Fluad^®

MIMS Revision Date: 01 March 2026

1 Name of Medicine

Fluad. Inactivated influenza vaccine (surface antigen), adjuvanted, suspension for injection; containing Influenza virus haemagglutinin as active ingredient.

2 Qualitative and Quantitative Composition

Each 0.5 mL dose contains influenza virus surface antigens (haemagglutinin and neuraminidase) of each of three strains representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2026 season:
A/Missouri/11/2025 (H1N1)pdm09-like virus (A/Switzerland/6849/2025 IVR-278): 15 micrograms HA*;
A/Singapore/GP20238/2024 (H3N2)-like virus (A/Singapore/GP20238/2024 IVR-277): 15 micrograms HA*;
B/Austria/1359417/2021-like virus (B/Austria/1359417/2021 BVR-26): 15 micrograms HA* per 0.5 mL dose.
*HA = haemagglutinin.
Fluad vaccine is prepared from virus grown in embryonated hens' eggs and inactivated with formaldehyde before purification and combination with MF59C.1, an adjuvant known to increase the immunogenicity of vaccines. MF59C.1 adjuvant is a squalene based oil-in-water emulsion. Squalene is of fish origin. It is also a normal component in the human body and is easily metabolized and excreted. For a full list of excipients, see Section 6.1 List of Excipients.
The type and amount of viral antigens in Fluad conform to the requirements of the Australian Influenza Vaccine Committee for the 2026 Southern Hemisphere Influenza season. The strains chosen for vaccine manufacture are endorsed by the Australian Influenza Vaccine Committee as being antigenically equivalent to the reference virus.
Fluad is manufactured in eggs and trace amounts of kanamycin sulfate, neomycin sulfate, ovalbumin (≤ 1 microgram/0.5 mL dose), formaldehyde (≤ 1 microgram/0.5 mL dose), cetrimonium bromide (≤ 18 micrograms/0.5 mL dose), sucrose and hydrocortisone may be present as residues of the manufacturing process.

3 Pharmaceutical Form

Fluad is a milky-white suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Active immunisation against influenza in persons 50 years of age and older.
For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

4.2 Dose and Method of Administration

Fluad is for use in adults 50 years of age and older only. See Section 4.1 Therapeutic Indications.
A single 0.5 mL dose should be administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.
Gently shake before use. After shaking, the normal appearance of the vaccine is a milky-white suspension.
Visually inspect the contents of each pre-filled syringe for particulate matter and/or variation in appearance prior to administration. If either condition is observed, do not administer the vaccine.
Fluad contains no antimicrobial preservative. Each pre-filled syringe is for use in one patient on one occasion only. Discard any residue.
Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.
Persons with a history of egg allergy (non-anaphylaxis) can receive a full dose of vaccine in any immunisation setting (also see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

The vaccine is contraindicated in individuals with known severe allergic reactions (e.g. anaphylaxis) to:
any component of the vaccine (see Section 6.1 List of Excipients), except egg proteins (also see Section 4.4 Special Warnings and Precautions for Use); or
a previous dose of any influenza vaccine.

