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Walvax PCV13-TT
Walvax PCV13-TT is a Conjugate vaccine Biologic drug developed by Walvax Biotechnology Co., Ltd.. It is currently in Phase 3 development for Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae.
Walvax PCV13-TT is a conjugate vaccine that stimulates the body's immune response to protect against pneumococcal disease.
Walvax PCV13-TT is a 13-valent pneumococcal polysaccharide conjugate vaccine used to study pneumococcal infections, pneumococcal disease, and invasive pneumococcal infections. It is a small molecule vaccine developed by Sinovac Biotech Co., Ltd.
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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 | Walvax PCV13-TT |
|---|---|
| Sponsor | Walvax Biotechnology Co., Ltd. |
| Drug class | Conjugate vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
It works by introducing antigens from 13 serotypes of Streptococcus pneumoniae to the body, which triggers the production of antibodies to fight the bacteria. This provides immunity against invasive pneumococcal disease, including pneumonia, meningitis, and sepsis.
Approved indications
- Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae
Common side effects
- Pain, redness, or swelling at the injection site
- Fever
Key clinical trials
- Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PHASE1)
- A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13 (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:
- Walvax PCV13-TT CI brief — competitive landscape report
- Walvax PCV13-TT updates RSS · CI watch RSS
- Walvax Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about Walvax PCV13-TT
What is Walvax PCV13-TT?
How does Walvax PCV13-TT work?
What is Walvax PCV13-TT used for?
Who makes Walvax PCV13-TT?
What drug class is Walvax PCV13-TT in?
What development phase is Walvax PCV13-TT in?
What are the side effects of Walvax PCV13-TT?
Related
- Drug class: All Conjugate vaccine drugs
- Manufacturer: Walvax Biotechnology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of invasive pneumococcal disease caused by 13 serotypes of Streptococcus pneumoniae
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing