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Seqirus Receives FDA Approval Of Afluria Quadrivalent (Influenza Vaccine) For People Five Years Of Age And Older In The U.S.



9/14/2017 9:58:58 AM

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  • Expanded AFLURIA QUADRIVALENT age indication offers protection against four influenza virus strains for people five years of age and older, and increases vaccine options for health care providers and their patients.
  • Both AFLURIA QUADRIVALENT (Influenza Vaccine) and AFLURIA (Influenza Vaccine), are available in the US for the 2017-2018 influenza season.
  • As the only global vaccine company solely dedicated to the prevention of influenza, the complete Seqirus portfolio includes both trivalent and quadrivalent options, manufactured using egg and cell-based technologies.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 U.S. in August 2016 for people aged 18 and older, helps protect against two influenza A strain viruses and two B strain viruses.3,10

“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. “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.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

The U.S. Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone six months of age and older.6 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.11 The CDC has accepted the ACIP recommendation in its 2017-2018 influenza recommendations published in the August 25, 2017 Morbidity and Mortality Weekly Report.9 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 U.S. 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.1,2

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.12

Demonstrated Immunogenicity of AFLURIA QUADRIVALENT (Influenza Vaccine)

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.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

In a randomized, observer-blinded, comparator-controlled trial conducted in the U.S. 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.1

About Seasonal Influenza

Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC encourages annual vaccination for all individuals aged six months and older.4 Because transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others.7

Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.7 The CDC estimates that 310,000 people in the United States were hospitalized due to influenza-related complications during the 2015-2016 influenza season.8 Since it takes about two weeks after vaccination for the antibodies that protect against influenza virus infection to develop inside the body, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.4

About Seqirus

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 U.S., the U.K. 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.

About PharmaJet

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 needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal. For more information, visit http://pharmajet.com/.

References

1. AFLURIA QUADRIVALENT (Influenza Vaccine) [prescribing information]. King of Prussia, PA: Seqirus, Inc. 2017.

2. AFLURIA (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2017.

3. U.S. Food & Drug Administration (FDA). “Influenza Virus Vaccine for the 2017-2018 Season.” Available at: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm567865.htm. Accessed July 2017.

4. Centers for Disease Control and Prevention (CDC). “Key Facts About Seasonal Flu Vaccine.” Available at: http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed July 2017.

5. Hartvickson R, et al. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. International Journal of Infectious Diseases. 2015;41:65-72. http://dx.doi.org/10.1016/j.ijid.2015.11.004. Accessed July 2017.

6. CDC. “Recommendations of the Advisory Committee on Immunization Practices — United States, 2016–17 Influenza Season.” Available at: https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm. Accessed July 2017.

7. CDC. “Key Facts About Influenza (Flu).” Available at: https://www.cdc.gov/flu/keyfacts.htm. Accessed July 2017.

8. CDC. “Seasonal Influenza-Associated Hospitalizations in the United States.” Available at: https://www.cdc.gov/flu/about/qa/hospital.htm. Accessed July 2017.

9. CDC. “Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season”Available at: https://www.cdc.gov/mmwr/volumes/66/rr/rr6602a1.htm?s_cid=rr6602a1_e. Accessed August 2017.

10. PR Newswire. “Seqirus receives FDA approval for AFLURIA QUADRIVALENT® (Influenza Vaccine) for people 18 years of age and older.” Available at: http://www.prnewswire.com/news-releases/seqirus-receives-fda-approval-for-afluria-quadrivalent-influenza-vaccine-for-people-18-years-of-age-and-older-300319234.html. Accessed July 2017.

11. American Academy of Pediatrics News. “Core flu vaccination recommendations carry over for 2017-’18.” Available at: http://www.aappublications.org/news/2017/06/21/ACIP062117. Access July 2017.

12. Business Wire. “Seqirus Begins Shipping 2017-2018 Influenza Vaccines to the U.S. Market.” Available at: http://www.businesswire.com/news/home/20170720005327/en/Seqirus-Begins-Shipping-2017-2018-Influenza-Vaccines-U.S. Accessed July 2017.

AFLURIA QUADRIVALENT is a trademark of Seqirus U.K. Limited or its affiliates.

PHARMAJET and STRATIS are trademarks of PharmaJet.

AFLURIA® QUADRIVALENT (Influenza Vaccine) Indication

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. AFLURIA QUADRIVALENT is approved for use in individuals five years of age and older.1

Important Safety Information

CONTRAINDICATIONS

  • Known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.1

WARNINGS AND PRECAUTIONS

  • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.1
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

ADVERSE REACTIONS

AFLURIA QUADRIVALENT administered by needle and syringe:

  • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (=40%). The most common systemic adverse events were myalgia and headache (=20%).1
  • In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (=20%). The most common systemic adverse event was myalgia (=10%).1
  • In children five through eight years, the most commonly reported injection-site adverse reactions were pain (=50%), redness and swelling (=10%). The most common systemic adverse event was headache (=10%).1
  • In children nine through 17 years, the most commonly reported injection-site adverse reactions were pain (=50%), redness and swelling (=10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (=10%).1

AFLURIA (trivalent formulation) administered by the PharmaJet Stratis Needle-Free Injection System:

  • In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were tenderness (=80%), swelling, pain, redness (=60%), itching (=20%) and bruising (=10%). The most common systemic adverse events were myalgia, malaise (=30%), and headache (=20%).1

Please see full prescribing information for AFLURIA QUADRIVALENT here.

AFLURIA® (Influenza Vaccine) Indication

AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.2 AFLURIA is approved for use in persons five years of age and older.2

Important Safety Information

CONTRAINDICATIONS

  • Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.2

WARNINGS AND PRECAUTIONS

  • Administration of CSL’s 2010 Southern Hemisphere influenza vaccine has been associated with increased rates of fever and febrile seizures in children predominantly below the age of five years as compared to previous years.2
  • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.2
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.2
  • Immunocompromised persons may have a diminished immune response to AFLURIA.2

ADVERSE REACTIONS

  • In children five through 17 years of age, the most common injection-site adverse reactions when administered by needle and syringe were pain (=60%), redness (=20%) and swelling (=10%). The most common systemic adverse events were headache, myalgia (=20%), irritability, malaise and fever (=10%).2
  • In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by needle and syringe were tenderness (=60%), pain (=40%), swelling (=20%), and redness, itching (=10%). The most common systemic adverse events were muscle aches (=30%) headache and malaise (=20%).2
  • In adults 18 through 64 years of age, the most common injection-site adverse reactions when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness (=80%), swelling, pain, redness (=60%), itching (=20%) and bruising (=10%). The most common systemic adverse events within this period were myalgia, malaise (=30%), and headache (=20%).2
  • In adults 65 years of age and older, when administered by needle and syringe the most common injection-site adverse reactions were tenderness (=30%) and pain (=10%). No systemic adverse events occurred in =10% of subjects in this age group. 2

Please see full prescribing information for AFLURIA here.

Padilla
Dani Jurisz, 612-455-1726
Dani.Jurisz@PadillaCo.com


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