TAIPEI (Taiwan News) — Taiwanese vaccine developer Medigen Vaccine Biologics Corporation (MVC) announced Thursday (June 10) that it has completed the phase II clinical trial for its COVID-19 vaccine candidate and that the results meet safety and efficacy standards set by the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA).
The company said it will submit analysis reports and documents related to the study to the FDA to seek EUA approval as soon as possible.
MVC said it will also soon apply with the European Medicines Agency and other international health authorities to begin phase III clinical trials.
According to the FDA’s guidelines, domestic vaccine candidates must have a neutralizing antibody potency level equal to or higher than that of the AstraZeneca COVID-19 vaccine to be eligible for an EUA.
More than 3,700 people were recruited to participate in the trials, according to the company.
MVC announced related data from the phase II clinical trial at a press conference on Thursday. Regarding immunogenicity, the seroconversion rate for the group 28 days after the second shot, regardless of age, was 99.8 percent. The vaccine has a GMT titer of 662 and a GMT ratio of 163, the company said.
The seroconversion rate means the percentage of people whose bodies have developed specific antibodies in their blood serum as a result of infection or immunization.
For participants aged 20 to 64, the seroconversion rate was 99.9 percent, and the GMT titer and GMT ratio were 773 and 180, respectively.
According to experts, a GMT titer range between 600 and 700 is a good result, and the GMT ratio is an important indicator — the larger, the better as far as efficacy is concerned. With regard to safety, the company said that so far, no one participating in the trial has had a severe adverse reaction, CNA reported.
MVC added that the second clinical trial for the vaccine is ongoing and that participants will continue to be monitored until six months have elapsed.