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V503 Vaccine
V503 Vaccine is a Vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18 in females aged 9 to 26 years.
V503 Vaccine works by stimulating the body's immune system to produce antibodies against the human papillomavirus (HPV) types 16 and 18.
The V503 vaccine is a multivalent human papillomavirus (HPV) L1 virus-like particle (VLP) vaccine used to prevent cervical cancers, vulvar cancer, vaginal cancer, genital lesions, and PAP test abnormalities. It induces an immune response through its biological vaccine mechanism as a component of a vaccine.
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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. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | V503 Vaccine |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine is a non-replicating virus-like particle (VLP) vaccine that contains the L1 protein of HPV types 16 and 18. Upon administration, the L1 protein is taken up by antigen-presenting cells, which then present the protein to T-cells, stimulating an immune response against the HPV types 16 and 18.
Approved indications
- Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18 in females aged 9 to 26 years
Common side effects
- Injection site pain
- Fatigue
- Headache
Key clinical trials
- A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004) (PHASE1)
- Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076) (PHASE3)
- Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064) (PHASE3)
- Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). (PHASE1)
- Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066) (PHASE3)
- Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) (PHASE3)
- Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024) (PHASE3)
- Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052) (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:
- V503 Vaccine CI brief — competitive landscape report
- V503 Vaccine updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about V503 Vaccine
What is V503 Vaccine?
How does V503 Vaccine work?
What is V503 Vaccine used for?
Who makes V503 Vaccine?
What drug class is V503 Vaccine in?
What development phase is V503 Vaccine in?
What are the side effects of V503 Vaccine?
Related
- Drug class: All Vaccine drugs
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18 in females aged 9 to 26 years
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing