# Spikevax (COVID-19 Vaccine, mRNA) by Moderna US, Inc.: new vaccine listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | Spikevax |
| Generic name | COVID-19 Vaccine, mRNA |
| NDC | 80777-114 |
| Labeler | Moderna US, Inc. |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125752 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | CX-055611 50 ug/.5mL |
| Marketing start | 2026-08-17 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=80777-114). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.