Russian COVID-19 vaccine completes Phase 1 of human trials. Report false success as’world’s first vaccine’

On Sunday, several media reports suggested that Russia had become the first country to complete clinical trials of the COVID-19 vaccine in humans. Initial results from human studies show that the vaccine is somewhat safe and effective, but it seems premature to celebrate the envisioned “world’s first COVID-19 vaccine.”

Russian vaccine progress

On June 18, Russia granted clinical trials for two possible forms of the COVID-19 vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology. The first vaccine was administered at the Bulldenco Military Hospital in the form of a solution for intramuscular administration.

“The study was completed and the vaccine proved to be safe. Volunteers will be discharged on July 15th and July 20th,” Smolyarchuk said in a report. However, there was no further information about at which phase of the clinical trial the vaccine was completed.

Also read: What You Need to Know About the COVID-19 Vaccine: The Science Behind Vaccine Preparation, Phase Trails, and More

Previously, the results of the COVID-19 vaccine test showed that volunteers were developing immunity to coronavirus. According to a previous statement by the Russian Ministry of Defense, “Data obtained by the Gamaray National Center for Epidemiology and Microbiology Research show that Group 1 and Group 2 volunteers form an immune response after injection of a vaccine against coronavirus. It proves that.”

Has the vaccine completed clinical trials or is it only Phase 1?

The first stage of the vaccine study at Cechenov University involved a group of 18 volunteers, the second included 20 volunteers. After vaccination, all volunteers were expected to remain isolated in the hospital for 28 days. The Russian vaccine has cleared the first phase of clinical trials, but there is a long way to go before being recognized as a proven vaccine against COVID-19.

The development of a vaccine against a virus or bacterium involves several stages of testing in both animals and humans. Therefore, it takes, on average, at least 10-12 months for the vaccines developed in the laboratory to be available to the general public. In extreme cases, it can take 10 to 12 years, depending on your understanding of the pathogen.

The number of volunteers who participated in the study by the University of Szechenov was less than 40, so success only means that the vaccine has cleared Phase 1 of a total of 3 phases of clinical trials. Only two vaccines from the Chinese company Sinovac and one from Oxford/AstraZeneca have reached Phase 3 of clinical trials following the World Health Organization (WHO) update of the COVID-19 Candidate Vaccine Draft Landscape. did.

Both Gamaleya Research Institute’s Russian vaccines are Phase 1 according to WHO reports. According to the ClinicalTrials.gov database, Phase 1 of these vaccines was estimated to be completed by August 15.

According to the WHO, at least 21 COVID-19 vaccines are currently in clinical trials and 139 other vaccine candidates are in preclinical evaluation. During preclinical trials, the vaccine will be tested in mice, monkeys and other animals to investigate its immune response. Only if it succeeds in animals will the vaccine proceed to human clinical trials.

Human trial stage

Human testing for vaccines has four important stages:

• Phase I study: In this study, several volunteers will be given an vaccine to help test safety, dose, and human immune response.
• Phase II Trial: Here, more people (about 100-200 people) are enrolled in more tests. In addition, the groups are categorized by age, and they understand how vaccines work in different age groups. Here, researchers will test vaccine safety, immunogenicity, suggested doses, vaccination schedules, and ways to inject it.
• Phase III Trials: If all of the above hurdles are met and this stage is successful, then vaccine candidates will be tested by approximately several thousand people. At this stage, scientists compare a group of real volunteers with an individual who received a placebo.
• Approval: At the final stage, vaccine developers are approved by a certification body. The vaccine will be submitted for further approval and manufacturing. Currently, the pharmaceutical company is in charge of that task, starting mass production and distributing it to the public.

According to data compiled by Johns Hopkins University, as of Monday morning, the total number of COVID-19 cases worldwide was approaching Rp130 ​​million and the number of deaths exceeded Rs 56,800. The United States has the highest number of infections and deaths in the world at 33,01,820 and 1,35,171, respectively. The Indian case count approaches Rs. 90,000 with more than 23,000 deaths.

(There is input from IANS)

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