Flu Surveillance in India - Current Status 2011. Safety & Clinical Effectiveness of Influenza Vaccine in health Indian Children

1. Flu Vaccine – Does it work for Indian Children? Dr. Gaurav Gupta, Practising Pediatrician Member AAP, IAP Charak Clinics, Mohali, Punjab

6. Choice of vaccine strains procedure Hannoun C. Role of international networks for the surveillance of influenza. Eur Journal of Epidemiol 1994;10:459-61 Sentinel Doctors National influenza Centers (112 national laboratories in over 80 countries) World Health Organisation (WHO - Geneva) Collaborating Reference Centers for Research against influenza (London, Atlanta, Melbourne and Tokyo) Vaccine Manufacturers Global Influenza Surveillance Network

16. Methodology-Clinical Effectiveness Study

17. Methodology-Clinical Effectiveness Study Continued…..

18. Methodology-Clinical Effectiveness Study Continued…..

19. Overall Results Vaccinated (198) vs Unvaccinated Cohort (397) # Parameter RR CI p value VE (%) 1 ILI 0.65 0.49-0.84 0.001 35 2 ARI 0.98 0.96-1.01 0.88 3 Unsch. Visit 0.75 0.52-0.99 0.003 25 4 Absenteeism 0.97 0.70-1.32 0.86

20. Clinical Effectiveness of Influenza vaccine-1 Fully vaccinated cohort (n=154) vs. Unvaccinated cohort (n=330)* Conclusion : Influenza vaccine is effective in reducing the ILI and visits to physician for ARI in fully vaccinated Indian children as compared to unvaccinated children. *Renuka R, Gupta G, Tiwari P. Clinical effectiveness of the 2010-2011 seasonal influenza vaccine among healthy Indian children. WSPID-2011, Melbourne. Sr.No Parameters Odds Ratio CI VE % P-value 1 Influenza like illness 0.58 0.24-0.92 42 0.009 2 Visits to Physician 0.71 0.33-1.09 29 0.039

21. Clinical Effectiveness of Influenza vaccine-2 Partially vaccinated cohort (n=16) vs. Unvaccinated cohort (n=330)* Conclusion: Partially vaccinated children had no significant protection against ILI and visits to physician as compared to unvaccinated children . *Renuka R, Gupta G, Tiwari P. Clinical effectiveness of the 2010-2011 seasonal influenza vaccine among healthy Indian children. WSPID-2011, Melbourne. Sr.No Parameters Odds Ratio CI P-value 1 Influenza like illness 0.69 0.39-0.99 0.20 2 Visits to Physician 0.64 0.29-1.01 0.64

22. *Ritzwoller DP, Bridges CB, Shetterly S, Yamasaki K, Kolczak M, France EK. Effectiveness of the 2003-2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses . Pediatrics. 2005;116:153-159. # ILI Parameters Present study Ritzwoller et al* 1 Fully vaccinated vs. Unvaccinated OR (CI) 0.58 (0.24-0.92) 0.77 (0.66-0.90) P value P=0.009 <0.001 VE% 42% 23% 2 Partially vaccinated vs. Unvaccinated OR(CI) 0.69 ( 0.39-0.99 ) 0.93 (0.82-1.04) P value 0.20 <0.01 VE% NA 7%

24. Clinical Effectiveness of Influenza vaccine-3 Age-wise efficacy for prevent of ILI * Conclusion: Children aged 3-9 year had the best protection rates against ILI as compared to unvaccinated children . *Renuka R, Gupta G, Tiwari P. Clinical effectiveness of the 2010-2011 seasonal influenza vaccine among healthy Indian children. WSPID-2011, Melbourne. Sr.No Age group (no.) Odds Ratio CI P-value VE % 1 6 m – 3 y (78) 0.57 0.46-1.31 0.55 2 3 y – 9 y (64) 0.48 0.17-0.72 0.002 52 % 3 9 y – 18 y (28) 0.69 0.39-1.03 0.06

25. Authors' conclusions Influenza vaccines are efficacious in children older than two but little evidence is available for children under two. There was a marked difference between vaccine efficacy and effectiveness. This version first published online: January 25. 2006 Last assessed as up-to-date: September 30. 2007

26. Results_ (Comparison of 2009-10 v/s 2010-11) Comparison of VE in 2 years in our center * Singh H, Gupta G, Tiwari P. Clinical effectiveness of the 2009-2010 seasonal influenza vaccine among healthy Indian children. ISPOR 4 th Asia Pacific Conference, Phuket, Thailand. Fully vaccinated (154) vs Unvaccinated Cohort (330) ( 2010-11 ) # Parameter RR CI p value VE (%) 1 ILI 0.65 0.48-0.86 0.003 35 2 Unsch. Visit 0.74 0.51-0.99 0.007 26 Fully vaccinated (101) vs Unvaccinated Cohort (141) * ( 2009-10 ) # Parameter RR CI p value VE (%) 1 ILI 0.57 0.32-0.09 0.05 43 2 Unsch. Visit 0.43 0.22-0.09 0.007 57

27. Singh H, Gupta G, Tiwari P. Safety and tolerability of trivalent inactivated influenza (TIV) vaccine in healthy Indian children. 62nd Indian Pharmaceutical Congress, 2010. Manipal, India. (Poster No. L-6).

29. *Delore V, Salamand C, Marsh G, Arnoux S, Pepin S and Saliou P. Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip®. Vaccine 2006; 24 : 1586-1592 . Reactions after vaccination The Present Study Delore et al* Local reactions (Inj. site tenderness) >6-35 months 8.5 % 6-36 months 8.6 % 3-9 years 24.1 % 3-10 years 32.1 % >9-18 years 46.6 % - - Systemic reaction >6-35 months 26.7 % 6-36 months 21.2 % 3-9 years 13.3 % 3-10 years 4.3 % >9-18 years 6.6 % - -

31. Hurdles to Flu vaccination

34. # Knowledge of parents of vaccinated children Percentage 1 Influenza is a serious problem and influenza vaccine prevents influenza 90% 2 Starting of winters is right time to get influenza vaccine 61% 3 Pediatrician is source of information about influenza vaccine 99% 4 Children and elderly with complications can be given influenza 15% 5 Influenza vaccine is an annual vaccine 76%

35. # Practices of parents of vaccinated children Percentage 1 Parents want to take Influenza vaccine next year also 48% 2 Find that influenza vaccine was not very effective and don’t want to get their child vaccinated next year 16% 3 Influenza vaccine prevents all ailments like cough or cold or runny nose or fever 28% 4 Health of the child was much better than before 44%

38. The European vaccine study involved an antibody that neutralizes all the influenza-A subtypes.