A recent study on the impact of the indigenous rotavirus vaccine in India found marked reductions in rotavirus-based gastroenteritis in sites across the country.
Published in the recent edition of The Nature Medicine, the study “Impact of the indigenous rotavirus vaccine Rotavac in the Universal Immunization Program in India during 2016–2020”, is an observational, multi-centre analysis by Nayana P. Nair and Samarasimha N. Reddy, on behalf of the collaborators of the rotavirus vaccine effectiveness and impact assessment network.
The study looked at 31 hospitals in nine States between 2016 and 2020, to compare proportions and trends before and after the introduction of Rotavac in the Universal Immunisation Programme (UIP). In 2016, India introduced Rotavac, an indigenous oral rotavirus vaccine, administered at 6, 10 and 14 weeks of age, in its UIP. When a vaccine is introduced in the UIP, it is provided free to all eligible beneficiaries.
The authors said: “Evaluating its effectiveness under routine programmatic conditions is critical, given the variable performance of rotavirus vaccines in low- and middle-income countries.”
They noted: “The effectiveness of the routine use of indigenous Rotavac vaccine in the national immunisation program was 54%; this was reassuringly similar to the efficacy of 54%, reported during the phase 3 vaccine trial.” Further, the effectiveness was sustained in the first two years of life, when the burden of rotavirus is at its greatest. They found that the proportion of paediatric rotavirus hospitalisations also declined substantially.
Rotavac was developed as part of a public-private partnership with the Department of Biotechnology, Bharat Biotech, the U.S. National Institutes of Health, the Centers for Disease Control and Prevention, Stanford University, and PATH, with support from the Bill & Melinda Gates Foundation, among others.
Gagandeep Kang, Indian virologist and microbiologist who played a key role in the development of Rotavac, stressed the importance of the study in a post on social media. “Rotavirus vaccine effectiveness is similar to efficacy in India! In other words, vaccines work in the real world and not in just controlled clinical trials. [This is] The first data from India from one of the largest- ever rotavirus vaccine effectiveness studies, contributed by collaborators across many States and organisations. It took a really long time to generate the data and a long time to publish it, but it was important to conduct this study for the first indigenous oral rotavirus vaccine.”
Rotavirus infects and damages the cells that line the small intestine, causing gastroenteritis, among children. Annually, 128,500 deaths among children under five are attributed to rotavirus. It is estimated that India accounts for one-fifth of the global rotavirus-attributed deaths.