Why in News ?
- Event: Publication of a multi–centre observational study on the effectiveness of India’s indigenous Rotavac vaccine under the Universal Immunisation Programme (UIP) 2016–2020.
- Source: Study led by Gagandeep Kang, Nayana P. Nair, and Samarasimha N. Reddy; published in Nature Medicine.
- Context: Evaluates real-world impact of Rotavac, India’s first indigenous oral rotavirus vaccine.
Relevance:
- GS-2: Governance – Universal Immunisation Programme, Public health policy, Evidence-based decision-making.
- GS-3: Economy – Domestic vaccine production, Atmanirbhar Bharat in healthcare, Cost-effective health interventions.
- GS-1: Society – Reduction in child mortality, Strengthening societal health outcomes.
Basics
- Rotavirus: Major cause of severe gastroenteritis and diarrhoealdeaths in children under 5.
- Global burden: ~128,500 deaths annually in India among under-five children.
- Rotavac vaccine:
- Oral, indigenous, developed by Bharat Biotech in collaboration with DBT, Indian govt., and international partners.
- Administration schedule: 6, 10, and 14 weeks of age under UIP.
- Publicly available and free to all eligible children under UIP.
Study Design & Coverage
- Type: Observational, multi-centre, real-world effectiveness study.
- Timeframe: 2016–2020, covering introduction of Rotavac in UIP.
- Scope:
- 31 hospitals across 9 Indian states.
- Compared proportion of paediatric rotavirus hospitalisations before and after vaccine introduction.
- Objective: Assess real-world vaccine effectiveness outside controlled clinical trials.
Key Findings
- Overall effectiveness:54% reduction in rotavirus-based gastroenteritis among vaccinated children.
- Comparable to phase 3 clinical trial efficacy (54%), confirming effectiveness in routine conditions.
- Age-specific impact:
- Effectiveness sustained in first two years of life, when disease burden is highest.
- Hospitalisation impact:
- Significant decline in rotavirus hospitalisations across study sites.
- Broader implication: Confirms indigenous vaccines can be effective in real-world settings, not just clinical trials.
Strategic & Operational Significance
- Indigenous development: Reduces reliance on foreign vaccines; aligns with Atmanirbhar Bharat in healthcare.
- Evidence-based policy:
- Provides data for scaling up Rotavac coverage and planning future vaccination campaigns.
- Global relevance: Adds India’s experience to rotavirus vaccine effectiveness in low- and middle-income countries.
Key Data / Facts
- Vaccine efficacy: 54% (both in trial and real-world).
- UIP introduction: 2016.
- Hospitals studied: 31 across 9 states.
- Burden: 128,500 under-five deaths annually from rotavirus in India.
- Administration schedule: 6, 10, 14 weeks.
