Advisory Committee on Immunization Practices

{{further|Vaccination policy}}

The ACIP was established in March 1964 by the US Surgeon General to assist in preventing and controlling communicable diseases,{{cite journal|title=History and Evolution of the Advisory Committee on Immunization Practices — United States, 1964–2014|journal=Morbidity and Mortality Weekly Report|volume=63|issue=42|pages=955–8|date=2014-10-24|url=https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6342a5.htm|first1=Jean Clare|last1=Smith|first2=Alan R|last2=Hinman|first3=Larry K.|last3=Pickering|pmid=25340913 |pmc=5779473 }} it recommends licensed new vaccines to be incorporated into the routine immunization schedule, recommends vaccine formulations, and reviews older vaccines to consider revising its recommendations.{{cite journal |doi=10.1016/j.vaccine.2010.02.037 |pmid=20413002 |title=The structure, role, and procedures of the U.S. Advisory Committee on Immunization Practices (ACIP) |journal=Vaccine |volume=28 |pages=A68–A75 |year=2010 |last1=Smith |first1=Jean Clare |doi-access=free }}

As of 2023, with the Inflation Reduction Act changes to Medicare Part D coverage of vaccines, the Affordable Care Act and Medicare insurance coverage of a vaccine ($0 cost sharing) are mandated when the CDC Director adopts the ACIP recommendation for the vaccines as published on the CDC website.{{Cite web |last=Duran |first=Vanessa |date=July 24, 2023 |title=Contract Year 2023 Guidance Related to Inflation Reduction Act Changes to Part D Coverage of Vaccines |url=https://www.cms.gov/files/document/irainsulinvaccinesmemo09262022.pdf |url-status=live |access-date=January 19, 2025 |website=CMS.gov}} Many private insurers follow CMS precedent.

Regularly scheduled ACIP meetings are held three times a year. Notices of each meeting, along with agenda items, are published in the Federal Register under the Federal Advisory Committee Act (FACA) requirements. A vote on vaccine recommendations may be taken when a quorum of at least eight eligible ACIP members is present. Eligible voters are those members who do not have a conflict of interest. If there are not eight eligible voting members present, the ACIP executive secretary can temporarily designate ex officio members as voting members, as provided in the committee charter. Meetings are advertised and open to the public and are now available online via webcast. The minutes of each meeting are available on the CDC website within 90 days of the conference.{{Cite web|title = ACIP Agendas, Minutes, Videos, Presentations {{!}} Immunization Practices {{!}} CDC|url = https://www.cdc.gov/vaccines/acip/meetings/meetings-info.html|website = www.cdc.gov|access-date = 2015-11-19}}

In October 2010, ACIP adopted the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.{{Cite web|title = New Framework (GRADE) for Development of Evidence-Based Recommendations by the Advisory Committee on Immunization Practices|url = https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6118a3.htm|website = www.cdc.gov|access-date = 2015-11-19}} Their process includes a review of labeling and package inserts; a review of the scientific literature on the safety and efficacy; an assessment of cost-effectiveness; a review of the morbidity and mortality associated with the disease; a review of the recommendations of other groups; and a consideration of the feasibility of vaccine use in existing programs. Each piece of evidence is judged as very low, low, moderate, or high quality. Problems such as lack of reliability and biases are taken into account, and the quality of the evidence is adjusted accordingly. Vaccines suitable for nearly all persons in an age- or risk-factor-based group are assigned Category A. Category B recommendations are made for individual clinical decision-making between the patient and physician. Both Category A and Category B vaccines must be covered by insurance companies (following the ACA).{{Cite journal |pmid = 29678594|pmc = 6123258|year = 2018|last1 = Kempe|first1 = A.|title = Knowledge and Attitudes Regarding Category B ACIP Recommendations Among Primary Care Providers for Children|journal = Academic Pediatrics|volume = 18|issue = 7|pages = 763–768|last2 = Allison|first2 = M. A.|last3 = MacNeil|first3 = J. R.|last4 = O'Leary|first4 = S. T.|last5 = Crane|first5 = L. A.|last6 = Beaty|first6 = B. L.|last7 = Hurley|first7 = L. P.|last8 = Brtnikova|first8 = M.|last9 = Lindley|first9 = M. C.|last10 = Liang|first10 = J. L.|last11 = Albert|first11 = A. P.|last12 = Smith|first12 = J. C.|doi = 10.1016/j.acap.2018.04.005}}

