Daily US Times: Denis Logunov, a director at Russia’s Gamaleya Institute that developed the country’s main coronavirus vaccine candidate said on Monday that preliminary results from the late-stage vaccine trial could include data from 5,000-10,000 participants.
Moscow’s plan to publish preliminary data about the Sputnik V vaccinje as early as November is likely to make it one of the first vaccine developers to share any data from a Phase III trial, the last phage of a trail, but also puts it at odds with competitors.
The Sputnik V vaccine trial, involving 40,000 volunteers, has been underway in Russia’s capital since the beginning of September.
Last month, Gamaleya developers told Reuters that interim results, when published, will be based on the first 42 days of monitoring participants.
To meet the target, the interim results will have to be based on a limited data set – between 5,000 and 10,000 people – due to logistical challenges.
At least two dozen clinics in Moscow have been racing to administer the vaccine to volunteers, but so far, only around 16,000 people have received the first dose of the two-shot jab. There is then a 21-day wait until the second dose can be given.
It is unusual to set a target timeframe for publishing interim results.
Many vaccine developers from western countries have said the publication of interim results depends on how many volunteers report becoming infected with coronavirus, thereby allowing the placebo and vaccine groups to be compared. A date for when this threshold is met cannot be set in advance.
Russia has been pushing ahead with its potential Covid-19 vaccine at full speed, licensing the vaccine for domestic use before large-scale trials had even begun.
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