The Sechenov First Moscow State Medical University (Sechenov University) has evaluated the vaccine in early-stage clinical trials
Russia approves Covid-19 vaccine Sputnik V. (Credit: Bao_5 from Pixabay.)
Russia has reportedly granted regulatory approval for a vaccine candidate against Covid-19, dubbed Sputnik V, developed by the Gamaleya Research Institute in Moscow.
The Sechenov First Moscow State Medical University (Sechenov University) has evaluated the vaccine in early-stage clinical trials, from 18 June 2020. The university has initially enrolled 18 volunteers, followed by a second group of 20 healthy volunteers in the clinical trials.
Russian authorities named the vaccine Sputnik V, after a Soviet satellite launched in 1957, and claimed that their vaccine is first in the world to receive regulatory approval. The vaccine is planned to be manufactured at the Gamaleya Research Institute and Binnopharm’s production sites.
The World Health Organization (WHO), however, has not included the Russian vaccine in its list of six vaccines that are under late-stage clinical trials, as Sputnik V was evaluated only on a limited number of volunteers in the clinical trials that lasted for less than two months.
Russian Health Ministry told news agency Sputnik: “The two-stage injection plan helps form a lasting immunity. The experience with vector vaccines and two-stage scheme shows that immunity lasts for up to two years.”
Russian President Putin’s daughter was administered with the new vaccine Sputnik V
Russia’s President Putin said that the vaccine has shown immunity against the coronavirus, and his daughter who was administered with the vaccine is feeling well, apart from a slight rise in temperature.
BBC reported that the Russian regulators have approved the vaccine, developed using adapted strains of the adenovirus, which causes the common cold, without completing a late-stage trial that involves larger populations.
According to Reuters, the regulatory approval of the vaccine before the completion of late-stage trials has raised concerns among a few experts.
The Russian government authorities are planning to administer the vaccine voluntarily, initially to medical personnel, followed by teachers starting from the end of August or early September, and roll-out in mass in October.