• Seqirus offers a differentiated portfolio of influenza vaccines, including FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine for eligible persons two years of age and older; and FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the only adjuvanted quadrivalent seasonal flu vaccine for adults over 65 years of age and older1,2, 
• Seqirus draws on over a century of experience in influenza vaccines, driven by the promise to safeguard communities against influenza around the globe3  
• The CDC recommends everyone six months of age and older without contraindications receive an annual influenza vaccine4; and has issued interim clinical considerations that COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing4

Seqirus, a global leader in influenza prevention, and a business of CSL Limited (ASX:CSL), today announced that it has begun to ship its portfolio of innovative seasonal influenza vaccines across the U.S. in preparation for the 2021/22 influenza season. The company is prepared to meet the record levels of demand seen during the 2020/21 influenza season amidst the ongoing COVID-19 pandemic, supplying approximately 60 million doses of influenza vaccines for healthcare providers across the U.S.

“We are proud to offer our portfolio of differentiated flu vaccines, including cell-based and adjuvanted vaccines that utilize innovative, proprietary technologies designed to address factors that may impact vaccine effectiveness,” said Dave Ross, Vice President, North America Commercial Operations at Seqirus. “Despite the immeasurable ways the world has changed in the last year, our mission for the upcoming influenza season hasn’t faltered. We are driven by our commitment to deliver safe and effective influenza vaccines to as many eligible people as possible, including vulnerable groups like young children and adults 65 years and older.”

Seqirus, the only global vaccine company with a singular focus on influenza, provides a portfolio of products that offer protection from influenza for people of all ages – from children as young as six months of age to adults 65 years and older – including:1,2,5 

• FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine for persons two years of age and older, and currently under review by the U.S. Food and Drug Administration (FDA) for an expanded age indication for children as young as six months of age;1
• FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine  for adults 65 and older;2 and 
• AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based quadrivalent influenza vaccine approved for use in eligible persons six months of age and older.5

“A continued focus on influenza vaccination is critically important because, while rates of influenza were generally low last season, we cannot assume this will be the case during the coming year and we need to be prepared,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “With our rich history and exclusive focus on influenza, we know that influenza vaccination can save lives and is an important step we can take to help protect ourselves, our loved ones and our communities.” 

Seqirus produces influenza vaccines across its international manufacturing network, which includes facilities in the U.S., U.K. and Australia. Since the start of the COVID-19 pandemic, the company has experienced record demand for influenza vaccines across all markets and has extended production across its three manufacturing sites.

“Now more than ever, people around the globe need a continuous, reliable supply of influenza vaccines and Seqirus is working around the clock to maintain our production focus to ensure that we deliver on our commitment to protect as many people as possible from the burden of influenza,” said Chris Larkins, Senior Vice President of Global Operations at Seqirus. “As a company on the front line of influenza prevention, our advanced vaccine technologies, including our cell-based manufacturing process, are critical to delivering safe, effective vaccines in a timely manner.”

The Centers for Disease Control and Prevention (CDC) has issued interim clinical considerations stating that COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.4

About Seasonal Influenza 
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.6 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.6 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.4 Because transmission of influenza viruses 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.6 Estimates from the CDC report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.7 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.8 The CDC recommends that people get vaccinated by the end of October.8 For non-pregnant adults, getting vaccinated too early (for example, in July or August), should be avoided, unless there is concern that later vaccination may not be possible, as it can be associated with reduced protection against influenza infection later in the flu season.4 However, getting vaccinated later can still be beneficial and vaccination should continue to be offered throughout the influenza season, even into January or later.8

About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). 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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life- saving products to more than 100 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit www.csl.com.

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

Intended Audience
This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.

Forward-Looking Statements
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
 

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FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), AFLURIA® QUADRIVALENT (Influenza Vaccine), and FLUCELVAX® QUADRIVALENT (Influenza Vaccine)
INDICATION and IMPORTANT SAFETY INFORMATION 

INDICATIONS AND USAGE

FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine and is approved for use in persons 65 years of age and older. These indications are approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT.

AFLURIA® QUADRIVALENT (Influenza Vaccine) 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.

FLUCELVAX® QUADRIVALENT (Influenza Vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 2 years of age and older. 

IMPORTANT SAFETY INFORMATION 

CONTRAINDICATIONS 

Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine.

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or FLUCELVAX 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.

Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT, and FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.

The immune response to FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.

Vaccination with FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS 

FLUAD QUADRIVALENT:
The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%).

AFLURIA QUADRIVALENT:
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%). 

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%). 

In children 5 through 8 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%). 

In children 9 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%). 

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%). 

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:
 
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when 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%). 

FLUCELVAX QUADRIVALENT:
In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 40%), erythema and induration (≥ 10%). The most common systemic adverse events were headache, fatigue and myalgia (≥ 10%). 

In adults ≥ 65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 20%) and erythema (≥ 10%). 

In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse events were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse events were headache (18.1%) and fatigue (17.0%).

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

Before administration, please see the full U.S. Prescribing Information for FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT.

FLUAD® QUADRIVALENT, AFLURIA® QUADRIVALENT and FLUCELVAX® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates. PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

USA-CRP-21-0039

REFERENCES

1 FLUCELVAX® QUADRIVALENT [package insert]. (2021). Holly Springs, NC: Seqirus Inc.
2 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. (2020). Holly Springs, NC: Seqirus Inc.
3 Seqirus (2021). Our Company. Retrieved from: https://www.seqirus.us/our-company. Accessed July 2021.
4 CDC. (2021). WG Considerations and Proposed Influenza Vaccine Recommendations, 2021-22 . Retrieved from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-influenza-grohskopf-508.pdf. Accessed July 2021.
5 AFLURIA® QUADRIVALENT [package insert]. (2020). Parkville, AU: Seqirus Inc.
6 CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm Accessed July 2021.
7 CDC. (2021). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2019–2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019-2020.html. Accessed July 2021.
8 CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed July 2021