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Review
. 2025 Jan 12:44:126551.
doi: 10.1016/j.vaccine.2024.126551. Epub 2024 Nov 29.

The evidence base for rotavirus vaccination in India: Current status, future needs

Niranjan Bhat  1 , Elisabeth Vodicka  2 , Allison Clifford  3 , Kanduri Balaji Ananth  4 , Ashish Bavdekar  5 , Arup Deb Roy  6 , Umesh Parashar  7 , Jacqueline Tate  7 , Pradeep Haldar  8 , Gagandeep Kang  9
Affiliations
Review

The evidence base for rotavirus vaccination in India: Current status, future needs

Niranjan Bhat et al. Vaccine. .

Abstract

Rotavirus is a leading cause of severe diarrheal disease in infants and young children worldwide. Vaccination offers the best protection against this disease, and two rotavirus vaccines were developed in India and included in its routine immunization program. The Government of India's decision to adopt this intervention was supported by a solid base of evidence from clinical trials, as well as substantial research regarding rotavirus disease burden and the potential health and economic value of immunization. Following program implementation, multiple studies were initiated, including three evaluations of effectiveness and several investigations regarding intussusception. These additional data regarding vaccine impact, safety, and delivery from post-introduction evaluations in conditions of real-world use will further strengthen and sustain the immunization program. This manuscript evaluates the status of existing and forthcoming evidence regarding rotavirus vaccination in India through a literature review and consultation with relevant stakeholders. Studies evaluating vaccine impact, effectiveness, safety, health economics, and acceptability, as well as operational and programmatic research, were included in the review. Overall, we found that the evidence base did not contain any major gaps. Nevertheless, additional smaller-scale research studies would be valuable in providing a more complete picture of rotavirus vaccine performance and benefit. Documentation of India's experience with rotavirus vaccines may provide lessons learned for other countries in the Asia region, where rotavirus disease burden remains high, yet vaccine adoption has been slow, as well as for countries worldwide that may be considering implementation of the Indian-made rotavirus vaccines.

Keywords: Diarrhea; India; Rotavirus; Rotavirus vaccine; Vaccination; Vaccine impact.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Niranjan Bhat reports financial support was provided by Bill & Melinda Gates Foundation. Elisabeth Vodicka reports financial support was provided by Bill & Melinda Gates Foundation. Allison Clifford reports financial support was provided by Bill & Melinda Gates Foundation. Kanduri Balaji Ananth reports financial support was provided by Bill & Melinda Gates Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Phased introduction of rotavirus vaccine in India. [6]. Panel A: Phased introduction of rotavirus vaccination and vaccinated birth cohort size by region; Panel B: Product distribution of rotavirus vaccine by region.
Fig. 2
Fig. 2
Location of surveillance sites in states introducing ROTAVAC. [33].
Fig. 3
Fig. 3
Key concepts and recommendations.
See this image and copyright information in PMC

References

    1. World Health Organization = Organisation mondiale de la Santé . Weekly Epidemiological Record = Relevé Épidémiologique Hebdomadaire. Vol. 96. 2021. Weekly Epidemiological Record; pp. 301–320. 28 [full issue]
    1. John J., Sarkar R., Muliyil J., Bhandari N., Bhan M.K., Kang G. Rotavirus gastroenteritis in India, 2011–2013: revised estimates of disease burden and potential impact of vaccines. Vaccine. 2014;32:A5–A9. doi: 10.1016/j.vaccine.2014.03.004. - DOI - PubMed
    1. Troeger C., Khalil I.A., Rao P.C., Cao S., Blacker B.F., Ahmed T., et al. Rotavirus vaccination and the global burden of rotavirus diarrhea among children younger than 5 years. JAMA Pediatr. 2018;172:958–965. doi: 10.1001/jamapediatrics.2018.1960. - DOI - PMC - PubMed
    1. List of Prequalified Vaccines . IVDs; Medicines, Vaccines and Immunization Devices, Vector Control: 2019. WHO - prequalification of medical products.https://extranet.who.int/pqweb/vaccines/list-prequalified-vaccines accessed October 20, 2021.
    1. Map | ViewHub n.d. https://view-hub.org/map (accessed October 20, 2021).

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