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

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 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

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”

Vaccine LicensedVaccine Licensed

Number of doses, intervalsNumber of doses, intervals

Re-immunization? Boosters?Re-immunization? Boosters?

Age limits?Age limits?

Other limits?Other limits?

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

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

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

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

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

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.

Vaccines that might be indicated for adults based on medical and other indications

– United States 2012.

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:

ACIPACIP

MembersMembers

Ex-Officio MembersEx-Officio Members

Liaison RepresentativesLiaison Representatives

Organized and run by CDC staffOrganized and run by CDC staff

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

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

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

ACIPACIP

Ex Officio Liaison

Liaison

The Public

Members

Press

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

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

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

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

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

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

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

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

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

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?

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

Beyond ACIPBeyond ACIP

Vaccine research & developmentVaccine research & development

Vaccine financingVaccine financing

Adult immunizationAdult immunization

Vaccine protest movementVaccine 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