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.
Amgen's Phase 3 bemarituzumab plus chemotherapy clinical trial meets primary endpoint
TuHURA Biosciences acquires Kineta
AbbVie agrees to acquire Capstan Therapeutics
Tyra Biosciences doses first patient in TYRA-300 Phase 2 study for bladder cancer
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer