# FLUZONE HIGH DOSE NORTHERN HEMISPHERE (INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE) by Sanofi Vaccines US Inc.: new vaccine listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | FLUZONE HIGH DOSE NORTHERN HEMISPHERE |
| Generic name | INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| NDC | 49281-126 |
| Labeler | Sanofi Vaccines US Inc. |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA103914 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL; INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL; INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug/.5mL |
| Marketing start | 2026-07-02 |
| 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=49281-126). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.