Fluzone is the commercial name of an influenza virus vaccine, distributed by Sanofi Pasteur. It is a split-virus vaccine that is produced by chemical disruption of the influenza virus. Therefore, it is incapable of causing influenza.
Fluzone is typically administered in a single dose by intramuscular injection; an intradermal injection is also available. It is presented as a 0.25 ml syringe for pediatric use, as a 0.5 ml syringe for adults and children, as a 0.5 ml vial for adults and children, and as a 5 ml vial for adults and children. Fluzone must be refrigerated under temperatures from 2 to 8 °C (36 to 46 °F) and is inactivated by freezing. Fluzone was initially approved in 1980 by the FDA.
Fluzone comes in three versions that are thimerosal-free. There is a 0.25 ml prefilled pediatric syringe, a 0.5 ml prefilled syringe, and a 0.5 ml vial. Thimerosal is used only in the 5 ml multi-use vial.
The use of Fluzone in infants less than six months of age is not recommended. Immunization with Fluzone may not protect 100% of susceptible individuals.
In January 2011 the FDA recognized that 36 children from 6–24 months old had fevers and seizures within a day of the fluzone vaccine.
The following adverse effects have been reported:
- Mild soreness, local pain and swelling at the local of the injection
- In small children and in people with no previous exposure to a flu vaccine, episodes of fever, malaise, myalgia (muscle pain)
- In people who are sensitive to egg protein, allergic reactions may ensue, such as hives, angioedema, asthma and anaphylaxis
A high-dose vaccine (Fluzone High-Dose) 4x the strength of standard flu vaccine was approved by the FDA in 2009. This vaccine is intended for people 65 and over, who typically have weakened immune response due to normal aging. The vaccine produces a greater immune response than standard vaccine. According to the CDC, "a study published in the New England Journal of Medicine [in August, 2014] indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine." CDC recommends the high-dose vaccine for people 65 and over but expresses no preference between it and standard vaccine. Further studies are underway.
- "Fluzone Prescribing Information". Sanofi Pasteur. June 2012.
- "Fluzone intradermal vaccine website". Sanofi Pasteur.
- "Feds Check Post-Vaccine Seizures In Young Kids" WTAE Pittsburgh
- "FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older" (Press release). U.S. Food and Drug Administration (FDA). December 23, 2009.
- Centers for Disease Control and Prevention (CDC) (April 2010). "Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010". MMWR. Morbidity and mortality weekly report 59 (16): 485–6. PMID 20431524.
- "Fluzone High–Dose Seasonal Influenza Vaccine" Centers for Disease Control and Prevention (CDC)
- "Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults"