Hille­man Be­gins Clin­i­cal Tri­als for Ro­tavirus, Cholera Vac­cines in B’desh

The Economic Times - - Companies: Pursuit Of Profit - Prabha.Raghavan @times­group.com

New Delhi: Delhi-based vac­cine re­search or­gan­i­sa­tion Hille­man Lab­o­ra­to­ries has ini­ti­ated clin­i­cal tri­als for its heat-sta­ble ro­tavirus vac­cine and cholera vac­cine in Bangladesh, ac­cord­ing to the com­pany’s chief ex­ec­u­tive of­fi­cer, Davin­der Gill. If proven safe and im­muno­genic (able to pro­voke an im­mune re­sponse in the body), the vac­cines could be brought to In­dia as early as 2020 and help bridge some of the gap in vac­ci­na­tion de­liv­ery, he said. Hille­man Labs re­ceived ap­provals to con­duct Phase I and II clin­i­cal tri­als for the two vac­cines in re­cent weeks from the Di­rec­torate Gen­eral of Drug Ad­min­is­tra­tion (DGDA), the drug reg­u­la­tor in Bangladesh, Gill told ET. The tri­als, in col­lab­o­ra­tion with Bangladesh­based In­ter­na­tional Cen­tre for Diar­rhoeal Dis­ease Re­search (ICDDR), will es­tab­lish the safety and im­muno­genic­ity of the vac­cines in adults and in­fants and would take around three years to com­plete, he said.

The or­gan­i­sa­tion could seek li­cen­sure based on the non-in­fe­ri­or­ity date for its ro­tavirus vac­cine within the four-year time­line as it is a heat-sta­ble for­mu­la­tion of an ex­ist­ing vac­cine. “Once we have es­tab­lished the early safety and im­muno­genic­ity, we can ad­vance our phase II & III tri­als quickly,” said Gill.

While it is too early to say whether this ap­proach would be pos­si­ble with its cholera vac­cine, it is an op­tion Hille­man Labs would ex­plore with its cholera vac­cine, he added. “If we are able to demon­strate clear non-in­fe­ri­or­ity (with the cholera vac­cine, which is a new de­sign al­to­gether) that gives us a pos­si­bil­ity to seek li­cen­sure based on this clin­i­cal trial,” he said.

These vac­cines, es­pe­cially the heat-sta­ble ro­tavirus vac­cine that can with­stand ex­treme cli­mates, would help In­dia bridge the vac­cine de­liv­ery gap caused by a high de­pen­dence on cold chain sys­tems for preser­va­tion. Ac­cord­ing to Gill, around 50% of vac­cines in the coun­try are wasted for rea­sons, in­clud­ing their de­pen­dence on a fully func­tion­ing cold chain sup­ply in­fra­struc­ture.

Hille­man got nods for Phase I and II clin­i­cal tri­als for the two vac­cines in re­cent weeks from the drug reg­u­la­tor in Bangladesh

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