Fluzone Tiv Sh 2026 Injection, Suspension
FDA Label NDC 49281-626

Fluzone^® Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Fluzone Southern Hemisphere is approved for use in persons 6 months of age and older.

For intramuscular use

The dose and schedule for Fluzone Southern Hemisphere are presented in Table 1.

Fluzone Southern Hemisphere is clear and slightly opalescent in color. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial.

A maximum of ten doses can be withdrawn from the multi-dose vial.

Administer each dose intramuscularly.

Fluzone Southern Hemisphere is an injectable suspension.

For individuals 6 months through 35 months, a single dose is 0.25 mL or 0.5 mL.

For individuals 36 months and older, a single dose is 0.5 mL.

Do not administer Fluzone Southern Hemisphere to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)], including egg protein, or to a previous dose of any influenza vaccine.

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

The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. (1)

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Fluzone Southern Hemisphere.

If Fluzone Southern Hemisphere is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

Vaccination with Fluzone Southern Hemisphere may not protect all recipients.

Syncope (fainting) has been reported following vaccination with Fluzone Southern Hemisphere. Procedures should be in place to avoid injury from fainting.

Fluzone Southern Hemisphere and Fluzone are manufactured using the same process. This section summarizes data obtained from clinical studies with Fluzone and Fluzone Quadrivalent.

In children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness (>50%) and redness (>25%); the most common solicited systemic adverse reactions were irritability and drowsiness (>25% of children 6 months through 35 months) and myalgia (>20% of children 3 years through 8 years).

In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain (>50%); the most common solicited systemic adverse reactions were headache and myalgia (>30%).

In adults ≥65 years of age, the most common injection-site adverse reaction was pain (>20%); the most common solicited systemic adverse reactions were headache, myalgia, and malaise (>10%).

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

Children 6 Months through 8 Years of Age

Study 1 (NCT00391391) was a multi-center study conducted in the US. In this study, children 6 months through 35 months of age received two 0.25 mL doses of Fluzone, and children 3 years through 8 years of age received two 0.5 mL doses of Fluzone, irrespective of previous influenza vaccination history. The two doses (2006–2007 formulation) were administered 26 to 30 days apart. The safety analysis set included 97 children 6 months through 35 months of age and 163 children 3 years through 8 years of age. Table 2 and Table 3 summarize solicited injection site adverse reactions and systemic adverse reactions reported within 7 days post-vaccination via diary cards.

During the period from the first vaccination through 6 months following the second vaccination, there were no serious adverse events considered to be caused by vaccination and no deaths reported in this study.

Study 2 (NCT01240746) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. In this study, children 6 months through 35 months of age received one or two 0.25 mL doses of either Fluzone Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either Fluzone Quadrivalent, TIV-1, or TIV-2. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). For participants who received two doses, the doses were administered approximately 4 weeks apart. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Among participants 6 months through 8 years of age in the three vaccine groups combined, 49.3% were female (Fluzone Quadrivalent, 49.2%; TIV-1, 49.8%; TIV-2, 49.4%), 58.4% Caucasian (Fluzone Quadrivalent, 58.4%; TIV-1, 58.9%; TIV-2, 57.8%), 20.2% Black (Fluzone Quadrivalent, 20.5%; TIV-1, 19.9%; TIV-2, 19.1%), 14.1% Hispanic (Fluzone Quadrivalent, 14.3%; TIV-1, 13.2%; TIV-2, 14.7%), and 7.3% were of other racial/ethnic groups (Fluzone Quadrivalent, 6.8%; TIV-1, 8.0%; TIV-2, 8.5%). Table 4 and Table 5 summarize solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards.

Participants were monitored for unsolicited adverse events for 28 days after each dose and serious adverse events (SAEs) during the 6 months following the last dose.

Among children 6 months through 8 years of age, unsolicited non-serious adverse events were reported in 1360 (47.0%) recipients in the Fluzone Quadrivalent group, 352 (48.0%) recipients in the TIV-1 group, and 346 (48.0%) recipients in the TIV-2 group. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient.

Study 3 (NCT02915302) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. In this study, 1950 children 6 months through 35 months of age were randomly assigned to receive Fluzone Quadrivalent administered in either a volume of 0.25 mL (Group 1) or 0.5 mL (Group 2). For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. Of these participants, 49.7% were female, 74.3% were Caucasian, 19.2% were Black, 6.5% were of other racial groups, and 22.0% were Hispanic/Latino. Data for Fluzone Quadrivalent are relevant to Fluzone because both vaccines are manufactured using the same process and have overlapping compositions.

