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Vaxigrip QIV
Vaxigrip QIV is a Inactivated vaccine Biologic drug developed by Sinovac Biotech Co., Ltd. It is currently in Phase 3 development for Prevention of influenza disease caused by four different strains of the influenza virus.
Vaxigrip QIV is a quadrivalent inactivated influenza vaccine that stimulates the body's immune system to produce antibodies against four different influenza viruses.
Vaxigrip QIV is a tetravalent inactivated influenza vaccine used to prevent influenza. It is administered as a single dose of 0.5 mL to individuals at risk for severe and complicated influenza.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Vaxigrip QIV |
|---|---|
| Sponsor | Sinovac Biotech Co., Ltd |
| Drug class | Inactivated vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine works by introducing inactivated forms of the influenza viruses to the body, which triggers an immune response and helps to protect against future infections. The quadrivalent formulation includes two influenza A viruses and two influenza B viruses, providing protection against a broader range of strains.
Approved indications
- Prevention of influenza disease caused by four different strains of the influenza virus
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women (PHASE3)
- INfluenza VaccInation To Mitigate typE 1 Diabetes (PHASE4)
- Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (PHASE3)
- Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza (PHASE4)
- Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile (PHASE3)
- Intradermal Influenza Vaccine With Topical Imiquimod in Elderly and Chronic Illness Patients (PHASE3)
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:
- Vaxigrip QIV CI brief — competitive landscape report
- Vaxigrip QIV updates RSS · CI watch RSS
- Sinovac Biotech Co., Ltd portfolio CI
Frequently asked questions about Vaxigrip QIV
What is Vaxigrip QIV?
How does Vaxigrip QIV work?
What is Vaxigrip QIV used for?
Who makes Vaxigrip QIV?
What drug class is Vaxigrip QIV in?
What development phase is Vaxigrip QIV in?
What are the side effects of Vaxigrip QIV?
Related
- Drug class: All Inactivated vaccine drugs
- Manufacturer: Sinovac Biotech Co., Ltd — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of influenza disease caused by four different strains of the influenza virus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing