On Sunday, several media reports suggested that Russia has become the first nation to complete clinical trials of a COVID-19 vaccine on humans. While the initial results of human trials do indicate that the vaccine is safe and effective to an extent, celebrating the supposed ‘world’s first COVID-19 vaccine’ seems premature.
Progress made by Russian vaccine
On June 18, Russia allowed clinical trials of two forms of a potential COVID-19 vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology. The first vaccine, in the form of a solution for intramuscular administration, was carried out at the Burdenko Military Hospital.
Another vaccine, in the form of a powder for the preparation of a solution for intramuscular administration, was carried out at Sechenov First Moscow State Medical University. On Sunday, Chief researcher Elena Smolyarchuk, who heads the Center for Clinical Research on Medications at Sechenov University, told Russian news agency TASS that the human trials for the vaccine have been completed at the university and they will be discharged soon.
“The research has been completed, and it proved that the vaccine is safe. The volunteers will be discharged on July 15 and July 20,” Smolyarchuk was quoted as saying in the report. There was, however, no further information on what phase of the clinical trials has this vaccine completed.
Earlier, the results of the COVID-19 vaccine tests showed that volunteers were developing immunity to the coronavirus. “The data obtained by the Gamalei National Research Center for Epidemiology and Microbiology proves that volunteers of the first and second groups are forming an immune response after injections of the vaccine against the coronavirus,” according to an earlier statement from the Russian Defense Ministry.
Did the vaccine conclude clinical trial or just phase 1?
The first stage of research on the vaccine at Sechenov University involved a group of 18 volunteers, and the second group comprised 20 volunteers. After vaccination, all volunteers were expected to remain in isolation in a hospital for 28 days. Even though the Russian vaccine has cleared the first phase of clinical trials, it has a long way ahead to be recognised as a proven vaccine against COVID-19.
Developing a vaccine against viruses or bacteria involves several phases of trials on both animals and humans. Hence, on average, it takes a minimum of 10-12 months to make a vaccine available for the general public after it is developed in a lab. In some extreme cases, it may also take 10-12 years also—depending on how better we understand the pathogen.
Developing a vaccine against viruses or bacteria involves several phases of trials on both animals and humans. Hence, on average, it takes a minimum of 10-12 months to make a vaccine available for the general public after it is developed in a lab. In some extreme cases, it may also take 10-12 years also—depending on how better we understand the pathogen.Advertisement
Since the number of volunteers involved in the study by Sechenov University was less than 40, the success only means that the vaccine has cleared phase 1 of a total of three phases of clinical trials. As per the ‘Draft landscape of COVID-19 candidate vaccines’ update by the World Health Organisation (WHO), only two vaccines—one from Chinese company Sinovac and another from University of Oxford/AstraZeneca—have reached the phase 3 of the clinical trials.
Even as per the WHO report, both the Russian vaccines from Gamaleya Research Institute are still under phase 1. As per the ClinicalTrials.gov database, phase 1 for these vaccines was estimated to be complete by August 15.
At least 21 COVID-19 vaccines are currently under clinical trials, in addition to 139 other vaccine-candidates under pre-clinical evaluation, according to the WHO. During pre-clinical trials, the vaccine is tested on animals like mice, monkey to investigate its immune response. Only when it is successful in animals, the vaccine goes on to clinical trials on humans.
Phases of human trial
Human trials of any vaccine involve the following four critical stages:
- Phase I trials: In this trial, the experimental vaccine is given to a few volunteer human candidates, which helps to test safety, dosage and human immune response.
- Phase II trials: Here, a larger group of people—approximately 100-200—are enrolled for more testing. Further, the group is divided into the basis of age to understand how the vaccine works in different age groups. Here, researchers test the vaccine safety, immunogenicity, proposed doses, schedule of immunisation, and the way to inject it.
- Phase III trials: Once it successfully reaches this stage—passing all the above hurdles—the vaccine candidate is tested in about thousands of people. In this stage, scientists compare groups of actual volunteers with individuals who receive a placebo.
- Approval: In the last stage, the vaccine developer gets approval from the authorised body. The vaccine is further submitted for licensing and manufacturing. The job is now taken by a pharmaceutical company to start mass production and distribute it to the general public.
The overall number of global COVID-19 cases was nearing 1.3 crores as of Monday morning, while the deaths have increased to more than 5.68 lakh according to the data compiled by the Johns Hopkins University. The US accounted for the world’s highest number of infections and fatalities at 33,01,820 and 1,35,171, respectively. The case tally in India is approaching 9 lakh with more than 23,000 deaths.
(with inputs from IANS)
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