FDA Approves Four-Strain Flu Vaccine for Children by TVR Staff

FDA Approves Four-Strain Flu Vaccine for Children

by TVR Staff

Published November 30, 2017 | Vaccination, Vaccines

The U.S. Food and Drug Administration (FDA) recently expanded the age indication for Seqirus’ Afluria Quadrivalent influenza vaccine to include patients aged five years or older.¹

The FDA first approved Afluria in August 2016 for patients aged 18 years or older. The vaccine is

intended to protect against two strains of influenza A virus, as well as two strains of influenza B virus.  The traditional seasonal flu vaccine covered two lineages of influenza A virus and one of influenza B virus. However, since 1985, two subtypes of influenza B have been circulating.¹
Approval was based on a randomized trial including 2,278 children aged five to 17 years in which Afluria Quadrivalent demonstrated non-inferiority to a comparator vaccine containing the same virus strain targets.¹
Like the  trivalent version of Afluria, the  quadrivalent version is available in pre-filled syringes, as well as multi-dose vials.¹
The Centers for Disease Control and Protection (CDC) had previously recommended against the use of Afluria for anyone younger than nine years, but changed its recommendation to be in line with the new FDA indication.²

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