Seqirus Begins Shipping 2020/21 Influenza Vaccines to U.S. Market

SUMMIT, N.J., July 30, 2020 /PRNewswire/ --

• Seqirus has started shipping its portfolio of seasonal influenza vaccines to United States (U.S.) customers for the upcoming 2020/21 U.S. influenza season
• Seqirus is well-positioned to supply up to 60 million doses* of influenza vaccines for healthcare providers across the U.S. depending on demand, a record number of doses for the company
• The Centers for Disease Control and Prevention (CDC) recommends everyone six months and older without contraindications receive an annual influenza vaccine as the best way to prevent seasonal influenza¹
• Influenza vaccination is also an important tool to reduce the impact of influenza in the population and resulting burden on the healthcare system during the COVID-19 pandemic²

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8724051-seqirus-ships-2020-2021-influenza-vaccines-us-market/

Seqirus, a global leader in influenza prevention, announced today it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world's largest influenza vaccine companies is well-positioned to supply up to 60 million doses* to the U.S. market this year, depending on demand.

"We are collaborating with our partners across the industry to ensure a reliable supply of influenza vaccines throughout the season to help ensure as many eligible people as possible get an influenza vaccination," said Dave Ross, Vice President, North America Commercial Operations at Seqirus. "Our healthcare system is facing an unprecedented public health crisis with COVID-19, and we are proud to provide healthcare providers and their patients with a broad range of influenza vaccine options as early as possible to help protect against influenza and help lessen the overall burden on our healthcare system."

Seqirus has a broad portfolio of differentiated products for individuals six months of age to adults 65 years and older, presented in pre-filled syringes as well as multi-dose vials.^3,4,5,6

This year Seqirus will provide FLUAD® (Influenza Vaccine, Adjuvanted), the first-and-only adjuvanted seasonal influenza vaccine approved for adults 65 and older, in addition to FLUAD® Quadrivalent (Influenza Vaccine, Adjuvanted). FLUAD® Quadrivalent contains an additional B strain to help prevent disease caused by all 4 influenza strains represented in the vaccine.^3,4 The Seqirus 2020/21 influenza vaccine portfolio also includes FLUCELVAX® QUADRIVALENT (Influenza Vaccine), a cell-based quadrivalent influenza vaccine approved for use in persons 4 years of age and older⁵ and AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based quadrivalent influenza vaccine approved for use in those six months of age and older.⁶

"Influenza vaccination is critical every year, and it is more important than ever this season as it can help reduce the risk of co-infection from seasonal influenza and COVID-19 and minimize the burden of flu on the healthcare system to preserve capacity for patients with COVID-19 and other serious disorders," said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. "Our cell-based and adjuvant vaccine technologies are designed to address influenza prevention challenges and deliver on our commitment to safeguard people and communities against seasonal influenza."

Seqirus produces influenza vaccines across its global manufacturing network, which includes facilities in the U.S., U.K. and Australia. The company has experienced record demand for influenza vaccines across all markets for the upcoming season and has extended production across its three manufacturing sites.

"We are exploring all possibilities to optimize supply across our global network to help meet the additional demand for the 2020/21 influenza season," said Chris Larkins, Senior Vice President of Global Operations at Seqirus. "We are collaborating with stakeholders across the public health community to ensure recommendations on influenza immunization practices are aligned with timing of available supply. Our focus right now is to ensure as many people as possible can be vaccinated prior to when influenza usually peaks in February and March."

About Seasonal Influenza 

Influenza is a common, highly contagious infectious disease that may cause severe illness and life-threatening complications in some people.⁷ To reduce the risk of more serious outcomes, such as hospitalization and death resulting from influenza, the CDC recommends annual vaccination for individuals aged 6 months and older.¹ 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.⁷ Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.⁷ Preliminary estimates from the CDC report that from October 1, 2019, through April 4, 2020, there have been an estimated 410,000 to 740,000 influenza-related hospitalizations in the U.S.⁸ 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.¹

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 70 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.
FLUAD® QUADRIVALENT, FLUAD®, FLUCELVAX® QUADRIVALENT and AFLURIA® QUADRIVALENT are trademarks of Seqirus U.K. Limited or its affiliates.

*Number of doses shipped may be impacted by variables outside of Seqirus control.

Intended Audience

This press release is issued from Seqirus U.S. Inc. in Summit New Jersey, U.S. 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.

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

INDICATIONS AND USAGE

FLUAD® (Influenza Vaccine, Adjuvanted) 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. 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. FLUAD and FLUAD QUADRIVALENT are 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 type B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older. For children and adolescents 4 through 17 years of age, approval is based on the immune response elicited by FLUCELVAX QUADRIVALENT. Data demonstrating a decrease in influenza disease after vaccination of this age group with FLUCELVAX QUADRIVALENT are not available.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS 

Do not administer FLUAD, 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 reaction (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, 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.

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

Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD, FLUAD QUADRIVALENT, and FLUCELVAX QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope.

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

ADVERSE REACTIONS

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

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:
The most common (≥10%) local and systemic reactions in adults 18 through 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%).

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%).

The most common (≥10%) local and systemic reactions in children 4 through 5 years of age after first dose of vaccine 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%).

The most common (≥10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%) and myalgia (12%).

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%) and myalgia (16%), and injection site induration (15%).

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.

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

FLUAD® , FLUAD® QUADRIVALENT, AFLURIA® QUADRIVALENT and FLUCELVAX® QUADRIVALENT are registered trademarks of Seqirus U.K. Limited or its affiliates.

US/CORP/0520/0233

MEDIA CONTACT
Polina Miklush  
+1 (908) 608-7170
Polina.Miklush@Seqirus.com

REFERENCES

¹ CDC. (2020). Key Facts About Seasonal Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed July 2020.

² CDC. (2020). Frequently Asked Influenza (Flu) Questions: 2020 – 2021 Season. Retrieved from: https://www.cdc.gov/flu/season/faq-flu-season-2020-2021.htm. Accessed July 2020.

³ FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. (2020). Holly Springs, NC: Seqirus Inc.

⁴ FLUAD® (Influenza Vaccine, Adjuvanted) [package insert]. (2020). Holly Springs, NC: Seqirus Inc.

⁵ FLUCELVAX® QUADRIVALENT [package insert]. (2020). Holly Springs, NC: Seqirus Inc.

⁶ AFLURIA® QUADRIVALENT [package insert]. (2020). Parkville, AU: Seqirus Inc.

⁷ CDC. (2019). Key facts about influenza (flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed July 2020.

⁸ CDC. (2020). 2019-2020 U.S. Flu season: Preliminary burden estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed July 2020.

 

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SOURCE Seqirus