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 Vice Director of Clinical Research Unit of Pasteur Institute of Ho Chi Minh city Nguyen Trong Toan.
According to Dr. Toan, the vaccine was first researched 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 Vietnam and Taiwan, with the number of Vietnamese children accounting for 80%.
In Vietnam, children in six districts of the Mekong Delta provinces of Tien Giang and Dong Thap were selected for clinical trials because these localities recorded high rates of HFMD.
The trial in Vietnam had to take longer than scheduled due to the impact of COVID-19, Toan 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%. 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.
Based on the clinical trial results, the production unit submitted a dossier to the Ministry of Health for approval, Toan said.
If approved, this will be the first HFMD vaccine in Vietnam against EV71 strain, he noted.
