Pharma major Dr Reddy’s Laboratories seeks emergency use authorisation of Sputnik V vaccine from DCGI

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

Pharma major Dr. Reddy’s Laboratories announced that it has initiated the process with the Drugs Controller General of India for Emergency Use Authorization of human adenoviral vector-based platform vaccine candidate, Sputnik V.

The Hyderabad-based firm yesterday said as part of the review process, it will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to be complete by February 21st.

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

The vaccine is currently in the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6 per cent 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 per cent even among the group of 2,144 volunteers over 60 years old.

G.V. Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said that the efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against Covid-19.

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

Tags

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Back to top button