Flu Vaccine Fluarix Quadrivalent Approved For Children 6 Months+
Fluarix approved for influenza A subtype viruses and type B viruses
The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanded the indication for FLUARIX® QUADRIVALENT, which is an influenza vaccine, for use in people 6 months and older.
During clinical trials with children aged 6 through 35 months, the most common adverse reactions from FLUARIX were pain and redness.
Quadrivalent vaccines are designed to help protect against two main types of flu viruses, A and B, which spread between people and can cause mild to severe illness.
Prior to this FDA approval, FLUARIX was only approved for influenza A subtype viruses and type B viruses, in persons 3+ years of age.
FLUARIX is also approved in 30 other countries worldwide.
Patrick Desbiens, Senior Vice President, US Vaccines said: "We can now offer two flu vaccines that enable providers to use the same vaccine dose to help protect all recommended persons aged 6 months and older against this potentially serious illness."
With this approval, providers and pharmacists will be able to use the same dose of FLUARIX® QUADRIVALENT (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from 6 months of age and up.
The supplemental Biologics License Application was based on a Phase III pivotal study of the efficacy of FLUARIX® QUADRIVALENT in children 6 months through 35 months of age and on two supportive studies.
According to the Centers for Disease Control and Prevention (CDC), the best tool available to help protect yourself and those around you against the flu is to get vaccinated.
Currently, the CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.
Most pharmacies in the USA offer several FDA approved flu vaccines.
The flu shot cost varies depending on your insurance and which state you live. The CDC Vaccine Price List provides the private sector vaccine prices for general information.
Flu vaccine discounts can be found here.
FLUARIX® QUADRIVALENT was first approved in 2012 in the US for the prevention of influenza disease in people 3 years of age and older. FLUARIX® QUADRIVALENT should not be given to anyone with a history of severe allergic reactions to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine. If FLUARIX® QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
- GSK receives FDA approval for expanded indication for FLUARIX® QUADRIVALENT (Influenza Vaccine) for persons 6 months and older
- Fluarix Quadrivalent
- Fluarix®/ FluLaval®/ Fluarix® Quadrivalent/ FluLaval® Quadrivalent Vaccine Pregnancy Registry
- A review of the value of quadrivalent influenza vaccines and their potential contribution to influenza control