MOSCOW, October 26. /TASS/. Production of a vaccine against the coronavirus developed by the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of the Russian Academy of Sciences may start next January if the registration certificate is obtained from Russia’s Healthcare Ministry, the Center’s Director General Aydar Ishmukhametov said in an interview with the Nauchnaya Rossiya/Scientific Russia web portal on Monday.
Clinical trials of the whole-virion inactivated vaccine against the coronavirus developed by the Center began this September. Phase One of trials was successfully completed, Phase Two was launched last week in Kirov and St. Petersburg.
"It is planned to complete Phase Two in early December of this year. In mid-December we will submit the paperwork to the Russian Healthcare Ministry and the future of the vaccine will depend on their decision. If we obtain the registration certificate from them, then we’ll be able to roll out production as early as January. We also plan to conduct Phase Three of trials with the involvement of as many as 3,000 volunteers; so we will simultaneously submit an inquiry to the Healthcare Ministry both for the registration and for Phase Three of trials," the scientist said.
According to him, to date, no adverse effects after inoculation were detected in volunteers. A couple of people had a slightly elevated body temperature during the first 24 hours which then subsided. "In general, local effects after vaccination, as a rule, disappear during one-three days," the director general added.
The scientist explained that the advantage of the whole-virion inactivated vaccine is that after a vast, almost a three-hundred-year period of studies, such vaccines have proven their safety, causing the least amount of side effects, while the technology of their production has been worked out extensively and in detail. "We work with the whole virus: we separate it, culture it, then kill it, and then use it to create a vaccine. In this situation, we think, the fullest immunity is formed," he added.
On August 11, Russia became the first country worldwide to register the vaccine against the coronavirus which was named Sputnik V. The preparation was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry and passed clinical trials in June - July.
On Wednesday, October 14, Russian President Vladimir Putin announced that the vaccine developed by the Vector Research Center obtained the registration certificate. Clinical trials were conducted on 100 volunteers. The Center will launch post-registration clinical trials in different Russian regions with the participation of 40,000 volunteers.
Also in Russia's Siberia there are clinical trials underway of the whole-virion inactivated vaccine developed by the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products which began in Novosibirsk on October 6.