Fluzone
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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.
History
Fluzone is typically administered in a single dose by intramuscular injection;[1] an intradermal injection is also available.[2] 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.[1] 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.[1]
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.[1]
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.[3]
Adverse effects
The following adverse effects have been reported:[1]
- 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
High-dose vaccine
A high-dose vaccine (Fluzone High-Dose) 4x the strength of standard flu vaccine was approved by the FDA in 2009.[4][5] 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,[6] "a study published in the New England Journal of Medicine[7] [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.
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "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"