Data updated: Jun 28, 2026
CAPVAXIVE (pneumococcal 21-valent conjugate vaccine) · Merck
Approved 2024-06-16
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-06-16
- Patent Cliff
- 2036
- Routes
- Intramuscular
- Dosage Forms
- Injection
CAPVAXIVE Approval History
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Jun 2024 ORIGINAL
Update · CBER biologic (Purple Book)
What CAPVAXIVE Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2024)
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
ENFLONSIA
2025 CLESROVIMAB-CFOR
1 designation
KEYTRUDA QLEX
2025 PEMBROLIZUMAB
1 designation
OHTUVAYRE
2024 ENSIFENTRINE
WINREVAIR
2024 SOTATERCEPT-CSRK
4 designations
VTAMA
2022 TAPINAROF
1 designation
VERQUVO
2021 VERICIGUAT
3 designations
WELIREG
2021 BELZUTIFAN
3 designations
RECARBRIO
2019 CILASTATIN SODIUM
2 designations
PIFELTRO
2018 DORAVIRINE
PREVYMIS
2017 LETERMOVIR
5 designations
STEGLATRO
2017 ERTUGLIFLOZIN
ZEPATIER
2016 ELBASVIR
3 designations
🔬
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.
CAPVAXIVE FDA Label Details
Track CAPVAXIVE 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.