Licensed vaccine
SPIKEVAX
FDA-licensed vaccine · Moderna Tx, Inc · STN 125752
Key facts
| Trade name | SPIKEVAX |
|---|---|
| Proper name | COVID-19 Vaccine, mRNA |
| Manufacturer | Moderna Tx, Inc |
| Submission tracking number (STN) | 125752 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | January 27, 2025 Approval Letter - SPIKEVAX, September 6, 2024 Approval Letter - SPIKEVAX, August 22, 2024 Approval Letter - SPIKEVAX, April 19, 2024 Approval Letter - SPIKEVAX, September 11, 2023 Statistical Review - SPIKEVAX, September 11, 2023 Clinical Review - SPIKEVAX, Spikevax (COVID-19 Vaccine, mRNA), September 11, 2023 Approval Letter - SPIKEVAX, May 9, 2023 Approval Letter - SPIKEVAX, Approval History, Letters, Reviews, and Related Documents - SPIKEVAX, Demographic Subgroup Information – COVID-19 Vaccine, mRNA (SPIKEVAX).Refer to Section 1.1 of the Clinical Review Memo for information about, January 30, 2022 Summary Basis for Regulatory Action - SPIKEVAX |
| FDA page updated | Jan 31, 2025 |
| 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: