Policy & Regulation
Dr. Reddy's Initiates Process for India Emergency Use Authorization of Sputnik V Vaccine Candidate
19 February 2021 - - Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) (NSEIFSC: DRREDDY) has initiated the process with the Drugs Controller General of India for Emergency Use Authorization of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V, the company said.

As part of the review process, Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st February 2021.

In September 2020, Dr. Reddy's partnered with the Russian Direct Investment Fund to conduct the clinical trials of the Sputnik V and for its distribution rights in India.

The vaccine is currently undergoing the phase 3 clinical trial in India.

Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine.

Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2,144 volunteers over 60 years old.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia on 11th August 2020 and became the World's first registered vaccine against COVID-19 based on the human adenoviral vector platform.

More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines.

Sputnik V is one of only three vaccines in the world with an efficacy of 91.6% and has most authorizations granted with 26 countries globally.

The vaccine has already been administered to more than 2 m people worldwide.

Dr. Reddy's Laboratories is an integrated pharmaceutical company, whose major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

The company's major markets include USA, India, Russia and CIS countries, and Europe.