and Related Biological Products Advisory Committee

1. ADVISORY COMMITTEE’S OFFICIAL DESIGNATION
Vaccines and Related Biological Products Advisory Committee

2. AUTHORITY
The Vaccines and Related Biological Products Advisory Committee (the Committee) is established under 15 U.S.C. §1451 et seq.; 21 U.S.C. §321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 355h, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. §217a, 241, 242, 242a, 262, 264; 21 CFR Part 14; and is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. §1001 et seq).

3. OBJECTIVES AND SCOPE OF ACTIVITIES
The Committee advises and informs the Commissioner of Food and Drugs (Commissioner) and appropriate designee(s) about the existing and relevant evidence of benefits and risks associated with ensuring the safety and effectiveness of vaccines, allergenics, and related biological products for human use, as well as, when required, any other product under the regulatory authority of FDA. The goal of this Committee is to convene experts to provide recommendations based on their interpretation of evidence, informed by their scientific, clinical, or other relevant expertise. The recommendations of this Committee will help FDA make informed decisions about the product/s or issues under consideration. Except where legally required to conduct a closed meeting, the committee meetings will be open to the public, consistent with 5 U.S.C. 1009 and in the interest of scientific innovation, education, and transparency. For clarity, the Committee provides advice and recommendations, but FDA retains full regulatory decision-making authority on the issues associated with the product/s or issues under consideration.

4. DESCRIPTION OF DUTIES
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines, allergenics, and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and as required, any other products for which FDA has regulatory responsibility. The Committee may consider the quality and relevance of FDA’s research program, which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner.

5. AGENCY OR FEDERAL OFFICER RECEIVING THE ADVISORY COMMITTEE’S ADVICE/RECOMMENDATIONS
The Committee provides advice to the Commissioner of Food and Drugs.

6. SUPPORT
Management and support services shall be provided by the Office of the Commissioner, Principal Deputy Commissioner, and / or the relevant Centers, Offices, and Programs.

7. ESTIMATED ANNUAL OPERATING COSTS AND STAFF YEARS
The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $69,893. The estimated person years of staff support required is 0.8, at an estimated annual cost of $115,550.

8. DESIGNATED FEDERAL OFFICER
The Commissioner will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all activities are within applicable statutory, regulatory, and HHS General Administration Manual directives, and any other relevant policies and procedures. The DFO will approve and prepare all meeting agendas, call all the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees. The DFO will also ensure committee members and subcommittee members, as applicable, receive appropriate training for efficient operation and compliance with all relevant member policies and procedures and applicable law. The DFO maintains information on committee activities and provides such information to the public as applicable, including as required by 5 U.S.C. § 1009(b).

9. ESTIMATED NUMBER AND FREQUENCY OF MEETINGS
FDA will convene the Committee as needed. The frequency of meetings will vary from year to year, depending on the specific issues upon which Committee’s advice and recommendations are sought. FDA is not required to convene the Committee each calendar year.

Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all such meetings shall be given to the public.

10. DURATION
The duration of the advisory committee is continuing, subject to the Termination section below.

11. TERMINATION
Unless renewed by appropriate action, the Vaccines and Related Biological Products Advisory Committee will terminate two years from the date the charter is filed.

12. MEMBERSHIP AND DESIGNATION
The Committee shall consist of at least fifteen voting members including the Chair. Subject to legal and regulatory requirements, members and the Chair are selected by and serve at the discretion of the Commissioner or designee. Each member, including the Chair, will be selected from among authorities knowledgeable in the fields of immunology, allergy and allergenic diseases, molecular biology, rDNA, virology, bacteriology, parasitology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, hypersensitivity reactions to vaccines, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.

Members may be invited to serve for terms of up to four years, or for less time in the discretion of the Commissioner or designee. Non-Federal members of this committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or Ex-Officios. Ex Officio voting members may consist of one each from the Centers for Disease Control and Prevention, and the National Institutes of Health.

In addition to the voting members, the Commissioner or designee may identify consumer and/or industry representatives to join the Committee as non-voting representative member(s), via a process consistent with legal and regulatory requirements. Individuals currently employed at FDA-regulated companies, such as pharmaceutical and medical device manufacturers, shall not be selected to serve as members of the Committee unless this Committee is expected to address issues for which inclusion of an industry representative is required by statute. If this Committee includes an industry representative, the Commissioner or designee will determine whether to invite them to participate in meetings on a case-by-case basis, according to applicable legal and regulatory requirements.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees to serve temporarily as voting members and to designate Special Government Employees to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking; or (3) when considered appropriate in the discretion of the Commissioner or designee.

A quorum for the Committee is a majority of the current voting members present at the time, provided that FDA may, in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members because of the size of the Committee and the variety in the types of issues that it will consider, or other reason determined appropriate in accordance with legal and regulatory requirements. 21 CFR §14.22(d).

Members appointed to an advisory committee serve for the duration of the Committee, or until their terms expire, they resign, or they are removed from membership by the Commissioner or designee. Committee members’ terms may be ended prior to their date of expiration, for reasons determined to be good cause. Good cause includes excessive absenteeism from Committee meetings, a demonstrated bias that interferes with the ability to render objective advice, failure to abide by established procedures, or violation of other applicable rules and regulations.

13. SUBCOMMITTEES
Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.

If requested, subcommittees may make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee. Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency or any other Federal officer.

14. RECORDKEEPING
Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws and Departmental policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records or other approved Agency records disposition schedule. These records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.

15. FILING DATE
December 31, 2025

APPROVED:
12/23/2025
/S/
Dr. Sara Brenner, M.D., M.P.H.
Principal Deputy Commissioner

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