Russia to Begin Phase 3 Clinical Trial of COVID-19 Vaccine 'Sputnik V' Possibly Starting on the 5th

[Image source=EPA Yonhap News]

[Asia Economy Reporter Jeong Hyunjin] The Russian government will begin the Phase 3 clinical trials of Sputnik V, the novel coronavirus (COVID-19) vaccine it developed and officially approved as the world's first, as early as the 5th.

According to TASS news agency on the 2nd (local time), Aleksandr Gintsburg, director of the Gamaleya National Research Center for Epidemiology and Microbiology under the Ministry of Health, which developed the vaccine, said that vaccination of volunteers as part of the Phase 3 vaccine trial will start between the 5th and 7th.

Director Gintsburg explained, "We have already entered the post-registration trial (Phase 3 clinical trial) stage," adding, "The vaccine will be distributed at hospitals in Moscow over 3 to 4 days." He added that the trial will be conducted at up to 20 outpatient clinics in Moscow, planning to vaccinate 40,000 people. Gintsburg also explained that volunteers must undergo medical examinations and the vaccine will be administered 2 to 3 days after the tests.

Following Gintsburg's remarks, on the next day, Alexey Kuznetsov, an advisor to the Ministry of Health, stated that Russian citizens aged 18 and over can participate in this trial and that those over 60 will not be excluded.

The Russian government announced on the 11th of last month that it had officially registered the COVID-19 vaccine developed by the Gamaleya Center, making it the world's first. The vaccine received national approval after completing only Phase 2 clinical trials. The vaccine was named Sputnik V after the artificial satellite launched by the former Soviet Union in 1957, the first ever sent into space by humanity.

Generally, new drugs such as vaccines undergo registration and approval only after completing Phase 1 clinical trials, which test on a small number of healthy subjects, through to Phase 3 clinical trials, which verify safety in a large number of recipients. However, Sputnik V has been criticized for skipping Phase 3 and not properly conducting Phases 1 and 2.

This content was produced with the assistance of AI translation services.