1. IAPCOI-2011-13: Rollout plan Vipin M. Vashishtha, MD, FIAP Convener, 2011-13 vmv@manglahospital.org July 16, 2011 IAP HQ, Mumbai

2. Plan of action: I. Objectives II. Operational issues III. Recommendations IV. Collaborations V. Future Activities: – Recommendations – Surveillance – Proposed new activities

3. I. Objectives & Scope of Activities* To issue guidelines to its members through publication of guidebook, updates in journals, website, etc on various issues related to vaccines and practice of immunization: To guide GOI on various issues related to constitution of NIP To guide GoI/ICMR through NTAGI on various issues related to introduction of a new vaccine in to its NIP. To extend IAP’s advocacy role in providing impetus to vaccination drive all over the country. To collaborate with MoH/ICMR/ health agencies in improving RI To collaborate with other IAP chapters/groups/ national agencies in gathering data on important VPDs To help national agencies to gather data on vaccine safety and AEFI To counteract any misinformation campaign against vaccines/vaccination *http://www.iapcoi.com/index-1.html

4. II. Operational issues Structure of the committee: – Voting Vs non-voting members Meeting schedule: – Periodicity: Twice in a year: Jan/Dec & July – Venues: Mumbai & Delhi Recommendations: – Immunization schedule : preferably revised annually – Interim recommendations: As & when the need arises – Guidebook: once in every two years (in the end of the committee’s tenure)

5. II. Operational issues Publications: – Guidebook – Interim recommendations – Replies to vaccination queries – Position papers? – Proceeding & Recommendations (to website & Academy Today, etc after every meeting)

6. II. Operational issues “Code of Conduct” issues: Committee’s stand on “Conflict of interest” Code of Ethics Regulations, 2002; MEDICAL COUNCIL OF INDIA AMENDMENT NOTIFICATION New Delhi, the 10th December, 2009 (Available from: http://mciindia.org/know/rules/ethics.htm)http://mciindia.org/know/rules/ethics.htm

7. II. Operational issues Division of Work/ Description of Duties: Assignment of jobs to each member – Data on individual vaccines: Surveillance Review of literature (national & global) Clinical trials: ongoing/planned/completed – Vaccinology in review Appointment of rapporteur

8. II. Operational issues Website: Needs improvement: ? Public information ? Interactive- Discussion Forum Meeting agenda, minutes, presentations ? Link to Idsurve: surveillance data posting Online courses ?

9. III. Recommendations Methodology of issuing recommendations: How to offer best evidence-based recommendations? Need to answer few questions: What is the evidence? – How to look for it? How to access? – How to assess & analyze? Which is the better evidence? (Hierarchy of evidence) How to grade the available evidence to issue recommendations?

10. III. Recommendations What are the models available? To develop a uniform approach to making explicit the evidence base for IAPCOI recommendations

11. III. Recommendations Focus on transparency Use of evidence of varying strengths Consider individual and community health Continually strive to improve the process Changes to existing recommendations? First apply proposed process to New recommendations ?

12. (GRADE) framework: Grades of Recommendation Assessment, Development and Evaluation (GRADE) framework

13. Description of Evidence Grades Proposed evidence grades for safety and efficacy, A, B, C, D June 2010 ACIP Meeting

14. Description of Evidence Grades: Note: Grades reflect the confidence in the estimated effect on health outcomes based on a body of evidence. Further research may not always be possible.

15. Proposed recommendation categories: Category I (recommendation for, or recommendation against) – Universal recommendation – Risk-based recommendation Category II (recommendation for individual clinical decision making) No recommendation/unresolved issue

16. Examples: Recommendation: ACIP recommends vaccination of U.S. infants with three doses of rotavirus vaccine administered orally at ages 2, 4, and 6 months (Recommendation category: I, Evidence grade: A). Remarks: Nearly every child in the U.S. is infected with rotavirus by age 5 years, resulting in approximately 410,000 physician visits, 205,000–272,000 emergency department visits, and 55,000–70,000 hospitalizations each year. Benefits of vaccination are large compared to potential harms.

17. Examples: IAPCOI recommends TWO/THREE doses of HRV/RV-5 administered orally at ages 6 & 10 OR 6, 10, 14 weeks (Category: ? Evidence: ? )

18. Examples: IAPCOI recommends OPV …… (Category: I Evidence: A ) IAPCOI recommendations on Typhoid vaccine: Vi-PS (Category: I ? Evidence: A/B ) Vi Conjugate (Category: II Evidence: C/D?)

19. Examples: Hepatitis A vaccines: Recommendations for use: (Category : ? ? Evidence: ? ) Killed vaccine: TWO doses (Category: I Evidence: A) Live H2 strain: TWO doses (Category: II ? Evidence: B/C )

20. IV. Collaborations Vaccine production & launch : Licensure: Recommendations on its utilization: – Community level (mass use) – Individual use level Ensure higher utilization/improving coverage Industry Regulatory authority GoI/NTAGI IAP Agencies & NGOs

21. IV. Collaborations With industry: Why? To maintain transparency To know: what’s going on? National, regional, global level? What we expect from them? What they expect from us? What’s happening once a new vaccine is introduced in the market? Data on utilization, PMS, etc? Can they help us in VPD surveillance? Collaborative research projects? Help in professional knowledge enhancement?

24. IV. Collaborations With NRA & GoI: Need to develop liaison with DCGI? Collaboration with GoI: on policy, implementation issues – NTAGI – IEAG – UIP managers – others

25. IV. Collaborations With Agencies & NGOs: WHO UNICEF Gates Foundation PATH/NPSP etc Immunize India

26. V. Activities: Current Bi-annual meetings Revision of IAP immunization schedule Reappraisals of previous recommendations Guidebook Drafting recommendations on any new issue Responding to vaccine-related issues & queries Maintenance of website

27. V. Activities: Future: Vaccine Congresses Online vaccinology course? Position papers? Brainstorming sessions/Single theme consultative meetings? Textbook of vaccinology?

28. V. Activities: Future: VPD surveillance: How to go about it? Structure (erecting & expanding the network) Idsurve ? Need to strengthen it Need other surveillance methodology to supplant ?

29. VPD Surveillance: COI Surveillance Committee: National & Joint-national coordinators Convener – Zonal coordinators State coordinators – Regional & District coordinators » Reporting units (Rus)

30. VPD surveillance: Data analysis: Need to analyze compiled data Periodicity? Annual/biannual? Interpretation Publication

31. THANK YOU!!