HYDERABAD: Pharmaceutical actor Hetero Labs has partnered with Russian sovereign wealth fund Russian Direct Investment Fund (RDIF) to manufacture more than 100 million doses of the Russian Covid-19 Sputnik V vaccine in India.
The Sputnik V will be manufactured by Hetero’s biologics division, Hetero Biopharma, at Jadcherla in Hyderabad, with production starting in the first quarter of 2021, Hetero and RDIF said on Friday.
RDIF already has a partnership with another large Hyderabad-based pharmaceutical company, Dr. Reddy’s Laboratories, to conduct phase 2/3 clinical trials for Sputnik V and to distribute 100 million doses in the Indian market.
The Russian vaccine has already received approval from Indian drug regulators for phase 2/3 clinical trials, even as phase 3 trials are underway in Belarus, the United Arab Emirates, Venezuela and other countries.
RDIF said that requests for more than 1.2 billion doses of Sputnik V come from more than 50 countries and that vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea, among others.
RDIF Executive Director Kirill Dmitriev said the partnership with Hetero will pave the way for the production of the Sputnik V vaccine in India. “The results of the provisional clinical trial of the vaccine show an efficacy of 95% on day 42 after the first dose. I am sure that Sputnik V should become an integral part of the national vaccine portfolio of all countries willing to protect their population from the coronavirus. Thanks to our cooperation with Hetero, we will be able to significantly increase production capacity and provide the people of India with an efficient solution in this challenging period of the pandemic, ”he said.
Hetero Labs Ltd International Marketing Director B Murali Krishna Reddy said: “We are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of Covid-19. While we await the results of clinical trials in India, we believe that manufacturing the product locally is crucial to allow quick access to patients. This collaboration is a further step towards our commitment in the battle against Covid-19 and the realization of the goal of ‘Make in India’ ”.
RDIF and the Gamaleya National Center for Epidemiology and Microbiology announced on November 24 that positive results had been obtained during the second interim data analysis of the largest Phase III, double-blind, randomized, placebo-controlled clinical trials of Sputnik V in the history of Russia that involved 40,000 volunteers.
RDIF said the results of the interim trial confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors.
The Sputnik V will be manufactured by Hetero’s biologics division, Hetero Biopharma, at Jadcherla in Hyderabad, with production starting in the first quarter of 2021, Hetero and RDIF said on Friday.
RDIF already has a partnership with another large Hyderabad-based pharmaceutical company, Dr. Reddy’s Laboratories, to conduct phase 2/3 clinical trials for Sputnik V and to distribute 100 million doses in the Indian market.
The Russian vaccine has already received approval from Indian drug regulators for phase 2/3 clinical trials, even as phase 3 trials are underway in Belarus, the United Arab Emirates, Venezuela and other countries.
RDIF said that requests for more than 1.2 billion doses of Sputnik V come from more than 50 countries and that vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea, among others.
RDIF Executive Director Kirill Dmitriev said the partnership with Hetero will pave the way for the production of the Sputnik V vaccine in India. “The results of the provisional clinical trial of the vaccine show an efficacy of 95% on day 42 after the first dose. I am sure that Sputnik V should become an integral part of the national vaccine portfolio of all countries willing to protect their population from the coronavirus. Thanks to our cooperation with Hetero, we will be able to significantly increase production capacity and provide the people of India with an efficient solution in this challenging period of the pandemic, ”he said.
Hetero Labs Ltd International Marketing Director B Murali Krishna Reddy said: “We are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of Covid-19. While we await the results of clinical trials in India, we believe that manufacturing the product locally is crucial to allow quick access to patients. This collaboration is a further step towards our commitment in the battle against Covid-19 and the realization of the goal of ‘Make in India’ ”.
RDIF and the Gamaleya National Center for Epidemiology and Microbiology announced on November 24 that positive results had been obtained during the second interim data analysis of the largest Phase III, double-blind, randomized, placebo-controlled clinical trials of Sputnik V in the history of Russia that involved 40,000 volunteers.
RDIF said the results of the interim trial confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors.
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