New vaccine by Pune-based institute safe against severe rotavirus gastroenteritis: Study

To be launched in Nov; Centre orders 3.8 million doses for use in Universal Immunisation Programme

3 min readPuneSep 27, 2017 08:51 AM IST

diarrhoea, diarrhoea vaccine, rotavirus gastroenteritis, rotavirus gastroenteritis vaccine, Serum Institute of India, ROTASIL vaccine,

The results showed that ROTASIL reduced severe rotavirus diarrhoea by more than a third, by 39.5 per cent over two years.

A new vaccine against rotavirus gastroenteritis, developed by the Pune-based Serum Institute of India, promises to be a cost-effective and heat-stable option in the global strategy for diarrhoea prevention, according to the results of a study published in the international journal Vaccine.

Rotavirus is the most common cause of diarrhoea and one of the leading causes of mortality among children who are under five years of age. Rotavirus accounts for approximately 40 per cent of all diarrhoea cases requiring treatment. A Rotavirus disease cannot be treated with antibiotics or other drugs.

The new vaccine, ROTASIL, is supposed to be orally administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time when the existing vaccinations under India’s Universal Immunisation Programme are administered.

The international non-profit PATH partnered with Serum Institute to evaluate this vaccine in the Phase 3 efficacy study. Initiated in May 2014, the study was conducted at clinical sites across six places in India — Pune, Kolkata, Sewagram, Delhi, Manipal, and Jammu. A total of 7,500 infants were followed from the time of vaccination until 2 years of age, to check the efficacy and safety outcomes.

The results showed that ROTASIL reduced severe rotavirus diarrhoea by more than a third, by 39.5 per cent over two years. The vaccine efficacy was nearly 55 per cent against the most severe and potentially life-threatening cases of rotavirus diarrhoea, which represent the highest risk of dehydration, hospitalisations, and deaths.

“The Centre has placed an order for 3.8 million doses of the vaccine to use in the Universal Immunisation Programme, which serves 26 million children. The Serum Institute has manufactured the vaccine doses and will launch the vaccine in November,” Dr Rajeev Dhere, executive director of the Serum Institute of India, told The Indian Express.

It is estimated that 11.37 million episodes of rotavirus gastroenteritis occur every year in India alone, and they require 3.27 million outpatient visits and 872,000 in-patient admissions. In 2013, an estimated 47,100 rotavirus deaths occurred in India — 22 per cent of all rotavirus deaths that occurred globally. Currently, two rotavirus vaccines — Rotarix and RotaTeq — are licensed internationally and are prequalified by the World Health Organisation. A third vaccine, Rotavac, was recently licensed in India.

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Despite the presence of these vaccines, there remains an overwhelming need for cost-effective and safe rotavirus vaccines for the worst-affected countries, said Dr Prasad Kulkarni, medical director at Serum Institute of India, who led the study.

Meanwhile, Médecins Sans Frontieres and Epicentre are also evaluating the efficacy and safety of ROTASIL in a separate Phase 3 study in Niger. That study is still ongoing, but results from the primary analysis also showed the vaccine to be highly efficient for the prevention of severe rotavirus diarrhoea, and with an excellent safety profile. The efficacy of the vaccine against severe and very severe rotavirus diarrhoea in the Niger study was 66.7 per cent and 78.8 per cent, respectively. These results were published in the New England Journal of Medicine in March 2017.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

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