First interim Phase 3 data shows promise for Russia’s Sputnik V COVID-19 vaccine

pharmafile | November 11, 2020 | News story | Research and Development COVID-19, Russia, Sputnik V, Vaccine 

The first interim Phase 3 data for Russia’s Sputnik V COVID-19 vaccine have been released by the Gamaleya Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF).

The data is drawn from a double-blind, randomised, placebo-controlled Phase 3 study conducted in Russia, incorporating 40,000 participants across 29 sites – the largest of its kind to evaluate the therapy.

The data covers 16,000 of these participants, in which a statistical analysis found 20 confirmed cases of COVID-19. Based on a case split between the vaccine and placebo groups, the researchers said the therapy had shown an efficacy rate of 92% following the second dose.

“The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” commented Alexander Gintsburg, Director at the Gamaleya Center. “Thanks to the production scale up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally.”

Sputnik V became the world’s first approved COVID-19 vaccine to some controversy on 11 August under emergency use authorisation, having only cleared Phase 2 trials.

“Sputnik V is the first registered vaccine against COVID-19 in the world, the vaccine is based on a safe and effective platform of human adenoviral vectors,” remarked RDIF CEO Kirill Dmitriev. “More and more countries are recognising the human adenoviral vector platform and plan to include these vaccines, as the most studied and known, in their respective national vaccine portfolio. I would also like to stress the importance of international cooperation and close partnership among vaccine-developing states. Vaccines should be above politics. The world needs a diversified portfolio of high-quality vaccines with Sputnik V, based on the well-tested human adenoviral vector platform, being an important element of it.”

Full study data is due to be published in a peer-reviewed journal following independent valuation. Over 20,000 study participants had received the first dose and 16,000 had received both doses as of 11 November. By that time, no unexpected adverse events had been reported. Study observation is set to continue for another six months.

Matt Fellows

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