NEW DELHI: Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF), has partnered with Hyderabad-based drug maker Dr Reddy’s Laboratories to cooperate on clinical trials and distribution of the Sputnik V vaccine in India, and deliveries for general use could begin later this year.
Once regulatory approvals to conduct trials in India have been established, RDIF will supply 100 million doses of the Covid vaccine, developed by Russian researchers, to DRL. The results of the early phases (Phase 1 and 2) of the vaccine trials were recently published in the Lancet, while India and Russia were in talks to conduct further trials and manufacture the vaccine in India. The Indian Council for Medical Research (ICMR) maintains that Russia has a good track record in developing vaccines.
The AstraZeneca or Oxford vaccine is also in phase 3 trials with the Serum Institute of India contracted to produce it and has been at the forefront of the race for public use. Two other Indian vaccines are in development and are in phase I and II trials and have not shown significant side effects yet.
Dr. Reddy’s will conduct Phase 3 clinical trials, where a vaccine is tested in thousands of humans to establish efficacy and safety, for Sputnik V in India, as required by Indian regulatory standards.
RDIF said deliveries could potentially begin in late 2020, subject to the completion of successful trials and registration of the vaccine by regulatory authorities in India. “Phase I and II clinical trials have shown promising results. We will conduct phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of Indian regulators. The Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India, ”said DRL Co-Chair and Managing Director GV Prasad.
Sputnik V is an adenovirus vector-based vaccine that was registered by the Russian Ministry of Health on August 11. It is the first Covid-19 vaccine registered in the world. Kirill Dmitriev, Executive Director of the Russian Direct Investment Fund, said: “We are very pleased to be partnering with Dr. Reddy’s in India. Dr Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. ”
“India is among the countries most affected by Covid-19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against Covid-19. RDIF partners will receive an effective and safe drug to combat the coronavirus, “he added.
According to Dmitriev, the human adenoviral vector platform, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and has been found to be safe without “potential long-term negative consequences.” “The agreement between RDIF and Dr. Reddy’s reflects the growing awareness of countries and organizations to have a diversified portfolio of Covid vaccines to protect their populations.”
While Russia and the Government of India have been in contact with various pharmaceutical companies in India to conduct clinical trials and manufacture the vaccine locally, Dr. Reddy’s is the first to sign an official agreement with RDIF.
Once regulatory approvals to conduct trials in India have been established, RDIF will supply 100 million doses of the Covid vaccine, developed by Russian researchers, to DRL. The results of the early phases (Phase 1 and 2) of the vaccine trials were recently published in the Lancet, while India and Russia were in talks to conduct further trials and manufacture the vaccine in India. The Indian Council for Medical Research (ICMR) maintains that Russia has a good track record in developing vaccines.
The AstraZeneca or Oxford vaccine is also in phase 3 trials with the Serum Institute of India contracted to produce it and has been at the forefront of the race for public use. Two other Indian vaccines are in development and are in phase I and II trials and have not shown significant side effects yet.
Dr. Reddy’s will conduct Phase 3 clinical trials, where a vaccine is tested in thousands of humans to establish efficacy and safety, for Sputnik V in India, as required by Indian regulatory standards.
RDIF said deliveries could potentially begin in late 2020, subject to the completion of successful trials and registration of the vaccine by regulatory authorities in India. “Phase I and II clinical trials have shown promising results. We will conduct phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of Indian regulators. The Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India, ”said DRL Co-Chair and Managing Director GV Prasad.
Sputnik V is an adenovirus vector-based vaccine that was registered by the Russian Ministry of Health on August 11. It is the first Covid-19 vaccine registered in the world. Kirill Dmitriev, Executive Director of the Russian Direct Investment Fund, said: “We are very pleased to be partnering with Dr. Reddy’s in India. Dr Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. ”
“India is among the countries most affected by Covid-19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against Covid-19. RDIF partners will receive an effective and safe drug to combat the coronavirus, “he added.
According to Dmitriev, the human adenoviral vector platform, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and has been found to be safe without “potential long-term negative consequences.” “The agreement between RDIF and Dr. Reddy’s reflects the growing awareness of countries and organizations to have a diversified portfolio of Covid vaccines to protect their populations.”
While Russia and the Government of India have been in contact with various pharmaceutical companies in India to conduct clinical trials and manufacture the vaccine locally, Dr. Reddy’s is the first to sign an official agreement with RDIF.
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