At meetings, the ACIP may vote to include new vaccines in the VFC program or to modify existing vaccine schedules. These votes are codified as VFC resolutions. In most cases, a resolution takes effect after establishing a CDC contract for purchasing that vaccine in the necessary amounts.{{cite web |url = https://www.cdc.gov/vaccines/programs/vfc/providers/resolutions.html|date = 2015-06-30|access-date = 2015-11-20|title = The ACIP-VFC vaccine resolutions|publisher = National Center for Immunization and Respiratory Diseases}}

Recommendations are then forwarded to the CDC Director for approval. Once approved, the recommendations appear in the CDC's Morbidity and Mortality Weekly Report and represent the official CDC recommendations for immunizations in the US.{{Cite web|title = ACIP {{!}} Home {{!}} Advisory Committee on Immunization Practices {{!}} CDC|url = https://www.cdc.gov/vaccines/acip/|website = www.cdc.gov|access-date = 2015-11-19}}

To ensure a thorough review of available information, ACIP often appoints working groups to assist in drafting its recommendations, composed of ACIP members, CDC staff, and others with immunization expertise. Workgroups work year-round to catalog specific vaccines and safety information. They review all available scientific information about vaccines which will be discussed at the next ACIP meeting so that they can present the relevant information after the vaccine is licensed at the meeting. Work groups do not vote on the final recommendation.

The ACIP nominally contains fifteen regular members, each an expert in one of the following fields:{{cite web |title = ACIP charter|date = 2014-04-01|access-date = 2015-11-20|url = https://www.cdc.gov/vaccines/acip/committee/charter.html|publisher = National Center for Immunization and Respiratory Diseases}}

• immunization practices and public health
• use of vaccines and other immunobiologic agents in clinical practice or preventive medicine
• clinical or laboratory vaccine research
• assessment of vaccine efficacy and safety
• consumer perspectives and/or social and community aspects of immunization programs; at least one member must be an expert in this category.

No one currently employed by or involved with any employees of vaccine manufacturing companies or who holds a patent for a vaccine can be a member of ACIP. In addition, the ACIP includes ex officio members from Federal agencies involved with vaccine issues, and non-voting liaison representatives from medical and professional societies and organizations.{{cite web |title = ACIP members|date = 2015-09-30|access-date = 2015-11-20|url = https://www.cdc.gov/vaccines/acip/committee/members.html|publisher = National Center for Immunization and Respiratory Diseases}}

Before leaving office, in January 2025, President Biden’s health secretary approved the appointment of eight new members to a key committee responsible for shaping U.S. vaccination policy.{{Cite web |last=Owermohle |first=Helen Branswell, Sarah |date=2025-01-31 |title=With little fanfare, Biden administration stacked vaccine advisory committee with new members |url=https://www.statnews.com/2025/01/31/vaccine-policy-acip-members-appointees-hhs/?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz-9eA0BKvNGzDYLcYd_fbtAIbfb_-IUgbMvIQtuwVa_ZDpDrbHHs_KSiboNFKNYAdHkBdjmUdNRFxjUhe1BH2EzywSh8bQ&_hsmi=345120439&utm_content=345120439&utm_source=hs_email#:~:text=Before%20leaving%20office,%20President%20Biden's,administration%20to%20shape%20the%20panel |access-date=2025-02-01 |website=STAT |language=en-US}} This rapid series of appointments within a few months could potentially limit the Trump administration’s ability to influence the panel with its selections.{{Cite news |date=2025-01-31 |title=Biden Stacked Vaccine Committee; Sickle Cell and Sudden Death; NFL Concussions Down |url=https://www.medpagetoday.com/infectiousdisease/vaccines/114020 |archive-url=http://web.archive.org/web/20250201115659/https://www.medpagetoday.com/infectiousdisease/vaccines/114020 |archive-date=2025-02-01 |access-date=2025-02-01 |language=en}} The decision to fill four newly created positions and replace four members whose terms end in June was aimed at safeguarding the committee’s scientific integrity. Unlike President Trump’s nominee for health secretary, Robert F. Kennedy Jr., who has voiced skepticism about vaccines, the newly appointed members are seen as strong immunization supporters. If confirmed as HHS secretary, Kennedy would likely be unable to appoint new members to the Advisory Committee on Immunization Practices until 2027, restricting his influence over vaccine policy at the Centers for Disease Control and Prevention.{{Cite web |title=Biden's Parting Panacea: 8 Members Added To Vaccine Advisory Panel |url=https://kffhealthnews.org/morning-breakout/bidens-parting-panacea-8-members-added-to-vaccine-advisory-panel/ |access-date=2025-02-01 |website=KFF Health News |language=en-US}}

