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

Cambridge, MA — 08/29/2016

  • 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

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

About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. 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. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.6 On average, more than 200,000 people are hospitalized due to influenza-related complications in the US each year.7

About AFLURIA QUADRIVALENT
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 persons 18 years of age and older.1

IMPORTANT SAFETY INFORMATION

Contraindications

  • AFLURIA QUADRIVALENT is contraindicated in individuals with 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 & Precautions

  • Guillain-Barré Syndrome: 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 The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.1


  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.1


  • Altered Immunocompetence: If AFLURIA QUADRIVALENT is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.1


  • Limitations of Vaccine Effectiveness: Vaccination with AFLURIA QUADRIVALENT may not protect all individuals.1

Adverse Reactions

  • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe 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 when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).1
  • In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions when AFLURIA® (trivalent formulation) was administered by the PharmaJet Stratis Needle-Free Injection System 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 accompanying US Full Prescribing Information for AFLURIA QUADRIVALENT.

About AFLURIA

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. AFLURIA is approved for use in persons 5 years of age and older.2

IMPORTANT SAFETY INFORMATION

Contraindications

  • AFLURIA is contraindicated in individuals with 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.2

Warnings & Precautions

  • Fever and Febrile Seizures: Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrileseizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 through 8 years of age.2
  • Guillain-Barré Syndrome: 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. The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.2
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.2
  • Altered Immunocompetence: If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.2
  • Limitations of Vaccine Effectiveness: Vaccination with AFLURIA may not protect all individuals.2

Adverse Reactions

  • In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA 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 observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), redness and itching (≥10%). The most common systemic adverse events observed were muscle aches (≥30%), headache and malaise (≥20%).2
  • In adults 18 through 64 years of age, using the PharmaJet Stratis Needle-Free Injection System, the most common injection-site adverse reactions observed in a clinical study with AFLURIA 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, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥30%) and pain (≥10%). No systemic adverse reactions occurred in ≥10% of subjects in this age group.2

Please see accompanying US Full Prescribing Information for AFLURIA.

About FLUAD

FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.10 FLUAD is approved for use in persons 65 years of age and older.8

Important Safety Information

CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.8

WARNINGS AND PRECAUTIONS

  • If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.8
  • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.8

ADVERSE REACTIONS

  • The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).8
  • The most common (≥ 10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%) and fatigue (13%).8

Please see accompanying US Full Prescribing Information for FLUAD.

About FLUCELVAX QUADRIVALENT FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. 11 FLUCELVAX QUADRIVALENT is approved for use in persons four years of age and older.9

Important Safety Information

CONTRAINDICATION

  • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.9

WARNINGS AND PRECAUTIONS

  • Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.9
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.9
  • Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.9
  • Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.9
  • Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.9

MOST COMMON ADVERSE REACTIONS

  • The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%) headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).9
  • The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).9
  • The most common (≥10%) local and systemic reactions in children 4 to <6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).9
  • The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).9
  • The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%) myalgia (16%), and injection site induration (15%).9

Please see accompanying US Full Prescribing Information for FLUCELVAX QUADRIVALENT.

About FLUVIRIN
FLUVIRIN is a trivalent, inactivated subunit influenza virus vaccine. It is available to order for the 2016-17 influenza season as both a prefilled syringe and a multidose vial.10

Important Safety Information

CONTRAINDICATION

History of severe allergic reactions (e.g., anaphylaxis) to egg proteins, or any component of FLUVIRIN, or life-threatening reactions to previous influenza vaccinations.10

WARNINGS AND PRECAUTIONS

  • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN should be based on careful consideration of the potential benefits and risks.10
  • Immunocompromised persons may have a reduced immune response to FLUVIRIN.10
  • The tip caps of the FLUVIRIN prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.10

ADVERSE REACTIONS

The most frequently reported adverse reactions are mild hypersensitivity reactions (such as rash), local reactions at the injection site, and influenza-like symptoms.10

Please see accompanying US Full Prescribing Information for FLUVIRIN.

About SeqirusSeqirus is the new global company created in July 2015 from the combined strength and expertise of bioCSL Inc. and the influenza vaccines business formerly owned by Novartis AG. As the second largest influenza vaccine provider in the world, Seqirus is driven by the promise it shares with parent company, CSL Limited, to provide medicines that help to protect and save lives.

Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally, with extensive research and production expertise and manufacturing plants in the US, Europe and Australia and a commercial presence in 20 countries.

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 16,000 people with operations in more than 30 countries.

For more information visit www.seqirus.com and www.csl.com.

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References:

  1. AFLURIA QUADRIVALENT [prescribing information]. King of Prussia, PA: Seqirus, Inc. 2016.
  2. AFLURIA [package insert]. King of Prussia, PA: bioCSL Inc.; August 2014.
  3. McAllister L, Anderson J, Werth K, et al. Needle free jet injection for administration of influenza vaccine: a randomised non-inferiority trial. Lancet. 2014;384(9944):674-681.
  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 April 2016.
  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.
  6. Centers for Disease Control and Prevention (CDC). Key Facts about Influenza (Flu) & Flu Vaccine. Updated 2015. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed April 2016.
  7. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004;292(11):1333-1340.
  8. FLUAD (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2016.
  9. FLUCELVAX QUADRIVALENT (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus, Inc. 2016.
  10. FLUVIRIN (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus; 2016.


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Sharon.McHale@csl.com.au
Phone: +61 409 978 314


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