Licensed vaccine
MNEXSPIKE
FDA-licensed vaccine · ModernaTX, Inc. · STN 125835
Key facts
| Trade name | MNEXSPIKE |
|---|---|
| Proper name | COVID-19 Vaccine, mRNA |
| Manufacturer | ModernaTX, Inc. |
| Submission tracking number (STN) | 125835 |
| Recent FDA documents | May 30, 2025 Approval Letter - MNEXSPIKE, Patient Package Insert - MNEXSPIKE, Package Insert - MNEXSPIKE |
| FDA page updated | May 31, 2025 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 1–9 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: