Entro Biotech, a subsidiary of Adimmune Corporation, has announced that its Enterovirus 71 vaccine (EnVAX-A71) has achieved a 99.12% efficacy rate in its Phase III clinical trial. This makes it the most effective enterovirus 71 vaccine currently available.
General Manager Zhang Zhewei detailed the multinational and multi-center trial, which involved 1,266 participants across seven medical centers in Taiwan and 2,727 participants at two hospitals in Vietnam. The trial, which collected a total of 3,993 valid samples, tracked 71 confirmed cases of enterovirus 71—two in Taiwan and 69 in Vietnam. The vaccine group saw just one confirmed case compared to 70 in the placebo group, resulting in a vaccine efficacy (VE) of 99.21%.
The trials in Vietnam began in 2022 and coincided with an outbreak of enterovirus 71 in 2023, enabling rapid accumulation of positive cases and confirmation of the vaccine’s efficacy and safety. The statistical analysis showed a 95% confidence interval of 94.31% to 99.89%, with a P value of < 0.001, indicating significant statistical relevance.
Entro Biotech plans to increase production capacity through its new generation high-throughput cell culture bioreactor at Adimmune’s facility. The company aims to expand into the Southeast Asian market by partnering with VABIOTECH, Vietnam’s largest state-owned vaccine company. An application for a drug license will be submitted in Vietnam soon, targeting the newborn market in Southeast Asia and China.
This vaccine development marks a significant advancement in protecting children under five, who are particularly vulnerable to severe complications from enterovirus 71. The success of the trials also aligns with Entro Biotech’s commitment to enhancing pediatric health and its plans to list on the stock exchange in mid-July.
