Download Update From the ACIP

CDC’s Advisory Committee on
Immunization Practices (ACIP)
How is Vaccine Policy Made?
William Schaffner, MD
Professor and Chair, Department of Preventive Medicine
Professor of Medicine (Infectious Diseases)
Vanderbilt University School of Medicine
As there are persons who mend torn garments, so there
are physicians who heal the sick; but your duty is far
nobler and one befitting a just person – namely to keep
people in health.
Zenophon in Cryopaedia 400 BC
Food and Drug Administration (FDA)
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Charged with licensing pharmaceuticals and
vaccines that are safe and effective

Vaccine manufacturers submit applications
Manufacturers’ Applications

Immunogenicity – is there an immune correlate
of protection?

Effectiveness – prospective, controlled trials
other methods

Safety – populations studied are “small”
Vaccine Licensed

Number of doses, intervals

Re-immunization? Boosters?

Age limits?

Other limits?
Advisory Committee on Immunization Practices
(ACIP)

Established in 1962 to guide vaccination
practices in public health clinics

Advisory to Director, CDC
and Secretary, DHHS
Advisory Committee on Immunization Practices
(ACIP)

Eliminate “two-tiered” approach to
immunization services

Developed collaborations with professional
societies – patients seen in both public and
private venues are provided comparable
immunization services
ACIP

“Harmonized” recommendations with:
American Academy of Pediatrics (AAP)
 American Academy of Family Physicians (AAFP)
 American College of Obstetricians and Gynecologists
(ACOG)
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American College of Physicians (ACP)
These organizations are key to distributing the
ACIP recommendations to their members
Infant and Childhood
Immunization Schedule
Recommended immunization schedule for persons aged 0 to 6 years – United States, 2012
For those who fall behind or start late, see the catch-up schedule
Adolescent
Immunization Schedule
Recommended immunization schedule for persons aged 7 through 18 years – United States, 2012
For those who fall behind or start late, see the catch-up schedule
Adult Immunization Schedule
Recommended adult immunization – United States, 2012
Note: These recommendations must be read with the footnotes that follow containing number of doses, intervals between
doses, and other important information.
Vaccines that might be indicated for adults based on medical and other indications
– United States 2012.
Links
Immunization Schedules:
http://www.cdc.gov/vaccines/schedules/index.html
List of Vaccine-Preventable Diseases and their vaccines:
http://www.cdc.gov/vaccines/vpd-vac/vpd-list.htm
ACIP
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Members

Ex-Officio Members

Liaison Representatives

Organized and run by CDC staff
ACIP
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Members

15 voting members
vaccinology, state and local public health, pediatrics,
family medicine, internal medicine, infectious diseases
one member must be a lay person representing the public
4-year terms
conflict of interest rules, public disclosure, voting
recrusals
ACIP

Ex-Officio
Centers for Medicare and Medicaid Services (CMS)
 Department of Defense (DOD)
 Department of Veterans Affairs (DVA)
 Food and Drug Administration (FDA)
 Health Resources and Services Administration (HRSA)
 Indian Health Service (IHS)
 National Institutes of Health (NIH)
 National Vaccine Program Office (NVPO)

ACIP

Liaison Representatives
AAFP
NACCHO
BIO
AAP
APhA
PhRMA
ACHA
AOA
AHIP
ACOG
SAM
NVAC
ACP
IDSA
HICPAC
AGS
NFID
AMA
SHEA
NMA
APTR
CANADA, MEXICO, U.K. – Immunization Committees
ACIP
Ex
Officio
Members
Liaison
Press
Liaison
The Public
ACIP


Three meetings per year (Feb., June, Oct.)
Working Groups
Disease epidemiology, morbidity, mortality
 Vaccine immunogenicity, efficacy, safety
 Cost-effectiveness
 Feasibility

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Recommendations
Clinical and public health guidance
 Dual function: protect individual and community
 Strength of evidence ranking, GRADE framework

ACIP
Working Groups
Vaccines
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Influenza
HPV
Japanese Encephalitis
Meningococcal
Pneumococcal
Rotavirus
Zoster (shingles)
Anthrax
Other
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General recommendations
Adult immunizations
Harmonized schedule
Combination vaccines
Evidence-based
recommendations
Vaccines during pregnancy
and breastfeeding
Dual Function: Protect Individual and Community
Historical Example: Measles Vaccine - 1



Measles: 400,000 cases reported/year
4,000 measles encephalitis
400 deaths
otitis media, pneumonia
Measles vaccine licensed 1963
95%-98% seroconversion
long-term immunity
ACIP recommendation: universal, routine
vaccination of all children
Dual Function: Protect Individual and Community
Historical Example: Measles Vaccine - 2

Cases decreased: 22,000 – 75,000/year

1978 DHEW (CDC): Measles Elimination Program

Eliminate indigenous measles from US

1984-88 3,750 cases/year
58% among vaccinated children

Investigation:
1) Use-effectiveness of measles vaccine 90-92%
2) Re-vaccinate non-responders – 99% seroconversion
Dual Function: Protect Individual and Community
Historical Example: Measles Vaccine - 3

Dilemma: Can public health goal of measles
elimination be achieved?

Note: Cases reduced by 99+%
Measles control achieved
Great clinical protection

How tolerant are “we” of 3750 cases/year?

If intolerant, what to do?
Dual Function: Protect Individual and Community
Historical Example: Measles Vaccine - 4

1989 ACIP recommended all children receive 2
doses of measles vaccine

1993 Transmission of indigenous measles
interrupted in US

Although clinical result had been achieved, the
public health (community) goal required
additional effort
Dual Function: Protect Individual and Community
Historical Example: Measles Vaccine - 5

Resurgent measles: 222 cases and 17 outbreaks
(most since ’96)
Importation transmission
among vaccine-exempt

Concern that vaccine exemption is a growing
public health problem
ACIP
Two Votes
1.
Working Group
ACIP
Members vote on new recommendation
2.
ACIP votes again, authorizing inclusion
of the new recommendation in the
Vaccines For Children program
For VFC, both authorization and appropriation functions
ACIP: Recent Recommendations

Pneumococcal conjugate vaccine for adults
PCV13 for immunocompromised adults, etc
PCV13 for normal adults – no recommendation yet

Hepatitis B vaccine for all persons with diabetes
<60 years of age; clinician’s judgment for >60
ACIP: Current Issues

New HCW without serologic confirmation of
hepatitis B protection

Use a third dose of MMR during a mumps
outbreak?

Should nasal spray influenza vaccine be
preferred for children?
ACIP
Use objective data and a transparent process
Define what we know, what we don’t know,
and, then, what we will do now
Be prepared to revise as new data become
available
Beyond ACIP
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Vaccine research & development
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Vaccine financing
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Adult immunization
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Vaccine protest movement
When meditating over a disease, I never think
of finding a remedy for it, but, instead, a
means of preventing it.
Louis Pasteur