Rotavirus is a major cause of diarrhea among children under 5 years old in Sri Lanka. Surveillance data from 2005-2010 showed that rotavirus accounted for 20-30% of diarrhea cases. The dominant circulating strains were G3 and G9. It was estimated that rotavirus causes over 5,000 cases and 1,500 deaths per year nationally. Two rotavirus vaccines (Rotarix and RotaTeq) have shown efficacy of 61-96% in other countries against severe rotavirus diarrhea. Introduction of the vaccine in Sri Lanka could prevent over 4,000 cases annually and save $135,000 in treatment costs. Further disease burden and economic studies were recommended to inform the decision on vaccine introduction.

1. Immunization Summit -2010
Rotavirus vaccines
Is a road map needed for
introduction to the EPI in
Sri Lanka ?
Dr. Pushpa Ranjan Wijesinghe, MD
Consultant Epidemiologist

2. Consensus statement
Immunization summit-2007
• Current rotavirus vaccine is less effective
against the serotype G9 which is the second
commonest reported serotype after G3 which is
the commonest
• Hence, introduction of rotavirus vaccine to
Sri Lanka should be considered at a later date.
• Rotavirus surveillance activities should be
extended and strengthened further.

3. What is known about rotavirus in SL ?
Authors
No of
Rotavirus +
patients
No of Diarrhea
patients
%
Rotavirus +
patients
Mendis L et al (1980)
98
326
30.1%
Chandrasena et al (2006) - NCTH
126
606
20.8%
EPID Unit / IVI study phase I
(2005-2007)
428
1806
23.9%
EPID Unit / IVI study phase II
( July 2008- June 2009)
182
624
29.1%
88
343
25.7%
103
360
28.6%
EPID Unit / WHO
( July 2008- Dec 2009)
EPID Unit / WHO (Jan – March 2010)

4. What are the circulating strains ?
• What was detected in the phase I
• Detection of antigens by enzyme-immunoassay
(EIA)
• WHO Reference lab was set up in Chennai –
2010
• Strain identification – from this month

5. What are the circulating strains ?
Type
G1
G2
G3
G4
G9
mixed
NT
Total
P4
0
4
0
0
0
0
1
5
P6
0
0
0
0
0
0
1
1
P8
6
0
17
0
14
4
13
54
P9
0
0
0
0
0
0
0
0
mixed
0
0
0
0
0
0
0
0
NT
3
3
13
0
14
0
0
33
Total
9
7
30
0
28
4
15
93
SOURCE : Epidemiology Unit

6. Epidemiology of rotavirus diarrhea
Source
Rate of gastroenteritis
1119.4/100000 population
(under estimate ?)
AHB 2007
Expected number of diarrhoeal
diseases among under five
19477
Based on
AHB 2007
Mean incidence rate of
Rotavirus diarrhoea
26.4%
(95% CI = 22.8%-30.0%)
Based on
all studies
Expected number of rotavirus
cases per year
5142 (4440- 5843)
Based on
all studies
Estimate of Rota specific
deaths for Sri Lanka
1500 per year
Case Fatality Ratio = 29%/?
(Over estimate ?)
CDC

7. Efficacy/Effectiveness of monovalent RV(Rotarix)
Efficacy of preventing
severe diarrhoea
South Africa &
Malavi combined
61.2% ( 95% CI-44-73%)
Efficacy of preventing
severe diarrhoea
South Africa
76.9% (95% CI-56-88%)
Efficacy of preventing
severe diarrhoea
Malawi
49.5 % (95% CI-19-68%)
Efficacy of preventing
severe diarrhoea
China, Hong
Kong, Taiwan &
Singapore
96.1%
Effectiveness of preventing
severe diarrhea
El Salvador
74% ( 95%CI- 51%-89%)
Effectiveness of preventing
very severe diarrhoea
El Salvador
88% (95% CI- 47%-97%)

8. Efficacy/Effectiveness of Pentavalent RV(Rotateq)
Efficacy of preventing
severe diarrhoea
Africa
64.2% (95% CI -40%-79%)
Efficacy of preventing
severe diarrhoea
Asia
51 (95% CI -13%-73%)
Effectiveness of preventing
severe diarrhoea
US
85%-95%
Effectiveness of preventing
Hospitalization needing IV
fluids
Nicaragua
46%(95%CI-18%-64%
( children under 2 years)
Effectiveness of preventing
severe diarrhea
Nicaragua
58% ( 95 % CI = 30%-74%)
Effectiveness of preventing
very severe diarrhoea
Nicaragua
77% ( 95% CI- 39%-92%)
Source – WHO

9. Source : WHO

10. Are these vaccines safe ?
• Recommendations of GACVS
– Vaccines are safe
– Risk of intussusception ruled out with confidence
– No data to support increased risk of intussusception
when administered outside the age range
• 6–15 weeks for the first dose
• 32 weeks for the second dose
– No interference with OPV and other EPI vaccines
– OPV inhibit the response of the first dose of Rota
vaccines
– No change in clinical status of
• HIV infected children
• Children born to HIV infected mothers.

