Dr Reddy's eyes to launch Sputnik V vaccine for COVID-19 under EUA in March
Dr Reddy's Laboratories (DRL) on Friday said it expected Russia's COVID-19 vaccine Sputnik V, under phase 3 trials being conducted by the city-based drug maker, to be launched in India through Emergency Use Authorisation (EUA) by March this year. The ongoing trial was expected to be completed by February after which it would approach the Drug Controller General of India (DCGI) for EUA and based on its approval the vaccine could be launched in March, DRL's Chief Executive Officer of APIs and Pharmaceutical Services Deepak Sapra said.
DRL partnered with Russian Direct Investment Fund (RDIF) in September to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
"The phase 3 (trial) is currently ongoing. We are dosing patients and we expect to complete the dosing as part of the phase 3 by February. After that we expect to compile the data and submit for Emergency Use Authorisation, make the request to the DCGI with our dossier," Sapra told a press conference.
"And based on the approval from the DCGI, we believe that we should be in a position to launch the vaccine through a EUA in the month of March 2021 (in India)," he said.
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 worlds first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
The DCGI has already given the nod for two COVID-19 vaccines -- Covaxin of city-based Bharat Biotech and Covishield of Oxford, being manufactured by Serum Institute of India in Pune, administered to frontline workers from January 16 across the country.
Sapra said DRL has tied up with RDIF for 125 million doses for India and was currently in discussions with the Centre and private players for supply of the vaccine.
According to him DRL, will import some quantities of the vaccine from Russia besides getting them from domestic firms which have tie-up with RDIF for manufacturing it in India.
He however, did not divulge the pricing strategy for the the vaccine.
On the efficacy of Sputnik V, Sapra said the interim efficacy on 22,000 of the subjects was showing a result of 91.4 per cent.
"In addition to the efficacy, safety, immunogenicity criteria have also been met as part of this ongoing Phase 3 as part of the interim result. We expect the full results of 33,760 subjects to come in the month of February," he said.
The official said though the initial agreement with RDIF was for 100 million doses, later it was enhanced to 125 million.
According to him 1.5 million doses of Sputnik V have already been administered globally and the EAU for the vaccine was now available in 12 countries.
