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IAPCOI-2011-13: Rollout plan

IAPCOI-2011-13: Rollout plan . July 16, 2011 IAP HQ, Mumbai. Vipin M. Vashishtha, MD, FIAP Convener, 2011-13 vmv@manglahospital.org. Plan of action: . I. Objectives II. Operational issues III. Recommendations IV. Collaborations V. Future Activities: Recommendations Surveillance

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IAPCOI-2011-13: Rollout plan

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

  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)

  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 issuesWebsite: • 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?

  22. IV. CollaborationsWith NRA & GoI: • Need to develop liaison with DCGI? • Collaboration with GoI: on policy, implementation issues • NTAGI • IEAG • UIP managers • others

  23. IV. CollaborationsWith Agencies & NGOs: • WHO • UNICEF • Gates Foundation • PATH/NPSP etc • Immunize India

  24. 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

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

  26. 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 ?

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

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

  29. THANK YOU!!

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