Russia plans to share preliminary results from the first six weeks of monitoring of its volunteer trials for COVID-19 vaccine Sputnik V.
Justifying pace of development, Gamaleya Institute Head Alexander Gintsburg, said the “wartime” conditions warranted it, adding that no corners are being cut. The Gamaleya Institute produces Sputnik V.
There has been global concern after Russia pushed ahead with mass vaccinations alongside human trials of Sputnik V. Some critics accused the country of prioritising “national prestige over solid science and safety,”
But Gintsburg defended the move, saying “People are dying just like during a war. But this fast-tracked pace is not synonymous, as some media have suggested, with corners being cut. No way.”
He also called early public use of the vaccine “the most ethical approach,” adding that the choice was between “giving people an opportunity to protect themselves, or letting them play roulette with this deadly infection.”
On side-effects, Gintsburg said no serious ones have been reported so far during Phase III, and 14-15 percent volunteers have had “anticipated side-effects”, while 25 percent received placebo.
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Acknowledging the tight deadline, Gintsburg emphasised that all guidelines for testing safety and efficacy had been followed. He added that they plan to publish interim results from the first 42 days of monitoring – as there is an argument for public interest for it. “For me, for example, it is too short. But for people who are interested in how things are going, it is already too long.”
If done, Russia would be the first to announce data from final-stage or Phase III vaccine trial.
The results are expected sometime after October 21 as the first 5,000 volunteers were vaccinated on September 9, and Russia’s sovereign wealth fund (investor) said it could come in October or November.
Further speaking about the trial observation period, Gintsburg said volunteers are to be monitored for 180 days after the last of 40,000 participants was vaccinated. The final result from this will also be published in an international journal in six months, he said.
Notably, Russia’s early-stage trial results for Sputnik V were peer-reviewed and published in The Lancet.