Table 6 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age.

The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates < 5%). Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination.

Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and 5 (0.5%) in Group 2.

Adults

Study 4 (NCT00772109) was a multi-center trial conducted in the US. In this study adults 18 through 64 years of age received Fluzone (2008–2009 formulation). The safety analysis set included 1421 Fluzone recipients. Table 7 summarizes solicited injection-site reactions and systemic adverse reactions reported within 7 days post-vaccination via diary cards.

Within 28 days and 6 months post-vaccination, a serious adverse event was reported by 5 (0.4%) and 20 (1.4%) Fluzone recipients, respectively. No serious adverse event was considered to be caused by vaccination. No deaths were reported during the 6 months post-vaccination.

In Study 5 (NCT00391053) adults 65 years of age and older received Fluzone (2006–2007 formulation). The study was a multi-center, double-blind trial conducted in the US. The safety analysis set included 1260 Fluzone recipients.

Table 8 summarizes solicited injection-site reactions and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the adverse reactions resolved within 3 days.

Within 6 months post-vaccination, 93 (7.4%) Fluzone recipients experienced a serious adverse event (N=1260). No deaths were reported within 28 days post-vaccination. A total of 7 deaths were reported during the period Day 29–180 post-vaccination: 7 (0.6%) among Fluzone recipients (N=1260). The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fluzone. Healthcare providers are encouraged to enroll women who receive Fluzone during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry at sanofipasteurpregnancyregistry.com or by calling 1-800-822-2463 (1-800-VACCINE).

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.

Available data with Fluzone use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes.

There were no developmental studies of Fluzone performed in animals. The developmental effects of Fluzone Quadrivalent are relevant to Fluzone because both vaccines are manufactured using the same process and have overlapping compositions. A developmental toxicity study was performed in female rabbits administered Fluzone Quadrivalent prior to mating and during gestation. The dose was 0.5 mL on each of five occasions (a single human dose is 0.5 mL). This study revealed no adverse effects to the fetus or pre-weaning development and no evidence of impaired female fertility due to Fluzone Quadrivalent (see Data).

Data

Animal Data: A developmental toxicity study was performed in female rabbits administered Fluzone Quadrivalent by intramuscular injection on 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation. The dose was 0.5 mL on each occasion (a single human dose is 0.5 mL). This study revealed no vaccine related fetal malformations and no adverse effects on pre-weaning development or female fertility.

Clinical Considerations

Disease-associated Maternal and/or Embryo/Fetal Risk

Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.

Fluzone is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:

Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

This product's labeling may have been updated. For the most recent prescribing information, please visit https://dailymed.nlm.nih.gov/dailymed/.

The following adverse events have been spontaneously reported during the post-approval use of Fluzone or Fluzone Quadrivalent. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluzone Quadrivalent.

• Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
• Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
• Eye Disorders: Ocular hyperemia
• Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
• Vascular Disorders: Vasculitis, vasodilatation/flushing
• Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, oropharyngeal pain, rhinorrhea, cough, wheezing, throat tightness
• Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
• General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain
• Gastrointestinal Disorders: Vomiting

Fluzone Southern Hemisphere and Fluzone are manufactured using the same process. Data in this section were obtained in studies with Fluzone.

It is not known if Fluzone is excreted in human milk. Data are not available to assess the effects of Fluzone on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone and any potential adverse effects on the breastfed child from Fluzone or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.

Safety and effectiveness of Fluzone in children below the age of 6 months have not been established. Safety and effectiveness of Fluzone in children 9 through 17 years of age is based on safety and effectiveness in children 6 months through 8 years of age and adults 18 years of age and older.

Safety and immunogenicity of Fluzone were evaluated in adults 65 years of age and older. [See Adverse Reactions (6.1) and Clinical Studies (14.3)] Antibody responses to Fluzone are lower in persons ≥65 years of age than in younger adults. [See Clinical Studies (14.5, 14.6)]

Fluzone Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton^® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation.

Fluzone Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color.

Antibiotics are not used in the manufacture of Fluzone Southern Hemisphere.

No presentation of Fluzone Southern Hemisphere is made with natural rubber latex.

Fluzone Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2025-Southern Hemisphere influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/Croatia/10136RV/2023 X-425A (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.

Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza virus infection. In some human studies, antibody titers ≥1:40 have been associated with protection from influenza illness in up to 50% of participants. (2) (3)

Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine.

Fluzone has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility in males.

