Flu Vaccine – Does it work for Indian Children?

Dr. Gaurav Gupta, Practising Pediatrician

DCH, DNB, Member AAP, IAP Charak Clinics, Mohali, Punjab

Today’s discussion

Though vaccine available in India since 2004, is it safe in Indian population?

Is the flu vaccine effective in Indian context, especially clinically?

What is the public perception of Flu vaccine in India?

Ours is the first set of studies from India

WHO collaborated Influenza WHO collaborated Influenza surveillance network in Indiasurveillance network in India

AIIMS

NICED

Kolkata

Chennai

RMRC Dibrugarh

Pune

Regional Centers

New Regional Centers

Mumbai

V P Chest

New Delhi

IGGMC

Nagpur

CMCVellore

Referral Center

Haffkine Inst

NIV

KIPM

Indian Scenario:Reality No data in public domain on annual Influenza cases and

deaths in Indian scenario*

Influenza vaccine is in Indian market since 2004

There is no published data on safety, tolerability and effectiveness of Influenza vaccine in Indian children**

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*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.

Private pediatric outpatient (clinical) setting

Aims of the study - Efficacy of Seasonal Flu vaccine in preventing ILI 1

Safety & Tolerability of the Seasonal Flu Vaccine 2

KAP Survey of Caregivers of children given the Seasonal Flu Vaccine 3

1. ISPOR Asia Conference, September 2010, Thailand.2. Data on File3. Under Review for Publication in Indian Pediatrics

Methodology-Clinical Effectiveness Study

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Methodology-Clinical Effectiveness Study

9

Continued…..

Clinical Effectiveness of Influenza vaccine-1

Sr.No

Parameters Odds Ratio

CI P-value

1 Influenza like illness 0.57 0.32-0.09 0.05

2 Visits to Physician 0.43 0.22-0.79 0.007

Fully vaccinated cohort (n=101) vs. Unvaccinated cohort (n=141)*

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.

*Singh H, Gupta G, Tiwari P. Clinical effectiveness of the 2009-2010 seasonal influenza vaccine among healthy Indian children. ISPOR 4th Asia Pacific Conference, Phuket, Thailand. (Abstract accepted for Presentation on 5th Sep, 2010).

Clinical Effectiveness of Influenza vaccine-2

Sr.No

Parameters Odds Ratio

CI P-value

1 Influenza like illness 1.54 0.77-3.07 0.24

2 Visits to Physician 1.81 0.65-5.27 0.30

Partially vaccinated cohort (n=52) vs. Unvaccinated cohort (n=141)*

Conclusion: Partially vaccinated children had no significant protection against ILI and visits to physician as compared to unvaccinated children.

*Singh H, Gupta G, Tiwari P. Clinical effectiveness of the 2009-2010 seasonal influenza vaccine among healthy Indian children. ISPOR 4th Asia Pacific Conference, Phuket, Thailand. (Abstract accepted for Presentation on 5th Sep, 2010).

# ILI Parameters Present study Ritzwoller et al*

1 Fully vaccinated vs. Unvaccinated

OR (CI) 0.57 (0.32-0.99) 0.77 (0.66-0.90)

P value P=0.05 <0.001

VE% 43% 23%

2 Partially vaccinated vs. Unvaccinated

OR(CI) 1.54 (0.77-3.07) 0.93 (0.82-1.04)

P value 0.24 <0.01

VE% -54% 7%

*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.

Cont…

Lack of awareness among pediatricians and physicians regarding influenza vaccine

Lack of awareness in parents/patients

# 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 as 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%

# Attitude of parents of Vaccinated children

Percentage

1 Influenza vaccine prevents all ailments like cough or cold or runny nose or fever 28%

2 Health of the child was same as before 27%3 Health of the child was not good after

vaccination 28%4 Health of the child was much better than

before 44%

# 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 Parents had not yet decided to get their child vaccinated next year 35%

4 Parents want their pediatrician to spread more awareness about influenza vaccine 64%

*Singh H, Gupta G, Tiwari P. Safety and tolerability of Influenza vaccine in Indian Children. NIPER & Charak Care Clinics. (Data On File)

*Singh H, Gupta G, Tiwari P. Safety and tolerability of Influenza vaccine in Indian Children. NIPER & Charak Care Clinics. (Data on file)

Reactions after vaccination

The Present Study Delore et al*

Local reactions (Inj. site tenderness)

>6-35 months

8.5(0) % 6-36 months 8.6(0)%

3-9 years 24.1(1.6)% 3-10 years 32.1(0.6)%

>9-18 years 46.6(0)% - -

Systemic reaction>6-35

months

26.7(0)% 6-36 months 21.2(2.1)%

3-9 years 13.3(4.1)% 3-10 years 4.3(0)%

>9-18 years 6.6(6.6)% - -

*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.

ConclusionFlu vaccine is effective in reducing ILI in fully

vaccinated children – 43 % reduction in ILI, 57 % reduction in School absenteeism. No effect of partial vaccination

It is safe & well tolerated by healthy Indian children. KAP – Awareness of flu vaccine is present, many

parents feel that it is effective and would like to take annual doses. More information needs to be provided by the pediatrician.

ConclusionsMore studies are needed with larger sample size to

establish the efficacy of Seasonal Influenza vaccineIdentify sub-groups in which it is more effectiveFurther research for more effective & single dose

Influenza vaccine is needed before it can be universally recommended in our country

Research TeamHimmat SinghDr. Gaurav GuptaProf. Pramil Tiwari