11. Update on rotavirus vaccines
• FDA recommendations – USA
• Addition of Severe Combined Immunodeficiency as a
Contraindication
• DNA from porcine circovirus type 1(PCV1) in the vaccine
(Monovalent RV)
• Fragments of DNA from PCV1 and from a related porcine
circovirus type 2 (PCV2) (pentavalent RV)
• Resumption of using both vaccines
• strong safety records-trials/post marketing surveillance
• Benefits > theoretical risks
•
Follow-ups by the FDA

12. Can Rotarix be incorporated into
the EPI schedule ?
• 2 & 4 months schedule – effectiveness demonstrated
• 6 weeks , 10 weeks schedule - effectiveness not
demonstrated

13. Can Rotateq be incorporated into
the EPI schedule ?
• Rotateq vaccine
– 3 dose schedule only used in clinical trials
– 6, 10, 14 weeks
• General guidelines
• first dose of either RotaTeq or Rotarix
– at age 6–15 weeks.
• The maximum age for administering the
last dose of either vaccine
– 32 weeks.

14. Preventable number of Rotavirus cases by live
attenuated monovalent vaccine in Sri Lanka
Non
vaccinated
scenario
Rotavirus
infection
Vaccinated –
vaccine
recipients
(90%)
Vaccinated –
vaccine non
recipients
(10%)
Total cases
prevented by
vaccine
5142
532
514
4096
Target population – under five children
Efficacy – 86 % with 2 doses of monovalent RV vaccine
Vaccine coverage – 90%

15. What are the costs involved ?
Approximate cost for
vaccines
7$
per a dose
(376843 X 7 $ X 2)
52 75 802 $
per year
12.4 $ a dose
(376843 X 12.4 $ X 2)
9345706 US $
Treatment cost in a
non vaccinated
scenario
33 $ per a case
( 33$X5142)
169686 $
per year
Treatment cost in a
vaccinated scenario
33 $ per a case
( 33$X1046)
34518$
per year
Treatment cost
saved from
vaccination
Cost per case
averted
135168 $ (0.14 million)
per year
Scenario I
Scenario II
1288 US $
2281 US $

16. What are the costs involved ?
Approximate annual cost for vaccines
7$
per a dose
2 dose schedule
5 million US $
Average cost of an episode of rotavirus
diarrhoea hospitalization
Rs. 3626 (US$ 33)
Cost saved through averting rotavirus
hospitalizations per year
US$ 0.26 million.
Deaths averted per a year
8
Hospital-based study of the severity and economic burden associated with
rotavirus diarrhea in Sri Lanka
Nilmini Chandrasena ,*, Shaman Rajindrajith b, Ahmed Kamruddin c,
Arunachalam Pathmeswaran d and Osamu Nakagomi e
Journal of Pediatric Infectious Diseases 2009; 4(4)

17. Future
• Rotavirus disease burden study
• General population
• Among high risk groups
•
Morbidity cost study
• Economic analysis
• Expansion of surveillance to other areas
• semi urban, rural ,slum, estate settings
• PCR training for the virological focal point @ MRI
( WHO support)
• Strain identification @ the MRI
•
A large base of rotavirus strains

18. Discussion points
• Is there a need for introduction of rotavirus vaccine ?
– present & future
• If so, what will be the time line ?
• If so what approach do we need ?
– Population or high risk
• What should be the risk groups
– Role of epidemiology and disease surveillance information
• What will be the communication strategy for the community
– Perception – all cause remedy for all diarrhoea
– One strategy in the intervention package
• What and how can NPI learn from the private sector ?

19. Acknowledgement
•
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Dr.Nihal Abeysinghe
Dr.Paba Palihawadana
Dr. Sudath Pieris
Dr. Ranjith Batuwanthudawe
Dr.Geethani Galagoda
Dr.Sarath Silva
Dr. Kalyani Guruge
Dr. Padmakanthi Wijesuriya
Dr.Paul Kilgore
Dr. Niyambat Batmunkh –IVI
Dr.Aparna Singh Shah
Royal Murdoch children’s hospital – Melborne
International Vaccine Institute
GAVI’s ROTAADIP
WHO- SEAR & HQ-Geneva
Asian Rotavirus Surveilance Network