Close on the heels of The Lancet publishing the outcome of the Phase-1 and Phase-2 clinical trial data of Russia's potential Covid-19 shot Sputnik V, the Russian research institute has presented “comprehensive data” on the vaccine’s safety to Indian authorities, The Indian Express reported. Top officials told the publication that India had asked for these details from the Gamaleya Research Institute of Epidemiology and Microbiology which is based in Moscow.
The report, citing a source, said that the Indian side is now "deeply engaged" with Russia on the vaccine. The comprehensive data is being analysed by Indian experts and sources told IE that conducting Phase 3 clinical trials is an option that's being explored.
The potential vaccine induced a "strong" immune response in Phase 1 and amp; 2 of the clinical trials on 76 individuals. As per the details available on the official website of Sputnik V, Russia aims to conduct Phase 3 clinical trials in several countries, including Saudi Arabia, UAE and Brazil. The production of the shot is slated to commence in September 2020.
The development comes after the Russian Ambassador to India, Nikolai Kudashev, formally reached out to India last month, seeking a partnership in the production of the Covid-19 vaccine, Sputnik V. Reports claim that Russia is planning to produce 6 million doses of coronavirus vaccine per month. Kirill Dmitriev, the CEO of the Russian Direct Investment Fund (RDIF), had also said that Russia is looking for a partnership with India for producing COVID-19 vaccine Sputnik V.
The engagement efforts are being overseen by Renu Swarup, Secretary, Department of Biotechnology, and, by Indian Ambassador D B Venkatesh Varma. Notably, Defence Minister Rajnath Singh, who was in Moscow for the Shanghai Cooperation Organisation (SCO) meeting, had also congratulated the Russian government and its scientists for developing a vaccine against Covid-19.
The preliminary results published in The Lancet journal on Friday revealed that the COVID-19 vaccine, which was approved by Russia last month, has been shown to elicit antibody response with no serious adverse events in small human trials. Results from early-phase non-randomised vaccine trials in a total of 76 people show that two formulations of the vaccine have a good safety profile detected over 42 days, and induce antibody responses in all participants within 21 days.