Flu Vaccine – Does it work for Indian Children? Dr. Gaurav Gupta,  Practising Pediatrician Member AAP, IAP Charak Clinics,...
Today’s discussion <ul><li>Is  there  effective Flu Surveillance  in India ? </li></ul><ul><li>Though vaccine available in...
 
Karnataka Andhra Pradesh Maharashtra Orissa Gujarat Rajasthan Madhya Pradesh Uttar Pradesh Jharkhand Jammu Kashmir Punjab ...
WHO National Influenza Center (as of April 2011) <ul><li>Pune (NIV), </li></ul><ul><li>Kasauli (CRI) </li></ul><ul><li>& M...
Choice of vaccine strains procedure Hannoun C. Role of international networks for the surveillance of influenza. Eur Journ...
 
Indian Scenario: Reality <ul><li>No robust data in public domain on annual Influenza cases and deaths in Indian scenario* ...
 
 
 
 
Private pediatric outpatient (clinical) setting <ul><li>Aims of the study -   </li></ul><ul><li>Clinical Effectiveness of ...
<ul><li>Differentiating Vaccine Efficacy from Vaccine Effectiveness  </li></ul><ul><li>In the clinical development of a va...
 
Methodology-Clinical Effectiveness Study
Methodology-Clinical Effectiveness Study Continued…..
Methodology-Clinical Effectiveness Study Continued…..
Overall Results Vaccinated (198) vs Unvaccinated Cohort (397) # Parameter RR CI p value VE (%) 1 ILI 0.65 0.49-0.84 0.001 ...
Clinical Effectiveness of Influenza vaccine-1 Fully  vaccinated cohort (n=154) vs. Unvaccinated cohort (n=330)* Conclusion...
Clinical Effectiveness of Influenza vaccine-2 Partially  vaccinated cohort (n=16) vs. Unvaccinated cohort (n=330)* Conclus...
*Ritzwoller DP, Bridges CB, Shetterly S, Yamasaki K, Kolczak M, France EK. Effectiveness of the 2003-2004 influenza vaccin...
 
Clinical Effectiveness of Influenza vaccine-3 Age-wise efficacy for prevent of ILI * Conclusion:  Children aged 3-9 year h...
Authors' conclusions Influenza vaccines are efficacious in children older than two but little evidence is available for ch...
Results_ (Comparison of 2009-10 v/s 2010-11) Comparison of VE in 2 years in our center * Singh H, Gupta G, Tiwari P. Clini...
Singh H, Gupta G, Tiwari P. Safety and tolerability of trivalent inactivated influenza (TIV) vaccine in healthy Indian chi...
<ul><ul><ul><ul><li>* Singh H, Gupta G, Tiwari P. Safety and tolerability of trivalent inactivated influenza (TIV) vaccine...
*Delore V, Salamand C, Marsh G, Arnoux S, Pepin S and Saliou P. Long-term clinical trial safety experience with the inacti...
 
Hurdles to Flu vaccination
Hurdles to Flu vaccination <ul><li>Lack of awareness among pediatricians and physicians regarding influenza vaccine </li><...
 
# Knowledge of parents of vaccinated  children Percentage 1 Influenza is a serious problem and influenza vaccine prevents ...
# Practices of parents of vaccinated  children Percentage 1 Parents want to take Influenza vaccine next year also 48% 2 Fi...
Conclusion <ul><li>Flu vaccine is effective in reducing ILI & unscheduled visits to doctor. No effect of partial vaccinati...
Conclusions <ul><li>More studies with larger sample size to establish efficacy </li></ul><ul><li>Identify sub-groups if ag...
The European vaccine study involved an antibody that neutralizes all the influenza-A subtypes.
<ul><li>Research Team </li></ul><ul><li>Himmat Singh  </li></ul><ul><li>Rahul Renuka </li></ul><ul><li>Dr. Gaurav Gupta </...
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Flu Surveillance in India - Current Status 2011. Safety & Clinical Effectiveness of Influenza Vaccine in health Indian Children

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

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  • slide: 7 International surveillance network - The isolation and identification of influenza virus strains circulating in different regions of the world are made possible by a complete surveillance system, established by WHO since 1947. - Sentinel doctors carry out naso-pharyngeal swabs on patients showing influenza like syndromes. The samples are sent rapidly for primary laboratory identification to the National Influenza Centers. - When a new strain is detected, samples are sent to the WHO collaborating centers for further identification and detailed antigenic analysis. - Information regarding new antigenic variants of influenza virus are sent to the WHO in Geneva. - Each year at the end of february, the WHO commitee of experts holds a meeting and recommends the strains to be included in the vaccine for the upcoming influenza season. At the end of september, the Melbourne Collaborating Reference Center organizes a meeting to review and adapt composition of the vaccine to local epidemiology. To date, three countries participate to that meeting: Australia, New Zealand and South Africa. - The early tracking and identification of influenza strains by the WHO surveillance network allows manufacturers to incorporate in the vaccine, antigenic variants that will accurately match with the ones that will circulate. The vaccine will therefore have an optimal efficacy. [40]
  • Flu Surveillance in India - Current Status 2011. Safety & Clinical Effectiveness of Influenza Vaccine in health Indian Children

