Influenza Vaccine Flucelvax® Trivalent 2024 - 2025 Flu Vaccine 60 mcg / 0.5 mL Indicated for People 6 Months of Age and Above Prefilled Syringe 0.5 mL by Seqirus USA, Inc. ID 70461-0654-03

FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FLUCELVAX is approved for use in persons 6 months of age and older.

For Intramuscular Use:

^a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

FLUCELVAX is an injectable suspension. A single dose is 0.5 mL.

Do not administer FLUCELVAX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX should be based on careful consideration of the potential benefits and risks.

Note: Adverse Reaction Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.

• In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%).
• In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).
• In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%).
• In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%).
• In adults ≥ 65 years who received FLUCELVAX the most commonly reported injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Pregnancy - Risk Summary:

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data collected in a prospective Pregnancy Exposure Registry from 665 women vaccinated with FLUCELVAX QUADRIVALENT showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when FLUCELVAX QUADRIVALENT is administered during any trimester of pregnancy. Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.

Geriatric:

Antibody responses were lower in adults 65 years and older than in younger adults.

FLUCELVAX (Influenza Vaccine) is a trivalent subunit influenza vaccine manufactured using cell derived candidate vaccine viruses (CVV) that are propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with β-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the virus strains are produced and purified separately then pooled to formulate the vaccine.

FLUCELVAX is a sterile, slightly opalescent injectable suspension in phosphate buffered saline. FLUCELVAX is standardized according to United States Public Health Service requirements for the 2024-2025 influenza season and is formulated to contain a total of 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following influenza strains:

A/Georgia/12/2022 CVR-167 (an A/Wisconsin/67/2022 (H1N1)pdm09-like virus);

A/Sydney/1304/2022 (an A/Massachusetts/18/2022 (H3N2)-like virus);

B/Singapore/WUH4618/2021 (a B/Austria/1359417/2021-like virus).

Each dose of FLUCELVAX may contain residual amounts of MDCK cell protein (≤ 21.6 mcg), protein other than HA (≤ 225 mcg), MDCK cell DNA (≤ 10 ng), polysorbate 80 (≤ 1125 mcg), cetyltrimethylammonium bromide (≤ 13.5 mcg), and β-propiolactone (< 0.5 mcg), which are used in the manufacturing process.

FLUCELVAX contains no egg protein or antibiotics.

FLUCELVAX 0.5 mL pre-filled syringes contain no preservative.

FLUCELVAX 5 mL multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury.

The tip caps and plungers of the pre-filled syringes and the multi-dose vial stopper are not made with natural rubber latex.

FLUCELVAX Product Presentations

Store this product refrigerated at 2°C to 8°C (36ºF to 46ºF). Between uses, return the multi-dose vial to the recommended storage conditions. Do not freeze. Protect from light. Do not use after the expiration date.