Drugs / TBE vaccine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | TICOVAC | tick-borne encephalitis | — | “whether and when the BLA pending in the U.S. may be approved” pfizer.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01131910 | May 2010 → May 2011 | immunodeficiency disease, rheumatoid arthritis, tick-borne encephalitis | Sormland County Council, Sweden | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04648241 | Jan 2021 → Feb 2022 | tick-borne encephalitis | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-08-13 | Pfizer | Regulatory U.S. FDA Approves TICOVAC™, Pfizer’s Tick-Borne Encephalitis (TBE) Vaccine pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TICOVAC™ (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. |
| 2021-02-23 | Pfizer | Regulatory U.S. FDA Accepts for Priority Review Pfizer’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine) pfizer.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-13 | Pfizer | U.S. FDA Approves TICOVAC™, Pfizer’s Tick-Borne Encephalitis (TBE) Vaccine pfizer.com ↗ |
| 2021-02-23 | Pfizer | U.S. FDA Accepts for Priority Review Pfizer’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine) pfizer.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TBE-vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01131910 ↗ |
| Modality | Vaccine | “TBE-vaccine” NCT01131910 ↗ |
| Route | Intramuscular | “Solution of 0.5 ml for intramuscular use.” NCT01131910 ↗ |