COVID-19 vaccine Sputnik V launch in India likely in March: Phase 3 trials to conclude in February

The Russian COVID-19 vaccine Sputnik V may be available in India in March after it is granted approval for Emergency Use Authorisation.

By: Jahnavi Sarma | | Updated: January 30, 2021 9:32 am

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform.

India is likely to have a third vaccine in the market soon if things go according to plan. Dr Reddy’s Laboratories Ltd hopes to launch the Russian COVID-19 vaccine Sputnik V in India in March after obtaining Emergency Use Authorisation (EUA). The pharma major expects the Phase 3 trials to be completed next month. According to Deepak Sapra, Chief Executive Office, API & Pharmaceutical Services, Dr Reddy’s, “About 70 per cent of the trials have already been completed. We hope to roll out the product in March.” He further added that the phase 3 trials will be completed in February after which data will be compiled and submitted to the Drug Controller General of India for EUA. Also Read - Akshay Kumar, Piyush Mishra, Sonam Kapoor and more Bollywood celebs who opened up on facing sexual abuse in childhood

Dr Reddy’s is ready to supply 125 million vaccine doses in India

Addressing a virtual press conference to announce third quarter results of the company, Sapra said Dr Reddy’s was gearing up for the production of the Sputnik V vaccine. Initially, it will be a combination of import and local manufacturing. He also revealed that the company is in talks with a couple of local manufacturers. It has already signed agreements for 125 million patient doses of Sputnik V in India. Also Read - Drinking Water On An Empty Stomach: 4 Health Benefits To Look Out For

Phase 3 trials to be conducted on 1,500 participants

The company plans to cater to both government and private demand. It was on January 15 that Dr. Reddy’s announced that it has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trials. The trials are to be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India. Also Read - Test Article 2 Covid 19 3rd wave

World’s 1^st registered vaccine already being administered in 12 countries

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. Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia 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 Sputnik V is being administered as part of emergency use in 12 countries.

Price of vaccine not fixed

The pricing of vaccine has not been decided yet. Meanwhile, Dr Reddy’s posted consolidated net profit of Rs 20 crore during third quarter against a loss of Rs 569.7 crore in the year-ago period. Revenues for the quarter ending December were Rs 4,930 crore which was up 12 per cent year on year and one percent over the second quarter. “We continued with our growth momentum while maintaining EBITDA margins. The profits were impacted due to trigger-based impairment charge taken on a few acquired products including gNuvaring. We are progressing well on the Phase 3 clinical trials for Sputnik V vaccine in India. We continue to focus on enhancing our product offerings to our patients to serve them better,” said Dr Reddy’s Co-chairman & MD, G.V. Prasad.

(With inputs from IANS)

Published : January 30, 2021 8:21 am | Updated:January 30, 2021 9:32 am

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