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Phase II results of Taiwan’s COVID-19 vaccine meet safety, efficacy thresholds


台灣 新冠肺炎 疫苗的 II 期結果符合安全性、有效性閾值


Company said so far no one participating in trial has had severe adverse reactions


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 the results of the trial meet safety and efficacy standards for an Emergency Use Authorization (EUA) set by the Food and Drug Administration (FDA).

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.

The vaccine samples must have a neutralizing antibody geometric mean titer ratio of at least 0.67 and a sero-response rate of at least 50 percent in order to be approved, the FDA said.

More than 3,700 people were recruited to participate in the trials, according to the company's data.

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 taking the second shot, regardless of age, was 99.8 percent. The vaccine had a GMT Titer of 662 and a GMT ratio of 163, the company said.

For participants aged 20 to 64, the seroconversion rate was 99.9 percent, and the GMT titer and GMT rates were 773 and 180, respectively.

With regard to the safety of the vaccine, the company said that so far no one participating in the trial has had severe adverse reactions, CNA reported.

MVC added that the second clinical trial for the COVID-19 vaccine is ongoing and that participants will continue to be monitored until six months have elapsed.

 
George Liao, Taiwan News, Staff Writer  
2021-06-10  

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