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Impact of the indigenous rotavirus vaccine Rotavac in the Universal Immunization Program in India during 2016–2020

Publication Type : Journal Article

Publisher : Springer Science and Business Media LLC

Source : Nature Medicine

Url : https://doi.org/10.1038/s41591-025-04062-2

Campus : Faridabad

School : School of Medicine

Department : Department of Neonatology, Paediatrics

Year : 2025

Abstract : In 2016, India introduced Rotavac (G9P[11]), an indigenous oral rotavirus vaccine administered at 6, 10 and 14 weeks of age through the Universal Immunization Program. Evaluating its effectiveness under routine programmatic conditions is critical, given the variable performance of rotavirus vaccines in low- and middle-income countries. Here we assessed Rotavac’s real-world effectiveness and impact across 31 hospitals in 9 states between 2016 and 2020 using a test-negative case–control design. Overall, 24,624 children were enrolled in surveillance (62% male and 38% female). Of 8,372 children aged 6–59 months eligible for effectiveness analysis (1,790 rotavirus-positive cases and 5,437 rotavirus-negative controls), 6,646 received 3 doses and 581 were unvaccinated. The adjusted vaccine effectiveness of 3 doses against severe rotavirus gastroenteritis was 54% (95% confidence interval (CI) 45% to 62%), with 1,574 vaccinated cases versus 5,072 vaccinated controls. Among children aged 6–23 months (1,486 vaccinated cases and 4,595 vaccinated controls), genotype-specific adjusted vaccine effectiveness was 51% (95% CI 36% to 62%) for G3P[8], 81% (95% CI 73% to 87%) for G1P[8] and 64% (95% CI 21% to 83%) for G1P[6]. Following vaccine introduction, rotavirus positivity among hospitalized children declined from 40% to 20%. These findings confirm that Rotavac provides substantial protection against severe rotavirus disease, including nonvaccine strains, and performs comparably to internationally licensed vaccines in similar settings.

Cite this Research Publication : Nayana P. Nair, Samarasimha N. Reddy, Sidhartha Giri, Tintu Varghese, Varunkumar Thiyagarajan, Jayaprakash Muliyil, Priya Hemavathy, Shainey Alokit Khakha, Rashmi Arora, Mohan D. Gupte, Jaqueline E. Tate, Umesh D. Parashar, Venkata Raghava Mohan, Gagandeep Kang, , Sunita Bidari, Sowmiya Senthamizh, Suhasini Mekala, GV Rama Devi, GS Rama Prasad, Krishna Babu Goru, J. Manikyamba, J. Bhaskar Reddy, Padmalatha Pamu, K. Kameswari, Gorthi Rajendra Prasad, Manohar Badur, Geeta Gathwala, Poonam Dalal, Suraj Chawla, Anil Kumar Goel, Manoj Rawal, Preeti Raikwar, Madhu Gupta, Adarsh Bansal, Ravi P. Kanojia, Arun Bansal, Kushaljit Singh Sodhi, Akshay Saxena, Jayashree Muralidharan, Mini P. Singh, Bhavneet Bharti, Rajesh Kumar, Shayam Kaushik, Pancham Kumar, Sanjeev Chaudhary, Jyoti Sharma, Subal Kumar Pradhan, Saroj Kumar Satpathy, Mrutunjay Dash, Jasashree Choudhury, J. Bikrant Kumar Prusty, Mamata Devi Mohanty, Nirmal Kumar Mohakud, Manas Kumar Nayak, Subrant Kumar Mohanty, Rajib Kumar Ray, Prasantajyoti Mohanty, Subrat Kumar Majhi, Samarendra Mahapatro, Rashmi Patnaik, Asit Mansingh, Mannancheril Abraham Mathew, Hemant Jain, Prachi Chaudhary, Raj Kumar Gupta, Bharti Malhotra, Alok Kumar Goyal, Shailja Vajpayee, Pramod Sharma, Vikas Katewa, Sunil Kothari, Prabhu Prakash, Dalpat Rajpurohit, Suresh Goyal, Bhupesh Jain, Asolie Chase, Koshy C. George, Shakti Lamichhane, Amrit Koirala, Jayanta Kumar Goswami, Balasubramanian Sundaram, Sumanth Amperayani, Senthilnathan Subramanian, Girish Kumar Chethrapilly Purusothaman, Priyadharishini Dorairaj, Sridevi A. Naaraayan, Ramasubramaniam Pitchumani, Kulandaivel Murugiah, Sanjeev Kumar Verma, Vipin M. Vashishtha, Vineeta Gupta, Sunil Kumar Rao, Mahima Mittal, Author Correction: Impact of the indigenous rotavirus vaccine Rotavac in the Universal Immunization Program in India during 2016–2020, Nature Medicine, Springer Science and Business Media LLC, 2025, https://doi.org/10.1038/s41591-025-04062-2

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