NEW DELHI, 19 Feb – RIA Novosti. Pharmaceutical company Dr Reddy's Laboratories said on Friday that it had requested emergency use of the Russian Sputnik V coronavirus vaccine in India.
“Dr. Reddy's today announced that it has initiated a process with the Comptroller General of Medicines of India to obtain an emergency use authorization for Sputnik V, a vaccine candidate based on the well-researched human adenoviral vector platform,” the company said in a statement posted on the website. Bombay Stock Exchange Infographics
At the moment, only two vaccines against coronavirus are allowed in India – the Indian version of the “Oxford” vaccine called Covieshield and the domestic Covaxin.
Dr Reddy's intends to submit to the Indian authorities “the safety profile of the Phase 2 study and interim data from the Phase 3 study, which is expected to be completed by 21 February 2021.”
“The initiation of the emergency use authorization (s) process will be a decisive step forward for us in ensuring rapid access to Sputnik V vaccine in India,” Managing Director Dr. Reddy's Ji Wee Prasad.
The Russian Direct Investment Fund (RDIF) and India's Dr Reddy's Laboratories Ltd previously agreed on clinical trials of the vaccine. The world's first vaccine for the prevention of COVID-19 “Sputnik V”, developed by the Gamaleya Research Center for Electrochemistry and Manufacturing in conjunction with RDIF, was registered by the Russian Ministry of Health in August last year. The vaccine involves the introduction of two components of the drug with an interval of three weeks.
The scientific journal Lancet previously published the results of the third phase of clinical trials “Sputnik V”, confirming its high efficiency and safety. During phase III clinical trials, Sputnik V demonstrated high rates of efficacy, immunogenicity and safety – the vaccine efficacy was 91.6%. The vaccine provides complete protection against severe cases of the new coronavirus infection. The Sputnik V vaccine has already been approved in more than 20 countries.
India is in the second place in the world in the number of detected cases of coronavirus. According to the latest data from the Ministry of Health, a total of 10.9 million cases of COVID-19 have been registered in the country. At the same time, more than 10.6 million people have defeated the disease, about 139 thousand are continuing treatment, 156 thousand people have died from coronavirus and associated diseases.