Phase 2 trial of Sputnik V may resume in India soon

The "multi-center and randomized controlled study" will be conducted by Dr Reddy's Laboratories, a Hyderabad-based pharmaceutical giant. More on Covid-19Dr Reddy's co-chairman and managing director G V Prasad termed it as a significant development that will allow the company to commence the clinical trials for Sputnik V in India. "We are committed to bringing in a safe and efficacious vaccine to combat the pandemic", he said.

On September 16, the Russian Direct Investment Fund (RDIF) and Dr Reddy's Laboratories Limited had agreed to cooperate on clinical trials and distribution of Sputnik V Covid-19 vaccine in India.

India's vaccines regulator has given the green light for a clinical study of the Russia-developed Covid-19 vaccine.

Now two indigenously developed vaccine candidates for Covid-19, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are undergoing phase 2 of human clinical trials. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russian Federation and became the worlds first registered vaccine against COVID-19 based on the human adenoviral vectors platform. After Sputnik V is cleared for Indian customers, RDIF will supply 100 million doses of the vaccine, according to the deal.

Sputnik V, the world's first registered vaccine developed by Russian Federation against Covid-19, has been approved for conducting an adaptive phase 2 and 3 trial in India.

It may be noted that on October 5, the Subject Expert Committee had done a thorough evaluation of the previous application submitted by Dr Reddy's lab.

The panel had earlier asked Dr Reddy's to resubmit the protocol with some additional information for conducting phase 2 and 3 trials. The vaccine uses two adenovirus vectors (rAd26 and rAd5) against SARS-CoV-2 virus.