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Press Release

Seqirus receives FDA approval for AFLURIA® QUADRIVALENT (Influenza Vaccine) for people 18 years of age and older

Seqirus
Posted on: 29 Aug 16

NOTE TO EDITORS: On July 31, 2015 the CSL Group and its Affiliates acquired the influenza vaccines business of Novartis AG in the US. The influenza vaccines business, previously owned by Novartis, has been integrated into CSL's influenza vaccine business and now operates as Seqirus.

- Seqirus is shipping trivalent and quadrivalent formulations of AFLURIA in the 2016-2017 influenza season

- AFLURIA® (Influenza Vaccine) is available in a needle-free option1

- AFLURIA® QUADRIVALENT, the third FDA approval for Seqirus within a year, adds to one of the broadest portfolios of influenza vaccines this season

CAMBRIDGE, Mass., Aug. 29, 2016 /PRNewswire/ -- Seqirus announced today that the US Food and Drug Administration (FDA) has approved AFLURIA® QUADRIVALENT (Influenza Vaccine) for use in persons 18 years of age and older. AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Both AFLURIA QUADRIVALENT and AFLURIA® (Influenza Vaccine), are available in the US for the 2016-2017 influenza season.1

AFLURIA QUADRIVALENT is the second quadrivalent influenza vaccine that Seqirus is offering this season after the FDA approved FLUCELVAX QUADRIVALENT™ (Influenza Vaccine) in May. AFLURIA QUADRIVALENT comes in single-dose, preservative-free pre-filled syringes while AFLURIA, indicated for persons 5 years of age and older, is available in prefilled syringes and multi-dose vials to provide choice and convenience to patients and caregivers who administer it.1,2

"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," said Gordon Naylor, President of Seqirus. "Seqirus is proud to be a leader in the prevention and control of seasonal influenza by offering a range of clinically proven vaccines to help protect people against the debilitating effects of the disease. AFLURIA QUADRIVALENT is the latest example of how Seqirus is delivering on its promise to help improve public health around the world." Seqirus has earlier announced the availability of Fluad™ (Influenza Vaccine, Adjuvanted), Fluvirin® (Influenza Virus Vaccine) and Flucelvax Quadrivalent for the 2016-2017 influenza season.

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.1,2 The device delivers the vaccine through a narrow stream of fluid that penetrates the skin in about a tenth of a second. This method is proven to provide an immune response that is non-inferior to the immune response to influenza vaccine given with a needle.3 Anyone 18 through 64 years of age who can get AFLURIA may ask for needle-free AFLURIA.1,2 Visit www.pharmajet.com for more information.

Demonstrated Immunogenicity of AFLURIA QUADRIVALENT (Influenza Vaccine) in Adults Aged 18 and Older

In a randomized, double-blind, active-controlled clinical trial conducted in 3,449 subjects aged 18 years and older, AFLURIA QUADRIVALENT demonstrated non-inferiority to two TIV comparators for all influenza strains contained in the vaccine. Additionally, non-inferiority was demonstrated for both endpoints in both age sub-groups, adults aged 18 through 64 years and 65 years and older for all strains. Superiority of the immune response to each of the influenza B strains contained in AFLURIA QUADRIVALENT was shown in relativity to the antibody response after vaccination with TIV formulation not containing B lineage strains for subjects 18 years of age and older. Superiority against the alternate B strain was also demonstrated for each of the influenza B strains in both age sub-groups; 18 through 64 years and 65 years and older.1

In a randomized, comparator-controlled study that enrolled 1,250 subjects aged 18 through 64 years of age, the trivalent formulation of AFLURIA (Influenza Vaccine) administered by the PharmaJet Stratis Needle-Free Injection System compared to administration of AFLURIA by needle and syringe demonstrated non-inferiority in the immunogenicity population for all strains. Post-hoc analyses of immunogenicity by age showed that younger subjects (18 through 49 years) elicited higher immunological responses than older subjects (50 through 64 years).1

The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A viruses and a single strain of influenza B virus.4 However, since 1985, two distinct lineages of influenza B virus have co-circulated with varying dominance. The use of a four-strain influenza vaccine like AFLURIA QUADRIVALENT may now provide protection against both B lineages.5

For more information:
www.prnewswire.com/news-releases/seqirus-receives-fda-approval-for-afluria-quadrivalent-influenza-vaccine-for-people-18-years-of-age-and-older-300319234.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 29/08/2016

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