Seqirus Receives FDA Approval of AFLURIA® QUADRIVALENT (Influenza Vaccine) for People Six Months of Age and Older in the U.S.

SUMMIT, N.J., Oct. 23, 2018 /PRNewswire/ -- Seqirus, a global leader in influenza prevention, today announced the U.S. Food and Drug Administration (FDA) has approved AFLURIA® QUADRIVALENT (Influenza Vaccine) for use in people six months of age and older,¹ extending the company’s broad portfolio of influenza vaccine offerings. The approval also applies to the trivalent formulation of AFLURIA® (Influenza Vaccine).²

AFLURIA QUADRIVALENT was first approved in the U.S. in August 2016, for adults aged 18 years and above and helps protect against two influenza A strain viruses and two B strain viruses.¹

“Younger children, who are more at risk for getting the flu because of their weaker immune systems, are a priority population for Seqirus,” said Gordon Naylor, President of Seqirus. “As a company on the front line of influenza protection, the approval of AFLURIA QUADRIVALENT for children six months and older is reflective of our dedication to providing broad and effective options across a variety of ages.”

AFLURIA QUADRIVALENT is available in the U.S. for the 2018-2019 influenza season, presented in pre-filled syringes as well as multi-dose vials.¹

The U.S. Centers for Disease Control and Prevention (CDC) recommends an annual influenza vaccine for everyone six months of age and older³ as the first and most important step in protecting against influenza and its potentially serious complications.

“As we enter a new flu season, we are reminded of the enormous impact that influenza can have on public health,” said Gregg Sylvester MD, Vice President of Medical Affairs at Seqirus. “Having another option to fight this disease can translate to saved lives and fewer flu-related hospitalizations this season and going forward.”

The complete Seqirus portfolio of seasonal influenza vaccines provides a range of options for children aged six months of age to people aged 65 years and older, including egg-based and cell-based technologies and adjuvant.

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 influenza-related outcomes, such as hospitalization and death, the CDC encourages annual vaccination for all individuals aged 6 months and older. Because transmission to others may occur one day before symptoms develop and up to 5 to 7 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. The CDC estimates that 600,000 people in the United States were hospitalized due to influenza-related complications during the 2016-2017 influenza season. Since it takes about 2 weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.

About AFLURIA® QUADRIVALENT (Influenza Vaccine)

• AFLURIA QUADRIVALENT received approval from the FDA for use in persons 6 months of age or older on October 4, 2018.^1,4
• The vaccine is available in single-dose, preservative-free pre-filled syringes and multi-dose vials to provide choice and convenience to patients and caregivers who administer it.^1,4

Please see the accompanying Important Safety Information and the US full Prescribing Information for AFLURIA QUADRIVALENT.

About AFLURIA^® (Influenza Vaccine)

• Afluria is a trivalent influenza vaccine developed with egg-based technologies and is indicated for persons aged five or older.²
• Afluria is available in both prefilled syringes and multi-dose vials to provide choice and convenience to patients and caregivers who administer it.²
• It is the only trivalent flu vaccine with a needle-free delivery option (PharmaJet^® Stratis^® 0.5mL Needle-Free Jet Injector) for persons 18 through 64 years of age.²

Please see the accompanying important safety information and the full Prescribing Information for AFLURIA.

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 31 July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As one of the largest influenza vaccine providers 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 UK 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.

References

1. AFLURIA QUADRIVALENT (Influenza Vaccine) [package insert]. Summit, NJ: Seqirus USA Inc; 2018.
2. AFLURIA (Influenza Vaccine) [prescribing information]. Summit, NJ: Seqirus USA Inc; 2018.
3. Centers for Disease Control and Prevention (CDC). Prevent Seasonal Flu. Retrieved from https://www.cdc.gov/flu/prevent/index.html. Accessed October 2018.
4. Food and Drug Administration (FDA). Vaccines, blood & biologics: Approved Products - AFLURIA QUADRIVALENT. Retrieved from: https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm518291.htm. Accessed October 2018.

AFLURIA® QUADRIVALENT (Influenza Vaccine) Important Safety Information

Indications and Usage

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 6 months of age and older.

Contraindications

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

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.
• 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 when administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).
• In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
• In children 5 through 8 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse event was headache (≥10%).
• In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%).
• In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).
• In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).

Afluria (trivalent formulation) administered by the PharmaJet Stratis Needle-Free Infection 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 systematic adverse events were myalgia, malaise (≥30%), and headache (≥ 20%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see accompanying U.S. full Prescribing Information for AFLURIA QUADRIVALENT.

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

AFLURIA® (Influenza Vaccine) 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.

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 5 years as compared to previous years.
• 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.
• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• Immunocompromised persons may have a diminished immune response to AFLURIA.

ADVERSE REACTIONS

• In children 5 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%).
• 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%) and headache, malaise (≥20%).
• 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%).
• 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.

Please see the accompanying important safety information and the full Prescribing Information for AFLURIA.

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SOURCE Seqirus

Company Codes: Australia:CSL, OTC-PINK:CSLLY