# Comirnaty (COVID-19 Vaccine, mRNA) by Pfizer Laboratories Div Pfizer Inc: new vaccine listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | Comirnaty |
| Generic name | COVID-19 Vaccine, mRNA |
| NDC | 0069-2631 |
| Labeler | Pfizer Laboratories Div Pfizer Inc |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125742 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | BNT-162B2 OMICRON (XFG) MRNA .042 mg/.418mL |
| Marketing start | 2026-08-27 |
| 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=0069-2631). Last refreshed: 2026-11-03T18:09:00.764Z.
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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.