During July, the Russian government reported that a coronavirus vaccine will be launched in August without undergoing the essential Phase III trials and will be tested in specific groups of people before making it available for the general public in the country.
The decision on the locally developed vaccine for SARS-CoV-2 received criticism from health experts from around the world, primarily due to launching without phase III, which is often considered the most important part of a clinical trial.
Prior to the coronavirus pandemic, the usual time span for creating an effective vaccine for a specific disease that is also safe is typically two to three years. The third stage of the trial is the largest and longest in comparison with the first two phases.
It is in Phase III where a vaccine’s safety and effectiveness is ensured. Sometimes, formulas that have passed successfully in the first two stages of a trial are not launched because of side effects noted in phase III.
This explains why Russia’s decision to launch a coronavirus vaccine without conducting a phase III sparked controversy and outrage around the world.
Some have even argued that the decision is a result of the politicization of the process of developing a coronavirus vaccine. Instead of ensuring safety, countries are seeing the process as a ‘race to win’.
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However, regardless of all the criticism on the Russian coronavirus vaccine, the latest results that have been reported and published in the journal the Lancet show positive effects of the vaccine on participants.
According to the report, the seventy-six participants of the study, all of whom were between the ages of eighteen to sixty and were healthy overall had antibody responses in a total of twenty-one days after receiving the vaccine.
In addition, no life-threatening or serious negative effects were seen or diagnosed in any of the participants even after more than forty days.
The leading investigator of the clinical trials and research, Dr. Denis Logunov of the Gamaleya National Research Centre for Epidemiology and Microbiology, explains that the effectiveness of the vaccine is due to adenovirus.
Adenoviruses are responsible for causing common colds and are usually harmless. After genetic tweaking, the spike protein present in the novel coronavirus is added to the adenoviruses.
Consequently, when a person receives a recombinant adenovirus vaccine, his or her immune system can easily recognize the protein genetic code, which can later be useful in identifying and killing coronavirus.
Read the results of Phase I and Phase II trials for vaccine here.
Although the Russian coronavirus vaccine continues to receive criticism on the grounds of the lack of a phase III trial and lack of guarantee of safety, the results are encouraging and positive.
The majority of the scientists hope that there are no side effects reported in the future as well even though the published findings are deemed as ‘insufficient’ by many, especially for long-term and rarer adverse effects of the vaccine that may appear months later.