FLUCELVAX TIV PRE-FILLED SYRINGES 10 PACK 2026

Flucelvax® Trivalent 0.5 mL Single-Dose Pre-Filled Syringe – Carton of 10
2026–2027 Influenza Season

** NEEDLES NOT INCLUDED **
Age Indication: 6 months and older
Preservative Status: Preservative-free
Latex Status: No latex
Antibiotics Status: No antibiotics
CPT Code: 90661
10 Doses

Storage and Handling:
** REFRIGERATED PRODUCT **
- Store refrigerated at 2-8°C (36-46°F).
- Do not freeze. Discard if the product has been frozen.
- Protect from light.
- Do not use beyond the expiration date printed on the label.

Flucelvax® Trivalent is a cell-based, injectable influenza vaccine formulated for the 2026–2027 flu season. Each 0.5 mL dose is administered intramuscularly and supplied in preservative-free, single-dose pre-filled syringes.

Cell-Based Manufacturing Advantage

Flucelvax is manufactured using cell-derived candidate vaccine viruses (CVVs) grown in Madin-Darby Canine Kidney (MDCK) cells. Unlike traditional egg-based influenza vaccines, this production process does not rely on eggs.

Why this matters:

• Avoids egg-adaptive mutations that can occur with egg-based production
• Fully egg-free formulation
• Modern, scalable manufacturing platform
• Strong clinical differentiation in the standard-dose category

During production, each influenza strain is:

• Inactivated using β-propiolactone
• Disrupted with cetyltrimethylammonium bromide
• Purified through multiple processing steps
• Manufactured and purified separately before being combined into the final trivalent formulation

Composition & Potency

Flucelvax is a sterile, slightly opalescent suspension in phosphate-buffered saline and is standardized in accordance with U.S. Public Health Service requirements for the 2026–2027 influenza season.

Each 0.5 mL dose contains:

• 45 micrograms (mcg) total hemagglutinin (HA)
  • 15 mcg HA from each of the three recommended influenza strains

Residual Components (Trace Amounts)

• MDCK cell protein (≤ 21.6 mcg)
• Non-HA protein (≤ 225 mcg)
• MDCK cell DNA (≤ 10 ng)
• Polysorbate 80 (≤ 1125 mcg)
• Cetyltrimethylammonium bromide (≤ 13.5 mcg)
• β-propiolactone (< 0.5 mcg)

Additional Product Information

• Does not contain egg protein
• Does not contain antibiotics
• Preservative-free pre-filled syringes
• Syringe components are not made with natural rubber latex