COVID-19 vaccine: Russia all set to approve second vaccine next week

“The Healthcare Ministry of the Russian Federation <…> began the procedure of registration of the EpiVacCorona vaccine. <…> The completion of the registration procedure of the EpiVacCorona vaccine is planned by October 15, 2020,” the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing earlier reported.

The Vector Research Center obtained the Russian Health Ministry’s permit to conduct clinical trials of its vaccine on volunteers in July. The first volunteer was injected with the vaccine on July 27. The final group of 20 volunteers was discharged from the medical facility on September 8, according to TASS report.

“The clinical trials have been very successful. The volunteers are developing the necessary titers and no one has any clinical signs after the vaccine – neither temperature nor any other reaction,” Russia’s chief sanitary doctor Anna Popova said.

The drugmaker will begin Phase III trials in November-December. Nearly 30,000 volunteers will take part in post-registration trials of the coronavirus vaccine, the press service of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing told TASS. The vaccine will be manufactured on the industrial site of the Vector research center.

“After the vaccine’s registration the centers of carrying out post-registration trials will be selected, and 30,000 volunteers will take part in them,” the statement said.

“After the registration of the EpiVacCorona vaccine in October 2020 clinical trials are planned with the participation of volunteers of the age group of over 60 and those with chronic illnesses, as well as placebo-controlled post-registration clinical trials involving 5,000 adult volunteers of different age groups,” the sanitary watchdog’s press service explained, according to TASS.

“There are not many such vaccines in the world, which are being developed by the Vector Center. This is a rather complicated process,” Popova told TASS.

Russia had in August approved a COVID-19 vaccine, named Sputnik V, even before its final trial. The vaccine is currently undergoing final trials in Russiaon around 40,000 subjects. Sputnik V has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.

Indian pharma company Dr Reddy’s has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine as well as for its distribution.

Source:- livemint