    1. 1. Flu Vaccine – Does it work for Indian Children? Dr. Gaurav Gupta, Practising Pediatrician Member AAP, IAP Charak Clinics, Mohali, Punjab
    2. 2. Today’s discussion <ul><li>Is there effective Flu Surveillance in India ? </li></ul><ul><li>Though vaccine available in India since 2004, is it safe in Indian pediatric population? </li></ul><ul><li>Is the flu vaccine clinically effective in Indian context ? </li></ul><ul><li>What is the public perception of Flu vaccine in India? </li></ul><ul><li>Ours is the first set of studies from India </li></ul>
    3. 4. Karnataka Andhra Pradesh Maharashtra Orissa Gujarat Rajasthan Madhya Pradesh Uttar Pradesh Jharkhand Jammu Kashmir Punjab Chattisgarh Uttaranchal Himachal Pradesh Haryana Bihar New Delhi Tamil Nadu Kerala West Bengal Sikkim Arunachal Pradesh Assam Nagaland Manipur Tripura Mizoram Meghalaya MONTHLY INFLUENZA ACTIVITY REPORTED BY-INDIAN SENTINEL DOCTOR’S NETWORK FEB-MAR 2008 No Report Source: Sentinel Doctor’s Network,March 2008 > 10 % positvity > 40% positivity <ul><ul><ul><ul><li>Location: Chennai (22 nd Feb-22 nd March 2008) </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Total Sample Collected : 55 Samples </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Total No. of Sample +ve : 23 Samples </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>% + ve : 41.82 % +ve </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Influenza A :13 Samples (56.5%) </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Influenza B : 10 Samples (43.3%) </li></ul></ul></ul></ul></ul><ul><ul><li>Location: Delhi ( Jan- Mar 2008 ) </li></ul></ul><ul><ul><ul><ul><li>Total Sample Collected :86 samples </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Total No. of Sample +ve :12 Samples </li></ul></ul></ul></ul><ul><ul><ul><ul><li>% +ve : 14%+ve </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Influenza A/H1N1 : 6 Samples </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Influenza B : 4 Samples </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Not determined but +ve : 2 Samples </li></ul></ul></ul></ul>
    4. 5. WHO National Influenza Center (as of April 2011) <ul><li>Pune (NIV), </li></ul><ul><li>Kasauli (CRI) </li></ul><ul><li>& Mumbai (Haffkine Institute) </li></ul>
    5. 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
    6. 8. Indian Scenario: Reality <ul><li>No robust data in public domain on annual Influenza cases and deaths in Indian scenario* </li></ul><ul><li>Influenza vaccine is in Indian market since 2004 </li></ul><ul><li>There is no published data on safety, tolerability and effectiveness of Influenza vaccine in Indian children** </li></ul>*India to compile database for influenza. Available from: URL: http://www.livemint.com/2009/05/31215156/India-to-compile-database-on-s.html . Accessed on 22 May, 2010. ** Joseph L Mathew. Influenza vaccination for children in India. Indian Pediatrics. 2009 ;46:304-307.
    7. 13. Private pediatric outpatient (clinical) setting <ul><li>Aims of the study - </li></ul><ul><li>Clinical Effectiveness of Seasonal Flu vaccine in preventing ILI 1, 2 </li></ul><ul><li>Safety & Tolerability of the Seasonal Flu Vaccine 3 </li></ul><ul><li>KAP Survey of Caregivers of children given the Seasonal Flu Vaccine </li></ul>1. WSPID, Nov 2011, Melbourne, Poster Presentation. 2. ISPOR Asia Conference, September 2010, Thailand, Poster Presentation. 3. Singh H, Gupta G, Tiwari P. 62nd Indian Pharmaceutical Congress, 2010. Manipal, India. (Poster No. L-6).
    8. 14. <ul><li>Differentiating Vaccine Efficacy from Vaccine Effectiveness </li></ul><ul><li>In the clinical development of a vaccine, an efficacy study asks the question, &quot;Does the vaccine work?&quot; </li></ul><ul><li>In contrast, an effectiveness study asks the question &quot;Does vaccination help people?&quot; </li></ul>
    9. 16. Methodology-Clinical Effectiveness Study
    10. 17. Methodology-Clinical Effectiveness Study Continued…..
    11. 18. Methodology-Clinical Effectiveness Study Continued…..
    12. 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
    13. 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
    14. 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
    15. 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%
    16. 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
    17. 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
    18. 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
    19. 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).
    20. 28. <ul><ul><ul><ul><li>* 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). </li></ul></ul></ul></ul>
    21. 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 % - -
    22. 31. Hurdles to Flu vaccination
    23. 32. Hurdles to Flu vaccination <ul><li>Lack of awareness among pediatricians and physicians regarding influenza vaccine </li></ul><ul><li>Lack of awareness in parents/patients </li></ul>
    24. 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%
    25. 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%
    26. 36. Conclusion <ul><li>Flu vaccine is effective in reducing ILI & unscheduled visits to doctor. No effect of partial vaccination </li></ul><ul><li>It is safe & well tolerated by healthy Indian children. </li></ul><ul><li>KAP – Awareness of flu vaccine is present, many parents feel that it is effective and would like to take annual doses. </li></ul>
    27. 37. Conclusions <ul><li>More studies with larger sample size to establish efficacy </li></ul><ul><li>Identify sub-groups if age in which it is more effective </li></ul><ul><li>Further research for more effective & single dose Influenza vaccine </li></ul>
    28. 38. The European vaccine study involved an antibody that neutralizes all the influenza-A subtypes.
    29. 39. <ul><li>Research Team </li></ul><ul><li>Himmat Singh </li></ul><ul><li>Rahul Renuka </li></ul><ul><li>Dr. Gaurav Gupta </li></ul><ul><li>Prof. Pramil Tiwari </li></ul>

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