…Questions still linger over Moscow university’s progress
According to a WHO document, as well as a registry set up by the US National Library of Medicine, the COVID-19 vaccine candidate tested by Russian researchers had only entered Phase I trials as of June 18.
On Sunday, July 12, cyberspace was inundated with reports that Russian researchers had successfully completed trials of the ‘world’s first coronavirus vaccine’.
The Russian news agency, TASS had reported that “clinical trials” of a vaccine conducted by scientists at Sechenov First Moscow State Medical University had concluded, with the drug tested on two groups of volunteers, the first of which was set to be discharged on July 15, and the second on July 20.
Vadim Tarasov, director of the Institute for Translational Medicine and Biotechnology was also quoted by Russian news agency, Sputnik, confirming the same. The Sputnik report noted that the vaccine had been developed by Gamelaya Institute of Epidemiology and Microbiology, with Alexander Lukashev the director of the Institute of Medical Parasitology, Tropical and Vector-Borne Diseases at the Moscow-based university stating, “it corresponds to the safety of those vaccines that are currently on the market.”
If, indeed, the Moscow varsity had made such a breakthrough, to say it would come as a sigh of relief for the rest of the world would be a mammoth understatement. The entire planet has been in the vice-grip of a pandemic for over six months, with Russia itself, the fourth-worst affected nation. However, on closer inspection, it appears that news of a commercially viable vaccine being developed by the Russian university’s researchers may be misplaced.
Just a Phase I trial?
According to ClinicalTrials.gov, a registry recording all of the ongoing clinical studies, set up by the US National Library of Medicine, the Sechenov University study first began on June 18, and is listed as an “open two-stage non-randomised Phase 1 study with the participation of healthy volunteers.”
The study was designed to test the efficacy of COVID-19 potential vaccine known as “Gam-COVID-Vac Lyo,” and, purportedly, included 9 volunteers in its first group, and an additional 9 in its second group during the first phase of trials. In the second phase, “20 volunteers and three understudies” were to be included. The registry also notes that the estimated completion date for the study is August 15, 2020.
Moreover, as per a World Health Organisation document labelled “Draft Landscape for COVID-19 candidate vaccines,’ the two vaccine trials being conducted by the Gamelaya Institute of Epidemiology are listed as Phase 1 trials.
A vaccine candidate has to undergo three different phases before it can be granted approval by a health regulatory authority such as the US’ Food and Drug Administration. A Phase I trial, typically, involves a smaller subset of volunteers that could range anywhere between 15 and 80 people. Following the success of Phase I trials, researchers can then enter into Phase II where the drug is tested on hundreds of participants. Phase III inolves testing the drug on thousands of people, and could last several years.
In light of this, it does appear that the two vaccine trials being sponsored by the Gamelaya Institute of Epidemiology and Microbiology have only concluded Phase I, which is to say that there is, quite likely, a long way to go before the vaccine candidate is authorised for distribution. According to the same WHO document, the only vaccine candidates to have reached Phase III trials were the University of Oxford/Astra Zeneca’s and China’s Sinovac’s.
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