Medigen Vaccine Biologics Corp (高端疫苗) on Wednesday said it plans to begin phase 2 clinical trials next week for its COVID-19 vaccine candidate and expects to apply by the end of June for emergency use authorization for the drug.
The company has started recruiting participants after last week obtaining Food and Drug Administration (FDA) permission to launch the phase 2 trials.
The company plans to recruit 3,700 participants, the most ever in such trials in Taiwan, as it aims to effectively examine the efficacy of its vaccine over the next three months, it said.
Photo: Kao Shih-ching, Taipei Times
Traditional phase 2 trials for vaccines enroll 100 to 300 participants, National Taiwan University Hospital associate professor Hsieh Szu-min (謝思民), the principal investigator of the trials, told a news conference.
Medigen would recruit at least 3,700 people, as experience shows that some participants might quit halfway through, Hsieh said.
The FDA has set strict requirements for the trials before it would grant emergency use authorization, including at least 3,000 people given the candidate vaccine in the experimental group and 500 given a placebo in the control group, he said, adding that they would be double-blind trials.
Medigen is working with 11 hospitals in Taiwan on the trials to accelerate the process, said National Health Research Institutes Chairman Lin Tzou-yien (林奏延), who is chief convener of the trials.
The vaccine, called MVC-COV1901, was developed by Medigen and the US National Institutes of Health.
Participants would be given a first dose next week and the second dose a month later, the firm said.
Medigen expects to file an application for emergency use authorization by the end of June, one month after all participants have been given both shots, it said.
The phase 2 trials might cost Medigen NT$800 million (US$28.14 million), with the average cost per participant ranging from NT$150,000 to NT$200,000, including transportation allowances, lab tests, result analyses and manufacturing costs, the company said.
The company received NT$1.7 million in government subsidies for its phase 1 trials and would receive another NT$300 million for its phase 2 trials.
In November last year it raised NT$1.92 billion by issuing 24 million new common shares.
Hsieh said that he is confident about the phase 2 clinical trials, as Medigen’s vaccine candidate showed good immunogenicity in the phase 1 trials and no participants showed any serious adverse reactions or fever.
The antibody levels in people given medium and high doses of the experimental drug were similar to those in people who contracted COVID-19 and recovered, he said.
“How long the antibodies last is still a question, but we anticipate they can persist for at least six months, which would effectively reduce the spread of the disease,” Hsieh said.
The efficacy of Moderna’s messenger RNA vaccine, which encodes the same stabilized COVID-19 spike immunogen, S-2P, in Medigen’s recombinant vaccine, could last 119 days at least, according to a preliminary analysis published by the New England Journal of Medicine, he said.
Medigen is thus far the only company in Taiwan to proceed to phase 2 clinical trials for a COVID-19 vaccine.
It would be given access to a government Web site that has recruited more than 200,000 volunteers for domestic COVID-19 vaccine trials.
Additional reporting by CNA
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