Dr Reddy s eyes to launch Sputnik V vaccine for COVID-19 under EUA in March

We expect the full results of33,760 subjects to come in the month of February, he said.The official said though the initial agreement with RDIFwas for 100 million doses, later it was enhanced to 125million.According to him 1.5 million doses of Sputnik V havealready been administered globally and the EAU for the vaccinewas now available in 12 countries.

Dr Reddys Laboratories (DRL) onFriday said it expected Russia's COVID-19 vaccine Sputnik V,under phase 3 trials being conducted by the city-based drugmaker, to be launched in India through Emergency UseAuthorisation (EUA) by March this year.

The ongoing trial was expected to be completed byFebruary after which it would approach the Drug ControllerGeneral of India (DCGI) for EUA and based on its approval thevaccine could be launched in March, DRL's Chief ExecutiveOfficer 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 Vvaccine and for its distribution rights in India.

''The phase 3 (trial) is currently ongoing. We are dosingpatients and we expect to complete the dosing as part of thephase 3 by February. After that we expect to compile the dataand submit for Emergency Use Authorisation, make the requestto the DCGI with our dossier,'' Sapra told a press conferencehere.

''And based on the approval from the DCGI, we believe thatwe should be in a position to launch the vaccine through a EUAin the month of March 2021 (in India),'' he said.

Sputnik V, developed by the Gamaleya National ResearchInstitute of Epidemiology and Microbiology, was registered bythe Ministry of Health of Russia and became the worlds firstregistered vaccine against COVID-19 based on the establishedhuman adenoviral vector platform.

The DCGI has already given the nod for two COVID-19vaccines -- Covaxin of city-based Bharat Biotech andCovishield of Oxford, being manufactured by Serum Institute ofIndia in Pune, administered to frontline workers from January16 across the country.

Sapra said DRL has tied up with RDIF for 125 milliondoses for India and was currently in discussions with theCentre and private players for supply of the vaccine.

According to him DRL, will import some quantities of thevaccine from Russia besides getting them from domestic firmswhich have tie-up with RDIF for manufacturing it in India.

He however, did not divulge the pricing strategy for thethe vaccine.

On the efficacy of Sputnik V, Sapra said the interimefficacy on 22,000 of the subjects was showing a result of91.4 per cent.

''In addition to the efficacy, safety, immunogenicitycriteria have also been met as part of this ongoing Phase 3 aspart of the interim result. We expect the full results of33,760 subjects to come in the month of February,'' he said.

The official said though the initial agreement with RDIFwas for 100 million doses, later it was enhanced to 125million.

According to him 1.5 million doses of Sputnik V havealready been administered globally and the EAU for the vaccinewas now available in 12 countries.