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1 1 (February 2, 2023)

handle is hein.crs/govekkp0001 and id is 1 raw text is: Congressional Research Servic As a Informing the legislitive debate since 1914 February 2, 2023 The Advisory Committee on Immunization Practices (ACIP) The Advisory Committee on Immunization Practices (ACIP) is a committee of nonfederal experts who make recommendations to the Department of Health and Human Services (HHS) regarding the use of vaccines and related agents for the control of vaccine-preventable disease in the U.S. civilian population. As a critical function, ACIP recommendations inform the Centers for Disease Control and Prevention's (CDC's) annual immunization schedules of recommended vaccines for both children and adolescents (18 years of age and younger) and adults (19 years of age and older). ACIP may also make recommendations regarding nonroutine vaccines, including for use in emergency situations such as the Coronavirus Disease 2019 (COVID-19) pandemic or the mpox outbreak. ACIP Establishment and History The Advisory Committee on Immunization Practices was established by the Surgeon General in March 1964 under general authority provided by Public Health Service Act (PHSA) in Section 222 (42 U.S.C. §217a). ACIP was established to provide ongoing expert advice on federal immunization policy in response to expanded federal immunization programs and the licensure of several new vaccines. In 1972, ACIP was designated a federal advisory committee under the Federal Advisory Committee Act (FACA, P.L. 92-463; 5 U.S.C. Appendix). Overvi ew Today, ACIP provides recommendations to CDC, the lead federal agency for domestic public health and immunization programs. The committee remains authorized under general authority, and its structure and functions are governed by its official charter per FACA requirements. However, under several federal laws, ACIP and its recommendations play a role in defining the relevant statutory requirements (as explained below in the Statutory Roles section.) Structure and Membership Per its charter, ACIP currently consists of 15 voting members who have clinical, scientific, and public health expertise in immunization. One lay member is a consumer representative with knowledge about social and community aspects of immunization programs. In addition, several federal health officials and representatives from national health organizations (e.g., American Academy of Pediatrics) serve as nonvoting representatives. Voting members are appointed by the HHS Secretary and serve overlapping four-year terms. Anyone can apply to become a member, with selection based on meeting certain qualifications. Per HHS policy, the department seeks to balance committee membership in terms of points of view, professional training, and personal backgrounds. ACIP holds full-committee public meetings at least three times per year to review evidence and vote on new recommendations. Outside these meetings, ACIP members serve on work groups to review evidence regarding specific vaccines on an ongoing basis. ACIP work groups can solicit and consider public comments. ACIP work groups present evidence reviews and draft recommendations to the full committee for consideration. Final recommendations must receive a vote from a majority of the committee. Recommendation Process and Criteria ACIP recommendations regarding vaccines and their use are related to, but distinct from, the U.S. Food and Drug Administration's (FDA's) licensure or authorization of vaccines. Per its charter, ACIP recommendations are focused on the control of vaccine-preventable diseases, whereas FDA generally focuses its review on the safety and efficacy of vaccines and the processes used to manufacture them. ACIP typically makes its recommendations after FDA has approved or authorized a new vaccine (or an existing vaccine for a new indication). Per a requirement added by the 21st Century Cures Act of 2016 (Cures Act; P.L. 114-255, §309), ACIP must consider any newly licensed vaccine (or new indication) at the committee's next regularly scheduled meeting. In addition, ACIP can make recommendations regarding other medical products (e.g., antimicrobial therapy) shown to be effective against a disease for which a vaccine is available. In its review and recommendation process, ACIP weighs whether the benefits of recommending a certain vaccine for a certain population-including the impact of such a recommendation on disease transmission or reduction in disease, hospitalizations, and deaths-outweigh any possible harms at an individual or population level. Harms could include, for example, considerations around vaccine safety (individual level) or disease distribution within the population (population level). ACIP also considers the potential public health importance, quality of the evidence used, implementation considerations, equity, and values and preferences of the people affected. In a few cases, ACIP's recommendations have differed from FDA-approved indications for use, resulting in recommendations for off- label use of vaccines. ACIP recommendations can be informed by the FDA- approved vaccine label, published and unpublished clinical data from the vaccine manufacturer, and other independent studies. ACIP follows the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for determining the quality and strength of evidence for recommendations. The GRADE approach is commonly used for formulating health recommendations in the United States and around the world.

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