The FDA’s Center for Biologics Evaluation and Research has expanded the indication for Fluarix Quadrivalent (influenza vaccine, GlaxoSmithKline) to include use in people 6 months of age and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses in people 3 years of age and older.
With this approval, providers 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 patients from 6 months of age and up.
The supplemental biologics license application was based on a phase 3 pivotal study of the efficacy of the vaccine in children 6 months through 35 months of age and on two supportive studies.
While anyone can get the flu, it can be particularly serious for young children, older people, pregnant women, and people with certain health conditions, such as asthma. 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. The more people who are vaccinated, the less chance the virus has to spread. Currently, the CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.
Fluarix Quadrivalent was first approved in 2012 in the U.S. for the prevention of influenza disease in people 3 years of age and older. It is also approved in more than 30 other countries worldwide.
Source: GlaxoSmithKline; January 11, 2018.