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.
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.