Fluad (Adjuvanted Influenza Vaccine) Should Not Be Given to Patients Under 65 Years Old
Fluad (adjuvanted influenza vaccine) is only approved for use in patients aged 65 years and older and should not be administered to patients under 65 years of age. 1
Approved Age Indications for Fluad
The 2024-25 Advisory Committee on Immunization Practices (ACIP) guidelines clearly state that Fluad (aIIV3) is specifically approved only for persons aged ≥65 years. This trivalent adjuvanted inactivated influenza vaccine contains 15 μg of hemagglutinin (HA) per vaccine virus (45 μg total) and MF59 adjuvant 1.
The age restriction for Fluad is consistently documented across multiple guidelines:
- The 2024-25 ACIP recommendations explicitly list Fluad among vaccines "approved only for persons aged ≥65 years" 1
- Previous ACIP recommendations from 2017-18 also clearly indicated Fluad's age indication as "≥65 years" 1
- The American Academy of Pediatrics' 2019-2020 recommendations similarly identified Fluad as being licensed only for those "≥65 years" 1
Alternative Influenza Vaccines for Patients Under 65
For patients under 65 years of age, several other influenza vaccine options are available and approved:
Standard-dose inactivated influenza vaccines (IIV3s) are approved for persons as young as 6 months, including:
- Afluria
- Fluarix
- FluLaval
- Fluzone
- Flucelvax (cell culture-based) 1
Dose considerations for children:
- Children aged 6-35 months: Some vaccines require reduced dosing (0.25 mL) while others use the standard 0.5 mL dose
- Children aged ≥36 months and adults: Standard 0.5 mL dose for all IIV3s 1
Special Considerations
Solid Organ Transplant Recipients
While most age restrictions are strictly followed, there is one exception noted in the guidelines: solid organ transplant recipients aged 18-64 years who are receiving immunosuppressive medications may receive either high-dose influenza vaccine (HD-IIV3) or adjuvanted influenza vaccine (aIIV3) as acceptable options 1. However, this is considered an off-label use and is specifically mentioned as an exception to the standard age indication.
Rationale for Age Restriction
The MF59 adjuvant in Fluad is designed to enhance immune response in older adults who typically have decreased immune responses to vaccination 2. The vaccine was specifically developed and tested for the elderly population, and safety and efficacy data in younger populations are limited.
Conclusion
Following the approved indications is critical for ensuring both safety and efficacy. For patients under 65 years old requiring influenza vaccination, multiple other age-appropriate options exist that have been properly studied and approved for younger age groups.