Berlin, Germany – In a significant step towards bolstering public health in Southeast Asia, Medigen Vaccine Biologics Corp. (MVC) and Substipharm Biologics have announced the approval of ENVACGEN®, the first Enterovirus A71 (EV-A71) vaccine, by the Drug Administration of Vietnam (DAV). This milestone promises increased protection for children against a virus that poses a substantial health threat across the region. The collaboration between MVC and Substipharm Biologics will see the latter responsible for the marketing and distribution of the vaccine throughout Vietnam, leveraging its established network, and expertise.
Enterovirus A71 is a leading cause of hand, foot, and mouth disease (HFMD), and more seriously, can lead to neurological complications, including encephalitis and paralysis, particularly in young children. Vietnam has experienced recurring outbreaks of EV-A71, with a significant impact on public health infrastructure and families. According to data reported in 2023, the country recorded approximately 180,000 cases of HFMD and 31 fatalities linked to the virus. KLSE Screener reports that this approval paves the way for broader access to preventative measures in the region.
ENVACGEN®: A Highly Effective Vaccine
ENVACGEN® has demonstrated a strong safety profile and high efficacy in clinical trials. The vaccine is described as “best-in-class,” offering 100% effectiveness in preventing confirmed EV-A71 infections in vaccinated individuals during the monitoring period, with all cases occurring in the placebo group. The Manila Times details that the vaccine provides early protection for infants as young as two months and maintains immunity for over five years. With approximately 1.36 million births annually in Vietnam, the availability of ENVACGEN® addresses a significant unmet medical require.
The Impact of EV-A71 and HFMD in Vietnam
Hand, foot, and mouth disease (HFMD), often caused by EV-A71, is a common viral infection among young children. While typically mild, HFMD can lead to serious complications, including viral meningitis, encephalitis, and even death. Vietnam has been particularly vulnerable to HFMD outbreaks, with a notable increase in cases in recent years. In 2025, the country reported 107,249 cases of HFMD, representing a 28.9% increase compared to the previous year. Substipharm Biologics emphasizes its commitment to working with Vietnamese health authorities and medical professionals to rapidly deploy the vaccine and protect children from the severe consequences of EV-A71 infection.
Collaboration for Expanded Access
The partnership between MVC and Substipharm Biologics is crucial for expanding access to ENVACGEN® throughout Southeast Asia. MVC, a Taiwanese vaccine manufacturer, has a strong track record in vaccine development and production, holding over 97% of the market share in Taiwan. Substipharm Biologics, a French pharmaceutical company, brings extensive experience in marketing and distributing pharmaceuticals across the region. Leo Lee, CEO of MVC, stated that the approval in Vietnam represents a “significant milestone” in the company’s global expansion plans. Fabrice Baschiera, CEO of Substipharm Biologics, highlighted the urgent need for an effective EV-A71 vaccine in Vietnam, given the ongoing burden of HFMD.
MVC is already planning to increase its production capacity to meet the anticipated demand in Southeast Asia. The company’s advanced cell culture technology and PIC/S GMP-certified biopharmaceutical facilities ensure the high quality and reliability of its vaccines. MVC’s portfolio includes vaccines for enterovirus and seasonal influenza, with ongoing research focused on Enterovirus D68 and multivalent enterovirus vaccines. Substipharm Biologics, with a presence in Switzerland, Thailand, and Vietnam, has a proven history of successfully launching and distributing vaccines, including IMOJEV®, a leading Japanese encephalitis vaccine, in 14 countries across the Asia-Pacific region.
This collaboration signifies a major advancement in the fight against EV-A71 and HFMD in Vietnam and potentially across Southeast Asia. The availability of a highly effective vaccine like ENVACGEN® offers a critical tool for protecting children and reducing the public health burden associated with this prevalent and potentially dangerous virus.
The next step will be the rollout of the vaccine across Vietnam, coordinated by Substipharm Biologics in collaboration with the Drug Administration of Vietnam and local healthcare providers. For the latest updates on vaccine availability and distribution, please consult the official website of the Drug Administration of Vietnam. Share your thoughts on this important development in the comments below.