Last reviewed · How we verify
TBE-vaccine
TBE-vaccine is a Biologic drug developed by Sormland County Council, Sweden. It is currently in Phase 2 development. Also known as: ATC-code J07B A01, J07B A01.
The TBE-vaccine, also known as the FSME vaccination, is a vaccine component that induces an immune response to protect against Tick Borne Encephalitis. It is typically administered in the form of an inactivated TBE whole virus vaccine, such as FSME-IMMUN 0.5ml Baxter.
-
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 | TBE-vaccine |
|---|---|
| Also known as | ATC-code J07B A01, J07B A01 |
| Sponsor | Sormland County Council, Sweden |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine (PHASE4)
- Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children (PHASE3)
- Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older (PHASE3)
- Primary TBE Vaccination for the Elderly (PHASE4)
- Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients (PHASE2)
- Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules (PHASE4)
- New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly (PHASE2, PHASE3)
- TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients (PHASE4)
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:
- TBE-vaccine CI brief — competitive landscape report
- TBE-vaccine updates RSS · CI watch RSS
- Sormland County Council, Sweden portfolio CI
Frequently asked questions about TBE-vaccine
What is TBE-vaccine?
Who makes TBE-vaccine?
Is TBE-vaccine also known as anything else?
What development phase is TBE-vaccine in?
Related
- Manufacturer: Sormland County Council, Sweden — full pipeline
- Also known as: ATC-code J07B A01, J07B A01
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing