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February 2, 2023
The Advisory Committee on Immunization Practices (ACIP)
The Advisory Committee on Immunization Practices
ACIP holds full-committee public meetings at least three
(ACIP) is a committee of nonfederal experts who make
times per year to review evidence and vote on new
recommendations to the Department of Health and Human
recommendations. Outside these meetings, ACIP members
Services (HHS) regarding the use of vaccines and related
serve on work groups to review evidence regarding specific
agents for the control of vaccine-preventable disease in the
vaccines on an ongoing basis. ACIP work groups can solicit
U.S. civilian population. As a critical function, ACIP
and consider public comments. ACIP work groups present
recommendations inform the Centers for Disease Control
evidence reviews and draft recommendations to the full
and Prevention’s (CDC’s) annual immunization schedules
committee for consideration. Final recommendations must
of recommended vaccines for both children and adolescents
receive a vote from a majority of the committee.
(18 years of age and younger) and adults (19 years of age
and older). ACIP may also make recommendations
Recommendation Process and Criteria
regarding nonroutine vaccines, including for use in
ACIP recommendations regarding vaccines and their use
emergency situations such as the Coronavirus Disease 2019
are related to, but distinct from, the U.S. Food and Drug
(COVID-19) pandemic or the mpox outbreak.
Administration’s (FDA’s) licensure or authorization of
vaccines. Per its charter, ACIP recommendations are
ACIP Establishment and History
focused on the control of vaccine-preventable diseases,
The Advisory Committee on Immunization Practices was
whereas FDA generally focuses its review on the safety and
established by the Surgeon General in March 1964 under
efficacy of vaccines and the processes used to manufacture
general authority provided by Public Health Service Act
them. ACIP typically makes its recommendations after
(PHSA) in Section 222 (42 U.S.C. §217a). ACIP was
FDA has approved or authorized a new vaccine (or an
established to provide ongoing expert advice on federal
existing vaccine for a new indication). Per a requirement
immunization policy in response to expanded federal
added by the 21st Century Cures Act of 2016 (Cures Act;
immunization programs and the licensure of several new
P.L. 114-255, §309), ACIP must consider any newly
vaccines. In 1972, ACIP was designated a federal advisory
licensed vaccine (or new indication) at the committee’s next
committee under the Federal Advisory Committee Act
regularly scheduled meeting. In addition, ACIP can make
(FACA, P.L. 92-463; 5 U.S.C. Appendix).
recommendations regarding other medical products (e.g.,
antimicrobial therapy) shown to be effective against a
Overview
disease for which a vaccine is available.
Today, ACIP provides recommendations to CDC, the lead
federal agency for domestic public health and immunization
In its review and recommendation process, ACIP weighs
programs. The committee remains authorized under general
whether the benefits of recommending a certain vaccine for
authority, and its structure and functions are governed by its
a certain population—including the impact of such a
official charter per FACA requirements. However, under
recommendation on disease transmission or reduction in
several federal laws, ACIP and its recommendations play a
disease, hospitalizations, and deaths—outweigh any
role in defining the relevant statutory requirements (as
possible harms at an individual or population level. Harms
explained below in the “Statutory Roles” section.)
could include, for example, considerations around vaccine
safety (individual level) or disease distribution within the
Structure and Membership
population (population level). ACIP also considers the
Per its charter, ACIP currently consists of 15 voting
potential public health importance, quality of the evidence
members who have clinical, scientific, and public health
used, implementation considerations, equity, and values and
expertise in immunization. One lay member is a consumer
preferences of the people affected. In a few cases, ACIP’s
representative with knowledge about social and community
recommendations have differed from FDA-approved
aspects of immunization programs. In addition, several
indications for use, resulting in recommendations for “off-
federal health officials and representatives from national
label” use of vaccines.
health organizations (e.g., American Academy of
Pediatrics) serve as nonvoting representatives.
ACIP recommendations can be informed by the FDA-
approved vaccine label, published and unpublished clinical
Voting members are appointed by the HHS Secretary and
data from the vaccine manufacturer, and other independent
serve overlapping four-year terms. Anyone can apply to
studies. ACIP follows the Grading of Recommendations,
become a member, with selection based on meeting certain
Assessment, Development and Evaluation (GRADE)
qualifications. Per HHS policy, the department seeks to
approach for determining the quality and strength of
balance committee membership in terms of points of view,
evidence for recommendations. The GRADE approach is
professional training, and personal backgrounds.
commonly used for formulating health recommendations in
the United States and around the world.
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The Advisory Committee on Immunization Practices (ACIP)
Recommendation Types
December 2020, ACIP recommended that health care
ACIP structures its recommendations to inform clinical and
personnel and residents of long-term care facilities be the
public health practice. ACIP recommendations include (1)
first to receive COVID-19 vaccines. Again, these were
the age and other population groups (e.g., by sex,
recommendations; some states set their own priority groups.
occupation) recommended to receive that vaccine; (2) the
recommended age or frequency to receive each dose and
Statutory Roles
the interval between doses (for multidose vaccines); and (3)
Some laws, such as the Cures Act (P.L. 114-255), have
any precautions and contraindications. Some ACIP
addressed ACIP and its recommendation process. In
recommendations are made for all people in a certain age
addition, ACIP and its recommendations play a role in
group, whereas others are risk-based or targeted to specific
defining some statutory requirements, including the
patients in specific circumstances (e.g., travel vaccines).
following:
ACIP recommendations are also made in two categories:
Vaccines for Children (VFC): Under Social Security
Standard Recommendation: Vaccination
Act (SSA) Section 1928 (42 U.S.C. §1396s) ACIP is
recommendations are made for all people in an age or
tasked with developing the list of vaccines covered
risk-based group.
under the VFC program, which provides vaccines at no
Shared Clinical Decisionmaking: Vaccination should
cost to eligible children.
be based on shared clinical decisionmaking between
Health care coverage: Several laws reference ACIP
providers and patients.
recommendations in the context of health care coverage
requirements, including for private health insurance
ACIP may revise its previous recommendations based on
(PHSA Section 2713; 42 U.S.C. §300gg–13), and more
new evidence or new circumstances, such as disease
recently for Medicare Part D, Medicaid, and the State
outbreaks or vaccine shortages. Some ACIP
recommendations are issued as “interim” recommendations,
Children’s Health Insurance Coverage Program as
added by P.L. 117-169. See CRS Report R47396,
meaning that they may be subject to change.
Health Care Provisions of the Budget Reconciliation
Agency Adoption of Recommendations
Measure P.L. 117-169.
ACIP’s recommendations are not automatically adopted as
ACIP recommendations may also play a role in determining
official federal recommendations. CDC reviews and
vaccines covered by the Vaccine Injury Compensation
decides whether to formally adopt ACIP’s
Program (VICP), a no-fault system to compensate
recommendations. Official recommendations are published
individuals injured as a result of a covered vaccine. Under
in the CDC Morbidity and Mortality Weekly Report. In
PHSA Section 2114 (42 U.S.C. §300aa-14), vaccines
emergency situations, CDC may issue a vaccine
recommended by CDC for routine administration to
recommendation without consultation from ACIP.
children and pregnant women must be added to the table of
Immunization Schedules
covered vaccines under VICP. ACIP is not explicitly
mentioned, but in practice, ACIP informs CDC
ACIP votes on the overall child and adult immunization
recommendations. However, VICP cannot provide
schedules once per year, which reflect recommendations
compensation for a new type of vaccine until that vaccine
already made by ACIP that year. The immunization
type is added to the list of taxable vaccines under 26 U.S.C.
schedules provide structured reference for clinicians on the
§4131. In other words, a CDC recommendation alone does
recommended ages and dosing schedules for vaccines,
guarantee compensation under VICP for a certain vaccine.
along with any contraindications or precautions. The
current immunization schedules adopted by CDC represent
Immunization Requirements
a harmonized set of recommendations made by ACIP and
ACIP recommendations are simply that: recommendations.
other medical associations, such as the American Academy
They do not constitute immunization requirements.
of Pediatrics and American Academy of Family Physicians.
Immunization requirements are primarily imposed by state
Vaccines listed on the immunization schedules are
law on specified populations, such as students. There are
considered recommended for routine use.
some federal requirements for limited populations, such as
Emergency Recommendations
for military personnel and immigrants, or in limited context,
such as for staff of Medicare and Medicaid-participating
ACIP can make recommendations for the use of vaccines in
entities in response to the COVID-19 pandemic.
emergency situations, such as the COVID-19 pandemic. As
required by the Cures Act (P.L. 114-255, §3091), ACIP is
to make recommendations “in a timely manner, as
With respect to state immunization requirements, some
appropriate” for vaccines that could be
state laws and regulations direct state health agencies to
used in a public
consider ACIP recommendations when determining school
health emergency. During the pandemic, ACIP made two
vaccination requirements. No state, however, automatically
types of recommendations. First, ACIP made
incorporates ACIP-recommended vaccines into their
recommendations regarding the use of vaccines and dosing
immunization requirements. Several states expressly ban
by age group following FDA authorizations or approvals.
student COVID-19 vaccine mandates.
Second, in the early stages of the vaccine distribution
program, ACIP made recommendations regarding the
allocation of vaccines, specifically priority groups to
Kavya Sekar, Analyst in Health Policy
receive the limited supply of vaccines. For example, in
IF12317
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The Advisory Committee on Immunization Practices (ACIP)
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress.
Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has
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United States Government, are not subject to copyright protection in the United States. Any CRS Report may be
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