A doctor at the Tropical Diseases Department of Quảng Ngãi Obstetrics and Children's Hospital checks the condition of the child infected with hand-foot-mouth disease. — VNA/VNS Photo

HCM CITY — The third trial of the vaccine against hand-foot-mouth disease (HFMD) caused by the Non-Mouse-Adapted Enterovirus 71 (EV71) strain has been completed and is waiting for the Ministry of Health's approval, said Deputy Director of Clinical Research Unit of Pasteur Institute of HCM City’s Nguyễn Trọng Toàn.

According to Dr. Toàn, the vaccine was first studied by the National Health Research Institute (NHRI) of Taiwan (China), then continued to be transferred and developed through clinical trials.

From 2019 to 2021, the third clinical trial was conducted on 3,049 children aged two months to six years in Việt Nam and Taiwan, with the number of Vietnamese children accounting for 80 per cent.

In Việt Nam, children in six districts of the Mekong Delta provinces of Tiền Giang and Đồng Tháp were selected for clinical trials because these localities recorded high rates of HFMD.

The trial in Việt Nam took longer than scheduled as due to COVID-19 pandemic, children mostly stayed at home leading to lower chances for hand-foot-mouth infections, Toàn said.

Findings show that the protective efficacy of the vaccine in helping defend against the EV71 strain – the most dangerous virus strain that causes HFMD with a high risk of death – is 96.8 per cent, as per the results published in The Lancet in 2022. During the study period, there were no cases of HFMD recorded among the children who received the vaccine.

Researchers have not detected any post-vaccination anaphylaxis, while 30 per cent witnessed some typical reactions like swelling or redness at the injection point just like any other vaccine. More full-body reactions are at mild levels and go away after one to three days.

Based on the clinical trial results, the production unit submitted a dossier to the Ministry of Health for approval, Toàn said.

If approved, this will be the first HFMD vaccine in Việt Nam against EV71 strain, he noted.

The Pasteur Institute in HCM City is also collaborating to implement phase three clinical trials of another EV71 hand, foot, and mouth disease vaccine, with results expected in 2025.

According to Dr Toàn, in addition to dengue fever, HFMD is an infectious disease that causes serious consequences for children's health.

For infectious diseases, vaccines are always the most effective and fundamental measure, and the early availability of a vaccine would play an important role in controlling the disease and reducing the burden of illness caused by HFMD. — VNS