Russia’s Sputnik V Covid-19 Vaccine Approves in India for Emergency Use
Delhi, 13 April 2021 – It’s a huge shot in the arm of India’s war against the Coronavirus. The third vaccine, Russia’s Sputnik V has been approved for emergency use. Developed by RDIF, Sputnik V is being manufactured by Hyderabad-based Doctor Reddy’s lab and has an efficacy of 91.6%.
India gets the third weapon in its fight against Coronavirus. Russia Sputnik V vaccine gets government panel Nord amid a surge in cases. The other two vaccines Co Vaccine and COVID Shield, developed by Bharat biotech and Serum Institute of India are also authorized under the restricted use approval category in India. Johnson and Johnson single-dose vaccine will also be approaching the DGCI to start trials. Genova biopharmaceuticals, which has developed India’s mRNA vaccine have the approval for trials too.
Bharat Biotech nasal vaccine has also started its trials. Covovax again has got the approval for phase three trials. Serum Institute has developed this vaccine, along with Novavax. Developed by Russia’s Gamaliel Research Institute of epidemiology and microbiology, Sputnik V demonstrated an efficacy rate of 91.6% after an interim analysis of the phase three trial, which was conducted on 19,866 volunteers in Russia. The data has been published in The Lancet.
In February this year Doctor Reddy’s lab these had applied for emergency use of the vaccine. Twice the regulator asked the Hyderabad-based company to come back with more data. The company has done bridging studies dosing 1300 participants. Data on all immunogenicity parameters, data of all serious adverse effects and RT PCR positive cases after dosing, correlation of immunogenicity data, comparative analysis of data from Russia and India, fat sheets, and consistency data concerning clinical outcomes.
Dr. Reddy’s laboratories and Russian direct investment fund had initiated adaptive phase two phase three trials for the Sputnik V vaccine in India. The RDIF (Russian Direct Investment Fund
) has tied up with at least four companies in India to manufacture the doses for use in India and outside.
The approval was given to Sputnik V perhaps is the best news that we have heard in a while on the pandemic front in the country. The approval comes at a time when cases of COVID-19 are going through the roof and there is a limited supply of the existing vaccine doses in the country. Also, the number of doses will be quite large given the fact that RDIF has had a tie-up with many companies in India to manufacture doses of Sputnik V for India and countries outside of India.
