Dr Reddy’s gets nod for phase 3 clinical trial of Russian COVID-19 vaccine Sputnik V

The Phase 3 study of Sputnik V COVID-19 vaccine will be conducted on 1500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India.

By: Jahnavi Sarma | | Published: January 16, 2021 10:09 am

नीति आयोग के सदस्य बोले- वैक्सीन सुरक्षित, अपने उत्पादों पर भरोसा रखें

India may soon get a third COVID-19 vaccine if things go according to plan. Pharma major Dr Reddy’s Laboratories Ltd on Friday announced that it has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trial for the Sputnik V vaccine in India. The Phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India, the Hyderabad-based company said in a statement. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the Phase 2 clinical trial of the vaccine and recommended the Phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified, and the study met the primary endpoints of safety. Also Read - New COVID-19 strain is here, protect yourself with three layered surgical masks: Experts

Trials expected to start this month

G.V. Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, termed this as an mportant milestone in the progress of this pivotal clinical trial of the vaccine. “We expect to commence the Phase 3 clinical trial within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population,” he said. In September 2020, Dr Reddy’s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India. Also Read - COVID-19 surge continues in Maharashtra: Night curfew, full lockdown on weekends in Aurangabad

Vaccine based on human adenoviral vector platform

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia last August and became the world’s first registered vaccine against COVID-19 based on the established human adenoviral vector platform. The vaccine’s efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia. 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. Also Read - CoWIN registration not a must for healthcare workers, front line warriors to get the COVID-19 vaccine

Thousands to be given the shot

Earlier, Indian scientists had looked at the data of this vaccine and agreed that there is a need for a Phase-3 trial. In this last stage trials, the vaccine is given to thousands of people and tested for efficacy and safety. 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 the Sputnik V COVID-19 vaccine in India.

About this vaccine candidate

Sputnik V is an adenovirus vector-based vaccine. It has been developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology in collaboration with the Russian Direct Investment Fund and registered on August 11. It became the first registered vaccine against the COVID-19 virus. In September last year, 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.

Published : January 16, 2021 10:09 am

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