It was found that the novel coronavirus (Corona 19) vaccine developed in Russia showed a preventive effect of 91.6%. It was analyzed that the prevention effect was evenly shown for all age groups, and it was 100% effective in preventing moderate or abnormal diseases.
In particular, unlike AstraZeneca vaccine, which received the same vaccine twice, the research team analyzed that there is no fear of deteriorating the effect of two doses in that it uses a different delivery system.
On the 2nd (local time), the research team of Dr. Denis Logunov, the National Center for Epidemiology and Microbiology of Russia, published the safety and effectiveness of Gam-COVID-Vac (Sputnik V), a Russian-developed COVID-19 vaccine in lancet, a global medical journal. The results of safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomized controlled phase 3 trial in Russia were published. This is the intermediate result of a phase 3 clinical trial conducted on 21,977 adults from September 7, last year.
According to the results of the study, the Corona 19 virus vaccine (Sputnik V) developed by Russian researchers is an adenovirus vector vaccine, which creates immunity by injecting an antigen into the body with an adenovirus as a carrier.
In the phase 3 clinical trial, 21,977 people were divided into a placebo group of 5,435 people and a vaccination group of 16427 people, each receiving a placebo drug and a vaccine twice.
As a result of analyzing 19,866 people who received both vaccinations, 16 patients (0.1%) in the 14,964 vaccination groups and 62 (1.3%) in the placebo group of 4,902 confirmed COVID-19 virus infections, 91.6 % Preventive effect.
In particular, Sputnik V was found to have a 91.8% preventive effect even over the age of 60 (2,144 people), which was not different from the preventive effect of 18-60 years old.
In addition, among the participants who were confirmed to be infected with COVID-19 during the clinical trial, 0 patients with moderate or severe COVID-19 infection were found in the vaccination group and 20 in the placebo group. Although it is a secondary endpoint of clinical trials, the researchers explained that the result shows 100% preventive effect against severe COVID-19 infection.
In addition, Sputnik V was found to have excellent stability as well as preventive effect. Flu symptoms, injection site reactions, headache, and weakness were the most common side effects, and most (94%) side effects were mild. There were a total of 70 serious side effects, but none of them were found to be related to the vaccine.
However, this clinical trial of Sputnik V was insufficient to evaluate the duration of prevention in that it was based on follow-up observations 48 days after the first vaccination. In the WHO, the criteria for emergency use of the COVID-19 vaccine are 50% or more of preventive effect, suitability in the elderly, maximum 2 doses, and minimum 6 months of prevention period.
Accordingly, the researchers explained, “Although Sputnik V is in need of additional research on the period of prevention, this vaccine is remarkable in that it has a 91.6% preventive effect and has a high effect on preventing the elderly and severe corona19 infection.
In addition, he emphasized that “Sputnik V minimized the decrease in vaccine effectiveness due to the immune response to the delivery system by using different types of delivery systems in two doses.”