In this handout photo taken on Thursday, Aug. 6, 2020, and provided by Russian Direct Investment Fund, a new vaccine is on display at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. Russia on Tuesday, Aug. 11 became the first country to approve a coronavirus vaccine for use in tens of thousands of its citizens despite international skepticism about injections that have not completed clinical trials and were studied in only dozens of people for less than two months.
Russia has become the first country to come up with a vaccine against coronavirus. Contrary to all the timelines and predictions made by the scientists across the world, Moscow's Gamaleya Institute has created a vaccine in much lesser time than what it takes.
Sputnik News Agency spoke to Gamaleya institute Deputy Research Director, Denis Logunov, and asked him how the research institute could come up with a vaccine in such a short period of time when it normally takes at least 1.5 years to make a vaccine.
"We have conducted a full range of preclinical studies on the vaccine's safety and efficacy, which were followed by two clinical studies that examined the vaccine in terms of safety and immunogenicity involving healthy volunteers. Based on the results of these studies, the vaccine showed a good safety profile and high immunogenicity. Speaking about specific indicators and numbers achieved, the volunteers' average geometric titer of antibodies reached more than 1 in 14,000, nearly 1 in 15,000. One hundred percent of the volunteers had seroconversion," Logunov said.
"Seroconversion is when a person's antibody titer increases more than 4 times compared to the initial, background values. Humoral immunity parameters were also assessed via a virus neutralisation reaction, that is, the virus's direct inactivation by antibodies. Virus neutralising antibodies have been found in all the volunteers immunised with our vaccine, both when using the dry and the liquid forms of the vaccine. Various cellular immune response indicators were also analysed, in particular, cytotoxic lymphocytes, which is a very important antiviral immunity parameter," he further added.
Speaking on the subject of the sample size of the people on whom the vaccine was tried, Logunov said that in total, there were 76 people on whom the vaccine was tried.
"The first and second phases involved 38 people each, a total of 76. The two protocols differed in that the vaccine’s active substance was the same, but its physical state was different. One form was freeze-dried, the other was frozen. There was one active substance but two forms of the vaccine. That is why there were 76 people," he said.
He also said that the age range of the participants was 18 to 60.
On the all important question of how the vaccine was manufactured in such a short span of time, Logunov said, "It would be wrong to say that we've managed to create a vaccine from scratch in a short time. Four decades have passed since adenoviral vector technology was introduced into practice. Over these four decades, a technological platform was created that has been tested on tens of thousands of people, both on the basis of the 5th and the 26th serotype vector. Since 2015, more than 3,000 people have been vaccinated with adenoviral vector-based vaccines developed at the Gamaleya Centre. Therefore, it was not a 5-month effort in any way, but work over several decades."
Russia's coronavirus vaccine is already into production and a large campaign to vaccinate the entire country is expected to be launched in October.
