Afluria, Afluria Quadrivalent Approved for Use in Patients 6 Months and Older
Previously, both vaccines were indicated only for patients ≥5 years of age.
The Food and Drug Administration has approved the use of Afluria (trivalent, inactivated influenza vaccine; Seqirus) and Afluria Quadrivalent (quadrivalent, inactivated influenza vaccine; Seqirus) for use in patients ≥6 months old. Previously, both vaccines were indicated for patients ≥5 years of age.
The vaccines are indicated for active immunization against influenza disease caused by virus subtypes A and type B present in the vaccine. For patients 6 months of age to less than 18 years old, both Afluria and Afluria Quadrivalent should be administered intramuscularly by needle and syringe; the PharmaJet Stratis Needle-Free Injection system is only approved as a method of administration for patients 18-64 years old.
The pediatric approval was based on a comparator-controlled trial involving children 6 months through 59 months of age. A total of 2247 patients were randomized 3:1 to receive Afluria Quadrivalent (N=1684) or a U.S.-licensed comparator quadrivalent influenza vaccine (N=563). Results showed that serum hemagglutination inhibition antibody responses to Afluria Quadrivalent were non-inferior for both geometric mean titer (GMT) ratio and seroconversion rates relative to the comparator vaccine for all influenza strains.
Afluria and Afluria Quadrivalent are supplied as prefilled syringes (0.25mL and 0.5mL) and multi-dose vials (5mL).
For more information visit Seqirus.com.