The Drug Administration of Vietnam under the Ministry of Health has just issued a decision to license the 58th batch of several new vaccines in Vietnam, including the Envacgen vaccine for preventing hand, foot and mouth disease (HFMD).
Envacgen is an inactivated suspension vaccine indicated for the prevention of severe complications from the EV71 virus, the most dangerous strain causing HFMD in young children.
This vaccine was researched and manufactured by Medigen Vaccine Biologics (Taiwan, China) and is licensed for circulation in Vietnam for 3 years.
Regarding packaging, the vaccine is designed as a pre-filled syringe with a capacity of 0.5 ml per dose. The product comes in two packaging options including a box of 1 syringe or a box of 20 syringes.
Along with the hand, foot, and mouth disease vaccine, the Ministry of Health also issued and renewed registration certificates for 13 other vaccines and biological products, as well as several biological drugs and drugs containing the active ingredients bevacizumab and rituximab used in cancer treatment.
According to the Ministry of Health, this licensing and renewal aims to ensure the supply of vaccines and biological products to meet domestic disease prevention and treatment needs. Registered and manufactured facilities must fully comply with regulations on quality, safety, and efficacy throughout the distribution period.
Currently, HFMD is a common endemic disease in Vietnam, mainly caused by the EV71 and Coxsackie A16 strains. The disease can occur in all age groups, but up to 90 percent of cases occur in children under 3 years old. In particular, EV71 often causes severe illness, leading to complications such as encephalitis, meningitis, respiratory failure in young children, and can be fatal.
According to health authorities, from the beginning of the year to March 8, Ho Chi Minh City recorded over 6,450 cases of hand, foot, and mouth disease, a significant increase compared to the same period in 2015. Meanwhile, Hanoi also recorded over 900 cases of HFMD with 16 scattered outbreaks throughout the city.
