DCGI Approves Russia’s Sputnik-V Vaccine: Finally India Gets The Third COVID-19 Vaccine!


Amid an unprecedented rise in new COVID-19 cases across India and reports of a shortage of vaccines in inoculation centers in at least 10 states about which the Government of India has been in a constant denial mode, the Indian drug regulator, Drugs Controller General of India (DCGI), has accorded its final approval to Russia’s Sputnik-V COVID-19 vaccine for emergency use. It is to be noted that the drug regulator had earlier approved Covishield (the Indian version of the Oxford AstraZeneca) and the indigenously produced Covaxin (even before its completion of the third phase of human trials) in January 2021 and a national vaccination drive had been launched from the 16th of January 2021. However, in the past three months the jabs administered have been falling far short of the Government’s goal of vaccinating 300 million people by July 2021 (just over 100 million jabs so far which needs to be much increased now as the vaccination drive opens up to all above the age of 45) amid demands to cover people of all ages and to approve new and newer vaccines, largely in view of the worrying spikes in new cases, total active cases and daily fatality figures. As per news reports India is set to import/produce 850 million doses of Sputnik-V annually which in turn would greatly speed up vaccination drive as has been urgently desired by all.


The Sputnik-V vaccine was announced by Russia in August 2020 and after its final phase of clinical trials had claimed an efficacy rate of 91.6%, in league only with Pfizer and Moderna vaccines showing 90%+ efficacy rates, apart from its immense immunogenic response. The vaccine has been conducting its clinical human trials in India since September 2020 in collaboration with Hyderabad-based Dr. Reddy’s laboratories, and has completed the third and final phase in March 2021 with the final results expected to come out anytime now. India becomes the 60th country to give emergency use authorization to Sputnik-V. Compared to Pfizer and Moderna, Sputnik-V is much cheaper at $10 per dose and it has two forms one of which can be stored at normal refrigeration temperatures, and therefore ideally suited for the Indian standards. Further, the benefits of large-scale production could also accrue to India in terms of lesser prices.


Although the Government of India has been in the denial mode about a shortage of the two vaccines coming from the financial capital Mumbai and then spreading to other major states with Kolkata joining in the chorus lately, it is apparent that it has got itself into a damage-control mode by strengthening the supply chain, fast-tracking the approval procedure of new vaccines and by, being under the charge by the opposition political parties about doing ‘export business’ enforcing a sort of duopoly of the vaccines, reducing the volume of exports. Under the guidelines of the World Health Organization no country can keep a vaccine only for its own people, and has to share with other nations, particularly the developing ones. But, as exhibited by the US, there is no bar on any country in stockpiling as many doses of all the vaccines available by producing, buying and importing to protect its own population. It augurs well for India that good sense has prevailed finally. Doses of the Sputnik-V, to be injected with a 21-day interval, are likely to be rolled out in May 2021 across India.