Sputnik V seeks DCGI nod for 'emergency use'; Dr. Reddy's to complete Ph-3 trials in Feb

Barely a month after Hyderabad-based Dr. Reddy's Lab started Phase-3 trials for its Coronavirus (COVID-19) vaccine - Sputnik -V, it has applied to Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) on Friday. With Phase-3 trials expected to be completed on February 21,  Dr. Reddy's will present the safety profile of the Phase 2 study and interim data of the Phase 3 study on Sputnik V to DCGI. Currently, only Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) have been allowed to manufacture and distribute their vaccines throughout India.

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

Sputnik V applies for emergency use

First batch of Sputnik V vaccine lands in Venezuela

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. Moreover, the Africa Vaccine Acquisition Task Team (AVATT), has secured over 300 million doses of Russia’s Sputnik V vaccine.

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, which has been reviewed by Lancet journal. 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.

India looking to collaborate with Russia to manufacture Sputnik V: Foreign Secy Shringla

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.

Togo files for procurement of Russia's Sputnik V vaccine, says Russia's MFA