Sputnik -V vaccine of Russia gets renewed approval for Clinical trials in India

The Directorate Control General of India renewed the approval of clinical trials of Sputnik-V vaccine in India.

• The Directorate Control General of India renewed the approval of clinical trials of Sputnik-V vaccine in India.
• The regulator has instructed the Russian Manufacturer of the vaccine to conduct all the phases of the clinical trials of the vaccines in India.
• This is because the phase I and phase II clinical trials of the vaccine conducted in Russia was too small. Hence, the regulator has renewed the approval to conduct all the three phases of the clinical trials in India.
• The Sputnik-V vaccine was developed by Russia in August 2020. It became the first registered COVID-19 vaccine in the world. On the other hand, Russia conducted the clinical trials of the vaccine only on 76 patients. This includes both phase I and phase II. Currently, phase III clinical trial is underway in Moscow with 40,000 participants.
• The Russian Direct Investment Fund will distribute 100 million doses to India. Also, RDIF has signed agreements to manufacture 300 million doses in India.
• Currently, Sputnik-V is under Clinical Trial Phase III in countries such as Venezuela, Belarus and United Arab Emirates.