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control pneumococcal polysaccharide vaccine
control pneumococcal polysaccharide vaccine is a vaccine Biologic drug developed by Aimei Vacin BioPharm (Zhejiang) Co., Ltd.. It is currently in Phase 3 development for Prevention of pneumococcal disease in adults 18 years of age and older.
This vaccine works by stimulating the body's immune system to produce antibodies against pneumococcal bacteria.
This vaccine works by stimulating the body's immune system to produce antibodies against pneumococcal bacteria. Used for Prevention of pneumococcal disease in adults 18 years of age and older.
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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 | control pneumococcal polysaccharide vaccine |
|---|---|
| Sponsor | Aimei Vacin BioPharm (Zhejiang) Co., Ltd. |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The pneumococcal polysaccharide vaccine contains inactivated pneumococcal bacteria, which are used to stimulate the body's immune system to produce antibodies against these bacteria. These antibodies help to protect against infections caused by pneumococcal bacteria.
Approved indications
- Prevention of pneumococcal disease in adults 18 years of age and older
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
- A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002) (PHASE1)
- Nasopharyngeal Carriage of S. Pneumoniae (NA)
- Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Prior Pneumococcal Vaccination (PHASE3)
- Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine (PHASE2)
- Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49 (PHASE3)
- A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age (PHASE3)
- Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases (PHASE4)
- Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (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:
- control pneumococcal polysaccharide vaccine CI brief — competitive landscape report
- control pneumococcal polysaccharide vaccine updates RSS · CI watch RSS
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd. portfolio CI
Frequently asked questions about control pneumococcal polysaccharide vaccine
What is control pneumococcal polysaccharide vaccine?
How does control pneumococcal polysaccharide vaccine work?
What is control pneumococcal polysaccharide vaccine used for?
Who makes control pneumococcal polysaccharide vaccine?
What drug class is control pneumococcal polysaccharide vaccine in?
What development phase is control pneumococcal polysaccharide vaccine in?
What are the side effects of control pneumococcal polysaccharide vaccine?
Related
- Drug class: All vaccine drugs
- Manufacturer: Aimei Vacin BioPharm (Zhejiang) Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of pneumococcal disease in adults 18 years of age and older
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing