Wednesday, April 27, 2016

Wellcome Trust/Merck Venture Now Enters Phase II With Heat-Stable Rotavirus Vaccine Candidate

It is hard to overstate the importance of having a vaccine that is heat-stable and lyophilized (in a powdered form, for transport), in the developing world. Getting sterile water to re-constitute the vaccine -- on the ground, at point of delivery, is far easier than perserving refrigeration for finished dosing vials -- in these mostly remote and often tropical climates.

As the WHO map at right indicates, rotovirus is a vast burden (especially among toddlers) in India, and Africa. One of the chief barriers to safe and effective administration of the current vaccine stock is the need to refrigerate the vaccine -- all the way to delivery. As many a prior viral epidemic has taught us, maintaining refrigeration of a liquid vaccine stock, in Sub-Saharan Africa, or in southern India -- all the way to point of delivery -- is a highly daunting endeavor. This portends a game-changing moment, then.

This Hilleman Labs venture, with MSD (that's "our" Merck's non-North American arm) and the Brits' Wellcome Trust -- is potentially a huge leap ahead, in preventing rotavirus in the developing world. Still a fair stretch to go yet -- but here is a bit from the press release, overnight:

". . . .Since beginning our collaboration with Hilleman Laboratories, we have been closely monitoring the development of both the rotavirus and cholera vaccines. We are now thrilled to get an opportunity to translate research into preventable treatment. . . ."

Lauding the Indian government’s efforts to reduce child mortality by including rotavirus vaccines under the Universal Immunisation Programme, Dr. Gill added, "This is a welcome step taken by the government of India. However, high dependence on cold-chain for vaccine preservation, is a major gap in the delivery system. With our heat-stable rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality. . . ."

Rotavirus is the leading cause of severe diarrhea and death among children less than 5 years of age, 90 per cent of these deaths occur in developing countries. According to the ministry of health and family welfare, nearly 80,000 to 100,000 children in India die annually due to rotavirus diarrhea while nearly 900,000 children are admitted to hospitals with severe diarrhea. . . .

And so, as I write this morning, I have upper-most in my mind these children -- millions of them -- who will live on, if and when this new vaccine becomes available, globally -- at an affordable price point. And that is the goal of this venture. Kudos, anew -- to Kenilworth. And I am. . . smiling.

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