Expanded Indication for Fluarix Quadrivalent Vaccine
January 11, 2018 – The U.S. FDA has approved an expanded indication for Fluarix® Quadrivalent (influenza vaccine), manufactured by GlaxoSmithKline. The vaccine is now approved for use in patients as young as six months of age. Previously, it was indicated for use only in patients three years of age and older.
Fluarix Quadrivalent was first approved for use in the United States in 2012, and is indicated to provide active immunization against influenza A subtype viruses and type B viruses. These viruses can cause seasonal influenza (the flu), which is most active in the United States from October through May. However, the flu tends to be most prevalent in the U.S. from December through February. Recommended dosing with Fluarix Quadrivalent is 0.5mL per injection. The patient’s age and vaccination history determine the dosing schedule.
According to the Centers for Disease Control and Prevention (CDC), all individuals six months of age and up should be vaccinated against the flu annually to help prevent spread of the disease. Although the flu may cause only mild illness in some patients, it can be especially dangerous for children, pregnant women, the elderly, and individuals with pre-existing health conditions, including those who have asthma.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.