Demonstrated Efficacy for FLUZONE^® High-Dose

Superior efficacy demonstrated for FLUZONE^® High-Dose compared to FLUZONE^®

National Advisory Committee on Immunization (NACI) recommendations for adults aged 65+ 

Recommendation for individual-level and public health program-level decision making²

NACI recommends that IIV-HD, IIV-Adj, or RIV should be offered, when available, over other influenza vaccine for adults 65 years of age and older. If a preferred product is not available, any of the available age-appropriate influenza vaccine should be used. Refer to the NACI Advisory for more information.

Safety Information

Clinical Use:

• Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FLUZONE^® High-Dose administration in children less than 18 years of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use.

• Geriatrics (≥65 years of age): FLUZONE^® High-Dose vaccine is indicated for active immunization for the prevention of influenza in adults 65 years of age and older.

Contraindications:

• Should not be administered to anyone with a history of severe allergic reaction to egg protein or any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents.

Relevant Warnings & Precautions:

• Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.
• As with any vaccine, immunization with FLUZONE^® High-Dose may not protect 100% of individuals. Current influenza virus vaccines are not effective against all possible strains of influenza virus. Protection is highest against those strains of virus from which the vaccine is prepared or against closely related strains.
• Do not administer by intravascular injection. Do not administer into the buttocks.
• Persons with serious acute febrile illness usually should not be vaccinated until their symptoms have abated. Those with mild non-serious febrile illness (such as mild upper respiratory tract infections) may be given influenza vaccine.
• FLUZONE^® High-Dose should not be administered to persons suffering from bleeding disorders or on anticoagulation therapy unless potential benefits outweigh administration risk. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid hematoma formation risk following injection.
• Immunocompromised persons (whether from disease or treatment) may not achieve the expected immune response. Nevertheless, as recommended by NACI, the possibility of lower efficacy should not prevent immunization in those at high risk of influenza-associated morbidity, since some protection is still likely to occur.
• Guillain-Barré syndrome (GBS) has been temporally associated with the administration of influenza vaccine. If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of any previous influenza vaccination, the decision to give FLUZONE^® High-Dose should be based on careful consideration of potential benefits and risks. Immunization should be delayed in a patient with an active neurological disorder but should be considered when the disease process has stabilized.
• Local reactions at injection site such as redness (erythema), swelling, (hardness) induration, and bruising may occur.

For More Information:

Consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information (particularly the administration route related precautions), which have not been discussed in this piece. The product monograph is also available through our medical department. Call us at 1-888-621-1146.

CI=confidence interval; IIV-HD=high-dose inactivated influenza vaccine; IIV-Adj=adjuvanted inactivated influenza vaccines; ILI=influenza-like illness; RIV=recombinant influenza vaccine.

^a In a multicentre study over two influenza seasons (2011-2012 and 2012-2013), adults aged 65+ were randomized to receive either FLUZONE^® High-Dose or FLUZONE^®. Per-protocol analysis set for efficacy assessments included 15,892 FLUZONE^® High-Dose and 15,911 FLUZONE^® recipients. Primary endpoint was occurrence of laboratory-confirmed influenza, defined as a new onset (or exacerbation) of at least one of the following: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature >37.2°C, chills, tiredness, headaches, or myalgia. In the first year, the influenza B vaccine component and the majority of influenza B cases were of the Victoria lineage; in the second year, the influenza B vaccine component and the majority of influenza B cases were of the Yamagata lineage.¹

^b The pre-specified statistical superiority criterion for the primary endpoint (lower limit of the 2-sided 95% CI of the vaccine efficacy of FLUZONE^® High-Dose relative to FLUZONE^® >9.1%; p-value against H0:VE ≤9.1% = 0.022 one-sided) was met.¹

^c FLUZONE^® High-Dose (1.43% lab-confirmed ILI, N=227/15,892), versus standard-dose FLUZONE^® vaccine (1.89% lab-confirmed ILI, N=300/15,911).

MAT-CA-2301819-v1.0-10/2025