7 Sep, 2020
The first batch of Russia’s pioneering coronavirus formula Sputnik V has been approved for public use and has already been placed into circulation, the Ministry of Health in Moscow has announced.
The world’s first Covid-19 vaccine, developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, “has undergone necessary quality tests” and “has entered civilian circulation,” the ministry said in a short statement on Tuesday.
More batches are on their way to be distributed across Russian regions, it added.
The announcement marks another milestone in the development of Gam-COVID-Vac, better known by its trade name Sputnik V. The formula was registered on August 11 after successfully completing its Phase 1 and Phase 2 clinical trials, making Russia the first country to officially unveil its own coronavirus vaccine.
The developers have faced allegations of “rushing” Sputnik V to the market and cutting corners in the process, with skeptics pointing to the small number of trial subjects. Russian researchers have denied those charges, arguing that the trial for the vaccine, which is currently undergoing post-registration studies, was designed to be “much more efficient and based on better assumptions,” than, for instance, the rival AstraZeneca trial.
That allowed the Sputnik V experiments to be carried out on a fewer number of volunteers, they said.
Earlier this week, one of the world’s most respected medical journals, The Lancet, published Sputnik V’s Phase 1 and Phase 2 clinical trials, while noting that longer-term tests are still necessary to attest its quality.
Meanwhile, Moscow Mayor Sergey Sobyanin has revealed that Sputnik V’s post-registration trials in Moscow could last from two to six months. The mass vaccination program in the city, which has borne the brunt of Russia’s Covid-19 outbreak, is expected to start in late 2020 or early 2021.