On Sunday (July 12), several reports claimed that Russia’s Sechenov University has successfully completed clinical trials of the world’s first coronavirus vaccine. However, the draft landscape of COVID-19 candidate vaccines prepared by the World Health Organization (WHO) lists the Russian coronavirus vaccine study as a phase 1 trial. As of July 7, WHO data shows the only candidates to reach phase 3 trials were Oxford/AstraZeneca’s ChAdOx1-S and Sinovac’s vaccine based on inactivated COVID-19 particles.
On June 18, clinical trials of two forms of a COVID-19 vaccine developed by Gamalei National Research Center for Epidemiology and Microbiology were approved by the country. The first vaccine was tested at the Burdenko Military Hospital. The country’s Defense Ministry reported that results of the vaccine tests performed on a group of volunteers showed they’re developing immunity to the virus. The ministry added that an in-ward treatment of the first group of volunteers, who were tested for the safety and tolerability of the vaccine, will end on July 15.
Well, The Russian scientists kept their word and here they are.
They claimed on Monday that they hope to launch the world’s first coronavirus as soon as next month. On Sunday, Russia’s Sechenov University said that it had successfully completed clinical trials of a COVID-19 vaccine developed by the state-run Gamalei Institute of Epidemiology and Microbiology.
The head and chief researcher at Sechenov University Center for Clinical Research on Medications Elena Smolyarchuk told that clinical trials of the vaccine on volunteers have been completed and study data showed the candidate’s effectiveness.
“The research has been completed and it proved that the vaccine is safe,” Smolyarchuk was quoted as saying of its trial.
The Gamaliel center’s director Alexander Ginsburg told that he hopes the vaccine will ‘enter civil circulation’ on August 12-14, adding that private companies may begin mass production by September.
Meanwhile, the World Health Organization’s protocols said that a vaccine has to go through three phases of studies before being approved for large-scale production. Also, WHO’s draft landscape of coronavirus vaccines lists the Russian candidate vaccine study as a phase 1 trial. Perhaps, to date, no vaccine has been approved for large-scale use without undergoing the third phase of testing, which is the largest in terms of the number of participants. A candidate vaccine usually undergoes industrial production if the last phase shows clear and definitive evidence of its safety and efficiency.
Effects of the shots
Smolyarchuk had said earlier in July that some participants developed typical responses to injections like headaches, elevated body temperatures. However, these symptoms were resolved within 24 hours.
In a July 3 press release, the university stated that the Russian Health Ministry will take a decision on the effectiveness of the substance based on the results of biochemical tests.
The Sechenov First Moscow State Medical University will discharge the two groups of volunteers on July 15 and July 20 after spending 28 days in isolation to protect them from exposure to other infections. The trial participants, aged 18-65, will be monitored for six months after their release, added Smolyarchuk.
It may be noted that the first stage of the vaccine trial at the university was launched on June 18 in a group of 18 volunteers who were vaccinated against the virus. The second group involving 20 participants were administered the vaccine on June 23.
Russia is one of the several nations racing against time to develop a safe vaccine against COVID-19, which has so far claimed at least 569,879 lives and infected about 12,992,640 people worldwide.
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