Dr Reddy's eyes to launch Sputnik V vaccine for COVID-19 under emergency use authorization in March

30-01-2021

India may soon have a third COVID-19 vaccine approved for emergency use by March this year, if all goes well with Sputnik V, the much-talked-about Russia's COVID-19 vaccine, being trialled and produced by Dr Reddy's Laboratories in Hyderabad, India. The phase 3 trials of the vaccine candidate are being conducted by the pharma company. The ongoing phase 3 trials were to be completed by the month of February. The pharma company planned to approach the Drug Controller General of India, the regulatory body for EUAs. Dr Reddy's Labs is positive that they will be able to launch the vaccine in March, based on the approvals. 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 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," DRL's Chief Executive Officer of APIs and Pharmaceutical Services Deepak Sapra said. "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 was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. It became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform, globally, when it was registered by the Ministry of Health in Russia, in August 2020. Sapra also said that DRL has tied up with RDIF for 125 million doses for India and was currently in discussions with public and private parties 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 a tie-up with RDIF for manufacturing it in India. He, however, did not comment on the price of the vaccine yet. Sputnik V has reported efficacy of 91.4 per cent in the late-stage trial results. "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," Sapra said. According to him 1.5 million doses of Sputnik V have already been administered globally and the vaccine has been approved for emergency use in as many as 12 countries.