Vietnam's first hand, foot and mouth disease vaccine awaits licensing

Children's Hospital 1 in Ho Chi Minh City treats many children with hand, foot and mouth disease.

The Ethics Committee noted that the vaccine helps protect children against hand, foot and mouth disease caused by EV71 at any severity, with an effectiveness of 96.8%. This result was published in the prestigious medical journal The Lancet in 2022. The vaccine is awaiting the Ministry of Health's license. This information was shared by Dr. Nguyen Trong Toan, Deputy Director of the Clinical Trial Center, Pasteur Institute of Ho Chi Minh City.

According to Dr. Nguyen Trong Toan, the vaccine to prevent hand, foot and mouth disease was first researched by the National Health Research Institute (NHRI, Taiwan, China), then continued to be transferred and developed in the clinical trial stages. In 2010, the NHRI conducted a phase 1 vaccine trial on 60 healthy volunteers. As a result, 90% of vaccine recipients had a 4-fold increase in antibodies to the virus after vaccination.

From 2014 to 2017, the vaccine continued to conduct phase 2 clinical trials with 365 volunteers aged 2 months to 12 months participating. From 2019 to 2021, phase 3 clinical trials were conducted on 3,049 children aged 2 months to 6 years in Vietnam and Taiwan (China); of which 80% were children in Vietnam. In Vietnam, children in 6 districts of Tien Giang and Dong Thap provinces were selected for clinical trials, because these are two localities with high rates of children with hand, foot and mouth disease in the southern region.

Dr. Nguyen Trong Toan said that the phase 3 clinical trial process in Vietnam encountered many difficulties due to the impact of Covid-19. Children mostly stayed at home, went to school less, and got sick less often. Therefore, the research time was forced to be longer than expected. The results of the phase 3 clinical trial showed that the overall protective efficacy of the vaccine to help children fight the EV71 virus strain was 96.8%, and no cases of hand, foot, and mouth disease were recorded in the group of children vaccinated during the study period. Researchers have not recorded anaphylactic shock after injection. About 30% of common adverse reactions after injection such as: swelling, pain, redness at the injection site... are similar to other vaccines. Systemic reactions accounted for 42.6%, mainly mild and moderate, and these reactions will resolve on their own within 1-3 days.

Based on the effectiveness assessment and following the clinical trial process, the manufacturing unit has submitted a dossier to the Ministry of Health for approval. “If approved, this is the first hand, foot and mouth disease vaccine in Vietnam, which helps children fight the EV71 virus strain (Enterovirus 71) - the most dangerous virus strain that causes severe hand, foot and mouth disease with a high risk of death,” said Dr. Nguyen Trong Toan.

The Pasteur Institute in Ho Chi Minh City is cooperating to conduct phase 3 clinical trials of another EV71 hand, foot and mouth disease vaccine, with results expected in 2025.

According to Dr. Nguyen Trong Toan, in addition to dengue fever, hand, foot and mouth disease is an infectious disease that causes serious consequences for children's health. For infectious diseases, vaccines are always the most effective and fundamental measure. Therefore, the early availability of a vaccine to prevent hand, foot and mouth disease is of great significance in helping to control the disease and reduce the burden of diseases caused by hand, foot and mouth disease.

According to VNA