Influenza Vaccine Afluria® Trivalent 2024 - 2025 Influenza Virus Vaccine, Inactivated, Preservative Free 60 mcg / 0.5 mL Injection 0.5 mL Prefilled Syringe by Seqirus USA, Inc. ID 33332-0024-03

• AFLURIA is an inactivated influenza vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.


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

For Intramuscular Use:

• By needle and syringe (6 months of age and older)
• By PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age)

AFLURIA Dosage and Schedule Table

^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.

AFLURIA is an injectable suspension. A single dose is 0.25 mL or 0.5 mL depending on age.

Do not administer AFLURIA 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 dose of any influenza vaccine.

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

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

Administered by needle and syringe (AFLURIA QUADRIVALENT data):

• In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse reactions were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).


• In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse reactions were malaise and fatigue, and diarrhea (≥ 10%).


• In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reaction was headache (≥ 10%).


• In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reactions were headache, myalgia, and malaise and fatigue (≥ 10%).


• In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse reactions were myalgia and headache (≥ 20%).


• In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse reaction was myalgia (≥ 10%).

Administered by the PharmaJet Stratis Needle-Free Injection System:

• In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse reactions were myalgia, malaise (≥ 30%), and headache (≥ 20%).

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 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. Data collected prospectively in a Pregnancy Exposure Registry from individuals vaccinated with AFLURIA QUADRIVALENT revealed no evidence of vaccine-associated increase in the risk of major birth defects or miscarriages. Data for AFLURIA QUADRIVALENT are relevant to AFLURIA because both vaccines are manufactured using the same process and have overlapping compositions.

Geriatric:

Antibody responses were lower in geriatric subjects than in younger adults.

AFLURIA, Influenza Vaccine, is a sterile, clear, colorless to slightly opalescent injectable suspension for intramuscular use with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza viruses propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the viruses are purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified viruses are inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce “split virions”. The disrupted viruses are further purified and suspended in a phosphate buffered isotonic solution.

AFLURIA is standardized according to USPHS requirements for the 2024-2025 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2024-2025 Northern Hemisphere 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); and B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus). A 0.25 mL dose contains 7.5 mcg HA of each of the same influenza strains.

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain preservative. The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury.

A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 61.5 nanograms [ng]), polymyxin B (≤ 10.5 ng), beta-propiolactone (< 2.3 ng) and hydrocortisone (≤ 0.56 ng). A single 0.25 mL dose of AFLURIA contains half of these quantities.

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial are not made with natural rubber latex.

Each product presentation includes a package insert and the following components:

• Store refrigerated at 2−8°C (36−46°F).
• Do not freeze. Discard if product has been frozen.
• Protect from light.
• Do not use AFLURIA beyond the expiration date printed on the label.
• Between uses, return the multi-dose vial to the recommended storage conditions.
• Once the stopper of the multi-dose vial has been pierced the vial must be discarded within 28 days.
• The number of needle punctures must not exceed 20 per multi-dose vial.