SUMMIT, N.J., March 5, 2021 /PRNewswire/ — Seqirus, a global leader in influenza prevention, today announced that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.1 FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older. FLUCELVAX QUADRIVALENT will be available as a 0.5ml intramuscular (IM) vaccine per dose for the 2021/22 U.S. influenza season.
The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator.2 This represents the first absolute efficacy study of a cell-based influenza vaccine in this population.
“Young children are at a high risk of complications from influenza, which is why annual vaccination is critical,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “The absolute efficacy results for FLUCELVAX QUADRIVALENT that served as the basis for this approval indicate that the cell-based vaccine offers an important new option for children as young as two years of age.”
According to the Centers for Disease Control…