Fluzone Southern Hemisphere and Fluzone are manufactured using the same process. Data in this section were obtained in studies with Fluzone and Fluzone Quadrivalent.

Study 6 (NCT not available) was a randomized, double-blind, placebo-controlled study conducted at a single US center during the 1999–2000 (Year 1) and 2000–2001 (Year 2) influenza seasons. The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. Participants received two 0.25ml doses of either Fluzone (N = 525) or a placebo (N = 261) 4 weeks apart. Among all randomized participants in both years, the mean age was 13.8 months; 52.5% were male, 50.8% were Caucasian, 42.0% were Black, and 7.2% were of other racial groups. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 10.

Study 7 ( NCT00538512) was a randomized, double-blind, placebo-controlled study conducted in a single US center during the 2007–2008 influenza season. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. Participants were 18 through 49 years of age (mean age was 23.3 years); 63.3% were female, 83.1% were Caucasian, and 16.9% were of other racial/ethnic groups. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 11.

In Study 1, a multi-center study conducted in the US, 68 children 6 months through 35 months of age given two 0.25 mL doses of Fluzone and 120 children 3 years through 8 years of age given two 0.5 mL doses of Fluzone were included in the per-protocol analysis set. The two doses (2006–2007 formulation) were administered 26 to 30 days apart. Females accounted for 42.6% of the participants in the 6 months through 35 months age group and 53.3% of the participants in the 3 years through 8 years age group. Most participants in the 6 months through 35 months and 3 years through 8 years age groups, respectively, were Caucasian (70.6% and 79.2%), followed by Hispanic (19.1% and 13.3%), and Black (7.4% and 4.2%).

The percentage of participants who received influenza vaccination during the previous influenza season was 54.4% for the 6 months through 35 months age group and 27.5% for the 3 years through 8 years age group. Table 12 shows seroconversion rates and the percentage of participants with an HI titer ≥1:40 pre-vaccination and one month following the second dose of Fluzone.

In Study 3 (NCT02915302) [see Adverse Reactions (6.1)], 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].

In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre- specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups >0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). GMT ratios (GMT_{0.5-mL dose} divided by GMT_{0.25-mL dose}) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI: 1.16; 1.74), 1.48 (95% CI: 1.21; 1.82), 1.33 (95% CI: 1.09; 1.62), and 1.41 (95% CI: 1.17; 1.70), respectively. Seroconversion rate (SCR) differences (SCR_{0.5-mL dose} minus SCR_{0.25-mL dose}) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 4.6% (95% CI: -0.4%; 9.6%), 5.1% (95% CI: 0.4%; 9.8%), 1.3% (95% CI: -2.9%; 5.6%), and 2.6% (95% CI: -1.4%; 6.5%). Data for Fluzone Quadrivalent are relevant to Fluzone because both vaccines are manufactured using the same process and have overlapping compositions.

Adults 18 through 64 years of age received Fluzone (2008–2009 formulation) in Study 4, a multi-center trial conducted in the US. For immunogenicity analyses, there were 1287 participants who received Fluzone in the per-protocol analysis set. There were fewer males (35.8%) than females. The mean age was 42.6 years (ranged from 18.2 through 65.0 years). Most participants were Caucasian (80.0%), followed by Hispanic (11.0%), and Black (6.3%). Table 13 shows seroconversion rates at 28 days following vaccination and the percentage of participants with an HI titer ≥1:40 prior to vaccination and 28 days following vaccination.

Adults 65 years of age and older received Fluzone (2006–2007 formulation) in Study 5, a multi-center trial conducted in the US. For immunogenicity analyses, there were 1275 participants who received Fluzone in the immunogenicity analysis set. Females accounted for 54.7% of participants. The mean age was 72.9 years (ranged from 65 through 94 years of age); 36% of participants were 75 years of age or older. Most participants were Caucasian (92.9%), followed by Hispanic (3.7%), and Black (2.7%). Table 14 shows seroconversion rates at 28 days following vaccination and the percentage of participants with an HI titer ≥1:40 prior to vaccination and 28 days following vaccination.

• 1 Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992–1993 and 1993–1994 influenza vaccines. N Engl J Med 1998;339:1797–802.
• 2 Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133–138.
• 3 Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767–777.

Multi-dose vial, 5 mL (NDC 49281-356-78) (not made with natural rubber latex). Supplied as package of one (NDC 49281-356-15). A maximum of ten doses can be withdrawn from the multi-dose vial.

Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-325-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-325-50).

Store all Fluzone Southern Hemisphere presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.

Between uses, return the multi-dose vial to the recommended storage conditions at 2° to 8°C (35° to 46°F).

Do not use after the expiration date shown on the label.

See FDA-approved patient labeling (Patient Information).

• Inform the patient or guardian that Fluzone Southern Hemisphere contains killed viruses and cannot cause influenza.
• Fluzone Southern Hemisphere stimulates the immune system to produce antibodies that help protect against influenza, but does not prevent other respiratory infections.
• Annual influenza vaccination is recommended.
• Instruct vaccine recipients and guardians to report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.
• Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Southern Hemisphere during pregnancy. Women who receive Fluzone Southern Hemisphere during pregnancy are encouraged to contact directly or have their healthcare provider contact Sanofi Pasteur Inc. at sanofipasteurpregnancyregistry.com or by calling 1-800-822-2463 (1-800-VACCINE).
• Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Please read this information sheet before getting Fluzone Southern Hemisphere vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.

What is Fluzone Southern Hemisphere vaccine?

Fluzone Southern Hemisphere is a vaccine that helps protect against influenza illness (flu).

Fluzone Southern Hemisphere vaccine is for people who are 6 months of age and older.

Vaccination with Fluzone Southern Hemisphere vaccine may not protect all people who receive the vaccine.

Who should not get Fluzone Southern Hemisphere vaccine?

You should not get Fluzone Southern Hemisphere vaccine if you:

• ever had a severe allergic reaction to eggs or egg products.
• ever had a severe allergic reaction after getting any influenza vaccine.
• are younger than 6 months of age.

Tell your healthcare provider if you or your child have or have had:

• Guillain-Barré syndrome (severe muscle weakness) after getting an influenza vaccine.
• problems with your immune system as the immune response may be diminished.

How is the Fluzone Southern Hemisphere vaccine given?

Fluzone Southern Hemisphere vaccine is given as an injection into the muscle.

What are the possible side effects of Fluzone Southern Hemisphere vaccine?

The most common side effects of Fluzone Southern Hemisphere vaccine are:

• pain, redness, swelling, bruising and hardness where you got the injection
• muscle aches
• tiredness
• headache
• fever

These are not all of the possible side effects of Fluzone Southern Hemisphere vaccine. Ask your healthcare provider about other side effects.

Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Southern Hemisphere during pregnancy. Women who receive Fluzone Southern Hemisphere during pregnancy are encouraged to contact directly or have their healthcare provider contact Sanofi Pasteur Inc. at sanofipasteurpregnancyregistry.com or by calling 1-800-822-2463 (1-800-VACCINE).

What are the ingredients in Fluzone Southern Hemisphere vaccine?

Fluzone Southern Hemisphere vaccine contains 3 killed influenza virus strains.

Other ingredients include formaldehyde and octylphenol ethoxylate. The preservative thimerosal is only in the multi-dose vial of Fluzone Southern Hemisphere vaccine.

Manufactured by:

Sanofi Pasteur Inc.

Swiftwater, PA 18370 USA

NDC 49281-325-88

Influenza Vaccine

Fluzone^®

Southern Hemisphere

2025 Formula
0.5 mL Single-Dose
No Preservative
Mfd by: Sanofi Pasteur Inc.

Rx only

For IM Use

Principal Display Panel (0.5 mL Syringe Label)

NDC 49281-325-50

2025
Formula

Influenza Vaccine
Fluzone^®

Southern Hemisphere

Rx only

For Intramuscular Use
For 6 months of age and older
10 single-dose prefilled syringes 0.5 mL each

sanofi

Principal Display Panel (0.5 mL Syringe Carton)

NDC 49281-356-78

Influenza Vaccine

Fluzone^®

Southern Hemisphere

5 mL Multi-Dose Vial
2025 Formula

Rx only

Contains Preservative. DO NOT FREEZE. Store at 2° to 8°C (35° to 46°F).
SHAKE WELL. Contents: One 5 mL multi-dose vial.
0.25 mL or 0.5 mL dose for 6 – 35 months.
0.5 mL dose for 3 years of age and older.
For Intramuscular Use. See package insert for details.

US Govt License #1725
Mfg by: Sanofi Pasteur Inc.

Principal Display Panel (5 mL Vial Label)

NDC 49281-356-15

2025
Formula

Influenza Vaccine
Fluzone^®

Southern Hemisphere

Rx only

For 6 months of age and older.
For Intramuscular Use.
5 mL multi-dose vial.
0.25 mL or 0.5 mL dose for 6 - 35 months.
0.5 mL dose for 3 years of age and older.

sanofi

Principal Display Panel (5 mL Vial Carton)