Indian rotavirus vaccine gets WHO pre-qualification certification

The first Indian vaccine against rotavirus has received a World Health Organisation certification, making it eligible for purchase by global agencies like Unicef and GAVI to tackle killer diarrhoea in other nations.

The WHO pre-qualification certification came nearly three decades after medical scientists from the All India Institute of Medical Sciences (AIIMS), Delhi, isolated the vaccine strain from an infant nursery in Delhi.

The rotavirus vaccine - manufactured by the Hyderabad-based Bharat Biotech - is being used in the universal immunisation programme in nine states and set to be rolled out in the tenth state, Jharkhand, in a month or two.

Because of the WHO norm, African nations like Angola, Democratic Republic of the Congo and Angola can look at the Indian vaccine as a cheaper option to tackle the disease burden, said Duncan Steele from the Bill and Melinda Gates Foundation that invested nearly $70 million in the Indian vaccine.

"In India, the vaccine is offered at a cost of one dollar for a dose. For other countries we will have two price bands for low and middle-income countries. We received the WHO certification on January 7. Now a team from Unicef is coming to discuss purchase," Krishna Ella, chairman and managing director of Bharat Biotech, told DH.

Currently there are three rotavirus vaccines from Merck, GSK and Bharat Biotech. A fourth one that can protect against multiple strains of rotavirus is under development at Serum Institute of India, Pune.

"There are scientific studies to show that the Bharat Biotech vaccine offers cross protection against other strains," said Steele, a former WHO official, who coordinated a global strategic agenda for vaccine research for major diarrhoeal and enteric diseases.

While there are other Indian vaccines with WHO pre-qualification, this is the first rotavirus vaccine from India with that certification.

Rotavirus is the commonest cause of diarrhoeal death among children. The estimated death count in India is up to 80,000 every year along with 8,00,000 hospitalisations. Even with its 60% efficacy, it can save thousands of children's deaths.

A modelling study published in the journal Vaccine in 2014 claimed if the rotavirus vaccine is introduced along with third dose of DPT, it will avert about 44,500 under-five deaths in India each year.