Seqirus Receives FDA Approval of Afluria Quadrivalent® (Influenza Vaccine) for People Five Years of Age and Older in the United States

Business Wire: September 14, 2017 – CAMBRIDGE, MA, U.S.A. – Seqirus announced today that the U.S. Food and Drug Administration (FDA) has approved 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 United States 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, M.D., vice president of medical affairs at Seqirus. “As the only global vaccine company solely dedicated to influenza, we are committed to providing health care professionals and their patients with the broadest range of vaccine options available.”

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 U.S. Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone six months of age and older. Recently, the CDC’s Advisory Committee on Immunization Practices (ACIP) 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 United States for the 2017–2018 influenza season as part of the extensive Seqirus influenza vaccine portfolio. Both are presented in prefilled syringes as well as multidose vials, and are the only influenza vaccines with a needle-free injection delivery option (PharmaJet® Stratis® 0.5 mL needle-free jet injector) for people aged 18–64 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 wide 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 noninferiority to two TIV comparators for all influenza strains contained in the vaccine. Additionally, noninferiority was demonstrated for both endpoints in both age subgroups, 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 subgroups: 18 through 64 years and 65 years and older.

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 noninferiority in the immunogenicity population for all strains. Post-hoc analyses of immunogenicity by age showed that younger subjects (18–49 years) elicited higher immunological responses than older subjects (50–64 years).

In a randomized, observer-blinded, comparator-controlled trial conducted in the United States in 2,278 children 5–17 years of age, Afluria Quadrivalent demonstrated noninferiority to that of a comparator vaccine containing the same recommended virus strains.

Seqirus is part of CSL Limited (ASX: CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.

Seqirus was established on July 31, 2015, following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As the second largest influenza vaccine provider in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the United States, the United Kingdom, and Australia and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products, and a commercial presence in more than 20 countries. For more information, visit www.seqirus.com and www.csl.com.

Based in Golden, Colorado, PharmaJet’s mission is worldwide acceptance of PharmaJet® needle-free devices as a standard of care in the vaccine delivery market. PharmaJet’s devices are also integral in the development of multiple novel pharmaceuticals. The innovative Stratis® device has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. In August 2014, the PharmaJet Stratis® device was cleared for delivery of an influenza vaccine to deliver needle-free flu shots. The Tropis® device for intradermal injections received authorization to apply the CE Mark in May 2016. The PharmaJet needle-free devices are safe, fast, and easy to use. They eliminate needle stick injuries, needle reuse, and crosscontamination, and help reduce sharps waste disposal. For more information, visit http://pharmajet.com/.