As the world races to contain the spread of the contagious Coronavirus, the scientists across the globe are searching for a cure or a vaccine.
In light of this, social media is abuzz with the news that Sechenov University in Russia has completed clinical trials of their COVID-19 vaccine. It is also being suggested that this is the first vaccine to complete human trials.
The Russian Embassy in India on Twitter made similar claims.
The Logical Indian had also misreported on the issue.
Wire agency IANS and ANI reported that Sechenov University in Russia has completed clinical trials of the COVID-19 vaccine.
The Logical Indian received several requests on the Fact check number to verify the claims.
Sechenov University in Russia has completed clinical trials of the COVID-19 vaccine.
The claim is false.
According to the World Health Organisation, Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. Further, Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start.
There are 4 phases of biomedical clinical trials:
Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
Phase III studies are conducted on larger populations and in different regions and countries and are often the step right before a new treatment is approved.
Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
According to a report by Firstpost, 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 of this vaccine are being conducted in the Sechenov University.
Reportedly, the vaccine is still in the first stage which has been split into two halves. ClinicalTrials.gov, a registry of ongoing clinical studies run by the US National Library of Medicine lists the Sechenov study as a two-stage Phase I trial of the drug Gam-COVID-Vac Lyo.
Below is a screenshot:
According to the registry, the trial is "An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers"
It is noteworthy to mention that the estimated date of completion of the study is August 15, 2020.
Below is a screenshot from the registry:
Further, a document issued by WHO on 'Draft landscape of COVID-19 candidate vaccines' shows two ongoing trials by the Gamaleya Research Institute as being Phase-I trials.
The website of Sechenov University says that the university 'recruited 38 healthy volunteers for the trial. The first group (18 people) was vaccinated on 18 June, and the second (20 people) — on 23 June'.
The volunteers all received the substance developed by Gamaleya Institute.
According to Yelena Smolyarchuk, Head of the Sechenov University Centre for Expert Evaluation of Medicinal Products, the tested vaccine has been proved safe for the patients, which is the key result of this clinical study.
The first group of volunteers was discharged from hospital on 15 July, and the second group of volunteers will be discharged from hospital on 20 July.
However, participants are to remain under observation for half a year, to monitor whether they should develop any health issues due to the vaccination in the long run.
After the vaccine has been proved safe, its developer, Gamaleya Institute, should make a decision on how to proceed with the next stages of the clinical trial.
Currently, Russia is developing 17 vaccines against COVID-19, of which 3 or 4 are expected to enter the production stage. Russia's Minister of Health Mikhail Murashko says the vaccination should be voluntary.
Thus we can say that the vaccine is still in the first phase of the first stage of the trial.
Alt News has fact-checked this information earlier.
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