Moscow’s Gamaleya Institute, the developer of the first Russian vaccine against COVID-19, said on Wednesday that volunteers in its large-scale final-stage trials for the Sputnik V shot will no longer receive placebos, RIA news agency reported.
Alexander Ginsburg, the institute’s director, said the Health Ministry had authorised a halt to the administration of placebos to new recruits to the stage III trial.
“Everything there has been proven and the pandemic is ongoing, so a placebo is not good at all,” RIA quoted Ginsburg as saying.
He added that he would like to identify those who had already received a placebo and offer them the vaccination, “but it’s still unclear whether the regulator will allow this”.
Russia rolled out the Sputnik V vaccine to medics and other frontline workers in Moscow this month, and more than 200,000 people have already been vaccinated.
Interim trial data published last week found Sputnik V, which Russian regulators approved in August after less than two months of human testing, to be 91.4 per cent effective. The emergency authorisation did not, as would be usual, await the results of the gold-standard stage III trial.
In stage III, a large number of volunteers randomly receive either the vaccine or a control injection of placebo, without knowing which they have been given, and their infection rates are compared after a sufficient number have become infected in the natural environment.