Presently, 150 coronavirus vaccine candidates are under development worldwide, with nearly half of them still either being tested on animals or in early stages of development.
Coronavirus vaccine: Russia’s vaccine far from being completed! On Sunday, several reports stated that the clinical trials of a vaccine candidate had been successfully completed. However, according to a report in IE, only Phase I of the clinical trials for the vaccine have been completed, with Phase II having begun on Monday and there being no clarity regarding Phase III. Russia currently only has one vaccine candidate which has reached the stage of human clinical trial, the report added.
About Russia’s vaccine candidate
The vaccine candidate is under development jointly by the Gamalei National Research Centre for Epidemiology and Microbiology and the Russian Defence Ministry, the report states. The vaccine had gone into the first phase of human trials on June 18. During the trials, 18 volunteers from the armed forces had been administered the vaccine. The IE report quoted a Russian news agency as saying that the first phase of the trials would conclude on July 15, while the second phase was scheduled to commence on July 13. The agency was further quoted as saying that the first group of volunteers had participated in the testing of safety and tolerability of the vaccine, and on July 15, an inward treatment of the group would conclude.
Coronavirus vaccine trials: Phase I explained
In vaccine trials, the first phase tests the safety as well as the tolerability of the vaccine and it is conducted on a small group of volunteers. As per the report, the Russian Defence Ministry has said that no volunteers showed any side-effects, nor did any of them report any complaints. It added that soon, they would also be discharged from the hospital.
The IE report quoted the Russian news agency as saying that the second phase, which began on July 13, would test the vaccine for its efficiency and immunogenicity, and would include the volunteers being injected with the second component of the vaccine. This phase also includes testing on civilian volunteers.
Vaccine testing: Purpose of Phase II
According to the IE report, the second phase includes the testing of efficiency and immunogenicity, or the generation of immune response. This is the stage researchers try to determine whether the vaccine is causing the desired immune response, along with figuring out the suitable dose for such a response.
Phase III of vaccine trials explained
Till now, there has been no vaccine for large-scale use that has been approved without undergoing a third phase of trials, the IE report stated. In the third phase of the trials, a large number of volunteers, usually several thousands, participate. In this phase, researchers try to determine whether the vaccine is able to generate the immune response that can fight with the virus in real-life situations. The phase usually lasts for several months.
Just like any other vaccine, the success of the second phase of the Russian vaccine candidate is not guaranteed, even as the phase will last for at least a couple of months.
Road after Phase II trials
The IE report stated that as of now it is unclear whether a Phase II of the trials would be conducted if the vaccine candidate successfully completes the second phase. Usually, a third phase is conducted, but considering the severity of the current situation, China recently saw a vaccine receive approval after the successful completion of Phase II itself. However, the vaccine can only be administered to army personnel as of now. The Russian regulatory authorities would decide on the requirement of a third phase of the vaccine, the report said.
Presently, 150 coronavirus vaccine candidates are under development worldwide, with nearly half of them still either being tested on animals or in early stages of development. Among others, 15 candidates are in the first phase of clinical trials, 10 are in Phase II, and three candidates are in the third phase of the clinical trials, the report added.