Sputnik V Vaccine of Russia gets renewed approval for Clinical Trials in India

Published: October 17, 2020

On October 17, 2020, 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.

Highlights

In September 2020, the Russian Direct Investment Fund and Dr Reddy’s signed an agreement to conduct clinical trials of Sputnik vaccine in India. However, the Central Drugs Standard Control Organization instructed to conduct an adaptive phase II and phase III of clinical trials in India instead of just phase 3. This is because, the safety and immunogenicity data of phase I and phase II trials conducted in Russia were small. There were no data available on Indian subjects on phase I and phase II trials of the vaccine. Earlier, based on data from Russian clinical trials, the phase III clinical trial of the Sputnik V vaccine was to be conducted in India. Now, the regulator has instructed to conduct adaptive phase II and phase III clinical trials in India.

Background

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.

Laboratories

Russia will also sign an agreement with the Department of Science and Technology to use its laboratories for the clinical trials.

What is the plan?

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.

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