4.4 Special Warnings and Precautions for Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case an anaphylactic event occurs following the administration of the vaccine.
Persons with a history of anaphylaxis to egg should be vaccinated only in medical facilities with staff experienced in recognising and treating anaphylaxis. For full details regarding recommendations for influenza vaccination in individuals with egg allergy, please refer to the relevant national immunisation guidelines.
Immunisation should be postponed in patients with acute febrile illness until the fever is resolved.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective response may not be elicited in all vaccine recipients.
If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluad should be based on careful consideration of the potential benefits and risks.
The syringe and all associated syringe components for Fluad AUST R 306718 pre-filled syringe needle-free do not contain natural rubber latex.
Fluad AUST R 90339 pre-filled syringe with attached needle cannot be considered to be latex-free as the sheath covering the needle contains natural rubber latex, refer to statement on carton. See Section 6.5 Nature and Contents of Container for further information.
Use in the elderly. Fluad is approved for active immunisation against influenza in persons 50 years of age and older. See Section 4.1 Therapeutic Indications; Section 5 Pharmacological Properties.
Paediatric use. Paediatric data have not been evaluated.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Data from two studies on the concomitant administration of Fluad with an approved 13-valent pneumococcal conjugate vaccine (PCV13) and an approved 23-valent pneumococcal polysaccharide vaccine (PPSV23) in an elderly population are available. These studies indicated that coadministration of Fluad with either PCV-13 or PPSV23 did not show significant interference in antibody response. Although concomitant vaccination induced more frequent local pain, most of the local adverse reactions were mild. Systemic adverse reactions were generally mild, and no serious vaccine-related adverse events occurred.
If Fluad needs to be used at the same time as another vaccine, immunisation should be given at separate injection sites, preferably on different limbs. It should be noted that the adverse reactions may be intensified.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category B2)
In a reproductive and developmental study in rabbits dosed with Fluad twice pre-mating (21 and 7 days before mating) and during gestation (gestation day 7 and 20), there were no significant effects on the does, their fetuses or pups. The HA dose in rabbits was approximately 11-times the recommended clinical dose of a HA dose per body weight basis. Circulating anti-H1N1 antibodies were detected in the does, fetuses and pups.
There are no adequate and well-controlled studies in pregnant women. Fluad is indicated for persons 50 years and over.
Use in lactation. No data available.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The overall safety profile of Fluad is similar to the adjuvanted quadrivalent influenza vaccine, Fluad Quad. Data for Fluad Quad are relevant to Fluad because both vaccines are manufactured using the same process and have overlapping compositions.
Clinical trials. 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.
Adult and elderly population, 50 years of age and older. Adults 50 to less than 65 years of age. The safety of Fluad Quad in adult subjects 50 to less than 65 years of age was evaluated in clinical study V118_23. This was a randomised observer-blind, controlled, multi-centre study conducted during the 2021-2022 Northern Hemisphere influenza season. In this study, subjects received Fluad Quad (N=1027) or a non-adjuvanted comparator quadrivalent influenza vaccine (N=1016).
Solicited local and systemic reactions were collected for 7 days after vaccination. The majority of solicited reactions were reported as mild or moderate in intensity and resolved within 3 days.
Commonly reported (≥ 10%) adverse reactions in adults 50 to less than 65 years of age who received Fluad Quad were injection site pain (47.1%), fatigue (29.5%), headache (22.2%), arthralgia (13.7%) and myalgia (13.0%).
The frequency of all solicited local and systemic adverse reactions reported in Study V118_23 is presented in Table 1.

