The Food and Drug Administration (FDA) today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.
The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.
Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.
"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”
With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.
Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.
Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.
Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.
Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.
CDC Urges Vigilance: New Recommendations for Monitoring and Testing H5N1 Exposures
July 11th 2025With avian influenza A(H5N1) infections surfacing in both animals and humans, the CDC has issued updated guidance calling for aggressive monitoring and targeted testing to contain the virus and protect public health.
IP LifeLine: Layoffs and the Evolving Job Market Landscape for Infection Preventionists
July 11th 2025Infection preventionists, once hailed as indispensable during the pandemic, now face a sobering reality: budget pressures, hiring freezes, and layoffs are reshaping the field, leaving many IPs worried about their future and questioning their value within health care organizations.
A Helping Hand: Innovative Approaches to Expanding Hand Hygiene Programs in Acute Care Settings
July 9th 2025Who knew candy, UV lights, and a college kid in scrubs could double hand hygiene adherence? A Pennsylvania hospital’s creative shake-up of its infection prevention program shows that sometimes it takes more than soap to get hands clean—and keep them that way.