FDA expands age indications for GSK's Fluarix Quadrivalent flu shot
The age indications for GSK's Fluarix Quadrivalent have been expanded to include administration to babies 6 months or older, from toddlers 3 years of age and older, following approval of the new indication from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, GSK announced Friday.
"The flu vaccine is the one vaccine that people of almost all ages – from 6-month-old infants to older adults – should receive annually," stated Patrick Desbiens, senior vice president, US Vaccines, GSK. "The expanded indication for Fluarix Quadrivalent in the U.S. builds upon GSK's commitment to being a reliable supplier and partner to healthcare providers and their patients. 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 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 flu vaccine is the one vaccine that people of almost all ages – from 6-month-old infants to older adults – should receive annually," stated Patrick Desbiens, senior vice president, US Vaccines, GSK. "The expanded indication for Fluarix Quadrivalent in the U.S. builds upon GSK's commitment to being a reliable supplier and partner to healthcare providers and their patients. 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 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.