Drugs / FluMist® Quadrivalent
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | FluMist Quadrivalent | influenza | 2023-10-24 | “FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA).” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03088904 | Oct 2014 → Dec 2018 | influenza | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-10-24 | AstraZeneca | Regulatory US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FluMist Quadrivalent astrazeneca.com ↗
AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). |
| 2023-10-11 | AstraZeneca | Results AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023 astrazeneca.com ↗
FluMist Quadrivalent data support the potential for a self-administered influenza vaccine to expand access to an important tool for prevention |
| 2016-06-23 | AstraZeneca | Regulatory AstraZeneca provides update on Flumist Quadrivalent Vaccine in the US for the 2016-17 influenza season astrazeneca.com ↗
The updated guidance states the vaccine should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons in the US, which indicated FluMist Quadrivalent did not demonstrate statistically significant effectiveness in children 2-17 years of age. |
All press releases naming this drug 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FluMist Quadrivalent | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03088904 ↗ |
| Modality | Vaccine | “LAIV4 vaccine dosage is 0.2 mL.” NCT03088904 ↗ |
| Route | Intranasal | “Vaccine will be administered as an intranasal spray.” NCT03088904 ↗ |