On February 26, 2015, ACIP voted to deliver a Category A recommendation for administering MenB vaccines to persons older than 10 years who were at higher risk of meningococcal disease.

On June 24, 2015, ACIP heard the arguments for recommending Pfizer and Novartis's serogroup B meningococcal vaccines for everyone in the 16-22 age group. The vaccines were licensed to be administered to persons 10 to 25 years of age. ACIP was unable to grade all of the evidence according to the GRADE system, but they considered the evidence given to be of enough quality to consider a recommendation. The proposed wording was as follows:

“A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age. (Category B)”

The motion was passed, 14 to 1.

In 2020 ACIP created a phased vaccine allocation recommendation for the COVID vaccines.{{Cite web|title=National Academies release framework for equitable allocation of a COVID-19 vaccine for adoption by HHS, state, tribal, local, and territorial authorities|url=https://www.sciencedaily.com/releases/2020/10/201002111729.htm|access-date=2021-01-01|website=ScienceDaily|language=en|date=2020-10-02}}{{Cite journal|last=Oliver|first=Sara E.|date=2020|title=The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020|journal=MMWR. Morbidity and Mortality Weekly Report|language=en-us|volume=69|issue=50|pages=1922–1924|doi=10.15585/mmwr.mm6950e2|pmid=33332292|pmc=7745957|issn=0149-2195|doi-access=free}}{{Cite web|title=Who should get the vaccine first? The debate over a CDC panel's guidelines, explained.|url=https://www.vox.com/future-perfect/22193679/who-should-get-covid-19-vaccine-first-debate-explained|website=Vox|language=en|first=Kelsey|last=Piper|date=2020-12-22|access-date=2021-11-15}}

In the 2024 case of Braidwood v. Becerra, the United States Court of Appeals for the Fifth Circuit entertained questions about the constitutionality of ACIP recommendations having certain binding legal effects, pursuant to the Presentment Clause of the Constitution of the United States, since members of the body are not appointed by the president to be confirmed by the Senate. Although the court did not decide that using such ACIP recommendations was unconstitutional, it held that another board that similarly made recommendations with binding legal effects was unconstitutional and remanded the question of the constitutionality of ACIP's role to the district court.{{Cite web|url=https://www.healthaffairs.org/content/forefront/braidwood-v-becerra-threat-preventive-services-just-got-worse|title=Braidwood v Becerra: The Threat to Preventive Services Just Got Worse|first1=Richard|last1=Hughes IV|work=Health Affairs|date=June 28, 2024}}

• [https://www.cdc.gov/acip/meetings/index.html ACIP Meeting Information]
• [https://www.cdc.gov/acip-recs/hcp/vaccine-specific/index.html Vaccine-Specific Recommendations]
• Most Recent Immunization Schedules
• [https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html Children and Adolescents]
• [https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html Adults]

• National Immunization Technical Advisory Group, generic terms for immunization advisory committee
• Joint Committee on Vaccination and Immunisation, the National Health Service counterpart in the United Kingdom
• National Advisory Committee on Immunization, immunization advisory committee in Canada
• Standing Committee on Vaccination, immunization advisory committee in Germany

{{reflist}}

• [https://www.cdc.gov/vaccines/acip/index.html ACIP home page]

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{{Vaccine safety}}

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Category:American advisory organizations

Category:Vaccination-related organizations based in the United States

Category:Medical and health organizations based in Georgia (U.S. state)