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CDC’s Advisory CDC’s Advisory Committee on Committee on
Immunization Practices Immunization Practices (ACIP)(ACIP)
How is Vaccine Policy Made?
William Schaffner, MDWilliam Schaffner, MD
Professor and Chair, Department of Professor and Chair, Department of Preventive MedicinePreventive Medicine
Professor of Medicine (Infectious Diseases)Professor of Medicine (Infectious Diseases)
Vanderbilt University School of MedicineVanderbilt University School of Medicine
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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
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Food and Drug Food and Drug Administration (FDA)Administration (FDA)
Charged with licensing Charged with licensing pharmaceuticals and vaccines that pharmaceuticals and vaccines that are are safesafe and and effectiveeffective
Vaccine manufacturers submit Vaccine manufacturers submit applicationsapplications
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Manufacturers’ Manufacturers’ ApplicationsApplications
Immunogenicity – is there an Immunogenicity – is there an immune correlate of protection?immune correlate of protection?
Effectiveness – prospective, Effectiveness – prospective, controlled trialscontrolled trials
other methodsother methods
Safety – populations studied are Safety – populations studied are “small”“small”
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Vaccine LicensedVaccine Licensed
Number of doses, intervalsNumber of doses, intervals
Re-immunization? Boosters?Re-immunization? Boosters?
Age limits?Age limits?
Other limits?Other limits?
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AAdvisory dvisory CCommittee on ommittee on IImmunization mmunization PPracticesractices
((ACIPACIP))
Established in 1962 to guide Established in 1962 to guide vaccination practices in public vaccination practices in public health clinicshealth clinics
Advisory to Director, CDC Advisory to Director, CDC and Secretary, DHHS and Secretary, DHHS
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AAdvisory dvisory CCommittee on ommittee on IImmunization mmunization PPracticesractices
((ACIPACIP))
Eliminate “two-tiered” approach to Eliminate “two-tiered” approach to immunization servicesimmunization services
Developed collaborations with Developed collaborations with professional societies – patients professional societies – patients seen in both public and private seen in both public and private venues are provided comparable venues are provided comparable immunization servicesimmunization services
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ACIPACIP ““Harmonized” recommendations with:Harmonized” recommendations with:
American Academy of Pediatrics (AAP)American Academy of Pediatrics (AAP) American Academy of Family Physicians (AAFP)American Academy of Family Physicians (AAFP) American College of Obstetricians and American College of Obstetricians and
Gynecologists (ACOG)Gynecologists (ACOG)
American College of Physicians (ACP)American College of Physicians (ACP)
These organizations are key to distributing These organizations are key to distributing the the ACIPACIP recommendations to their members recommendations to their members
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Infant and ChildhoodInfant and ChildhoodImmunization ScheduleImmunization 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
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AdolescentAdolescentImmunization ScheduleImmunization 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
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Adult Immunization ScheduleAdult Immunization ScheduleRecommended 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.
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Vaccines that might be indicated for adults based on medical and other indications
– United States 2012.
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LinksLinks
http://www.cdc.gov/vaccines/schedules/index.html
http://www.cdc.gov/vaccines/vpd-vac/vpd-list.htm
Immunization Immunization Schedules:Schedules:
List of Vaccine-Preventable Diseases and List of Vaccine-Preventable Diseases and their vaccines:their vaccines:
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ACIPACIP
MembersMembers
Ex-Officio MembersEx-Officio Members
Liaison RepresentativesLiaison Representatives
Organized and run by CDC staffOrganized and run by CDC staff
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ACIPACIP
MembersMembers 15 voting members15 voting members
vaccinology, state and local public health, pediatrics, vaccinology, state and local public health, pediatrics, family medicine, internal medicine, infectious family medicine, internal medicine, infectious diseasesdiseases
one member must be a lay person representing the one member must be a lay person representing the publicpublic
4-year terms4-year terms
conflict of interest rules, public disclosure, voting conflict of interest rules, public disclosure, voting recrusalsrecrusals
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Ex-OfficioEx-Officio Centers for Medicare and Medicaid Services Centers for Medicare and Medicaid Services
(CMS)(CMS) Department of Defense (DOD)Department of Defense (DOD) Department of Veterans Affairs (DVA)Department of Veterans Affairs (DVA) Food and Drug Administration (FDA)Food and Drug Administration (FDA) Health Resources and Services Health Resources and Services
Administration (HRSA)Administration (HRSA) Indian Health Service (IHS)Indian Health Service (IHS) National Institutes of Health (NIH)National Institutes of Health (NIH) National Vaccine Program Office (NVPO)National Vaccine Program Office (NVPO)
ACIPACIP
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ACIPACIP Liaison RepresentativesLiaison 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
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ACIPACIP
Ex Officio Liaison
Liaison
The Public
Members
Press
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ACIPACIP Three meetings per year (Feb., June, Oct.)Three meetings per year (Feb., June, Oct.) Working GroupsWorking Groups
Disease epidemiology, morbidity, mortalityDisease epidemiology, morbidity, mortality Vaccine immunogenicity, efficacy, safetyVaccine immunogenicity, efficacy, safety Cost-effectivenessCost-effectiveness FeasibilityFeasibility
RecommendationsRecommendations Clinical and public health guidanceClinical and public health guidance Dual function: protect individual and Dual function: protect individual and
communitycommunity Strength of evidence ranking, GRADE Strength of evidence ranking, GRADE
frameworkframework
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ACIPACIPWorking GroupsWorking Groups
InfluenzaInfluenza HPVHPV Japanese Japanese
EncephalitisEncephalitis MeningococcalMeningococcal PneumococcalPneumococcal RotavirusRotavirus Zoster (shingles)Zoster (shingles) AnthraxAnthrax
General General recommendationsrecommendations
Adult immunizationsAdult immunizations Harmonized scheduleHarmonized schedule Combination vaccinesCombination vaccines Evidence-based Evidence-based
recommendationsrecommendations Vaccines during Vaccines during
pregnancy and pregnancy and breastfeedingbreastfeeding
Vaccines
Other
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Dual Function: Protect Individual and Dual Function: Protect Individual and Community Community
Historical Example: Measles Vaccine - 1Historical Example: Measles Vaccine - 1
Measles: 400,000 cases reported/yearMeasles: 400,000 cases reported/year 4,000 measles encephalitis4,000 measles encephalitis 400 deaths400 deaths
otitis media, pneumoniaotitis media, pneumonia Measles vaccine licensed 1963Measles vaccine licensed 1963
95%-98% seroconversion95%-98% seroconversionlong-term immunitylong-term immunity
ACIPACIP recommendation: universal, recommendation: universal, routineroutine
vaccination of all childrenvaccination of all children
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Cases decreased: 22,000 – 75,000/yearCases decreased: 22,000 – 75,000/year
1978 DHEW (CDC): Measles Elimination Program1978 DHEW (CDC): Measles Elimination Program Eliminate indigenous measles from USEliminate indigenous measles from US
1984-88 3,750 cases/year1984-88 3,750 cases/year 58% among vaccinated children58% among vaccinated children
Investigation:Investigation: 1) Use-effectiveness of measles vaccine 90-92%1) Use-effectiveness of measles vaccine 90-92% 2) Re-vaccinate non-responders – 99% 2) Re-vaccinate non-responders – 99% seroconversionseroconversion
Dual Function: Protect Individual and Dual Function: Protect Individual and Community Community
Historical Example: Measles Vaccine - Historical Example: Measles Vaccine - 22
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Dilemma: Can public health goal of Dilemma: Can public health goal of measles elimination be achieved?measles elimination be achieved?
Note: Cases reduced by 99+%Note: Cases reduced by 99+% Measles control achievedMeasles control achieved Great clinical protectionGreat clinical protection
How tolerant are “we” of 3750 How tolerant are “we” of 3750 cases/year?cases/year?
If intolerant, what to do?If intolerant, what to do?
Dual Function: Protect Individual and Dual Function: Protect Individual and Community Community
Historical Example: Measles Vaccine - Historical Example: Measles Vaccine - 33
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1989 ACIP recommended 1989 ACIP recommended allall children children receive 2 doses of measles vaccinereceive 2 doses of measles vaccine
1993 Transmission of indigenous 1993 Transmission of indigenous measles interrupted in USmeasles interrupted in US
Although clinical result had been Although clinical result had been achieved, the public health achieved, the public health (community) goal required additional (community) goal required additional efforteffort
Dual Function: Protect Individual and Dual Function: Protect Individual and Community Community
Historical Example: Measles Vaccine - Historical Example: Measles Vaccine - 44
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Resurgent measles: 222 cases and 17 Resurgent measles: 222 cases and 17 outbreaksoutbreaks(most since ’96)
Importation transmissionImportation transmission
among vaccine-exemptamong vaccine-exempt
Concern that vaccine exemption is a Concern that vaccine exemption is a growing public health problemgrowing public health problem
Dual Function: Protect Individual and Dual Function: Protect Individual and Community Community
Historical Example: Measles Vaccine - Historical Example: Measles Vaccine - 55
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ACIPACIPTwo VotesTwo Votes
1.1. Working Group Working Group ACIPACIP Members vote on new Members vote on new recommendationrecommendation
2.2. ACIPACIP votes again, authorizing inclusion votes again, authorizing inclusion
of the new recommendation in the of the new recommendation in the
Vaccines For Children programVaccines For Children programFor VFC, both authorization and For VFC, both authorization and
appropriation functionsappropriation functions
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ACIPACIP: Recent : Recent RecommendationsRecommendations
Pneumococcal conjugate vaccine for adultsPneumococcal conjugate vaccine for adultsPCV13 for immunocompromised adults, etcPCV13 for immunocompromised adults, etc
PCV13 for normal adults – no recommendation yetPCV13 for normal adults – no recommendation yet
Hepatitis B vaccine for all persons with Hepatitis B vaccine for all persons with diabetes <60 years of age; clinician’s judgment diabetes <60 years of age; clinician’s judgment for >60for >60
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ACIPACIP: Current Issues: Current Issues
New HCW without serologic New HCW without serologic confirmation of hepatitis B protectionconfirmation of hepatitis B protection
Use a third dose of MMR during a Use a third dose of MMR during a mumps outbreak?mumps outbreak?
Should nasal spray influenza vaccine Should nasal spray influenza vaccine be preferred for children?be preferred for children?
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ACIPACIP
Use objective data and a transparent Use objective data and a transparent processprocess
Define what we know, what we don’t Define what we know, what we don’t know, and, then, what we will do nowknow, and, then, what we will do now
Be prepared to revise as new data Be prepared to revise as new data become availablebecome available
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Beyond ACIPBeyond ACIP
Vaccine research & developmentVaccine research & development
Vaccine financingVaccine financing
Adult immunizationAdult immunization
Vaccine protest movementVaccine protest movement
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When meditating over a
disease, I never think of
finding a remedy for it, but,
instead, a means of
preventing it.
Louis Pasteur