What is the name and administration protocol of the high-dose (influenza) vaccine, specifically Fluzone High-Dose (inactivated influenza vaccine), for adults aged 65 years and older?

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High-Dose Influenza Vaccine: Name and Administration Protocol

The high-dose influenza vaccine is called Fluzone High-Dose, manufactured by Sanofi Pasteur, and is specifically licensed for adults aged 65 years and older. 1, 2

Key Information About Fluzone High-Dose

  • Fluzone High-Dose is a trivalent inactivated influenza vaccine (TIV High-Dose) containing 60 μg of hemagglutinin per vaccine strain, which is four times the amount in standard-dose influenza vaccines (15 μg per strain) 1
  • It is available as a 0.5 mL prefilled syringe with 0.0 μg mercury content 1
  • The Advisory Committee on Immunization Practices (ACIP) now recommends preferential use of higher-dose or adjuvanted influenza vaccines for adults 65 years and older 2
  • Fluzone High-Dose is administered as a single dose via the intramuscular (IM) route 1

Prescribing and Administration Protocol

  • Prescribe as "Fluzone High-Dose" for patients aged 65 years and older 1
  • Administration is via intramuscular injection in the deltoid muscle 1
  • Only one dose (0.5 mL) is required per influenza season 1
  • The vaccine should be stored according to manufacturer specifications and administered at room temperature 3
  • Document administration in the patient's immunization record and report to appropriate immunization information systems 2

Important Considerations and Precautions

  • Fluzone High-Dose should not be administered to persons under 65 years of age unless they have specific indications (such as immunocompromised status) 2
  • If Fluzone High-Dose is not available, standard-dose influenza vaccine should be administered rather than delaying vaccination 2
  • Most adults, particularly those ≥65 years, should not be immunized in July and August due to concerns about waning immunity before the peak of influenza season 2
  • Common side effects may include injection site reactions (pain, redness, swelling) and systemic reactions (myalgia, malaise, headache) that are typically mild and transient 3

Special Populations

  • For immunocompromised individuals who have received hematopoietic cell transplantation or solid organ transplantation, clinicians could consider administering 2 doses of high-dose trivalent inactivated vaccine 2
  • Patients with rheumatic and musculoskeletal diseases aged >18 and <65 years who are taking immunosuppressive medication may benefit from high-dose influenza vaccine, though this would be off-label use 2
  • For patients with malignant neoplasms receiving chemotherapy, influenza vaccination should generally be administered 2 weeks before cytotoxic chemotherapy when clinically possible 2

Clinical Evidence

  • Immunogenicity data from multiple studies have shown that Fluzone High-Dose elicits higher hemagglutination inhibition (HAI) titers against influenza virus strains compared to standard-dose vaccines in older adults 1, 4
  • While Fluzone High-Dose produces enhanced immunologic responses in adults ≥65 years, the ACIP initially did not express preference for high-dose over standard-dose vaccines 1
  • Recent evidence has led to updated recommendations favoring high-dose or adjuvanted vaccines for older adults 2
  • Despite improved immunogenicity, high-dose vaccine recipients may still have lower vaccine efficacy than younger adults receiving standard-dose vaccines 5

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

High-Dose Influenza Vaccine Recommendations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Fluzone® High-Dose Influenza Vaccine.

Expert review of vaccines, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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