Russia's COVID-19 vaccine successfully completes first phase of human clinical trials
The vaccine is being developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian Defence Ministry.
Six months since the first coronavirus case was reported, we are seeing a Russian contender come out with some positive results. Till now only a Chinese vaccine by CanSino Biological Inc has been approved for use on the military for a period of one year.
Yesterday, the Russian embassy in India tweeted out an update on the vaccine they have been working on. The Sechenov First Moscow State Medical University conducted human trials on a group of a total of 38 volunteers in two batches. It seems that the vaccine has proved to be effective and the volunteers are safe. They will soon be discharged from the facilities in two batches – Wednesday, 15 July and five days after that on Monday, 20 July.
— Russia in India (@RusEmbIndia) July 12, 2020
"Sechenov University has successfully completed tests on volunteers of the world's first vaccine against Coronavirus," Vadim Tarasov, director of the Institute for Translational Medicine and Biotechnology, told Sputnik.
In a report by TASS, Russia's official news agency, the chief researcher Elena Smolyarchuk said, "The results of research proved the medication’s effectiveness."
What do we know about the Russian vaccine?
The vaccine is being developed and produced by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian defence ministry. The trials are being conducted in the Sechenov University.
A clinical trial for a vaccine has multiple phases. According to the Centres for Disease Control and Prevention (CDC), there are three phases in the development of a vaccine. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
In the Russian vaccine trials, the first stage of research on the vaccine began on 18 June when a group of 18 volunteers were vaccinated. The second stage had 20 volunteers and they were vaccinated on 23 June.
According to a report by The Week, the vaccine is still in the first stage which has been split into two halves.
The study has been listed in ClinicalTrials.gov, which is a US registry of all the ongoing clinical studies. It states that it is a two-stage Phase I trial of the drug Gam-COVID-Vac Lyo.
The registry lists the trial as "an open two-stage non-randomised 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."
According to the World Health Organisation's 'Draft landscape of COVID-19 candidate vaccines,' there are two trials listed by the Gamaleya Research Institute as being Phase-I trials.
The trials are split into two half as the two groups are being given different doses of the vaccine.
According to a report by TASS, the Russian defence ministry said 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 15 July."
"On Monday, 13 July, the second group of volunteers, who are tested for the efficiency and immunogenicity of the vaccine, will be injected with the second component of the vaccine against the coronavirus," the ministry stated. "The booster scheme of the vaccination, which is intended for the second group of volunteers, will enable to strengthen the immune system and will also prolong its endurance."
The main objective of the first stage of the study "was to show the vaccine's safety on humans, which was successfully done," said Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University to Sputnik.
The Russian Defence Ministry said the volunteers that were given the vaccine were feeling well and "had no complaints, experienced no side effects and were developing immunity to the coronavirus"
TASS reported that "Both the first and second groups were forming an immune response after injections of the vaccine."
The vaccine is supposed to protect people and give them immunity against the virus for at least two years said Alexander Gintsburg, the director of the national research centre.
"The vaccine is given twice with the same gene injected using different carriers, which allows to not just get protective immunity, but to acquire it for a longer period of time," said Gintsburg. The person who gets the booster form of the vaccine is guaranteed to get protection against the virus for two years or more.
If all goes well with the vaccine in the next phases and it is approved for use, Gintsburg said that "about 50-60 million doses of the vaccine, or maybe even 70 million, will need to be produced in order to carry out mass coronavirus vaccination in Russia."
After they are discharged, the volunteers will remain under medical supervision on an out-patient basis, Smolyarchuk told TASS.
After the USA, Brazil, and India, Russia is the fourth country with 733,699 number of infected cases and 11,439 deaths.
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The vaccine has been approved ahead of a large scale advanced study that was scheduled to start in November or December. The results of the early-stage human trials of the vaccine have not yet been published