Vietnam has approved its first HFMD vaccine, ENVACGEN®, marking a major step in tackling hand, foot and mouth disease as Medigen and Substipharm expand across Southeast Asia. Rollout in Vietnam signals shift towards prevention-led child healthcare in ASEAN
KUALA LUMPUR, 18 March — Vietnam has approved its first HFMD vaccine, marking a significant breakthrough in the fight against hand, foot and mouth disease (HFMD) and signalling a broader shift towards preventive healthcare strategies across Southeast Asia.
The vaccine, ENVACGEN®, developed by Taiwan-based Medigen Vaccine Biologics Corp (MVC), received marketing authorisation from Vietnam’s Drug Administration, with Substipharm Biologics leading its distribution in the country.
The move positions Vietnam at the forefront of regional efforts to address EV71, a key virus responsible for severe HFMD complications among young children.
A long-standing regional health challenge
HFMD remains endemic across Southeast Asia, with recurring outbreaks affecting millions of children and placing sustained pressure on public healthcare systems.
Vietnam alone recorded approximately 180,000 cases and 31 deaths in 2023. In 2025, infections surged again to more than 107,000 cases — a 28.9% increase compared to the previous year.
With over 1.3 million births annually, the introduction of an HFMD vaccine could play a critical role in reducing severe infections, hospitalisations and fatalities.
High efficacy and early protection
ENVACGEN® has demonstrated strong clinical performance, with efficacy reported at up to 100% during follow-up periods, and no infections observed among vaccinated individuals in trials.
The vaccine can be administered to infants as young as two months old and provides long-term immunity lasting more than five years.
MVC currently holds over 97% market share for EV71 vaccines in Taiwan, underscoring its established track record in this space.
HFMD vaccine expansion across Southeast Asia
The Vietnam approval is expected to serve as a springboard for wider regional expansion, as demand grows for more effective HFMD prevention measures.
MVC CEO Leo Lee described the approval as a “pivotal milestone”, adding that the company is scaling up production capacity to meet anticipated demand across Southeast Asia.
Substipharm Biologics, which operates in over 100 countries, will leverage its regional presence to accelerate distribution and engagement with healthcare authorities.
Its CEO, Fabrice Baschiera, highlighted the urgency of addressing recurrent outbreaks, noting that EV71 has remained a persistent threat to child health in Vietnam.
Implications for Malaysia and the region
The introduction of an HFMD vaccine in Vietnam may influence neighbouring countries, including Malaysia, to reassess their approach to HFMD prevention.
As ASEAN nations strengthen healthcare resilience and pandemic preparedness, vaccine-led strategies are expected to play an increasingly central role.
The approval of ENVACGEN® not only addresses an immediate public health need but also signals a broader regional shift towards proactive disease prevention. – NMH
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