Introduction
MVC's Enterovirus A71 Vaccine is the world's 1st enterovirus A71 vaccine with clinical data for infants aged 2-6 months. Enterovirus A71 Vaccine is also one of the best preventive agents to control enterovirus infection with severe complications.
Enterovirus A71 is significantly more pathogenic than other known enteroviruses, especially for neurological complications. According to Taiwan CDC's survey data, children under the age of 5 in particular, are more prone to critical complications and death. The case-fatality rate for enterovirus infection with severe complications (EVSC) ranges from 1.3% to 33.3%.
Features
- The Vaccine efficacy against Enterovirus A71 infection is as at least 96.8%.
- Good safety and tolerability profiles for infants 2-6 months of age.
- The booster vaccination after 1 year of prime series achieves protection for at least 2 years.
- Manufactured in PIC/S GMP certificated cell culture facility.
- Cross-protection against different Enterovirus A71 subgenogroups proven in an MRCT large-scale clinical study.
Progress
- On Oct 1, 2021, MVC submits a New Drug Application (NDA) for Enterovirus A71 Vaccine to the Taiwan FDA.
- In June 2021, the Data and Safety Monitoring Board (DSMB) meeting was held online to review the efficacy endpoint. The study results demonstrate that Enterovirus A71 Vaccine has good cross-protection against different Enterovirus A71 strains in Taiwan and Vietnam, and has a good safety profile in infants and children aged 2 months to 6 years.
- In April 2021, the sub-study for primary immunogenicity was completed and met its endpoint.
- The MRCT phase III clinical trial for Enterovirus A71 Vaccine was initiated in April 2019 and the first study intervention was completed for all 3,049 subjects in December 2019.
EV71 Vaccine
R&D/Preclinical
Phase I
Phase II
Phase III
Marketed
Publications
Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial
12 April 2022|The Lancet
READ MOREImmunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan
22 March 2019|Vaccine
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