Russia has announced that it would test its coronavirus vaccine Sputnik-V, the world’s first vaccine for COVID-19, on 40,000 people. The vaccination will be done during phase 3 human trials. Russia’s decision came after it received severe criticism over the efficacy and safety of the vaccine which has been termed by Moscow as “World’s First Coronavirus vaccine”. Russia had approved the vaccine without completion of the mandatory Phase 3 human trials as Sputnik-V has completed the only Phase 1 and Phase 2 clinical trials. Russia is yet to publish the detailed trial design or data of Sputnik-V, developed by Moscow-based Gamaleya Research Institute for Epidemiology and Microbiology in coordination with the defence ministry of that country, as per an AFP report.
Russia earlier tried to denounce criticism as an attempt to undermine Moscow’s research. Now it has adopted publicity overdrive measures to counter and minimise damage by launching a dedicated website for the Sputnik-V. The website sputnikvaccine.com denotes the vaccine as the “world’s first registered COVID-19 vaccine proven human adenoviral vector technology”. In this website, Russian authority has provided details such as partnerships, general information, vector creation, vaccination, how adenoviral vector-based vaccines work, and most importantly the vaccine’s safety and efficacy.
Russian Direct Investment Fund (RDIF) has stated that phase 3 Human Trials of Sputnik-V will commence next week. Phase 3 human trials will involve over 40,000 volunteers at more than 45 locations. RDIF has clarified that the scale of Phase 3 human trials was “previously planned” one. The phase 3 clinical trials were supposed to take place “post-registration” of Sputnik-V with the drug regulator in Russia. The Philippines government has said that phase 3 trials of the Russian vaccine will begin in the country in October.
Meanwhile, Deputy Director for scientific work at Gamaleya Institute Denis Logunov announced that Sputnik-V was granted a “conditional registration certificate” by the Russian authority. This means the Russian vaccine was obligated to undergo phase 3 clinical trials.
