Flucelvax Quadrivalent Receives Expanded Flu Indication

March 5, 2021 – The U.S. FDA has approved an expanded indication for Flucelvax® Quadrivalent (influenza vaccine), manufactured by Seqirus. The vaccine is indicated to provide active immunization in individuals who are at least two years old to prevent influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Previously, the vaccine was approved for individuals four years of age and older.

Influenza, more commonly known as the flu, is a contagious respiratory disease that can cause fever, cough, headache, fatigue, body aches, and other symptoms. Severe cases can require hospitalization and may be fatal. According to the U.S. Centers for Disease Control and Prevention (CDC), children under five years of age have a high risk of developing serious complications from the flu. The CDC recommends that adults and children who are at least six months old and have no contraindications to vaccination receive a flu vaccine annually to prevent the disease and its spread.

In a clinical study, Flucelvax Quadrivalent was 50.5% effective in children two through eight years old in preventing confirmed influenza illness caused by any influenza type A or B strain. Recommended dosing in this age group is one or two 0.5mL doses, depending on the individual’s vaccination history. If two doses are given, they should be spaced at least four weeks apart. Recommended dosing for individuals at least nine years of age is a single 0.5mL dose.

Flucelvax Quadrivalent first received FDA approval in 2016.