Licensed vaccine
JYNNEOS
FDA-licensed vaccine · Bavarian Nordic · STN 125678
Key facts
| Trade name | JYNNEOS |
|---|---|
| Proper name | Smallpox and Monkeypox Vaccine, Live, Non-Replicating |
| Manufacturer | Bavarian Nordic |
| Submission tracking number (STN) | 125678 |
| FDA product areas | Biologics |
| Recent FDA documents | November 25, 2024 Approval Letter - JYNNEOS, October 18, 2024 Approval Letter - JYNNEOS, May 28, 2024 564A expiry extension letter - Jynneos, September 29, 2023 Approval Letter - JYNNEOS, March 16, 2023 Approval Letter - JYNNEOS, March 14, 2023 Approval Letter - JYNNEOS, September 2, 2022 Approval Letter - JYNNEOS, June 16, 2021 Approval Letter - JYNNEOS, June 7, 2021 Approval Letter - JYNNEOS, Demographic Subgroup Information - JYNNEOS, Approval History, Letters, Reviews, and Related Documents - JYNNEOS, September 24, 2019 Summary Basis for Regulatory Action - JYNNEOS |
| FDA page updated | Nov 25, 2024 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 10–99 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: