The first batch of Russia’s pioneering coronavirus vaccine Sputnik V has been greenlighted for public use and has already entered civilian circulation, the Russian Ministry of Health has announced.
The 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 immunization 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 vaccine’s 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 “much more efficient and based on better assumptions,” than, for instance, the rival AstraZeneca trial. That allowed the Sputnik V trials to be carried out on a fewer number of volunteers, they said.
Earlier this week, one of the most respected medical journals, The Lancet, published Sputnik V’s Phase 1 and Phase 2 clinical trials, while noting that longer-term trials 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.