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Sanofi unit takes low-cost rotavirus vaccine into phase III

Licensed vaccines still too expensive for countries hit hardest

Sanofi reception

A cheaper vaccine for rotavirus that could boost vaccination against the severe diarrhoeal disease is starting phase III trials in India.

Rotavirus is the most common cause of severe childhood diarrhoea and results in half a million child deaths every year, mainly in low-income countries in Africa and Asia.

The study - conducted by Sanofi affiliate Shantha Biotechnics - aims to show that the live-attenuated vaccine candidate is at least as good as currently-licensed vaccines such as GlaxoSmithKline's Rotarix and Merck & Co's RotaTeq which, while effective, are still unaffordable for many countries battling with the infection.

Despite being offered at a discount to countries hit hard by rotavirus, the licensed vaccines "continue to be more expensive than most traditional childhood vaccines" and so remain out of reach for many countries, said the World Health Organization (WHO) in a report issued last year.

Olivier Charmeil, chief executive of Sanofi's vaccines division Sanofi Pasteur, commented: "We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India."

Shantha's study will test three liquid doses of the ready-to-administer vaccine - which can be given orally - starting from six-to-eight weeks of age in around 1,200 children. Subsequent doses will be given at monthly intervals.

In an earlier phase I/II trial, this dosing schedule induced a strong immune response in Indian infants that was able to protect against the development of rotavirus gastroenteritis.

Sanofi and Shantha are not alone in trying to bring a low-cost rotavirus vaccine to market, as last year Indian drugmaker Bharat Biotech took its own Rotavac candidate into phase III trials, promising to make it available at around one-tenth the price of Rotarix and RotaTeq.

In March, Bharat said its vaccine was safe but had modest protective efficacy at around 54%, although this was sufficient for it be granted a license for use in Indian vaccination programmes. Bharat and partners such as the PATH Initiative are now working to get Rotavac pre-qualified by the WHO, which would make it eligible for use in other countries.

Meanwhile, other groups with vaccines in trials include Serum Institute of India Ltd (SIIL) and China's Wuhan Institute of Biological Products, so in the coming years there could be multiple candidates available which will help make all of the rotavirus vaccines on the market more affordable.

"By reducing deaths from rotavirus-associated diarrhoea, universal access to rotavirus vaccines could greatly contribute to the attainment of the United Nations' Millennium Development Goal of reducing child mortality," commented the WHO.

Article by
Phil Taylor

14th October 2014

From: Research

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