On December 25th, Medigen Vaccine Biologics Corp. (MVC) has completed the enrollment of phase III multi-region clinical trial for EV71 Vaccine. The total enrollment is over 3,000 subjects which met the target.
This phase III MRCT aims to evaluate the efficacy, safety, and immunogenicity of EV71 Vaccine in infants and children, and is conducted in Taiwan and Vietnam.
Enterovirus 71 (EV71) virus is one of the most prevalent infectious diseases in Taiwan, China and Southeast Asia. However, there are currently no vaccines available in these regions except China. In 2018, EV71 vaccine market reached 30 billion TWD in China, indicating EV71 vaccine's great market potential. Therefore, MVC aims to complete phase III MRCTs in Taiwan and Vietnam to speed up EV71 vaccine's availability in most ASEAN countries. Meanwhile, MVC continues to collaborate with strategic partners to submit NDA applications in ASEAN countries.