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Peer reviewedOpen accessGastroenteritisSARSCOVID-19

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

Nature Medicine·

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

DOI
10.1038/s41591-025-03998-9
PMID
41057654
PMCID
PMC12618247
OpenAlex
W4414886651
Study type
Case-control study
Publisher
Springer Science and Business Media LLC
Article type
journal-article
Integrity
current

Why this research matters now

Findings from the abstract suggest Rotavac provided substantial protection against severe rotavirus disease under programmatic conditions in India, including against non-vaccine strains, and was characterized as performing comparably to internationally licensed vaccines in similar settings.

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Structured evidence summary

Research question

The study evaluated how well an indigenous oral rotavirus vaccine (Rotavac) performed when delivered through India's national immunization program between 2016 and 2020.

Study design

A multi-site test-negative case-control analysis was conducted using hospital-based surveillance across 31 facilities in 9 Indian states between 2016 and 2020.

Population and setting

The study enrolled 24,624 children (62% male, 38% female) in hospital surveillance, with 8,372 children aged 6-59 months included in the effectiveness analysis across 9 Indian states.

Main findings

Adjusted effectiveness of three Rotavac doses against severe rotavirus gastroenteritis was 54% (95% CI 45-62%). In children aged 6-23 months, genotype-specific effectiveness was 51% for G3P[8], 81% for G1P[8], and 64% for G1P[6]. Rotavirus positivity among hospitalized children fell from 40% to 20% over the study period.

Public-health relevance

Findings from the abstract suggest Rotavac provided substantial protection against severe rotavirus disease under programmatic conditions in India, including against non-vaccine strains, and was characterized as performing comparably to internationally licensed vaccines in similar settings.

Important limitations

This summary is limited to the supplied single-article abstract and bibliographic metadata and requires review of the original paper for decision-grade interpretation; limitations explicitly stated in the full text are not available here.

GIDS interpretation

Within the GIDS literature evidence workflow, this article represents a peer-reviewed, multi-site hospital-based evaluation of an indigenous rotavirus vaccine; the abstract itself does not contain a live surveillance signal, and no connection to current surveillance data is made here.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 14 auditable classifier relationships to diseases, places, topics, and study design.

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