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Seqirus Announces U.S. FDA Approval of Expanded Age Indication of Its Cell-Based Quadrivalent Influenza Vaccine for People Two Years of Age and Older


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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- ....

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