Unsolicited Adverse Events (AEs) were collected for 21 days after vaccination. There were no individual unsolicited adverse reactions reported as possibly or probably related in ≥ 1% of subjects who received Fluad Quad.
Serious adverse events (SAEs), AEs leading to withdrawal and adverse events of special interest (AESIs) were collected up to Day 271. There were no SAEs, AEs leading to withdrawal, AESIs or deaths in this study that were related to Fluad Quad.
Elderly population 65 years of age and older. The safety of a single dose of Fluad Quad in subjects 65 years of age and older was evaluated in clinical study V118_20. See Section 5.1 Pharmacodynamic Properties for further details.
In study V118_20, adverse events were collected as either solicited or unsolicited AEs. Solicited local and systemic events were collected for 7 days after vaccination (Table 2). Unsolicited AEs were collected for 21 days following vaccination, and for the full duration of study participation for SAEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), AESIs.
In the study, 51.8% of subjects reported any solicited AE after Fluad Quad vaccination, compared with 48.7%, and 48.2% in the Fluad and aTIV-2 groups respectively. The most commonly reported (≥ 10%) solicited AE's were injection site pain (31.9%), fatigue (16%) and headache (12.0%) (see Table 2). The majority of the adverse events reported were mild or moderate in intensity and resolved within 3 days. Solicited AEs with severe intensity were uncommon in all study groups.
Overall, the solicited AEs show that the safety profile of Fluad Quad in subjects 65 years of age and older was generally similar compared to the aTIV comparators.
Unsolicited Adverse Events (AEs) were collected for 21 days after vaccination. The frequency of unsolicited AEs was similar between the different vaccination groups, Fluad Quad (15.3%), Fluad (11.3%) and aTIV-2 (15.3%). Influenza-like-illness (2.0%), injection site bruising (1.1%) and cough (1.0%) were reported in ≥ 1% of subjects who received Fluad Quad.
No treatment-related SAE or death were reported in the study.
Two AESIs were reported during the study: one in the Fluad group, and one in the Fluad Quad group. Neither of the AESIs was considered to be related to study vaccine.
The frequency of unsolicited events leading to NOCD was similar across study groups: Fluad Quad (2.6%); Fluad (3.6%) and aTIV-2 (3.2%). NOCDs were heterogeneous in nature and consistent with the clinical conditions spontaneously occurring in subjects 65 years of age and older. No reported NOCDs were considered related to study vaccine.
No unsolicited AEs led to withdrawal from the study.
Post-marketing surveillance. In addition to the adverse reactions observed during clinical trials, the following adverse events were reported from post-marketing surveillance for Fluad Quad or for Fluad, which is relevant because both vaccines are manufactured using the same process and have overlapping compositions.
As these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Blood and lymphatic system disorders. Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm³), lymphadenopathy.
General disorders and administration site conditions. Extensive swelling of injected limb, injection site swelling, peripheral swelling, injection-site cellulitis-like reaction, asthenia, malaise, pyrexia.
Immune system disorders. Allergic or immediate hypersensitivity reactions, including anaphylactic shock (in rare cases), anaphylaxis.
Musculoskeletal and connective tissue disorders. Muscular weakness, pain in extremity.
Nervous system disorders. Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope, dizziness.
Skin and subcutaneous tissue disorders. Generalised skin reactions including erythema multiforme, urticaria, pruritus or non-specific rash, erythema, angioedema.
Vascular disorders. Vasculitis which may be associated with transient renal involvement.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia).

4.9 Overdose

There are no data on overdose with Fluad.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Fluad provides active immunisation against three influenza virus strains (two A subtypes and one B type) contained in the vaccine.
Fluad has been shown to evoke antibody responses to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies provide protection against clinical illness in a high proportion of vaccine recipients.
The antibody response to Fluad Quad is similar to Fluad which is increased when compared to the response to vaccines without adjuvant, and is most pronounced for A/H3N2 influenza antigens. This increased response is even more pronounced in subjects 65 years of age and older.
The adjuvant MF59 broadens the overall immune response allowing the vaccine to offer greater protection against heterologous strains of the virus. This may be important when there is a mismatch between the virus strains included in the vaccine and the strains circulating in the community. The antibody response is increased when compared to the response to non-adjuvanted Inactivated Influenza Vaccine. This increased response is seen particularly in elderly subjects with low pre-immunisation titres and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza infection.
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. In some human studies in adults, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.
Antibody against a specific influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to a specific antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
The addition of the squalene-based MF59 oil-in-water emulsion adjuvant in Fluad leads to enhanced antigen uptake by recruiting immune cells at the injection site and differentiating into antigen presenting cells. This results in an increased magnitude, breadth and persistence of the immune response through the duration of the influenza season compared with non-adjuvanted influenza vaccines.
Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.
Clinical trials. Data for Fluad Quad are relevant to Fluad because both vaccines are manufactured using the same process and have overlapping compositions.
Immunogenicity. Adults 50 to less than 65 years of age. Immunogenicity of Fluad Quad in adults 50 to less than 65 years of age was evaluated in Study V118_23. This was a randomised, observer-blind, controlled, multi-centre, trial conducted in the US, Germany, and Estonia, during the 2021-22 Northern Hemisphere season. In the study, adults 50 to less than 65 years of age who were healthy or had comorbidities that increased their risk of hospitalisation for influenza-associated complications, were enrolled to receive one dose of either Fluad Quad (N=1027) or a non-adjuvanted quadrivalent comparator influenza vaccine (Comparator QIV; Fluarix Quadrivalent) (N=1017). The mean age of subjects enrolled in the Fluad Quad group was 57.8 years and females represented 62% of subjects.
The primary endpoints to assess noninferiority were haemagglutination inhibition (HI) geometric mean antibody titre (GMT) and seroconversion rates (SCR) 21 days after vaccination. Fluad Quad met the noninferiority criteria for all 4 strains (Table 3).
A superior immune response was assessed based on post-vaccination GMTs with a prespecified superiority criteria that the upper limit of the 95% CI for the inter-group GMT ratio (Comparator QIV/Fluad QIV) be < 1. A/H1N1 and A/H3N2 met the superiority criteria. The B strains did not meet the pre-specified criteria for immunological superiority.

