Serum Institute’s rotavirus vaccine shows significant efficacy against severe diarrhoea

One lakh children die of severe diarrhoea, owing to rotavirus, each year in India.

Results from a Phase-III efficacy study in India that were published in the journal Vaccine on Tuesday have found a more effective vaccine against rotavirus that causes severe diarrhoea in children.

Union health minister JP Nadda administering rotavirus vaccine in Agartala, Tripura, earlier this year.(HT File photo)

Of the total diarrhoea deaths of children due to rotavirus world over, more than 20% die in India.

The Serum Institute of India developed and manufactured the rotavirus vaccine BRV-PV (known as Rotasiil).

The study showed the vaccine to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis. In 2013, an estimated 47,100 rotavirus deaths occurred in India.

Rotasiil reduced severe rotavirus diarrhea by more than a third— 39.5% over two years. Significantly, the vaccine efficacy was nearly 55% against the most severe and potentially life-threatening cases of rotavirus diarrhea, which represent the highest risk of dehydration, hospitalizations, and deaths.

The international nonprofit PATH partnered with Serum Institute on evaluating this vaccine in the Phase 3 efficacy study. Six study sites across India enrolled 7,500 infants in the trial. ROTASIIL is an oral vaccine administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time as routine vaccinations under India’s Universal Immunization Programme.

The office of the Drugs Controller General of India, through its subject expert committee, reviewed the Phase 3 safety and efficacy results and subsequently inspected Serum Institute’s manufacturing facilities leading to licensure of ROTASIIL in January 2017.

The Government of India has placed an order for 3.8 million doses of ROTASIIL to use in the Universal Immunization Programme, which serves 26 million children.

Serum Institute has manufactured the vaccine doses and is awaiting instructions from the health ministry for its distribution. ROTASIIL will also be available for sale in India’s private market later this year.