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Pneumovax II
Pneumovax II is a vaccine Biologic drug developed by University of Oxford. It is currently in Phase 3 development for Prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae in adults 50 years of age and older.
Pneumovax II stimulates the immune system to produce antibodies against Streptococcus pneumoniae.
Pneumovax II is a protein-based vaccine that targets Streptococcus Pneumoniae. It is used to prevent infections caused by Streptococcus Pneumoniae, as indicated by its study in ClinicalTrials.gov for conditions such as Infections and Streptococcal infections.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Pneumovax II |
|---|---|
| Sponsor | University of Oxford |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This is achieved through the administration of inactivated pneumococcal polysaccharides, which are recognized by the immune system as foreign and trigger an immune response. This response leads to the production of antibodies that can recognize and bind to the polysaccharide capsule of S. pneumoniae, thereby preventing the bacteria from causing disease.
Approved indications
- Prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae in adults 50 years of age and older
Common side effects
- Injection site pain
- Fatigue
- Headache
Key clinical trials
- Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (PHASE3)
- Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer (PHASE1, PHASE2)
- Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine (PHASE1, PHASE2)
- Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial (PHASE2)
- Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (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:
- Pneumovax II CI brief — competitive landscape report
- Pneumovax II updates RSS · CI watch RSS
- University of Oxford portfolio CI
Frequently asked questions about Pneumovax II
What is Pneumovax II?
How does Pneumovax II work?
What is Pneumovax II used for?
Who makes Pneumovax II?
What drug class is Pneumovax II in?
What development phase is Pneumovax II in?
What are the side effects of Pneumovax II?
Related
- Drug class: All vaccine drugs
- Manufacturer: University of Oxford — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae in adults 50 years of age and older
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing