1. CDC’s Advisory Committee on Immunization Practices (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

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 Charged with licensing pharmaceuticals and vaccines that are safe and effective Vaccine manufacturers submit applications Vaccine manufacturers submit applications

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

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

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

7. Advisory Committee on Immunization Practices (ACIP) Eliminate “two-tiered” approach to immunization services 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 Developed collaborations with professional societies – patients seen in both public and private venues are provided comparable immunization services

8. ACIP “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 Gynecologists (ACOG) American College of Obstetricians and Gynecologists (ACOG) American College of Physicians (ACP) American College of Physicians (ACP) These organizations are key to distributing the These organizations are key to distributing the ACIP recommendations to their members

10. 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

11. 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

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 http://www.cdc.gov/vaccines/schedules/index.html http://www.cdc.gov/vaccines/vpd-vac/vpd-list.htm Immunization Schedules: List of Vaccine-Preventable Diseases and their vaccines:

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

16. ACIP Members Members 15 voting 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. Ex-Officio Ex-Officio Centers for Medicare and Medicaid Services (CMS) Centers for Medicare and Medicaid Services (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 Administration (HRSA) Health Resources and Services 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) ACIP

18. ACIP Liaison Representatives Liaison Representatives AAFPNACCHOBIO AAPAPhAPhRMA ACHAAOAAHIP ACOGSAMNVAC ACPIDSAHICPAC AGSNFID AMASHEA NMAAPTR CANADA, MEXICO, U.K. – Immunization Committees

19. ACIP Ex Officio Liaison The Public Members Press

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

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

22. Dual Function: Protect Individual and Community Historical Example: Measles Vaccine - 1 Measles: 400,000 cases reported/year Measles: 400,000 cases reported/year 4,000 measles encephalitis 4,000 measles encephalitis 400 deaths 400 deaths otitis media, pneumonia otitis media, pneumonia Measles vaccine licensed 1963 Measles vaccine licensed 1963 95%-98% seroconversion long-term immunity ACIP recommendation: universal, routine ACIP recommendation: universal, routine vaccination of all children

23. Cases decreased: 22,000 – 75,000/year Cases decreased: 22,000 – 75,000/year 1978 DHEW (CDC): Measles Elimination Program 1978 DHEW (CDC): Measles Elimination Program Eliminate indigenous measles from US Eliminate indigenous measles from US 1984-88 3,750 cases/year 1984-88 3,750 cases/year 58% among vaccinated children 58% 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% seroconversion 2) Re-vaccinate non-responders – 99% seroconversion Dual Function: Protect Individual and Community Historical Example: Measles Vaccine - 2

24. Dilemma: Can public health goal of measles elimination be achieved? Dilemma: Can public health goal of measles elimination be achieved? Note: Cases reduced by 99+% Note: Cases reduced by 99+% Measles control achieved Measles control achieved Great clinical protection Great clinical protection How tolerant are “we” of 3750 cases/year? How tolerant are “we” of 3750 cases/year? If intolerant, what to do? If intolerant, what to do? Dual Function: Protect Individual and Community Historical Example: Measles Vaccine - 3

25. 1989 ACIP recommended all children receive 2 doses of measles vaccine 1989 ACIP recommended all children receive 2 doses of measles vaccine 1993 Transmission of indigenous measles interrupted in US 1993 Transmission of indigenous measles interrupted in US Although clinical result had been achieved, the public health (community) goal required additional effort Although clinical result had been achieved, the public health (community) goal required additional effort Dual Function: Protect Individual and Community Historical Example: Measles Vaccine - 4

26. Resurgent measles: 222 cases and 17 outbreaks Resurgent measles: 222 cases and 17 outbreaks (most since ’96) Importation transmission Importation transmission among vaccine-exempt among vaccine-exempt Concern that vaccine exemption is a growing public health problem Concern that vaccine exemption is a growing public health problem Dual Function: Protect Individual and Community Historical Example: Measles Vaccine - 5

27. 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

28. ACIP: Recent Recommendations Pneumococcal conjugate vaccine for adults 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 Hepatitis B vaccine for all persons with diabetes 60

29. ACIP: Current Issues New HCW without serologic confirmation of hepatitis B protection New HCW without serologic confirmation of hepatitis B protection Use a third dose of MMR during a mumps outbreak? Use a third dose of MMR during a mumps outbreak? Should nasal spray influenza vaccine be preferred for children? 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 research & development Vaccine financing Vaccine financing Adult immunization Adult immunization Vaccine protest movement 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