US FDA approves Seqirus’ influenza vaccine

30 August 2016 (Last Updated August 30th, 2016 18:30)

The US Food and Drug Administration (FDA) has approved Seqirus’ Afluria Quadrivalent (influenza vaccine) for use in people aged 18 and above.

The US Food and Drug Administration (FDA) has approved Seqirus’ Afluria Quadrivalent (influenza vaccine) for use in people aged 18 and above.

The inactivated vaccine is indicated for active immunisation against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

The vaccine is available in single-dose, preservative-free pre-filled syringes, while Afluria is indicated for individuals aged five and older and comes in prefilled syringes and multi-dose vials.

Both vaccines are available in the US for the 2016-2017 influenza season.

"Afluria Quadrivalent is the latest example of how Seqirus is delivering on its promise to help improve public health around the world."

Seqirus president Gordon Naylor said: "As a new quadrivalent seasonal influenza vaccine, Afluria Quadrivalent will provide healthcare providers and their patients with an important option to further broaden their influenza vaccine offerings.

“Afluria Quadrivalent is the latest example of how Seqirus is delivering on its promise to help improve public health around the world."

The trivalent forumation of Afluria is the only flu vaccine approved by the FDA to be administered without a needle, using the pharmajet stratis needle-free injector.

The device delivers the vaccine through a narrow stream of fluid that penetrates the skin in one tenth of a second.

In a randomised, double-blind, active-controlled clinical trial conducted in 3,449 subjects, Afluria Quadrivalent demonstrated non-inferiority to two TIV comparators for all influenza strains contained in the vaccine.

In a comparator-controlled study that enrolled 1,250 subjects aged between 18 to 64, the trivalent formulation of Afluria administered by the needle-free injection system compared to administration of Afluria by needle and syringe demonstrated non-inferiority in the immunogenicity population for all strains.