Vietnam introduces Southeast Asia’s first EV71 vaccine to combat severe paediatric hand, foot and mouth disease

Vietnam has begun administering Envacgen, the first EV71 vaccine in Southeast Asia, in a move expected to significantly reduce severe cases of hand, foot and mouth disease among young children, following approval and successful trials in the region.

Vietnam has begun rolling out its first vaccine designed to protect young children against hand, foot and mouth disease caused by EV71, a development that doctors and parents have long awaited as the illness continues to drive serious paediatric cases. VNVC said it started administering the shot on 25 September 2026 at nearly 300 vaccination centres nationwide, making Vietnam the first country in South-east Asia to put the vaccine into routine use, according to the company and Thanh Nien.

The first day of the rollout drew a brisk response from parents in Hanoi, Ho Chi Minh City, Da Nang and Can Tho, who brought their children in for vaccination soon after the centres opened. In Ho Chi Minh City, one father told Thanh Nien he moved quickly because his 23-month-old son was at the age when children constantly put toys and fingers in their mouths, and nursery settings can make infection a constant worry. The vaccine, called Envacgen, is approved for children aged from two months to under six years, with a schedule of two or three doses depending on when immunisation begins, according to VNVC and the Ministry of Health.

Doctors say the importance of the shot lies in the speed and severity with which EV71-related cases can worsen. Bạch Thị Chính, VNVC’s medical director, said hand, foot and mouth disease is caused by several viruses and there is still no specific treatment, which is why a preventive vaccine has been so eagerly anticipated. Trương Hữu Khanh, a senior infectious-diseases specialist in Ho Chi Minh City, said many families had spent years asking when a vaccine would finally be available, while hospitals faced intense pressure during outbreaks as some children deteriorated within hours. Nguyễn An Nghĩa, of Children’s Hospital 1 in Ho Chi Minh City, said severe cases can progress from mild symptoms to neurological, cardiac and respiratory complications in as little as six to eight hours.

Clinical data supplied by VNVC says the vaccine has shown 96.8% protection against EV71-related hand, foot and mouth disease, with no EV71 cases recorded in the vaccinated group in the study cited by the company. VNVC also says the vaccine was tested in a phase III trial in Vietnam and generated strong immune responses across multiple EV71 subtypes. The Ministry of Health granted circulation approval on 17 March 2026, and VNVC says it had worked with Switzerland-based Substipharm Biologics for several years to bring the product to market.

Substipharm Biologics said the launch gives Vietnam access to a vaccine that has already seen large-scale use in Taiwan, where more than 600,000 doses have been administered since August 2023, according to figures cited by the company. Li-Min Huang, who has led paediatric infectious-diseases work in Taiwan, said post-launch monitoring there had continued to show strong safety and effectiveness, while Taiwan’s disease control authorities had not reported EV71 in severe hand, foot and mouth cases in 2024-26, according to the company’s account. That broader evidence base has helped fuel hopes that the vaccine may ease both the medical burden and the financial toll of the disease in Vietnam, where a 2019 study published in Open Forum Infectious Diseases estimated annual losses at more than $90.7 million.

Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.