The Russian Ministry of Health on 16 June sanctioned the trial for the candidate for the coronavirus vaccine. It would disperse the very first group of activists on July 15 and the second group on July 20.
Russia’s Sechenov University accomplished the human trial round of the world’s first novel coronavirus vaccine with great success.
Chief researcher Elena Smolyarchuk, who heads Sechenov University’s Center for Clinical Research on Medicines, informed the Russian news agency TASS on Sunday that the human trials for the vaccine were completed at the university and they will be released soon.
The director of the Institute for Translational Medicine and Biotechnology, Vadim Tarasov, also stated that the university had completed the vaccine test developed by the Gamaleya Institute, a Moscow epidemiology research center.
Here’s how the clinical trials happened:
- On June 18, the first batch of 18 healthy individuals were vaccinated.
- The vaccine was acquired by way of the 2nd group of 20 volunteers on June 23 at the Interventional Cardiovasology Practical Research Centre.
- The volunteers were males and females aged between 18 and 65 years.
- They were given a lyophilized immunization or a powder through which a solution is ready for intramuscular injection.
- Some participants reported headaches and increased body temperature, but the university indicated that these symptoms had been fully resolved within 24 hours of the administration of the vaccine.
- Volunteers were kept in single or double rooms on campus at the University of Sechenov.
- After the infusion of the vaccine, they would have to devote 28 days in isolation to protect them from exposure to other infections and would be monitored for another 6 months after discharge.
- Psychological support was offered to volunteers throughout their isolation period.
- The Covid-19 vaccine formulated by the Gamaleya Institute has also been tested at the Burdenko Military Hospital in Moscow.
- During the clinical trial, the medical facility used the liquid solution of the medication.
How was the trial of the human challenge done?
- In a human challenge trial, volunteers were purposefully subjected to the infection (in this case the SARS-CoV-2 virus) in order to observe the disease and test the vaccines.
- The exact strain of the virus that is used to infect the participant and the dose or how much of the virus, volunteers need to be subjected to needs to be assessed and authorized by the regulatory authorities.
This method was not new and was used to develop seasonal influenza, typhoid, malaria, and cholera vaccines, among others.
Global impact of the COVID-19
More than 1.2 crore confirmed cases of COVID-19 have emerged, globally. So far, more than 5.6 lakh people have died.
Gilead Sciences, researchers at Oxford University, and the American biotech company Moderna were also considered to be at the forefront of the development of a novel coronavirus vaccine.
The general phase of the vaccine development cycle is as follows:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
Initial safety tests are usually performed in animals to give an idea of human would respond. They are also used to see how effective the vaccine is in preventing the disease and to enable researchers to adapt the vaccine.
While on an epidemic, researchers and practitioners often work together to accelerate this process.
Clinical trials – testing in humans
This is where many highly promising vaccines fail. There are 3 phases throughout the clinical trial:
- Evaluating a few dozen healthy subjects, desperately searching at how safe the vaccine is, and whether it has any negative effects;
- Testing for effectiveness on several hundred people (the target population- ideally those who are very much at risk of disease); the extended phase two trials give an indication of the efficiency of the vaccine. This is often measured by analyzing human blood to see if antibodies or other outbreak immunities are present that can neutralize the target disease. Testing on several thousand people for efficacy and safety.
- In these phases, the vaccine needs to be proven to be safe, to establish a solid immune system response as well as provide reliable treatment against the virus. Observational vaccines could be used in seriously impacted population groups in an outbreak when they’re at high risk of disease prior to regulatory approval.
Several vaccines undertake formal phase IV, extensive research after the vaccine has been approved and licensed.
But the true challenge scientists say, comes when these preventive medicines are approved and given widely.
Charlie Weller, director of the Wellcome vaccines program, a London-based biomedical re/search funder, says a clinical trial is performed in a very structured environment.
Those who engage in vaccine trials would be more cautious about their behavior and take fewer chances that might expose them to a virus because doctors are monitoring them. During a clinical trial, a person knows when he/she is in a clinical trial and that can alter their behavior. The true measure for a vaccine, therefore, is when it’s rolled out into a population.
Even if some vaccines have progressed through these trials, they are obviously more successful than others. (The explanations for this are often not clear. It could have to do with the intrinsic factors of the targeted virus — its ability to mutate and how it propagates in the body — and how our immune system deals with it naturally.)
Flu virus strains vary from year to year, and this is part of the reason that receiving the annual vaccine will reduce the risk of virus infection by only about 40 to 60 per cent.
However, there was no further information as to when this vaccine would enter the commercial production stage.