NVAC Charter

The National Vaccine Advisory Committee (NVAC) Charter is renewed every two years in accordance with Federal advisory committee guidelines. The current charter expires July 7, 2028.

National Vaccine Advisory Committee 

Authority

Section 2105 of the Public Health Service (PHS) Act, as amended (42 U.S.C. § 300aa-5). The Committee is governed by the provisions of the Federal Advisory Committee Act (5 U.S.C. Ch. 10).

Objectives and Scope of Activities

The Secretary of Health and Human Services is mandated under Section 2101 of the PHS Act (42 U.S.C. § 300aa-1) to establish a National Vaccine Program (NVP or Program) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. To achieve these goals, the Program and NVAC should consider and coordinate with broader communicable disease authorities including non-immunization strategies for individuals who are unable to be vaccinated, or who choose not to be vaccinated due to medical contraindications or strongly held personal, conscientious or religious beliefs. Those strategies should include healthy lifestyle and disease prevention initiatives, off label repurposed use of existing FDA approved drugs and the use of dietary supplements known to support healthy immune function. The Assistant Secretary for Health (ASH) serves as Director of the NVP. The National Vaccine Advisory Committee (NVAC or the Committee) was established to provide advice and make recommendations to the Director of the NVP on matters related to the Program’s responsibilities. PHS Act section 2105 (42 U.S.C. § 300aa-5).

Description of Duties

The functions of the Committee as stated in Section 2105 of the PHS Act (42 U.S.C. § 300aa-5) are as follows:

1. Study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States.
2. Recommend research priorities and other measures the Director of the NVP should take to enhance the safety and efficacy of vaccines.
3. Advise the Director of the NVP in the implementation of Sections 2102 and 2103 of the PHS Act (42 U.S.C. §§ 300aa-2 and 300aa-3).
4. Identify annually for the Director of the NVP the most important areas of governmental and non-governmental cooperation that should be considered in implementing Sections 2101 and 2103 of the PHS Act (42 U.S.C. §§ 300aa-2 and 300aa-3).

Official to Whom the Committee Reports

As stipulated in the authorizing legislation, under Section 2105 of the Public Health Service Act (42 U.S.C. § 300aa-5), the Committee makes recommendations to and advises the Director of the NVP. The ASH, as assigned by the Secretary, serves as Director of the NVP. 

Support

Management and support services for Committee activities are provided by the Office of Infectious Disease and HIV/AIDS Policy (OIDP), an office within the Office of the Assistant Secretary for Health (OASH). See Statement of Organization, Functions, and Delegations of Authority (84 Fed. Reg. 14951 (Apr. 12, 2019)). OASH is a staff division in the Office of the Secretary of the Department of Health and Human Services.

Estimated Annual Operating Costs and Staff Years

The estimated annual fiscal year’s cost to operate the Committee is $756,918.00. The estimate of annual person-years of staff support required is 2 full-time employees or equivalent time for part-time staff or full-time staff who do not work on the Committee full-time.

Estimated Number and Frequency of Meetings

Meetings will be held, at a minimum, three times per year, approximately every four months. A quorum for the conduct of business by the full Committee shall consist of a majority of the Committee’s voting members. Meetings shall be open to the public except as determined otherwise by the Secretary, or other official to whom the authority has been delegated, in accordance with guidelines under 5 U.S.C. § 552b(c) (Government in the Sunshine Act) and 5 U.S.C. Ch. 10 (Federal Advisory Committee Act). Notice of all meetings is provided to the public 15 calendar days prior to the meeting. Meetings will be conducted, and records of the proceedings will be kept, as required by applicable laws and Departmental policies.

When it is determined by the Secretary or designee that a meeting will be closed or partially closed to the public, in accordance with stipulations of Government in the Sunshine Act, 5 U.S.C. § 552b(c), then a report will be prepared that includes, at a minimum, a list of the members and their business addresses, the Committee’s functions, date and place of the meeting, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.

Duration

The National Vaccine Advisory Committee is statutorily mandated, and no specific end date has been established. The duration of the Committee is continuing, subject to the Termination section below.

Termination

Unless renewed by appropriate action, the charter for the Committee will terminate two years from the date it is filed.

Membership and Designation

Pursuant to 42 U.S.C. § 300aa-5(a), the members of the committee shall be appointed by the Director of the National Vaccine Program, who serves as the final appoint authority. The Director shall consult with the National Academy of Sciences regarding potential appointees; however, this consultation is advisory and non-binding.

The Committee consists of 17 voting members: 15 individuals, including the Chair, who are appointed to serve as public members, and two individuals who are designated to serve as official representatives of the vaccine manufacturing industry. The Director shall seek a balanced membership that includes a selection of public members who are engaged in gold standard science, vaccine safety or efficacy research, or who are physicians, scientists, members of parent organizations concerned with immunizations, representatives of state or local health agencies or public health organizations. The public members are classified as special government employees (SGEs) or tribal organizations. Affected entities of the vaccine industry will be consulted as well for selection of two representative members.

Committee membership should not consist of more than one-third who are from pharmaceutical industry or who are in academia and receive funding from pharmaceutical companies or organizations that receive funding from pharmaceutical companies. Committee membership from academia should not represent more than one-third of the membership, should be free of conflicts of interest and represent a balanced range of scientific, clinical, and public health expertise relevant to NVAC mission. Members of the public should not be less than one-third of the membership and should include broad range of expertise and balanced perspectives.

The Committee membership also consists of non-voting representative members from appropriate non-federal entities and federal agencies serving as ex-officio members. The federal ex-officio members are regular government employees who may attend Committee meetings and share information at such meetings to inform the Committee in generating recommendations with respect to the Committee’s functions under Section 2105 of the PHS Act. Non-federal members will be representative of physicians, members of parent organizations (including nonprofits) concerned with immunizations (including safety, efficacy, policy and ethical research), or representatives of state or local health agencies or public health organizations or tribal organizations that are engaged in vaccine research, or the manufacture of vaccines, or immunizations. The Director of the NVP or designee can extend an invitation of non-voting membership to federal and non-federal entities and/or interest groups as it is deemed necessary to accomplish the established mission of the Committee.

Voting members are invited to serve for overlapping terms of up to four years, except any member appointed to fill the vacancy of an unexpired term will be appointed to serve for the remainder of that term. Terms of more than two years are contingent upon renewal of the Committee by appropriate action prior to its termination. A member may serve after the expiration of their term until their successor has taken office, but no longer than 180 days. The Chair shall be appointed for a three-year term unless otherwise specified.

The Chair will be chosen from among the committee members with at least one year’s experience as a voting member and, preferably, who have demonstrated an ability both to lead the work of similar bodies and to work effectively in partnership with federal agencies and partner organizations. In the event there are no members that have served at least one year, the chair will be selected by Director of NVP or HHS Secretary.

The voting members of the Committee shall be paid travel expenses, as authorized by 5 U.S.C. § 5703 for persons employed intermittently in the Government service. The public voting members shall serve on the Committee without any other compensation, pursuant to an advance written agreement. Individuals who are appointed to serve as official representative members of the vaccine manufacturing industry or any particular interest group or business sector will serve without compensation. The representative members may be allowed per diem and any applicable expenses for all travel performed that is related to conducting business for the Committee.

Subcommittees

In carrying out its functions, the Committee may establish standing or ad hoc subcommittees composed of members of the parent Committee, as well as other individuals (e.g., individuals from organizations and the public at-large who are concerned and knowledgeable about immunizations, adverse reactions, and other topics pertaining to the NVAC mission), with approval and/or recommendation of the Director of the NVP or designee. Subcommittees may address issues such as achieving optimal prevention against infectious diseases (opportunities to boost natural immunity through healthy lifestyle) opportunities to prevent adverse reactions to vaccines (identification of individuals who may be at higher risk based on medical history, age, sex, genetic susceptibility, and immune dysregulation), development of personalized vaccinology approaches, identification of effective non-immunization strategies to protect those unable or to be vaccinated including non-pharmaceutical interventions, the roll of immunizations in addressing disease prevention and the chronic disease epidemic, scientific integrity and safety for vaccine products, the ethics of informed consent, among other topics as determined by the Chair of the Committee or Director of NVP. The Department Committee Management Officer will be notified upon establishment of each subcommittee, and will be provided with information on its name, membership, function, and estimated frequency of meetings. All reports and recommendations of the subcommittee must be reported back to the full Committee for public deliberation by the full Committee. No recommendation or report of the subcommittee can be given directly to the Director of the NVP without first being provided to and deliberated on by the full Committee.

Recordkeeping

Records of the Committee and any established subcommittees will be managed in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved agency records disposition schedule. Applicable records will be made available to the public for inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. § 552.

Filing Date:

July 7, 2026
Approved:
Assistant Secretary for Health and
Director, National Vaccine Program