Influenza Vaccine FLUAD™ Trivalent 2024 - 2025 Flu Vaccine, Adjuvanted 45 mcg / 0.5 mL Indicated For People 65 Years of Age and Above Prefilled Syringe 0.5 mL Thimerosal-Free by Seqirus USA, Inc. ID 70461-0024-03

FLUAD is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in adults 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

For Intramuscular Use:

A single 0.5 mL dose for intramuscular injection.

FLUAD is an injectable emulsion. A single dose is 0.5 mL.

Do not administer FLUAD to anyone with a history of a severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.

If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.

The most common (≥10%) local and systemic adverse reactions in adults 65 years of age and older who received FLUAD were injection site pain (25%), injection site tenderness (21%), myalgia (15%), fatigue (13%) and headache (13%).

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:

FLUAD is not approved for use in persons < 65 years of age. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. 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. The data are insufficient to establish if there is vaccine-associated risk with FLUAD in pregnant women.

Pediatric Use

The safety and effectiveness of FLUAD in infants less than 6 months of age and in children older than 72 months of age have not been evaluated.

Geriatric Use

Safety and immunogenicity of FLUAD have been evaluated in adults 65 years of age and older.

FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus.

FLUAD is standardized according to United States Public Health Service requirements and each 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following influenza strains recommended for the 2024-2025 influenza season: A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Thailand/8/2022 IVR-237 (an A/Thailand/8/2022 (H3N2)-like virus), B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus). FLUAD also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. Each of the strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). The antigen preparation is further purified.

FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant. After combining, FLUAD is a sterile, milky-white injectable emulsion supplied in single-dose pre-filled syringes containing 0.5 mL dose. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the three recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7.

FLUAD may contain trace amounts of neomycin (≤ 0.02 mcg by calculation), kanamycin (≤ 0.03 mcg by calculation) and hydrocortisone (≤ 0.005 ng by calculation) which are used during the initial stages of manufacture, as well as residual egg protein (ovalbumin) (≤ 0.4 mcg), formaldehyde (≤ 10 mcg) or CTAB (≤ 12 mcg).

FLUAD does not contain a preservative. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex.

FLUCELVAX Product Presentations

The syringe, syringe plunger stopper and tip cap are not made with natural rubber latex.

Store FLUAD refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.