Scientist behind Sputnik V vaccine defends Russian strategy

Russia plans to share preliminary results of its COVID-19 vaccine trial based on the first six weeks of monitoring participants, raising the tempo in an already frenzied global race to end the pandemic. Alexander Gintsburg, head of the Gamaleya Institute that produced the Sputnik V vaccine, told Reuters that the pace of its development was necessary under the “wartime” conditions of a pandemic but no corners were being cut. Russia has pushed ahead with its potential COVID-19 vaccine at top speed, with mass public vaccinations alongside the main human trial, raising concerns among some observers that it was prioritising national prestige over solid science and safety. “People are dying just like during a war,” said Gintsburg, holding a crystal model of a coronavirus in his hand. “But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way.” Sitting in his wood-panelled office at the institute in Moscow, Gintsburg said his team had been set a tight deadline to produce a vaccine but that all guidelines for testing Sputnik V’s safety and efficacy had been followed. The plan to publish interim results based on the first 42 days of monitoring volunteers means Russia has a high chance of becoming the first worldwide to announce any data from a final-stage, or phase-three, trial. The first of 5,000 volunteers was vaccinated on September 9, which means interim results could be issued some time after October 21. Russia’s sovereign wealth fund, which has invested in the vaccine’s roll-out, has said it expects interim results to be published in October or November. Public interest Several Western developers are conducting final-stage trials that have already been going on for more than 42 days but have not published any interim results. Drugmakers have said they would wait until they have enough infections to get a reliable read-out from the data before publication, rather than assigning a specific date. Gintsburg said there was a public interest argument for sharing interim results after 42 days as they would show the general trend in the data. “For me, for example, it is too short. But for people who are interested in how things are going, it is already too long.” Gintsburg said volunteers would be monitored for 180 days after the last of 40,000 participants was vaccinated. Six months on, his team plans to tally final results and publish them in an international journal. Their early-stage trial results were peer-reviewed and published in The Lancet. In parallel with the trial, Russia began inoculating members of the general public considered at high risk on September 8, another unconventional move by Moscow in the race for a vaccine. About 400 people have been inoculated so far, according to the health ministry. They undergo a less rigorous medical exam than trial volunteers, though they can submit data about their health following inoculation via an online platform. A government source told Reuters the interim phase-three trial results would likely inform a decision on whether to expand this mass inoculation drive, starting with people over 60. style="width: 100%; height: 100%; position: absolute; top: 0; bottom: 0; right: 0; left: 0;">