Indian drugmaker Dr.Reddy’s Laboratories Ltd said on Monday an independent board found Russia’s Sputnik V Covid-19 vaccine to be safe in its mid-stage trial in India, and recommended progressing to late-stage trials.
The company has submitted the mid-stage trial safety data to India’s drug regulator for review and approval to continue late-stage trials, Dr.Reddy’s said in a regulatory filing.
Sputnik V is the world’s first registered vaccine based on a well-researched human adenoviral vector-based platform. It currently ranks among top-10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organization’s list.
The ongoing Sputnik V post-registration clinical trial in Russia involves 40,000 volunteers.
Clinical trials of Sputnik V have been announced in the UAE, India, Venezuela and Belarus.
The Sputnik V vaccine’s efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials. The Sputnik V vaccine efficacy against severe cases of coronavirus is 100 per cent.
The cost of one dose of the vaccine for international markets will be less than $10. Sputnik V is a two-dose vaccine. The lyophilized (dry) form of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius.
Requests for more than 1.2 billion doses of the Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by Russian Direct Investment Fund’s international partners in India, Brazil, China, South Korea and other countries.