Russia’s Sputnik V, COVID-19 vaccine to be tested on 40,000 volunteers amid safety concerns.
The vaccine, called “Sputnik V” has been hailed by Russian authorities as safe and effective after it received domestic regulatory approval earlier this month.
Sputnik V the first to be registered worldwide will soon be tested on 40,000 people in order to test its reliability.
However, health experts and public officials expressed concerns over the proposed vaccine, citing the speed of its approval and lack of available data. The results of two months of small-scale human trials in Russia have not yet been made available to the public.
“The so-called conditioned registration certificate means that we are obliged to conduct an additional expanded clinical trial,” Denis Logunov, Deputy Director for scientific work of Gamaleya Research Institute of Epidemiology and Microbiology, said in an online briefing on Thursday, according to a translation.
“And currently we have agreed on a huge protocol for 40,000 participants. The purpose of this protocol is not that much to study the immunogenicity and safety of the vaccine, that goes without saying … But, additionally, we will have to assess the epidemic efficacy of this vaccine,” Logunov said.
Russia’s vaccine is being developed at the Gamaleya Research Institute in Moscow.