Enimmune Corp announced yesterday that its Enterovirus 71 (EV71) vaccine, EnVAX-A71, has successfully met its primary endpoints in a multinational, multicenter Phase III clinical trial. The vaccine demonstrated a protective efficacy of 99.12%, with a statistically significant p-value of less than 0.001. Enimmune plans to apply for listing on the Taiwan Stock Exchange by mid-July.
The General Manager of Enimmune, Che-Wei Chang, stated that the overseas Phase III clinical trial for its EV71 vaccine commenced in Vietnam in 2022. During the EV71 outbreak in Vietnam in 2023, positive cases accumulated rapidly, confirming that the vaccine is not only safe but also highly effective. The unblinding results were unsurprising, affirming the vaccine’s superior safety and efficacy, and highlighting its international competitiveness. Mr. Chang expressed deep gratitude to the trial participants and their families for their contributions, which provided a real-world validation of the vaccine.
Enimmune's EV71 vaccine received approval from the Taiwan Food and Drug Administration (TFDA) in 2023. The company has established a new high-capacity cell culture bioreactor process at its Taichung plant, which is expected to significantly increase production capacity starting in 2025. To expand into the Southeast Asian market, Enimmune has signed a sales agreement with Vietnam’s largest state-owned vaccine company, VABIOTECH, and plans to apply for regulatory approval in Vietnam soon. The company also aims to enter other Southeast Asian newborn markets and eventually the Chinese market.
The Phase III clinical trial was conducted across multiple countries and centers. In Taiwan, the trial was conducted at seven medical centers, including China Medical University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Linkou Chang Gung Memorial Hospital, NTU Hsinchu Branch, Taichung Veterans General Hospital, and Changhua Christian Hospital, enrolling a total of 1,266 participants. In Vietnam, the trial was conducted in collaboration with the Pasteur Institute of Vietnam at two hospitals in Ben Tre Province and Vinh Long Province, enrolling 2,727 participants. The total effective sample size was 3,993 participants. During the trial, 71 cases of confirmed EV71 infection were tracked (2 cases in Taiwan and 69 cases in Vietnam). Among these, only 1 case was from the vaccine group, while 70 cases were from the placebo group. According to the clinical development guidelines for enterovirus vaccines, the calculated vaccine efficacy (VE) was 99.21%, with a 95% confidence interval of 94.31%-99.89% and a p-value of less than 0.001, indicating statistical significance.
Enterovirus is a prevalent infectious disease in Asia, with children under five years old being particularly susceptible to severe complications from EV71. In 1998, Taiwan experienced a major outbreak of hand, foot, and mouth disease (HFMD) and herpangina, infecting 1.4 million children, resulting in 405 severe cases and 78 deaths. The severe neurological complications were primarily caused by EV71.
Resource (mandarin) :
安特羅腸病毒71型疫苗解盲達標，疫苗保護力99.21%
