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Seqirus Receives FDA Approval for FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) for Adults 65 Years and Older

CSLLY | February 24, 2020

SUMMIT, N.J., Feb. 24, 2020 /PRNewswire/ --

Quadrivalent formulation of the first-and-only adjuvanted seasonal influenza vaccine for older adults (65+ years) receives FDA approval1
Designed with MF59® adjuvant to help strengthen, broaden and lengthen the body's immune response against the influenza strains contained in the vaccine1,2,3,4

Seqirus announced today that the U.S. Food and Drug Administration (FDA) has approved the first adjuvanted quadrivalent influenza vaccine, FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), to help protect adults 65 years and older against seasonal influenza.1

"Adults 65 years and older are at high risk for influenza-related complications each season and it is important to have influenza vaccines to help protect this vulnerable population," said Anjana Narain, Executive Vice President and General Manager at Seqirus. "As part of our leading role on the front line of influenza prevention, we are pleased to offer FLUAD QUADRIVALENT as another seasonal vaccine option for healthcare providers and their patients in the fight against influenza."

In the U.S., influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults.5 During the 2017/18 influenza season, 70 percent of influenza-related hospitalizations and 90 percent of influenza-related deaths occurred in this age group.6 Influenza vaccine effectiveness also tends to be lower in this population due to age-related immune decline, which reduces the body's ability to produce a sufficient, protective immune response to the vaccine.7

FLUAD QUADRIVALENT (aQIV) utilizes the same MF59® adjuvant technology as FLUAD® (aTIV),8 designed to create a strong, broad and durable immune response.1,2,3,4 FLUAD QUADRIVALENT includes an additional strain to FLUAD, which has an extensive clinical legacy, with 114+ million doses distributed and licensure in 29 countries since it was first approved in 1997.9,10

"The burden of seasonal influenza among adults 65 and older, remains an important public health concern," said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. "At Seqirus, we're committed to developing advanced technologies and vaccines designed to address unmet needs, especially in vulnerable populations, such as adults 65 years and older."

According to the Centers for Disease Control and Prevention (CDC), everyone who is six months and older should receive an annual flu shot, but it is particularly important for those 65 years and older who are at risk of developing serious complications from influenza.11

FLUAD QUADRIVALENT and FLUAD are the first-and-only adjuvanted seasonal influenza vaccines approved in the U.S. for adults 65 years and older.1,8,12

About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people.13 To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC recommends annual vaccination for all individuals aged 6 months and older.14 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.13 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.13 Preliminary estimates from the CDC report that up to 647,000 people in the United States were hospitalized due to influenza-related complications during the 2018/19 influenza season.15 Since it takes about two 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.14

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 UK and Australia, and leading R&D capabilities, Seqirus utilises 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 haemophilia 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 60 countries and employs more than 22,000 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.

MF59® is a registered trademark of Seqirus UK Limited or its affiliates.

Intended Audience
This press release is issued from Seqirus U.S. 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.

IMPORTANT SAFETY INFORMATION for FLUAD® (Influenza Vaccine, Adjuvanted) and FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)

INDICATIONS AND USAGE
FLUAD and FLUAD QUADRIVALENT are inactivated influenza vaccines 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.

This indication is approved under accelerated approval based on the immune response elicited by FLUAD and FLUAD QUADRIVALENT. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Data demonstrating a decrease in influenza disease after vaccination with FLUAD or FLUAD QUADRIVALENT is not available.

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

WARNINGS AND PRECAUTIONS

If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD or FLUAD 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 or FLUAD 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 and FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope.

ADVERSE REACTIONS
FLUAD administered by needle and syringe:

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

FLUAD QUADRIVALENT administered by needle and syringe:

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

Other adverse events may occur. For a comprehensive list of local and systemic adverse reactions, please see full prescribing information.

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

Before administration, please see the full Prescribing Information for FLUAD or FLUAD QUADRIVALENT.

FLUAD® and FLUAD® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.

MF59® is a registered trademark of Seqirus UK Limited or its affiliates.

US/FQIV/0919/0007

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

REFERENCES

1 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2020.
2 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034.
3 O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-3
4 Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249
5 Centers for Disease Control and Prevention (CDC). (2018). People 65 years and older & influenza. Retrieved from: https://www.cdc.gov/ncird/index.html. Accessed February 2020.
6 CDC. (2018). Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States – 2017 – 2018 influenza season. https://www.cdc.gov/flu/about/burden/2017-2018.htm. Accessed February 2020.
7 Monto AS, Ansaldi F, Aspinall R, et al. (2009). Influenza control in the 21st century: Optimizing protection of older adults. Vaccine. 2009;27:5043-5053.
8 FLUAD® TRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2018.
9 Data on file. Seqirus Inc; 2019.
10 Data on file. Seqirus Inc; 2019.
11 CDC. (2019). What you should know and do this flu season if you are 65 years and older. Retrieved from: http://www.cdc.gov/flu/about/disease/65over.htm. Accessed February 2020.
12 Food and Drug Administration (FDA). (2015). Accelerated approval – Department of Health and Human Services. Retrieved from: https://www.fda.gov/vaccines-blood-biologics/vaccines/fluad. Accessed February 2020.
13 CDC. (2018). Key facts about influenza (flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed February 2020.
14 CDC. (2018). Key facts about seasonal flu vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed February 2020.
15 CDC. (2019). 2018-2019 U.S. Flu season: Preliminary burden estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed February 2020.