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EV71 Inactivated Vaccine
EV71 Inactivated Vaccine is a Biologic drug developed by Sinovac Biotech Co., Ltd. It is currently in Phase 2 development for Prevention of EV71 infections.
EV71 Inactivated Vaccine works by exposing the body to a small, harmless piece of the EV71 virus to stimulate the immune system to produce antibodies and provide immunity against future EV71 infections.
The EV71 Inactivated Vaccine is a vaccine component that induces an immune response through biological mechanisms. It is used to prevent Hand, Foot and Mouth Disease, Enterovirus 71 Human, Herpangina, and other EV71-associated diseases, and is typically administered in a dose of 400U /0.5ml.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | EV71 Inactivated Vaccine |
|---|---|
| Sponsor | Sinovac Biotech Co., Ltd |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 2 |
Mechanism of action
This vaccine is designed to induce a specific immune response against the EV71 virus, which can cause severe neurological diseases in children. By exposing the body to a small, inactivated piece of the virus, the vaccine stimulates the production of antibodies that can recognize and neutralize the virus, providing protection against future infections.
Approved indications
- Prevention of EV71 infections
Common side effects
- Pain, redness, swelling, or itching at the injection site
- Fatigue
- Headache
Key clinical trials
- Tolerability, Safety, and Immunogenicity of Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). (PHASE1, PHASE2)
- Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial (PHASE1, PHASE2)
- A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years (PHASE3)
- Study on the Persistence of Immunity Following EV71 Vaccination
- Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) (PHASE3)
- A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children (PHASE3)
- Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine (PHASE4)
- Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EV71 Inactivated Vaccine CI brief — competitive landscape report
- EV71 Inactivated Vaccine updates RSS · CI watch RSS
- Sinovac Biotech Co., Ltd portfolio CI
Frequently asked questions about EV71 Inactivated Vaccine
What is EV71 Inactivated Vaccine?
How does EV71 Inactivated Vaccine work?
What is EV71 Inactivated Vaccine used for?
Who makes EV71 Inactivated Vaccine?
What development phase is EV71 Inactivated Vaccine in?
What are the side effects of EV71 Inactivated Vaccine?
Related
- Manufacturer: Sinovac Biotech Co., Ltd — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Prevention of EV71 infections
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing