Data updated: Jun 28, 2026
Abrysvo (respiratory syncytial virus vaccine) · Pfizer
Approved 2023-05-30
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-05-30
- Routes
- Intramuscular
- Dosage Forms
- Injection
Abrysvo Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
May 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What Abrysvo Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2023)
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
HYMPAVZI
2024 MARSTACIMAB-HNCQ
2 designations
LITFULO
2023 RITLECITINIB TOSYLATE
PAXLOVID (COPACKAGED)
2023 NIRMATRELVIR
3 designations
ELREXFIO
2023 ELRANATAMAB
5 designations
ZAVZPRET
2023 ZAVEGEPANT HYDROCHLORIDE
NGENLA
2023 SOMATROGON-GHLA
1 designation
VELSIPITY
2023 ETRASIMOD ARGININE
CIBINQO
2022 ABROCITINIB
2 designations
NURTEC ODT
2020 RIMEGEPANT SULFATE
LORBRENA
2018 LORLATINIB
4 designations
TALZENNA
2018 TALAZOPARIB TOSYLATE
1 designation
DAURISMO
2018 GLASDEGIB MALEATE
2 designations
📋
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06551506 | 24-0003 5UM1AI148684-04 | Ph 4 | completed | The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products |
| NCT07232706 PIPELINE-RSV-F | 24-04 2025-521755-23-00, PIPELINE-RSV-France | Ph 3 | recruiting | Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination |
| NCT07041190 PIPELINE-RSV | PIPELINE RSV-International 2025-522194-11-00 | Ph 3 | not yet recruiting | Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination. |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Abrysvo FDA Label Details
Track Abrysvo with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.