Federal Vaccine Advisory Committees: Roles and Current Issues

The federal government routinely relies on external advisory committees to inform policy across multiple areas. In the context of vaccines, these include several committees that assist in informing the government on vaccine policy, vaccine approvals, and vaccine recommendations for use among the public. Still, while advisory committees have served an important function in this regard for years, members of the Trump administration have raised critiques and questions about the role of these committees and taken actions in the past few weeks that have bypassed their input altogether. For example, Secretary of Health and Human Services (HHS) Robert F. Kennedy, Jr. has long raised concerns about conflicts of interest and a lack of transparency on federal vaccine advisory committees, and has recently said he intends to make changes to these committees. In recent days, officials at HHS and FDA announced a number of changes to policies regarding the review, approval, and recommendations for COVID-19 vaccines, which were implemented without any input from advisory committees. These statements and actions raise questions about the extent to which key federal health agencies will rely on the advice and input from external vaccine advisory committees going forward.

Given this context, this brief provides an overview of key federal vaccine advisory committees and discusses policy issues and questions they currently face.

Background

External advisory committees are established by Congress, federal departments, and agencies as tools for “furnishing expert advice, ideas, and diverse opinions.” Almost all federal external advisory committees are governed by the Federal Advisory Committee Act (FACA), and operate under a common set of rules and guidelines. Each advisory committee under FACA is required to have a charter, which outlines key processes and procedures such as how members are selected, how long members serve, the number of members and voting privileges, meeting schedules, reporting, and other aspects.

External advisory committees are typically comprised of the following types of members:

• Special Government Employee (SGE) members are subject matter experts drawn from outside the U.S. government. SGEs are expected to provide independent input and judgment on behalf of the government and to be free of conflicts of interest – U.S. Code prohibits SGEs from serving on a committee if doing so has a “direct and predictable effect” on their financial interests.
• Ex-officio members are federal employees who represent relevant federal offices.
• Representative members are individuals from non-government entities that represent points of view from particular groups or interested parties. For example, there may be representatives present on advisory committees from interested professional associations and/or patient groups.

Committees are overseen by and report to staff from associated federal departments or agencies. For the most part, federal external committees are advisory only – they do not set federal policy and instead only provide input and recommendations for consideration. However, some committees, such as the Advisory Committee on Immunization Practices, have certain statutory roles related to federal vaccine programs (see more below).

In the context of federal vaccine policy, there are four main advisory committees that have been established: the Vaccines and Related Biological Products Advisory Committee (VRBPAC) at the Food and Drug Administration (FDA); the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC); the National Vaccine Advisory Committee (NVAC) at the Department of Health and Human Services (HHS); and the Advisory Commission on Childhood Vaccines (ACCV) at HHS.

Vaccines and Related Biological Products Advisory Committee (VRBPAC)

Overview and governance: The Vaccines and Related Biological Products Advisory Committee (VRBPAC) at FDA reviews and evaluates scientific data on the safety and effectiveness of vaccines and provides independent advice on these issues to the FDA Commissioner. It was initially established in 1979 under U.S. code (21 U.S.C 394) and is subject to the provisions of the FACA. It is managed by the FDA’s Center for Biologics Evaluation and Research (CBER). Its most recent charter was approved in July 2024; the charter must be renewed every two years or the committee will be terminated, so charter renewal will be due by July 2026.

Membership: There are 15 voting members of VRBPAC, including a Chair. Committee members are selected by the FDA Commissioner from individuals outside the government with expertise in relevant areas and serve for up to four-year terms. One voting member, as selected by the Commissioner or designee, can be selected to represent “consumer interests” while one non-voting member can be selected to represent “industry interests.” There are two ex-officio voting members: one representing the CDC and one representing the National Institutes of Health (NIH). Voting members are subject to FDA and federal government conflict of interest standards and safeguards.

Responsibilities and process: According to its current charter, VRBPAC is meant to be convened approximately six times a year, with meetings open to the public except as determined by the FDA Commissioner or their designee. Each VRBPAC meeting is announced in advance, with an agenda of topics for review by committee members. Typically, the committee is convened to consider one or more candidate vaccines under review by the FDA, which can be new vaccines or updates to existing vaccines. Committee members review background materials and receive presentations that summarize information on the safety and efficacy of the candidate vaccine(s). There is time allotted for questions and deliberation, including public comments and questions. Voting members are typically asked to vote on specific questions, such as whether the candidate vaccine should or should not be approved by the FDA. The vote results and other information from the meeting are then reviewed and considered by FDA staff and the Commissioner as they make final decisions regarding vaccine approval or authorization, but the FDA Commissioner is not required to follow the recommendations of the committee.

Recent and upcoming meetings & topics: In 2024, the committee met four times. Since taking office, the Trump Administration has convened one VRBPAC meeting, which was held May 22, 2025 and focused on formula selection for COVID-19 vaccines for the 2025-2026 season. Earlier this year, there had been a VRBPAC meeting scheduled for March to review influenza vaccine composition for the 2025-2026 season, but it was cancelled with no reason given. Instead, FDA announced it held a closed-door interagency meeting of government experts to discuss this topic and that group agreed on a set of recommendations for influenza vaccine composition for the coming season without external input from VRBPAC.

Advisory Committee on Immunization Practices (ACIP)

Overview and governance: The Advisory Committee on Immunization Practices (ACIP) provides the CDC Director with expert opinion and recommendations about the use of vaccines. ACIP was initially established in 1964 under Section 305a of the Public Health Service Act, and has a Secretariat composed of CDC staff, including an Executive Secretary from the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) who is responsible for overall management and compliance with federal law. The ACIP Secretariat is responsible for renewing the charter every two years (or the committee will be terminated), and any revisions to the charter are subject to review and approval by the Secretary of HHS. The current ACIP charter was approved in April 2024, with renewal due by April 2026.

Membership: There are up to 19 voting members of ACIP including a Chair and Vice Chair; currently, there are 16 voting members serving. Committee members are selected from technically qualified people from outside government trained in a clinical medical field with knowledge of vaccines and immunization. ACIP must include a consumer representative as one of the voting members of the committee. ACIP members are selected by the Secretary of HHS and serve for up to four year terms. Voting members are considered SGEs subject to federal government conflict of interest standards and safeguards. In addition, ACIP voting members cannot be directly employed (or have an immediate family member who is directly employed) by a vaccine manufacturer and cannot hold a patent on a vaccine or related product. Further, members disclose sources of research funding at the beginning of every committee meeting and cannot vote on decisions where they are conflicted. ACIP also has six ex-officio members who are non-voting representatives from related U.S. government agencies such the FDA, the National Institutes of Health, and the Centers for Medicare and Medicaid services. In addition, there are 31 liaison (non-voting) representatives primarily representing professional organizations such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians.

Responsibilities and process: ACIP responsibilities include generating recommendations for the CDC Director regarding who should get a vaccine (e.g., specifying age or other criteria), what dose of the vaccine should be given, and what the timing of vaccine doses should be. In addition to generating recommendations for the CDC Director, ACIP also has certain statutory roles assigned by Congress. For example, ACIP has the responsibility to establish the list of vaccines, number of doses, schedule and contraindications for the Vaccines for Children (VFC) program, which provides vaccines to children whose parents or guardians may not be able to afford them. In addition, the Affordable Care Act and subsequent laws have indicated that health insurance plans must cover ACIP-recommended immunizations after those recommendations have been formally adopted by the CDC Director. ACIP also recommends which vaccines are required for individuals immigrating to the United States.

According to its charter, ACIP holds three regular meetings each year, though additional meetings may be scheduled as needed. Meetings are open to the public, except as otherwise determined by the CDC Director or their designee. The ACIP Steering Committee, which is comprised of representatives from each of the major centers at CDC, plans the agenda for ACIP meetings. Before meetings, each new or modified use of an existing vaccine on the agenda is reviewed by a work group consisting of ACIP members and CDC staff, which then proposes questions for consideration by the full committee. During meetings the full committee reviews this and other background information, listens to presentations, and engages in discussion and debate. In its deliberations, ACIP considers disease epidemiology and burden of disease, efficacy and effectiveness, safety, the quality of evidence reviewed, economic analyses, and implementation issues for each vaccine. The committee then votes on specific proposals or the wording of recommendations, the results of which are submitted to the CDC Director for consideration, but the CDC Director is not required to follow these recommendations.

Recent and upcoming meetings & topics: A February 2025 ACIP meeting was initially postponed and subsequently held in April 2025. That meeting covered topics that included meningococcal, respiratory syncytial virus, and chikungunya vaccines. There is another ACIP meeting scheduled for June 2025, which is expected to focus on COVID-19 vaccines for the 2025-2026 season, coming after the May 22 VRBPAC meeting on that topic. The June meeting also comes on the heels of an announcement by HHS Secretary Kennedy on May 27 that the CDC will no longer recommend COVID vaccines for healthy children or healthy pregnant women, a policy change that was reported to be a surprise to CDC staff and which was made without any input from ACIP.

National Vaccine Advisory Committee (NVAC)

Overview and Governance: The National Vaccine Advisory Committee (NVAC) serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health at HHS, in their capacity as the Director of the National Vaccine Program. A senior staff member of the Office of Infectious Disease and HIV/AIDS Policy (OIDP) with the Assistant Secretary of Health at HHS serves as the federal officer responsible for NVAC. The committee was established in 1986 under Section 2105 of the Public Health Service Act, and its charter was renewed in July 2023 and is due for renewal every two years or will be terminated; its next renewal would be July 2025.

Membership: NVAC consists of 17 voting members, comprised of 15 public members who are SGs, including the chair, and two members designated to serve as official representatives of the vaccine manufacturing industry. The committee also includes non-voting ex-officio representatives from federal agencies, as well as non-voting liaison representatives from other groups such as state and local health departments or non-governmental public health organizations. Members are appointed by the Assistant Secretary of Health at HHS in consultation with the National Academy of Sciences; vaccine industry groups are consulted for selection of the two voting representative members.

Responsibilities and process: NVAC advises the Assistant Secretary for Health at HHS on how to close gaps in immunization coverage and makes recommendations for how the U.S. vaccine enterprise broadly can improve the prevention of infectious diseases through vaccination. The committee’s advice and recommendations cover areas such as: barriers in the immunization delivery system, public trust in vaccines, immunization infrastructure, support for providers of immunization services, demand for immunization, vaccine safety, and fostering vaccine development and innovation. NVAC’s advice is presented to the Assistant Secretary for Health, who by law serves as the Director of the U.S. National Vaccine Program. NVAC is the only federal advisory committee that considers and makes recommendations across the entire U.S. immunization system broadly.

According to its charter, NVAC meets three times per year, and meetings are open to the public except as otherwise determined by the HHS Secretary or their designee. Meetings can cover recent and timely topics affecting the vaccines and immunizations broadly in the U.S.

Recent and upcoming meetings & topics: NVAC has not met since September 2024. At that meeting, the committee focused on areas such as Hepatitis B vaccine recommendations and implementation, approaches to equity in immunizations, provider payments for vaccination, and a review of HIV vaccine development. No NVAC meetings have been held under the Trump administration, and none have been publicly scheduled for future dates.

Advisory Commission on Childhood Vaccines (ACCV)

Overview and Governance: The Advisory Commission on Childhood Vaccines (ACCV) advises the Secretary of HHS on matters related to the implementation of the National Vaccine Injury Compensation Program (VICP). VICP is a federal program established by Congress in 1986, that provides financial compensation to individuals found to have been injured by a vaccine covered by the program (primarily childhood vaccines). The ACCV was established in 1986 under Title 42 of U.S. Code (42 U.S.C. 300aa-19). The committee is managed by the Health Systems Bureau of the Health Resources and Services Administration (HRSA). The current AACV charter was renewed in July of 2024; the charter is meant to be renewed every two years or will be terminated; the next renewal would be before July 2026.

Membership: Nine voting members appointed by the Secretary as follows: “three health professionals who are not employees of the federal government with expertise in health care of children, the prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two are pediatricians; three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine-related injury or death; and three attorneys, of whom at least one is an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death and one who is an attorney whose specialty includes representation of vaccine manufacturers.” Voting members are considered SGEs. In addition, the Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the CDC, and the FDA Commissioner (or designees of these officials) participate as ex-officio, non-voting members.

Responsibilities and process: According to its charter, ACCV is meant to meet four times a calendar year to advise the Secretary of HHS on matters related to the implementation of the VICP. The committee does not make final decisions about individual claims (the United States Court of Federal Claims is responsible for resolving claims for compensation under the VICP) but instead makes observations about and recommendations for improvements to the VICP program. Meetings are open to the public, except as determined otherwise by the Secretary of HHS or their designee.

Recent and upcoming meetings & topics: The most recent ACCV meeting took place in July 2024, where the committee reviewed and discussed topics such as the finding from a National Academy of Medicine review of the adverse effects of COVID-19 vaccination, the latest information from CDC’s Immunization Safety Office and updates from other federal agencies on vaccine injury information. No meetings of ACCV have been held under the Trump administration, and none have been publicly scheduled for future dates. An ACCV meeting that had been scheduled for January 29, 2025 was postponed indefinitely.

Issues to Watch

Committee composition and membership. To date, no direct action has been taken to remove current members of these external vaccine committees, but officials have voiced an intention to do so. While FDA Commissioner Makary said he had no plans to rearrange or remove experts on FDA external advisory committees such as VRBPAC, Secretary Kennedy, who has the authority to remove members, continues to raise concerns about corruption at FDA and the committee members’ independence. According to reports, Kennedy also says he plans to remove some or all current members of ACIP based on conflict of interest concerns (more below) even though he stated during his confirmation hearings he would “maintain the [ACIP] without changes.”

Handling of alleged conflict of interests. The primary concerns expressed by Secretary Kennedy and others in relation to external advisory committees – especially VRBPAC and ACIP – revolves around accusations of conflicts of interest. Commissioner Makary, for example, has said the FDA under his leadership will have to “review the ethics policy” because of a “cozy relationship between industry and the regulators.” Regarding ACIP, one of the first steps Kennedy took to address transparency concerns was launching a new online tool to allow the public to search for conflicts of interest among ACIP committee members. However, there is little evidence of major conflicts of interest for current VRBPAC and ACIP committee members, and all federal vaccine advisory committee members are already required to comply with federal regulations regarding disclosing potential conflicts of interest. For example, FDA says it “screens all advisory committee members carefully” for current financial interests and any other interests and relationships that could create the appearance that a member lacks impartiality.” In addition, VRBPAC members cannot be directly employed (or have an immediate family member who is directly employed) by a vaccine manufacturer and cannot hold a patent on a vaccine or related product. Likewise, ACIP members file annual financial disclosures, cannot work for or own vaccine manufacturer stock (nor can their family members), and cannot accept gifts from vaccine companies. Even so, more changes to these committees may be coming in the future based on perceived conflicts of interest.

Uncertainty about meeting frequency and cancelations. Under the Trump administration, the pace of convenings for these committees has been relatively slow compared to the recommended frequencies noted in their charters, and compared to past years. For example, VRBPAC has met once since President Trump took office this year, even though the frequency has been four to six meetings in previous years. A VRBPAC meeting initially scheduled for March 2025 was cancelled, and a February 2025 ACIP meeting was postponed for over a month. No meetings have been scheduled for either NVAC or ACCV, which according to their charters are meant to have three and four meetings a year, respectively. NVAC, for example, met at least twice and usually three times in each of the previous six years, while ACCV met four times a year over that time frame.

Officials bypassing or ignoring committee input on key policy decisions. In the past, FDA and CDC have typically sought input from VRBPAC and ACIP when considering key vaccine policy questions. Furthermore, final policy decisions coming from these agencies regarding vaccine approvals and recommendations have typically aligned with the input provided by these committees. However, this year has seen Trump administration health officials make several vaccine policy changes without seeking committee input or doing so while ignoring committee recommendations. For example, seasonal influenza vaccine composition this year was decided without external input, in contrast to previous years. Also, FDA leaders announced that updated COVID-19 vaccines would have to undergo new placebo-controlled trials to be approved in some cases, without any input on this change from VRBPAC. In addition, HHS Secretary Kennedy recently announced CDC would no longer be recommending COVID-19 vaccines for healthy children and pregnant women, a change that was instituted without ACIP consultation and which goes against existing committee recommendations. Further, Kennedy has thus far not acted on issuing new CDC guidance expanding the recommended age range for meningitis and respiratory syncytial virus vaccinations in the U.S., even though these changes were recommended by ACIP in its April 2025 meeting (CDC guidance regarding the chikungunya vaccine, however, was updated following ACIP recommendations from the same meeting). While there is past precedent for FDA and CDC ignoring or breaking with advisory committee recommendations, it has been rare. Ultimately, the leadership of these agencies has authority to take unilateral action, and in fact the Secretary of HHS has ultimate authority over vaccine approvals and recommendations. Therefore, further changes to federal vaccine policy changes that bypass or ignore these committees may be coming.

Table 1 Key Characteristics of Federal Vaccine Advisory Committees
Committee	Home Agency	Primary responsibilities	Initially Established	Number of Voting Members	Typical frequency of meetings	Most recent/ upcoming meeting
Vaccines and Related Biological Products Advisory Committee (VRBPAC)	Food and Drug Administration (FDA)	Advises and provides recommendations to the FDA Commissioner on the safety and effectiveness of vaccines, through review of the scientific data, to inform approval and/or authorization of vaccines in the United States.	1979	15	Six times per year	Last meeting: May 2025; next meeting not yet scheduled
Advisory Committee on Immunization Practices (ACIP)	Centers for Disease Control and Prevention (CDC)	Advises and provides recommendations to the CDC Director on the public use of vaccines in the United States; also has certain statutory roles including authority to establish the list of vaccines used in the Vaccines for Children (VFC) program. ACIP recommendations also have implications for which vaccinations are required to be covered by private health insurance under the Affordable Care Act.	1964	up to 19	Three times per year	Last meeting: April 2025; next scheduled meeting: June 2025
National Vaccine Advisory Committee (NVAC)	Department of Health and Human Services (HHS)	Advises the Assistant Secretary for Health at HHS on how to close gaps in immunization coverage and makes recommendations for how the U.S. vaccine enterprise can improve the prevention of infectious diseases through vaccination	1986	17	Three times per year	Last meeting: September 2024; no future meetings publicly scheduled
Advisory Commission on Childhood Vaccines (ACCV)	HHS/Health Resources and Services Administration (HRSA)	Advises the Secretary of HHS on matters related to the implementation of the National Vaccine Injury Compensation Program (VICP), which provides financial compensation to individuals found to have been injured by a vaccine.	1986	9	Four times per year	Last meeting: July 2024; no future meetings publicly scheduled