GSK announced it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older.
Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.
“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the US every flu season,” said Patrick Desbiens, Senior Vice President, US Vaccines. “Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness. This expanded indication builds upon GSK’s commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the US market.”
Before the approval of an expanded age indication for FluLaval® Quadrivalent, providers who preferred prefilled syringes had to order and stock two separate influenza vaccines to be able to immunize all patients. With this approval, providers are now able to use the same dose of FluLaval® Quadrivalent (15ug of hemagglutinin per virus strain in 0.5 mL) to vaccinate all recommended persons aged 6 months and older.The supplemental Biologics License Application was based on one Phase III pivotal study and three supportive clinical studies conducted in children 6 months through 35 months of age. For more information about quadrivalent vaccines, visit www.ChooseMoreChooseFour.com
About Seasonal Influenza in Children
Seasonal influenza (the “flu”) is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness. Most flu activity in the US occurs from October-May, and it usually peaks in January and February.According to the US Centers for Disease Control and Prevention (CDC), the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, many children get sick with seasonal influenza and some of those illnesses result in death. On average, 20,000 children under the age of 5 are hospitalized because of influenza complications. The CDC recommends that everyone aged 6 months and older get a seasonal flu vaccine.
