At the Department of Infection and Neurology of Children's Hospital 1 in HCM City (Photo: VNA) According to Dr. Toan, the vaccine was first researched by the NationalHealth Research Institute (NHRI) of Taiwan (China), then continued to betransferred and developed through clinical trials.
From 2019 to 2021, the third clinical trial was conducted on3,049 children aged two months to six years in Vietnam and Taiwan, with the numberof Vietnamese children accounting for 80%.
In Vietnam, children in six districts of the Mekong Deltaprovinces of Tien Giang and Dong Thap were selected for clinical trials becausethese localities recorded high rates of HFMD.
The trial in Vietnam had to take longer than scheduled dueto the impact of COVID-19, Toan said.
Findings show that the protective efficacy of the vaccine inhelping defend against the EV71 strain - the most dangerous virus strain thatcauses HFMD with a high risk of death, is 96.8%. During the study period, therewere 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 unitsubmitted a dossier to the Ministry of Health for approval, Toan said.
If approved, this will be the first HFMD vaccine in Vietnam againstEV71 strain, he noted./.
VNA
