Taiwan's Medigen COVID vaccine gets green light for manufacturing

TAIPEI (Taiwan News) — A domestic COVID-19 vaccine developed by Medigen Vaccine Biologics Corp. (高端疫苗 MVC) has received government approval to begin mass production.

Health Minister and CECC head Chen Shih-chung (陳時中) on Monday (July 19) announced that the Ministry of Health and Welfare (MOHW) has provided emergency use authorization (EUA) for a COVID-19 vaccine developed by Medigen, enabling manufacturing to begin. Medigen Executive Vice President Lee Szu-Hsien (李思賢) said that the contract his firm has signed with Taiwan’s Centers for Disease Control (CDC) includes the quantity and delivery schedule.

He said that once his company receives the EUA, it will begin sealing operations and deliver in accordance with CDC instructions. At a recent online press conference, Medigen CEO Charles Chen (陳燦堅) said that his firm should be able to produce 10 million doses by the end of the year.

Due to the tremendous demand for vaccines worldwide, a major headwind Medigen will face is the shortage of raw materials. This global rush for vaccines is also causing the price of raw materials to soar, leading to an increase in costs for the company.

A group of 21 experts assembled by Taiwan’s Food and Drug Administration (FDA) has determined that its antibody response in comparison with AstraZeneca is higher than the established criteria. Chen said that some doses of Medigen’s vaccine could be delivered as early as August, but this will still depend on approval by the Advisory Committee on Immunization Practices (ACIP).

The Phase II clinical trials for Medigen’s vaccine found that the geometric mean titer ratio (antibody concentration) among recipients of the Medigen and AstraZeneca vaccines was 3.4, much higher than the required 0.67. In addition, the seroconversion rate (potency of response) of the Medigen vaccine recipients was 95.5%, far higher than the standard requirement of 50%.

The FDA has approved the manufacture of the vaccine for adults 20 and over. The vaccine is to be delivered in two doses, with an interval of 28 days.

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