No Generic Form of Fluzone Vaccine Available

There is currently no generic form of the Fluzone influenza vaccine available. 1

Available Influenza Vaccine Products

Fluzone is a brand-name influenza vaccine manufactured by Sanofi Pasteur that comes in several formulations including standard-dose, high-dose, and intradermal versions 1
For the 2024-25 influenza season, various inactivated influenza vaccines (IIVs) are expected to be available, all of which are trivalent (IIV3s) 1
Standard-dose Fluzone contains 15 μg of hemagglutinin (HA) per vaccine virus in a 0.5-mL dose (or 7.5 μg of HA per vaccine virus in a 0.25-mL dose for certain age groups) 1
Fluzone High-Dose (HD-IIV3) contains 60 μg of HA per vaccine virus (180 μg total) in a 0.5-mL dose and is specifically approved for persons aged ≥65 years 1, 2

Influenza vaccines are biological products that undergo complex manufacturing processes, making them different from small-molecule drugs that can be more easily replicated as generics 3
Influenza vaccines must be updated annually to match circulating virus strains, requiring ongoing development rather than simple replication of an existing formula 3, 4
The FDA has specific regulatory pathways for influenza vaccines that differ from those of conventional drugs 4
Over 150 million doses of seasonal trivalent and quadrivalent vaccines are produced annually in the United States, with components that usually change yearly 4

While there is no generic version of Fluzone, multiple influenza vaccine products are available from different manufacturers 1
Other standard-dose, egg-based trivalent inactivated vaccines include Afluria, Fluarix, and FluLaval 1
Flucelvax is a cell culture-based trivalent inactivated vaccine (ccIIV3) that offers an alternative manufacturing process 1
For persons aged ≥65 years, Fluad (aIIV3) is an adjuvanted alternative to Fluzone High-Dose 1

The Advisory Committee on Immunization Practices (ACIP) makes no preferential recommendation for the use of any one influenza vaccine over another when more than one licensed and recommended vaccine is available, except for selection of influenza vaccines for persons aged ≥65 years 1
Vaccination should not be delayed to obtain a specific product when an appropriate one is available 1
For adults aged ≥65 years, higher-dose or adjuvanted influenza vaccines are preferentially recommended 2
Certain IIVs have different approved dose volumes for children aged 6 through 35 months compared to older children and adults, so care should be taken to administer the appropriate dose volume 1

Solid organ transplant recipients aged 18-64 years who are receiving immunosuppressive medications may benefit from high-dose or adjuvanted vaccines, though standard-dose vaccines are acceptable alternatives 1, 2
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 2