Last Sunday, Russia`s Sechenov University announced that it had successfully completed clinical trials of a COVID-19 vaccine, developed by Russia’s Defense Ministry’s Gamalei Institute of Epidemiology and Microbiology.
Alexander Lukashev, the director of Sechenov`s Institute of Medical Parasitology, Tropical and Vector-Borne Diseases, told Sputnik that the trials had established the vaccine’s safety on human health.
“This was only the first stage of trials — to test [the vaccine’s] safety on human health.
One has to understand that it is far from being the end of trials, those will continue.
But it was encouraging and made it clear that Russia has the necessary technological potential,” Schelkanov said.
According to the virologist, a biological preparation has to go a long way with several phases of trials before it can begin industrially produced as a ready vaccine in quantities enough to cater for an entire population.
“The soonest we will launch the industrial production is in the fall, only if all phases of trials go perfectly well.
But making forecasts is inappropriate. In biotechnology, it is a rare phenomenon for everything to go perfectly,” Schelkanov said.
The industrial production of a coronavirus vaccine in Russia can be expected in the fall at the earliest, albeit forecasting a definite time frame is still premature Says Mikhail Schelkanov, the head of the microbe ecology lab at the School of Biomedicine of Russia’s Far Eastern Federal University.
This is due to fact that according to the World Health Organization’s protocols, a vaccine has to go through three phases of studies to be approved for large scale production.
Phase 1
Normally involves small-scale studies to determine a candidate vaccine`s clinical tolerance and safety.
Phase 2
A larger number of subjects, with a focus on determining the optimal dose, intervals between doses, and the minimum necessary number of doses of a candidate vaccine in a target population.
Phase 3
Trials are the largest in terms of the number of subjects. A candidate vaccine is ready to move into industrial production if the last phase provides clear and definitive evidence of its safety and efficacy.
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