It is an entirely new design, says Davinder Gill, Chief Executive of Hilleman Laboratories, explaining the innovation behind their oral cholera vaccine that has received global patents in different countries.

The oral cholera vaccine (OCV) is more simplified in formulating and production, he said, comparing it to existing vaccines present in the market that are more complex to make and hence more expensive. Hilleman's OVC, he indicates will be “significantly less” expensive when it enters the market.

There are at present three cholera vaccines that are on the WHO's (World Health Organisation) list of pre-qualified vaccines that countries could include in their vaccination programmes.

Hilleman's OCV is currently undergoing trials in Bangladesh, a region that bears a huge burden of the disease, says Gill. A final product could be out in Bangladesh, possibly by the end of the year. A vaccine could be about two years away in India, he said, with some of the regulatory process expected later this year. A patent filed on the product in India is still pending, Hilleman representatives said. The organisation is in talks with companies to make the product once it is ready for the local market, he said.

Hilleman Laboratories is a joint-venture between MSD and Wellcome Trust and its OCV has been granted patents in countries including the US, European Union, Australia, China, Canada and South Africa. The organisation partnered with Gotovax AB, a Sweden-based company, and Incepta Vaccine Ltd, Bangladesh, to develop the OCV. But the patent has been assigned to Hilleman, he said. A patent grants the innovator a period of exclusivity that could bring with it a monopoly of sorts, including price. But in this case, Gill said, the mandate of the organisation was to bring in affordable and easily administerable products.

Cholera resulted in 68,000 deaths across all age groups around the world and 29,000 deaths in children less than five years of age, a Hilleman note said quoting the 2015 Global Burden of Disease report. Hilleman's OCV will make mass vaccination a reality in cholera endemic zones due to ease of manufacturing and low cost, thereby improving vaccine affordability and accessibility, it said.

Nevertheless, cholera continues to be a serious health problem in India and there is high prevalence of the diseases due to its vast estuaries, poor sanitation and unsafe drinking water. Affordable and low cost vaccines will help in reducing the burden of disease and contribute to cholera control efforts, it added.

Oral vaccine

Giving details of the vaccine, Hilleman Laboratories said the simplified OCV, “HILLCHOL” consists of a single, genetically engineered Hikojima strain which could replace three virulent O1 strains inactivated by two different methods used in currently licensed vaccines, thereby reducing production costs. Hilleman Laboratories is also developing a second generation traveller’s cholera vaccine, Gill said, referring to global travellers who could benefit from it.

jyothi.datta@thehindu.co.in

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