Sputnik V submits safety data of Phase-2 clinical trials to DCGI; seeks to proceed to Ph-3

As India gears for Coronavirus vaccine rollout on January 16, another vaccine candidate - Sputnik V - produced by Russian government-Dr. Reddy's Labs has submitted its phase-2 trial data to Drug Controller General of India (DCGI) on Monday. Sputnik V's Indian manufacturer Dr. Reddy's issued a statement that it has sought to continue phase-3 clinical trials after Sputnik V met the primary endpoint of safety in the phase-2 trials. Currently, DCGI has approved vaccines of Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) for restricted use in an emergency situation, while Zydus Cadila's ZyCov-D has been approved for phase 3 trials.

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Sputnik V applies for phase 3 trials

Dr Reddy's further stated that the Data and safety monitoring board has recommended to continue Sputnik V clinical trial without any modifications. As of 6 January, Russia had vaccinated more than one million people with Sputnik V, as per international reports. Russia started with vaccinating people over the age of 60, and as of now, over 1.5 million have been vaccinated in Russia and  300,000 people in Argentina.

The vaccine’s efficacy is reported at 91.4%  based on data analysis of the final control point of clinical trials, states its official website. Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation, state reports. In September 2020, Dr. Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India. 

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About Sputnik V

As per its official website, Sputnik V is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. Ranking as one of WHO's top 10 candidate vaccines, Sputnik V is currently conducting post-registration clinical trial in Russia with 40,000 volunteers. While the vaccine's overall efficacy is confirmed at 91.4%, it boasts a 100% efficacy against severe cases of coronavirus. The cost of one dose of the vaccine for international markets will be less than $10 and Sputnik V is a two-dose vaccine that can be stored at a temperature of +2 to +8 degrees Celsius. Apart from India, Brazil, China, South Korea are RDIF's international partners.

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