Enimmune Corporation, a subsidiary of ADIMMUNE, has released the complete Phase III clinical trial results for its enterovirus 71 (EV71) vaccine, EnVAX-A71. The data shows an impressive protective efficacy of 99.21% and a 100% reduction in the risk of hospitalization caused by EV71 infection. Following the submission of its drug registration application in Macau at the end of February, Enimmune is also accelerating its efforts to expand into the Southeast Asian market.
On February 5, Enimmune disclosed the full Phase III clinical trial report for EnVAX-A71, conducted in both Taiwan and Vietnam. The key findings are as follows:
The overall protective efficacy of the EV71 vaccine reached 99.21%. Protection remained consistently high across all age groups, including infants and young children aged 2–11 months, 12–23 months, 24–35 months, and 36–71 months, each showing over 95% efficacy.
The vaccine demonstrated 100% efficacy in preventing hospitalizations due to EV71 infection. The 95% confidence interval was 91.14% to 100.00%, with a statistically significant p-value of less than 0.001.
The trial enrolled infants and young children between 2 months and under 6 years of age. Results confirmed that the vaccine is both safe and well-tolerated across the study population.
Je-wei Chang, General Manager of Enimmune, stated that the company is actively engaged in negotiations with several Southeast Asian countries and plans to soon submit applications for drug registration in regions where EV71 outbreaks remain a serious public health concern. In addition to targeting the Southeast Asian market, Enimmune filed its first "Western Medicine Registration" application for EnVAX-A71 with the Pharmaceutical Administration Bureau of Macau at the end of February.
EnVAX-A71 received regulatory approval from Taiwan’s Food and Drug Administration in 2023. In collaboration with ADIMMUNE’s next-generation high-capacity cell culture bioreactor technology, Enimmune has established a large-scale production line at its Taichung Tanzi facility. This will significantly boost production capacity for EnVAX-A71, with plans to expand supply starting this year.
As part of its Southeast Asia strategy, Enimmune has already signed a sales agreement for EnVAX-A71 with Vietnam’s largest state-owned vaccine company, VABIOTECH, and will soon submit a drug registration application in Vietnam. The company is also aiming to penetrate the newborn markets in multiple Southeast Asian countries and, leveraging its entry into Macau, plans to extend its reach into the Chinese mainland market.
Resource: 安特羅腸病毒71型疫苗完整3期數據公開，保護力99.21%，住院率100%降低
