CDC’s Advisory Committee on Immunization Practices (ACIP) How is Vaccine Policy Made?

1. 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

2. 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

3. Food and Drug Administration (FDA) Charged with licensing pharmaceuticals and vaccines that are safe and effective Vaccine manufacturers submit applications

4. Manufacturers’ Applications Immunogenicity – is there an immune correlate of protection? Effectiveness – prospective, controlled trials other methods Safety – populations studied are “small”

5. Vaccine Licensed Number of doses, intervals Re-immunization? Boosters? Age limits? Other limits?

6. Advisory Committee on Immunization Practices(ACIP) • Established in 1962 to guide vaccination practices in public health clinics • Advisory to Director, CDC and Secretary, DHHS

7. 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

8. ACIP • “Harmonized” recommendations with: • American Academy of Pediatrics (AAP) • American Academy of Family Physicians (AAFP) • American College of Obstetricians and Gynecologists (ACOG) • American College of Physicians (ACP) • These organizations are key to distributing the ACIP recommendations to their members

10. Infant and ChildhoodImmunization 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

11. AdolescentImmunization 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

12. 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.

13. Vaccines that might be indicated for adults based on medical and other indications – United States 2012.

14. 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

15. ACIP • Members • Ex-Officio Members • Liaison Representatives • Organized and run by CDC staff

16. ACIP • 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

17. 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)

18. 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

19. ACIP Members Ex Officio Liaison Press Liaison The Public

20. ACIP • Three meetings per year (Feb., June, Oct.) • Working Groups • Disease epidemiology, morbidity, mortality • Vaccine immunogenicity, efficacy, safety • Cost-effectiveness • Feasibility • Recommendations • Clinical and public health guidance • Dual function: protect individual and community • Strength of evidence ranking, GRADE framework

21. Influenza HPV Japanese Encephalitis Meningococcal Pneumococcal Rotavirus Zoster (shingles) Anthrax General recommendations Adult immunizations Harmonized schedule Combination vaccines Evidence-based recommendations Vaccines during pregnancy and breastfeeding ACIPWorking Groups Vaccines Other

22. 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

23. 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

24. 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?

25. 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

26. 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

27. ACIPTwo Votes • Working Group ACIP Members vote on new recommendation • ACIP votes again, authorizing inclusion of the new recommendation in the Vaccines For Children program For VFC, both authorization and appropriation functions

28. 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

29. 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?

30. 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

31. Beyond ACIP • Vaccine research & development • Vaccine financing • Adult immunization • Vaccine protest movement

32. When meditating over a disease, I never think of finding a remedy for it, but, instead, a means of preventing it. Louis Pasteur