July 13, 2020: After over 6 months of novel coronavirus, which has infected 12,681,472 people with rocketing death toll climbed up at 500,000 globally, the clinical trial (human trial) of the first vaccine to cure COVID-19 have been successfully completed.
As the world crawls under the spiking COVID-19 cases, Russia’s Sechenov University has successfully completed the first Human Trial of COVID-19 Vaccine in the world, confirmed Russian media reports.
Vadim Tarasov, the director of the Institute of Translational Medicine and Biotechnology said that the first group of volunteers would be discharged on 15 July and second will be free on 20 July, according to Russian news agency Sputnik.
A much-cited report published in Sputnik News stated that clinical trials of the “world’s first coronavirus vaccine” had been completed. The report said the vaccine was produced by the Gamalei Institute of Epidemiology and Microbiology and that its safety had been confirmed. “It corresponds to the safety of those vaccines that are currently on the market,” Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, was quoted as saying.
While many news reports claimed this would be the first vaccine to complete human trials, the time-frame and objective of the research suggest that it has only cleared—or is still ongoing—phase 1 of the vaccination trial.
In vaccine trials, the first phase usually involves a small group of people with the goal of testing the vaccine’s safety for humans. Subsequent phases expand testing exponentially and can run into years before determining a vaccine is safe for mass production. The vaccines typically take 10-15 years to reach the market as a result.
For Phase I, the US Department of Health and Human Services says this phase “tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.”
The Sechenov study is listed in the official website—a registry of ongoing clinical studies run by the US National Library of Medicine—as a two-stage Phase I trial of the drug Gam-COVID-Vac Lyo”.
Specifically, the registry lists the trial as “an open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug “Gam-COVID-Vac Lyo”, lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers.
“Sechenov University in an epidemic situation served more than just an educational institution, it acted as a scientific and technological research center that has the potential to participate in the development of such essential & complex products as drugs… We worked with this COVID-19 vaccine, raising through preclinical studies and protocol development, and expert’s approval is underway,” confirmed Tarasov.
As of 12 July, the global COVID-19 cases went beyond 12.5 million, which the death toll marked at 564,420, according to a report of Johns Hopkins University, USA. However, some Indian medical research centers such as Glenmark, Zydus Cadila and Serum Institute are currently working on the COVID-19 vaccine and in the race.
