FLUNITY-HD Study Demonstrated the
Superior Protection Beyond Flu of High-Dose Flu Vaccine vs Standard-Dose Flu Vaccine^*

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Efluelda^®, (Trivalent influenza vaccine (split virion, inactivated)), suspension for injection in pre-filled syringe, 60 micrograms HA/strain

A/Victoria/4897/2022 (H1N1) pdm09-like strain, A/Croatia/10136RV/2023 (H3N2)-like strain, B/Austria/1359417/2021 -like strain

- Compulsory Information

Presentation: Efluelda contains 60 micrograms of antigen (per 0.5 mL) from each of the three virus strains recommended by the World Health Organization for the present influenza season. It is supplied as a single dose pre-filled syringe containing 0.5 mL of suspension for injection. The vaccine may contain traces of eggs, such as ovalbumin, formaldehyde which are used during the manufacturing process. Indication: Efluelda is indicated for active immunisation in adults 60 years of age and older for the prevention of influenza disease. Efluelda should be used in accordance with official recommendations on vaccination against influenza. Dosage and administration: In adults 60 years of age and older: one dose of 0.5 ml. The preferred route of administration is intramuscular although it may also be given subcutaneously. The recommended site for intramuscular injection is the deltoid region. It should not be injected into the gluteal region, or into areas where there may be a major nerve trunk. The safety and effectiveness of Efluelda in children less than 18 years of age have not been established. Contraindications: Hypersensitivity to the active substances or to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins) and formaldehyde. Warnings and precautions: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Do not administer intravascularly. Vaccination should be postponed in patients with acute febrile illness until the fever is resolved. If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of any previous influenza vaccination, the decision to give Efluelda should be based on careful consideration of the potential benefits and risks. The vaccine should be administered with caution to subjects with thrombocytopaenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions. Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. As with any vaccine, a protective response may not be elicited in all vaccine recipients. Efluelda contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”. Interactions: Co-administration of Efluelda Tetra with an investigational booster 100 mcg dose of COVID-19 mRNA vaccine (nucleoside modified/elasomeran) has been evaluated in a limited number of participants in a descriptive clinical study. If Efluelda needs to be given at the same time as another injectable vaccine(s), immunisation should be carried out on separate limbs. Adverse reactions may be intensified by any co-administration. The immunological response may be reduced if the patient is undergoing immunosuppressant treatment. Fertility, pregnancy and lactation: Efluelda is only indicated for use in adults aged 60 years and older. Efluelda has not been clinically evaluated in pregnant and breast-feeding women. Undesirable effects: Very common: Injection site pain, injection site erythema, malaise, myalgia, headache; Common: Injection site swelling, injection site induration, injection site bruising, fever (≥37.5 °C), shivering. For a complete list of undesirable effects please refer to the full Summary of Product Characteristics. Health care professionals are asked to report any suspected adverse reactions via their national reporting system. Marketing authorization holder: Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly. Legal Classification of the medicinal product regarding medical prescription: Prescription Only Medicine. Date of last review: July 2025.
Abbreviated Prescribing Information based on the EU SmPC as of July 2025.

Before prescribing the product always refer to your full local prescribing information as this information may vary from country to country.

SWEDEN: Influensavirus (inaktiverat, split). ATC-code: J07BB02. Prescription status: Rx. Local representative: Sanofi AB, Box 300 52, 10425 Stockholm, Tel +46 8 634 50 00, infoavd@sanofi.com. Revision date of promotional material: August 2025. Reimbursement status: EF (no subvention). Reference: See www.fass.se for further information.

Full SmPC

1. Johansen ND, Modin D, Pardo-Seco J, et al. Effectiveness of high-dose influenza vaccine against hospitalisations in older adults (FLUNITY-HD): an individual-level pooled analysis. Lancet 2025; published online Oct 17. https://doi.org/10.1016/ S0140-6736(25)01742-8.

2. DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenzavaccine in older adults. N Engl J Med. 2014;371(7):635-645. doi:10.1056/NEJMoa1315727

3. Efluelda produktresume, www.fass.se october 2025