Covid-19 vaccine: Volunteers of Sputnik V trial to no longer receive placebos
Russia rolled out the Sputnik V vaccine to medics and other frontline workers in Moscow this monthData published last week by the Gamaleya Institute had revealed that the Sputnik V vaccine is 91.4% effective
PremiumVolunteers of the large-scale final-stage trials for the Sputnik V will not receive placebos anymore, said the vaccine's developer Gamaleya Institute in Moscow on Wednesday.
"The Health Ministry had authorised a halt to the administration of placebos to new recruits to the stage III trial," said Alexander Ginsburg, the institute's director.
"Everything there has been proven and the pandemic is ongoing, so a placebo is not good at all," he added.
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Ginsburg said 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 data results
Data published last week by the Gamaleya Institute had revealed that the Sputnik V vaccine is 91.4% effective in protecting people against Covid-19.
The results were based on data from 22,714 participants in the trial and were published after 78 confirmed coronavirus cases were reported among the group.
In the first control point of data analyses, the vaccine demonstrated a 92% calculated efficacy rate while at the second point efficacy rate was 91.4%. The high efficacy rate of the vaccine above 90% was confirmed at each of the three control points of clinical trials.
According to the protocol of Phase III clinical trials of the Sputnik V vaccine, its interim efficacy is calculated at three statistically significant representative control points - upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine, the Gamaleya Institute said.
The emergency authorisation to the frontline workers, however, did not, as would be usual, await the results of the gold-standard stage III trial.
With inputs from agencies.
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