Ministry of Health approves phase III trials of Chinese vaccine V-01 against COVID-19

The Ministry of Health of Russia has issued a permit to conduct phase III trials of a vaccine against coronavirus V-01 to the Chinese company Livzon Mabpharm Inc., according to the website of the state register of medicines.

"An international, multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of a recombinant vaccine based on the SARS-CoV-2 (V-01) fusion protein in adults aged 18 years and older," the statement said.

According to the agency, 5.5 thousand volunteers over 18 years of age will take part in the studies, some of them will be immunized with a real vaccine, the other part will receive a placebo. Completion is scheduled for June 30, 2023.

According to the Chinese Ministry of Health, the drug has already passed phase I and II clinical trials in the country. 223 patients took part in two stages of the first phase. In phase II, the evaluation of the drug was carried out with the participation of 880 people. They were divided into two age subgroups: from 18 to 59 years old and over 60 years old. The period between the first and second dose was 21 days.