In addition, the Sputnik V phase 1 and phase 2 clinical trials showed no serious side effects, while the incidence of serious side effects for COVID-19 vaccine candidates differs from 1% to 25%.
The above results were published by the Russian Federation Direct Investment Fund (RDIF) and the Russian National Institute of Microbiology and Epidemiology Gamaleya – the unit responsible for the development of Sputnik V vaccines – published in the prestigious scientific journal The Lancet on September 4.
According to the same report, the antigen levels of the volunteers injected with Sputnik V were 1.4 to 1.5 times higher than the antibody levels of the recovered COVID-19 patients.
Meanwhile, the levels in the vaccine clinical trial volunteers of British pharmaceutical company AstraZeneca and patients with COVID-19 recovered are on par, according to the Gamaleya Institute.
During an online press conference on the same day, the international press response to questions about the denominator was too few in this trial, Kirill Dmitriev, director of RDIF, said that the number of people participating in the clinical trial was received 2 doses of Russian vaccine, 4 times higher than that of AstraZeneca (UK).
Sputnik V is developed based on vector adenovirus technology studied by the Gamaleya Institute since 1953.
“During a pandemic, it is especially important to use a vaccine with proven safety, as Sputnik V did. Do not let the world lack effective protection against SARS-CoV-2 and at the same time not endanger human life with unproven experimental technologies “- Mr. Dmitriev said, expressing doubts with new technologies that Western countries are pursuing.
According to Mr. Dmitriev, there has been a change in approach to COVID-19 vaccine registration in the US, UK, and China when these countries began to accelerate the production of vaccines, allowing emergency use before the end of the 3rd test period.
Professor Alexander Gintsburg, head of the Gamaleya Institute, said the phase 3 clinical trial of the Sputnik vaccine has also been licensed.
At the end of August, 40,000 Russian volunteers received the Sputnik V vaccine in the largest mass test ever. On August 31, Russian Health Minister Mikhail Murashko said the country would vaccinate high-risk populations by the end of 2020.
“There are more than 40 countries interested in importing Sputnik V vaccines, but our current productivity is not guaranteed to meet the demand” – Mr. Dmitriev said.
Russia is discussing cooperation with India and Brazil to transfer the technology to produce this vaccine while leaving the possibility of export open until November.
“In the short term, our big priority is to ensure that there are enough vaccines for the Russian people,” said Professor Gintsburg.
There is no evidence of an increased risk of HIV
To develop the Sputnik V vaccine, Russian researchers extracted the encoding gene from the coronavirus spikes and then attached to a vector adenovirus for transfer into human cells. Vaccine users will need two shots, using two different vectors, Ad5 and Ad26. In particular, the first vector type will deceive the human body, immunostimulate and the second vector will be responsible for increasing the effectiveness of the induced immunity.
An HIV vaccine trial using Ad5 by US pharmaceutical company Merck & Co in 2004 found that people with pre-existing immunity become more susceptible to the AIDS virus, according to Reuters.
Researchers, including leading US infectious diseases expert Dr. Anthony Fauci, in a 2015 article, said this side effect may only occur with HIV vaccines. However, they warn that HIV prevalence should be monitored during and after testing all Ad5 vaccines in at-risk populations.
Before this question, Professor Gintsburg answered that at present there is not any scientific evidence that vaccines using Ad5, in particular Sputnik V, increase the risk of HIV.