The drug was named "Mir-19" because, according to the head of the FMBA Veronika Skvortsova,
"microRNA is absolutely safe for humans, it does not affect the human genome and immunity, but at the same time it is highly effective in hitting the virus (in animal experiments, viral transmission is reduced by 10 thousand times), but, in addition, it prevents the most severe forms of coronavirus infection, including prevents pneumonitis, acute respiratory distress syndromes on the background of coronavirus infection".
Veronika Skvortsova, at a meeting with Russian President Vladimir Putin on March 1, said that permission for clinical trials of the drug was received on December 30 last year and immediately after the New Year, these clinical trials were launched.
"But taking into account the fact that this is a new molecule – it is new and patented and has no analogues – we are going through the first phase especially carefully, because we need to prove safety already in humans. We will finish the first phase by mid-March. And we are already moving on to work with patients, moving on to the second phase."
The second development that the head of the FMBA stopped at was a new technological platform for creating next-generation COVID-19 vaccines.
"In the event that the variability of the virus is such that the accumulated mutation in the S-protein in the receptor domain will not allow antibodies to bind, we are developing a vaccine that differs in that it does not affect the S-protein, but other protein components of the virus and primarily causes the development of non-humoral immunity, that is, through activation of antibodies, and the development of cellular immunity, cytotoxic immunity, the advantage of which is the duration",
— Skvortsova clarified. If antibody immunity, as a rule, lasts for months, then cellular immunity lasts for years, and in certain experimental works, the preservation of this immunity up to 13-17 years has been proven.
Veronika Skvortsova added that the first formulation of this drug has already been received. Currently, preparations are underway for clinical trials, which may be released in the second half of this year (from July). The first and second phases will be combined, as it is currently allowed by the vaccine testing protocol. The Federal Medical and Biological Agency serves 3.5 million residents of our country. First of all, these are employees of more than 700 organizations with particularly dangerous working conditions and risks, in addition, their family members and the population of 20 administrative closed territories, 39 satellite cities and science cities. They are located in 54 regions of Russia and on Baikonur.
