First Covid-19 Vaccine
Just a day after the news broke about the first stage of clinical trials of the purportedly world’s first coronavirus vaccine successfully being completed in Russia, another report came in about its production, which can be expected during this year’s fall at the earliest.
The report was learnt by Sputnik which cited Mikhail Schelkanov, the head of the microbe ecology lab at the School of Biomedicine of Russia’s Far Eastern Federal University saying so as well as emphasising on the fact that forecasting a definite time frame is still premature.
Earlier on Sunday, Russia’s Sechenov University announced that it had successfully completed clinical trials of a coronavirus 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, adding that the first group of volunteers would be discharged on 15 July and the second on 20 July.
“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.
Meanwhile, Director of the Gamaleya Scientific Research Institute, Alexander Gintsburg, said that the second phase of tests of Russia’s vaccine against Covid-19 will last until 28 July, and after that the institute will submit documents for registration.
Moreover, the Russian Defence Ministry stressed that tests of the vaccine against coronavirus are being conducted in full compliance with methodological regulations, with no attempts to reduce the duration of the research.
“The Russian Defence Ministry tests the vaccine on volunteers in full compliance with the acting legislation and scientific methodological regulations, in order to prevent further risks, without any attempt to reduce the duration of the research”, the ministry said in a statement, as reported by Sputnik.
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 then includes 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 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.
With inputs from agencies