EnVAX-A71 is an inactivated enterovirus A71 (EV-A71) vaccine developed for the prevention of EV71-associated hand, foot and mouth disease (HFMD) and herpangina in infants and young children. Manufactured using a bioreactor-based process, EnVAX-A71 demonstrated 99.21% vaccine efficacy in a multicenter Phase III clinical trial with a favorable safety profile. The vaccine showed 100% efficacy in preventing EV71-associated hospitalization and severe complications. Cross-neutralization has been demonstrated against EV71 sub-genogroups B4, B5, C2, C4 and C5. Long-term follow-up showed sustained immunity with SPR of 100% at 2 years in Vietnam and 94.7% at 7 years in Taiwan.
Indication: Prevention of EV71-mediated HFMD and herpangina
Dosage: 1 µg / 0.5 mL per dose (≥1.5 U per dose)
Regimen: 2 doses, intramuscular injection, 28 days apart
Age: 2 months to <6 years old
