15 September 2017 - - The US Food and Drug Administration has approved vaccine manufacturer Seqirus' Afluria Quadrivalent (Influenza Vaccine) for use in people five years of age and older, extending the company's broad portfolio of influenza vaccine offerings.

Afluria Quadrivalent, which was first approved in the US in August 2016 for people aged 18 and older, helps protect against two influenza A strain viruses and two B strain viruses.

Pediatric health care providers now have a new vaccine option to help protect children five years and older against influenza," said Gregg Sylvester MD, vice president of Medical Affairs at Seqirus.

The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A virus and a single strain of influenza B virus.

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.

The US Centers for Disease Control and Prevention recommends annual influenza vaccination for everyone six months of age and older.

Recently, the CDC's Advisory Committee on Immunization Practices voted to include AFLURIA (Influenza Vaccine) as one of the recommended trivalent influenza vaccine options for people aged five years and older for the upcoming 2017-2018 season.

The CDC has accepted the ACIP recommendation in its 2017-2018 influenza recommendations published in the August 25, 2017 Morbidity and Mortality Weekly Report.

As a result, both Afluria and Afluria Quadrivalent are now both licensed and recommended for people aged five years and older.

Afluria Quadrivalent and Afluria are both available in the US for the 2017-2018 influenza season as part of the extensive Seqirus influenza vaccine portfolio.

Both are presented in pre-filled syringes as well as multi-dose vials, and are the only influenza vaccines with a needle-free injection delivery option (PharmaJet Stratis 0.5ML Needle-Free Jet Injector) for people aged 18 to 64 years.

As the only global vaccine company solely dedicated to the prevention of influenza, the complete Seqirus portfolio of seasonal influenza vaccines includes both trivalent and quadrivalent options, manufactured using egg and cell-based technologies, to provide a range of options for people aged four years and older.

The portfolio also includes the only adjuvanted seasonal influenza vaccine specifically developed for people 65 years and older.

In a randomized, double-blind, active-controlled clinical trial conducted in 3,395 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.

In a randomised, 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).

In a randomised, observer-blinded, comparator-controlled trial conducted in the US in 2,278 children five through 17 years of age, Afluria Quadrivalent demonstrated non-inferiority to that of a comparator vaccine containing the same recommended virus strains.