Last reviewed · How we verify
VLA2001 - adolescent part
VLA2001 - adolescent part is a vaccine Biologic drug developed by Valneva Austria GmbH. It is currently in Phase 3 development for COVID-19 prevention in adolescents.
VLA2001 is a COVID-19 vaccine that uses a recombinant, replication-incompetent chimpanzee adenovirus vector to express the SARS-CoV-2 spike protein.
VLA2001 is a small molecule vaccine being studied for its effectiveness against SARS-CoV-2 virus infection. The VLA2001 adolescent part is a component of the COV-COMPARE study, which compares the immunogenicity of VLA2001 to AZD1222 in individuals of various age groups, including adolescents.
-
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 | VLA2001 - adolescent part |
|---|---|
| Sponsor | Valneva Austria GmbH |
| Drug class | vaccine |
| Target | SARS-CoV-2 spike protein |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine induces an immune response against the SARS-CoV-2 spike protein, which is a key component of the virus responsible for COVID-19. By expressing the spike protein, the vaccine stimulates the body to produce antibodies and immune cells that can recognize and neutralize the virus. This provides protection against COVID-19 infection.
Approved indications
- COVID-19 prevention in adolescents
Common side effects
- Pain, redness, or swelling at the injection site
- Fatigue
- Headache
Key clinical trials
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:
- VLA2001 - adolescent part CI brief — competitive landscape report
- VLA2001 - adolescent part updates RSS · CI watch RSS
- Valneva Austria GmbH portfolio CI
Frequently asked questions about VLA2001 - adolescent part
What is VLA2001 - adolescent part?
How does VLA2001 - adolescent part work?
What is VLA2001 - adolescent part used for?
Who makes VLA2001 - adolescent part?
What drug class is VLA2001 - adolescent part in?
What development phase is VLA2001 - adolescent part in?
What are the side effects of VLA2001 - adolescent part?
What does VLA2001 - adolescent part target?
Related
- Drug class: All vaccine drugs
- Target: All drugs targeting SARS-CoV-2 spike protein
- Manufacturer: Valneva Austria GmbH — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for COVID-19 prevention in adolescents
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing