Russia's FMBA starts clinical trials of its Covid-19 vaccine
MOSCOW. July 19 (Interfax) - The Federal Medical-Biological Agency (FMBA) has received the Russian Health Ministry's permission to carry out the Phase 1 and Phase 2 clinical trials of its Covid-19 vaccine, launching the trials on Monday, July 19, the FMBA's press service said.
"The Federal Medical-Biological Agency has received official permission from the Health Ministry of the Russian Federation to conduct the Phase 1 and Phase 2 clinical trials of its subunit recombinant vaccine for preventing the coronavirus infection caused by the SARS-CoV-2 virus. The clinical trials began on July 19, 2021," the press service said on Monday.
The trials will involve 200 participants aged 18 to 60.
"The preclinical trials of the vaccine were successfully completed in June 2021. The results of the trials have proven its safety, immunogenicity, and protective potential," the press service said.
The new vaccine is primarily meant to induce cellular immunity, using coronavirus conservative proteins the least prone to mutations as the target, it said.
According to the Health Ministry's register of permission for clinical trials, the trials of the FMBA's vaccine will be conducted in St. Petersburg at the Smorodintsev Research Center of Influenza of the Russian Health Ministry and the Eco-Safety Research Center.
FMBA head Veronika Skvortsova said earlier that the agency would complete the preclinical trials of its Covid-19 vaccine in June and would launch its clinical trials in July.
Skvortsova said during a meeting with Russian President Vladimir Putin on March 1, 2021 that the vaccine developed by the FMBA is a vaccine of a new generation using a new technological platform.
Mass vaccination for Covid-19 began in Russia on January 18. Four vaccines are available, that is, Sputnik V and Sputnik Light (the first component of Sputnik V), both developed by the Gamaleya State Research Center of the Russian Health Ministry, EpiVacCorona, developed by the Vector Center of Russian consumer health watchdog Rospotrebnadzor, and the CoviVac vaccine, developed by the Chumakov Center of the Russian Academy of Sciences.