U.S. labeling overview for the 2025–2026 season. Use per FDA labeling; local/CDC recommendations may differ.
Preservative-free
Latex-free components
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| Product | Presentation / Age | NDCs (Unit-of-Use / Unit-of-Sale) | Preservative | Latex statement | Storage (before use) |
|---|---|---|---|---|---|
| SPIKEVAX Moderna — mRNA (2025–2026) |
Single-dose prefilled syringe 0.5 mL (≥12 y) |
80777-0112-01 (UoU, syringe)80777-0112-96 (UoS, carton of 10)80777-0112-88 (UoS, carton of 2)80777-0112-93 (UoS, blister 10) |
Does not contain a preservative. | Tip cap & plunger not made with natural rubber latex. | Store −50 °C to −15 °C. After thaw: 2–8 °C up to 60 days or 8–25 °C up to 12 h. Do not refreeze. |
| SPIKEVAX Moderna — mRNA (2025–2026) |
Single-dose prefilled syringe 0.25 mL (6 m–11 y) |
80777-0113-09 (UoU, syringe)80777-0113-80 (UoS, carton of 10)80777-0113-87 (UoS, carton of 2) |
Does not contain a preservative. | Tip cap & plunger not made with natural rubber latex. | Same as above. |
| COMIRNATY Pfizer-BioNTech — mRNA (2025–2026) |
Single-dose prefilled syringe 0.3 mL (≥12 y) |
00069-2528-01 (UoU, syringe)00069-2528-10 (UoS, carton of 10) |
Does not contain preservatives. | PFS tip cap & plunger not made with natural rubber latex. | Store 2–8 °C. Do not freeze. May be at 8–25 °C for up to 12 h before use. |
| COMIRNATY Pfizer-BioNTech — mRNA (2025–2026) |
Single-dose vial 0.3 mL (5–11 y; blue cap) |
00069-2501-01 (UoU, vial)00069-2501-10 (UoS, carton of 10) |
Does not contain preservatives. | Vial stoppers not made with natural rubber latex. | May ship ultra-cold; after thaw 2–8 °C. Do not refreeze. Up to 12 h at 8–25 °C before use. |
| NUVAXOVID Novavax — protein subunit + Matrix-M |
Single-dose prefilled syringe 0.5 mL (≥65 y or 12–64 y with ≥1 high-risk condition) |
80631-0207-01 (UoU, syringe)80631-0207-10 (UoS, carton of 10) |
Does not contain a preservative. | Syringe tip cap & plunger not made with natural rubber latex. | Store 2–8 °C; protect from light. Do not freeze. |
Abbreviations: UoU = Unit-of-Use; UoS = Unit-of-Sale. Always verify lot-specific expiration and local policy before administration.