Russia’s Sputnik V vaccine could make an entry into India by the end of 2020, after getting regulatory approvals for clinical trials in India. The Hyderabad-based Dr Reddy’s Laboratories Ltd has entered into an agreement with Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, to cooperate on clinical trials and distribution of Sputnik V vaccine in India.
Dr Reddy's Laboratories will undertake Phase III of the clinical trials after regulatory approval. And once the trials are over and the vaccine is cleared, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine, according to a press statement.
The Sputnik V vaccine is based on human adenoviral vector platform with proven safety, claims RDIF. The vaccine is presently undergoing clinical trials in Russia.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, told the media, “India is amongst most severely impacted countries from COVID-19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID-19.” Dr Reddy’s has had a very well-established and respected presence in Russia for over 25 years, Kirill added.
RDIF claims vaccine to be an effective and safe drug to fight the coronavirus. “The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences,” Kirill added.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com.
The announcement of the Russian vaccine was announced by the Russian President Vladimir Putin on August 12.
On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, a leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020.
There are about 46 vaccines that are currently undergoing clinical trains in India and seven of these vaccines are in phase 3 of clinical trials.
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