A RECOMBINANT COVID-19 fusion protein vaccine (V-01) developed and manufactured in China has been approved for phase-III clinical trials in the Philippines.

The V-01 vaccine was developed by the Institute of Biophysics under the Chinese Academy of Sciences and Livzon Pharmaceutical Group Inc. (LivzonBio) in Guangdong Province.

V-01 is a fusion recombinant protein vaccine with the receptor-binding domain (RBD) as the antigen. RBD is the most important part of the virus spike protein binding with human cellular ACE2 receptors. The binding process grants the virus access to the host’s cells and leads to infection.

The Food and Drug Administration of the Philippines had granted approval for phase-III clinical trials of the V-01 vaccine to evaluate its safety and efficacy. The country has started recruiting adults aged 18 and older to take part in the trials. The first participant was enrolled on Aug. 25 and inoculated with the first dose.

Hu Zhenxiang, vice president of LivzonBio, told Xinhua that the phase-I and phase-II interim report for the V-01 vaccine has been obtained and shows satisfactory results.

A total of 1,060 participants enrolled in the phase-I and phase-II trials. The phase-II trials had a total of 880 participants, including 440 aged 18 to 59 and 440 aged 60 and older. The oldest participant is 83 years old. The results showed that no serious adverse events related to the vaccine had been observed. The adverse reactions were at a mild level, with spontaneous recovery occurring within three days.

With regard to immunogenicity, the seroconversion rate of the neutralizing antibody reached over 97 percent after two doses of V-01.

Hu noted that the V-01 vaccine could generate immune responses rapidly in both the adult group and the senior group, with no significant statistical difference in the geometric mean titer (GMT) of neutralizing antibodies titer between the two groups. (Xinhua)