Russia has become the first country in the world to grant regulatory approval to a COVID-19 vaccine, ‘Sputnik V’.
Russian President Vladimir Putin (pictured above) announced the approval for widespread use of the vaccine yesterday, and maintained that it is safe for use despite concerns raised by health experts across the world.
The approval comes before large-scale phase 3 safety trials of the vaccine, which can take months, had been completed. By comparison, Moderna began testing its COVID-19 vaccine candidate in March and expects to complete enrolment for its phase 3 trial in September.
Both of these timescales are still unprecedented, with vaccine trials usually taking years to complete before a product achieves regulatory approval.
“Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous, both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” said Francois Balloux, professor of computational systems biology at University College London.
The vaccine’s name refers to the first artificial earth satellite launched by the Soviet Union, with Putin likening the vaccine approval to Russia’s success in the Cold War space race.
Russian business corporation Sistema has said that it expects to start manufacturing and producing doses of the vaccine at a scale of about 1.5 million doses a year, with its products initially going to Russian doctors and teachers. It added that the first batches of the vaccine are ready and will be supplied to regions in Russia soon.
“I know that it works quite effectively, forms strong immunity and, I repeat, it has passed all the needed checks,” Putin said in a government meeting on state television on Tuesday.
Putin also confirmed that one of his daughters had volunteered to receive the vaccine, adding that she had a temperature of 38C after receiving the first dose of the vaccine, which dropped to just over 37C the next day. “She’s feeling well and has a high number of antibodies,” he added.
It was developed by Moscow’s Gamaleya Institute, which has faced criticism after researchers and directors injected themselves with the prototype months ago, bypassing the usual process of initiating human trials.
Tarik Jasarevic, spokesman for the World Health Organization, said the agency is currently in talks with Russia for possible WHO prequalification of the vaccine, although the candidate will be subject to rigorous review and assessment.