High-Dose Influenza Vaccine is Not Recommended for People Under Age 65
High-dose influenza vaccine is not recommended for people under 65 years of age as it is not approved by the FDA for this age group. 1
FDA Approval and General Recommendations
- High-dose influenza vaccine (HD-IIV4) is specifically licensed only for adults aged 65 years and older 1, 2
- The vaccine contains 60 μg of hemagglutinin per vaccine strain, which is four times the amount in standard-dose influenza vaccines 2
- For individuals under 65 years of age, standard-dose influenza vaccines are the appropriate choice 3
- The dose volume for all inactivated influenza vaccines for persons aged ≥36 months (≥3 years) is 0.5 mL per dose, with the exception of Fluzone High-Dose Quadrivalent which is only for those ≥65 years 1
Special Populations Exception
- The American College of Rheumatology conditionally recommends high-dose or adjuvanted influenza vaccination for patients with rheumatic and musculoskeletal diseases (RMD) aged >18 and <65 years who are taking immunosuppressive medication 1
- This recommendation is based on very low to moderate evidence that suggests these patients may benefit from enhanced immune response 1
- Solid organ transplant recipients aged 18-64 years who are receiving immunosuppressive medications may also benefit from high-dose vaccines 3
Efficacy Considerations
- While high-dose vaccines generally improve protection in older adults compared to standard-dose vaccines, they are specifically designed to address the reduced immune response in the elderly population 4, 5
- Even with high-dose formulations, older adults may still have lower vaccine efficacy than younger adults receiving standard-dose vaccines 2, 6
- The relative effectiveness of high-dose versus standard-dose influenza vaccines increases with age, with the greatest benefit seen in those aged ≥85 years 7
Important Caveats
- Insurance barriers may inhibit implementation of high-dose influenza vaccine for RMD patients <65 years of age taking immunosuppressive medications 1
- If a healthcare provider determines that a high-dose vaccine would benefit an immunocompromised patient under 65, this would be considered off-label use 2, 3
- Vaccination should never be delayed if only standard-dose vaccine is available, as any influenza vaccine is preferred over no vaccination 3, 8
Practical Approach
- For healthy individuals under 65 years: Use standard-dose influenza vaccine 1, 3
- For immunocompromised individuals under 65 years:
- Standard-dose influenza vaccine is the FDA-approved option 1
- Consider high-dose vaccine only if the patient has specific conditions like rheumatic disease with immunosuppressive therapy or solid organ transplantation 1, 3
- Any such use would be off-label and may require prior authorization from insurance 1
In summary, while high-dose influenza vaccine shows benefits in adults 65 years and older, it is not FDA-approved for younger individuals except in specific circumstances involving immunocompromised patients, where off-label use might be considered based on clinical judgment.