Chennai: While stating that Russia’s Sechenov University had completed clinical trials of a vaccine for the novel coronavirus, many media reports have claimed the same as the first vaccine in the world to complete human trials.
Russian news agency TASS said ‘clinical trials’ of a Covid-19 vaccine being tested by Sechenov University had been completed: The first stage of research on the vaccine started on 18 June when a group of 18 volunteers were vaccinated, and the second stage on 23 June with a group of 20 volunteers being vaccinated.
A 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 woul 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 trials.
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. Vaccines typically take 10-15 years to reach 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 ClinicalTrials.gov—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.