Formalin-inactivated EV71 vaccines demonstrated >90% efficacy against EV71-related hand, foot, and mouth disease and >80% against EV71-associated serious diseases in young children.
Do formalin-inactivated EV71 vaccines prevent EV71-related hand, foot, and mouth disease in young children?
Formalin-inactivated EV71 vaccines are highly efficacious against EV71-related hand, foot, and mouth disease in young children, though they do not provide cross-protection against coxsackievirus A16.
Effect estimate: >90% efficacy against EV71-related HFMDs and >80% against EV71-associated serious diseases
Enterovirus 71 (EV71) and coxsackieviruses are the major causative agents of hand, foot, and mouth disease (HFMD) outbreaks worldwide and have a significant socioeconomic impact, particularly in Asia. Formalin-inactivated (FI) EV71 vaccines evaluated in human clinical trials in China, Taiwan, and Singapore were found to be safe and to elicit strong neutralizing antibody responses against EV71 currently circulating in Asia. The results from 3 different phase 3 clinical trials performed in young children (6-60 months) indicate that the efficacy of FI-EV71 vaccines is >90% against EV71-related HFMDs and >80% against EV71-associated serious diseases, but the vaccines did not protect against coxsackievirus A16 infections. Here we discuss the critical factors affecting EV71 vaccine product registration, including clinical epidemiology, antigenic shift issues in cross-protection and vaccine strain selection, standardized animal models for potency testing, and cost-effective manufacturing processes for potential incorporation of FI-EV71 vaccine into Expanded Programme on Immunization vaccines.
Chong et al. (Tue,) conducted a review in Enterovirus 71 (EV71) and hand, foot, and mouth disease (HFMD). Formalin-inactivated (FI) EV71 vaccines was evaluated on EV71-related HFMDs and EV71-associated serious diseases (>90% efficacy against EV71-related HFMDs and >80% against EV71-associated serious diseases). Formalin-inactivated EV71 vaccines demonstrated >90% efficacy against EV71-related hand, foot, and mouth disease and >80% against EV71-associated serious diseases in young children.