Article type
Year
Abstract
Background:
Framing a health policy at global or national level for an intervention should be based on high quality locally-generated evidence and its cost effectiveness. Recently, an indigenously developed monovalent rotavirus vaccine (RV1) was tried in Indian children.
Objectives:
To evaluate the latest evidence on RV1 so as to modify Indian immunization policy guidelines.
Methods:
We conducted a meta-analysis that included efficacy studies of RV1 from low- and high-mortality countries during the first rotavirus season. We compared results from the meta-analysis to the results of the Indian indigenous rotavirus vaccine (116E strain) efficacy study. We applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to find the strength of evidence.
Results:
The meta-analysis showed 80% and 89% reduction by RV1 compared to 53% and 31% reduction by indigenous vaccine (116E strain) in severe rotavirus gastroenteritis (RVGE) and hospitalizations respectively. The pooled meta-analysis including the Indian trial (116E strain) showed 78% and 87% reduction respectively. The evidence from the indigenous vaccine was moderately efficacious compared to the recommended monovalent vaccine. Since the burden of RVGE in Indian children is much higher, the modest efficacy of the indigenous rotavirus vaccine may prevent severe RVGE cases and its related hospitalizations, and decrease disease burden in infants and the burden for families. The evidence from the GRADE profiler assigned moderate quality to studies included previously in the meta-analysis in comparison to the trial on indigenous vaccine which was graded high. Moreover the indigenous vaccine is cost effective (< INR54/dose) when compared to the available vaccine in the market (> INR1000/dose).
Conclusions:
Policy makers should consider the high-quality evidence of moderate efficacy and low cost of the indigenously developed vaccine (116E strain) against severe RV diarrhea and related hospitalizations in Indian children and consider its incorporation into the national immunization programme.
Acknowledgement: Indian Council of Medical Research, New Delhi, India
Framing a health policy at global or national level for an intervention should be based on high quality locally-generated evidence and its cost effectiveness. Recently, an indigenously developed monovalent rotavirus vaccine (RV1) was tried in Indian children.
Objectives:
To evaluate the latest evidence on RV1 so as to modify Indian immunization policy guidelines.
Methods:
We conducted a meta-analysis that included efficacy studies of RV1 from low- and high-mortality countries during the first rotavirus season. We compared results from the meta-analysis to the results of the Indian indigenous rotavirus vaccine (116E strain) efficacy study. We applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to find the strength of evidence.
Results:
The meta-analysis showed 80% and 89% reduction by RV1 compared to 53% and 31% reduction by indigenous vaccine (116E strain) in severe rotavirus gastroenteritis (RVGE) and hospitalizations respectively. The pooled meta-analysis including the Indian trial (116E strain) showed 78% and 87% reduction respectively. The evidence from the indigenous vaccine was moderately efficacious compared to the recommended monovalent vaccine. Since the burden of RVGE in Indian children is much higher, the modest efficacy of the indigenous rotavirus vaccine may prevent severe RVGE cases and its related hospitalizations, and decrease disease burden in infants and the burden for families. The evidence from the GRADE profiler assigned moderate quality to studies included previously in the meta-analysis in comparison to the trial on indigenous vaccine which was graded high. Moreover the indigenous vaccine is cost effective (< INR54/dose) when compared to the available vaccine in the market (> INR1000/dose).
Conclusions:
Policy makers should consider the high-quality evidence of moderate efficacy and low cost of the indigenously developed vaccine (116E strain) against severe RV diarrhea and related hospitalizations in Indian children and consider its incorporation into the national immunization programme.
Acknowledgement: Indian Council of Medical Research, New Delhi, India