Elderly population 65 years of age and older. The immunogenicity of Fluad Quad was evaluated in clinical study V118_20, a multi-centre, randomised, double-blind, non-inferiority, comparator-controlled study conducted in subjects 65 years of age and older in the 2017-18 Northern Hemisphere influenza season. In this study, 888 received Fluad Quad, 444 subjects received the licensed trivalent influenza vaccine (Fluad, aTIV-1) and 444 subjects received an adjuvanted trivalent influenza vaccine containing the alternative B strain (a-TIV-2).
The per protocol immunogenicity set included a total of 1741 subjects: Fluad Quad (N=872), Fluad (N=436) and aTIV-2 (N=433). In the per protocol set, the mean age of subjects at enrolment who received Fluad Quad was 72.4 years.
Non-inferiority of the immune response of Fluad Quad to that of Fluad (aTIV-1) and TIV-2 among adults 65 years of age or older was assessed as a co-primary endpoint.
Adjusted HI Geometric Mean Titre (GMT) ratios and the difference in seroconversion rates for each vaccine strain were assessed 21 days after vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (GMT_aTIV/GMT_{Fluad Quad}) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (SCR_aTIV-SCR_{Fluad Quad}) did not exceed 10% for each strain.
Fluad Quad was non-inferior for all 4 influenza strains for both HI antibody titres and seroconversion rates (Table 4).
Immunogenicity based on CBER (Center for Biologics Evaluation and Research) criteria as measured by the percentage of subjects achieving seroconversion for HI antibodies and percentage of subjects achieving an HI antibody titre ≥ 1:40 at 21 days post-vaccination was assessed as a second co-primary endpoint. Success criteria was met if the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody met or exceeded 30% and the lower limit of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titre ≥ 1:40 met and exceeded 60%.
The second co-primary objective was met for A strains (H1N1 and H3N2), but not for B strains (B-Yamagata and B-Victoria). Results for B strains in the Fluad and aTIV-2 groups were similar to those obtained for Fluad Quad.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated-dose toxicity (60 microgram HA/dose), local tolerance and sensitization (45 microgram HA/dose). For the reproductive and development toxicity see Section 4.6 Fertility, Pregnancy and Lactation.
Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 0.5 mL dose of Fluad contains MF59C.1 (a proprietary adjuvant): containing squalene (of fish origin) 9.75 mg, polysorbate 80 1.175 mg, sorbitan trioleate 1.175 mg, sodium citrate dihydrate 0.66 mg, citric acid monohydrate 0.04 mg and water for injections and the following excipients. See Table 5.

Fluad contains no antimicrobial preservative.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (Refrigerate. Do not freeze). Discard if the vaccine has been frozen. Protect from light.

6.5 Nature and Contents of Container

Not all presentations or pack sizes may be marketed.
AUST R 306718. Fluad, inactivated, trivalent influenza vaccine (surface antigen) adjuvanted, suspension for injection, 0.5 mL pre-filled syringe, needle-free (AUST R 306718) is a 0.5 mL suspension for injection in a needle-free pre-filled syringe (type I glass).
The syringe barrel, plunger and rubber stopper are not manufactured with natural rubber latex.
Pack sizes: 1's; 10's.
AUST R 90399. Fluad, inactivated, trivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection, 0.5 mL pre-filled syringe, with attached needle (AUST R 90339) is a 0.5 mL suspension for injection in a pre-filled syringe (type I glass) with attached needle.
The sheath covering the needle contains natural rubber latex, refer to statement on carton (see Section 4.4 Special Warnings and Precautions for Use).
The syringe barrel, plunger and rubber stopper are not manufactured with natural rubber latex.
Pack sizes: 1's; 10's.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Date of First Approval

15 October 2002

Date of Revision

16 October 2025

Summary Table of Changes