Rotasil vaccine safe, 55% effective against severe rotavirus gastroenteritis

The administration of pentavalent rotavirus vaccine, BRV-PV, during infancy was found to be safe, well-tolerated and 55% effective in severe cases of rotavirus gastroenteritis, according to phase 3 results published in Vaccine.

Developed by the Serum Institute of India, the BRV-PV (Rotasil) vaccine reduced severe rotavirus gastroenteritis by 39.5% over two years with comparable effectiveness as RotaTeq (RV5, Merck) and Rotarix (RV1 GlaxoSmithKline) in Bangladesh and within some African countries.

“We are delighted with these results, which indicate that Rotasil could save the lives of tens of thousands of children each year in India and, potentially, around the world,” Rajeev Dhere, PhD, executive director of the Serum Institute, said in a press release.

In collaboration with the nonprofit organization PATH, the Serum Institute conducted a phase 3 efficacy study in which the three-dose oral vaccine was examined in six study sites for 7,500 infants. The vaccine was administered to infants at 6, 10 and 14 weeks as a part of routine vaccination through India’s Universal Immunization Program. The efficacy results and the Serum Institute’s manufacturing facilities were reviewed by a committee from the office of the Drugs Controller General of India in January 2017.

Rotasil has been ordered by the Government of India for use in the Universal Immunization Program, who will administer 3.8 million doses of the oral vaccine. Distribution will commence once the Ministry of Health and Family Welfare provide instructions. The vaccine is also expected to be sold in the country’s private market later in 2017.

Currently, the Serum Institute is seeking prequalification from WHO to distribute Rotasil globally. Data needed for this prequalification were collected by PATH and the Serum Institute in a phase 3 study conducted in India. This information will be published this year.

The efficacy and safety of the vaccine are also currently under evaluation in Niger by Médecins Sans Frontières and Epicenter, where preliminary results show high efficacy (66.7% against severe rotavirus gastroenteritis and 78.8% against very severe rotavirus gastroenteritis).

“This is great news for India,” David Kaslow, MD, vice president of essential medicines at PATH and global head of the Center for Vaccine Innovation and Access, said in the release. “The results and successful licensure of this rotavirus vaccine is an exciting and encouraging milestone toward the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide.” – by Katherine Bortz