Russia’s health ministry has given regulatory approval for the world’s first COVID-19 vaccine, developed by Moscow’s Gamaleya Institute, after less than two months of human testing
President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine. a move hailed by Moscow as evidence of its scientific prowess.
Kirill Dmitriev, head of Russia’s sovereign wealth fund, hailed the development as a historic “Sputnik moment”
The move paves the way for mass inoculation even as the final stages of clinical trials to test safety and efficacy continue.
The speed at which Russia is moving to roll out its vaccine highlights its determination to win the global race for an effective product but has stirred concerns that it may be putting national prestige before science and safety.
Russia says a billion doses of new coronavirus vaccine have been ordered by twenty countries
The vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.
Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks,- Reuters reported.
The vaccine will be marketed under the name ‘Sputnik V’ on foreign markets,
However, The vaccine’s approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.
Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.
Duncan Matthews, a professor of intellectual property law at Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “but safety must be the priority”