Medigen Vaccine Biologics Corp. ('MVC')'s EV71 vaccine obtained the approval from Taiwan's Food and Drug Administration (TFDA) on 12 April, which is the first enterovirus vaccine approved in Taiwan without the accelerated approval pathway. MVC pointed out that it will be marketed in Taiwan as soon as possible and will apply for approvals in Southeast Asia and other markets.

In a multi-centre phase III clinical trial, the EV71 vaccine achieved 100% real-world vaccine protection (all confirmed cases occurred in the placebo group, with zero infections in infants and toddlers administered during the follow-up period), and the data has been published by The Lancet.

EV71 is prevalent in humid regions and is endemic in Southeast Asia and mainland China, with the exception of Taiwan, where it has been endemic for years. In terms of vaccine development, only three vaccine companies in mainland China have been marketed and two vaccine companies in Taiwan are preparing to launch their products.

Currently, in Taiwan, one approach to the drug certification of enterovirus vaccines is to apply for accelerated drug approval from TFDA based on neutralising antibodies (which still requires confirmatory trials to prove clinical efficacy), while the other approach is for MVC's vaccine to apply for approval based on complete Phase III clinical vaccine efficacy data.

After obtaining the approval for the enterovirus vaccine in Taiwan, MVC will continue to develop its overseas market by applying for drug certificates in countries where the EV71 epidemic is prevalent, such as Vietnam, Thailand and Malaysia, as well as in countries with specific market segments, using the excellent Phase III clinical trial efficacy data and Taiwan's approval.