Phase 2 trial data of a COVID-19 vaccine developed by Medigen Vaccine Biologics Corp (高端疫苗) looked promising, but professional review is needed to assess the vaccine’s efficacy, Minister of Health and Welfare Chen Shih-chung (陳時中) said at a news briefing at the Central Epidemic Command Center yesterday.
Medigen announced the results of the vaccine trial on Thursday afternoon, following the Food and Drug Administration’s (FDA) announcement of emergency use authorization standards for locally developed vaccines earlier that day.
Despite Medigen’s optimistic outlook, questions have been raised whether the successful phase 2 trial is enough to determine whether the vaccine offers adequate protection against COVID-19.
Screen grab from the Legislative Yuan Parliamentary TV Web site
Asked about the issue, Chen echoed the FDA criteria, saying that the vaccine was administered to more than 3,000 trial participants and that the developer’s data proved its safety.
Chen said that the reported seroconversion rate of 99.8 percent is “a good sign,” proving that most trial participants showed virus-specific immune responses.
The company’s data showed it was able to produce three vaccine batches with consistent quality, he said.
Medigen also reported a moderately good antibody concentration ratio, with a geometric mean titer (GMT) of 662, but whether the drug is effective needs further expert review, Chen said.
Studies suggest a positive correlation between the GMT figure and vaccine efficacy, but whether a person’s blood antibody level determines whether they are protected against the virus needs further review, Chen said.
Medigen’s results would be compared with a control group of 200 people who were given two doses of the AstraZeneca COVID-19 vaccine, Chen said.
Those results would be available later this month, he added.
The Centers for Disease Control (CDC) on May 28 signed preorder contracts with Medigen and United Biomedical Inc (聯亞生技開發), another domestic developer of a COVID-19 vaccine, to procure 5 million doses each, CDC Deputy Director-General Chuang Jen-hsiang (莊人祥) said on May 30.
The contracts also include options for an additional 5 million doses from each company, meaning that the government could obtain up to 20 million doses of domestically produced vaccines, Chuang said at that time.
Separately yesterday Chen said during a question-and-answer session at the Legislative Yuan that the government is in talks with US vaccine developer Moderna Inc about contracted manufacturing of its COVID-19 vaccine in Taiwan.
Academia Sinica, the nation’s top research institution, has achieved a breakthrough in its research on messenger RNA technology used in the Moderna vaccine, Chen added.
If collaboration with Moderna could be secured, Academia Sinica would work together with local manufacturers to boost Taiwan’s vaccine development, Chen said.
Additional reporting by Peng Wan-hsin and CNA
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