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wSp vaccine
wSp vaccine is a Biologic drug developed by Serum Life Science Europe GmbH. It is currently in Phase 2 development. Also known as: SPWCV, PATH-wSP.
The wSp vaccine is a vaccine component that induces an immune response, used to prevent invasive pneumococcal disease, pneumonia, and other pneumococcal-related conditions such as acute otitis media. It is a whole-cell Streptococcus pneumoniae vaccine, administered as a single dose to healthy adults in clinical trials.
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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).
| 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 | wSp vaccine |
|---|---|
| Also known as | SPWCV, PATH-wSP |
| Sponsor | Serum Life Science Europe GmbH |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of wSp Vaccine in Young Children (PHASE2)
- Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults (PHASE1)
- Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
- Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers (PHASE1, PHASE2)
- A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya (PHASE1, PHASE2)
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:
- wSp vaccine CI brief — competitive landscape report
- wSp vaccine updates RSS · CI watch RSS
- Serum Life Science Europe GmbH portfolio CI
Frequently asked questions about wSp vaccine
What is wSp vaccine?
Who makes wSp vaccine?
Is wSp vaccine also known as anything else?
What development phase is wSp vaccine in?
Related
- Manufacturer: Serum Life Science Europe GmbH — full pipeline
- Also known as: SPWCV, PATH-wSP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing