CDC Advisory Committee Includes FLUAD^® QUADRIVALENT as a Preferentially Recommended Influenza Vaccine for Adults 65 and Older

• ACIP recommends adults 65 years of age and older receive an enhanced flu vaccine, such as FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), to help protect against four strains of seasonal influenza annually 
• The committee reviewed randomized studies and real-world data spanning multiple seasons and numerous flu-related outcomes in support of FLUAD QUADRIVALENT to inform their recommendation

Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has included FLUAD® QUADRIVALENT as a preferentially recommended seasonal influenza vaccine for adults 65 years of age and older. The preferential recommendation for FLUAD^® QUADRIVALENT for all adults 65 years and older is based on the clinical benefits compared to standard egg-based influenza vaccines, as demonstrated within the total body of evidence¹. 

“It is critical that we do everything we can to protect vulnerable populations like older adults against influenza,” said Gregg Sylvester, MD, Chief Health Officer, Seqirus. “Today’s recommendation is evidence of the ACIP’s commitment to providing clear, evidence-backed guidance to protect public health. We are proud to offer one of the enhanced flu vaccines that was preferentially recommended by the ACIP for adults 65 years and above in the U.S.” 

Immunosenescence, the age-associated decline of the immune system, may result in a reduced immune response to antigens in the vaccine.²  FLUAD QUADRIVALENT is specifically created for adults 65 years and older using Seqirus’ MF59^® adjuvant, designed to help strengthen, broaden and lengthen the immune response to influenza vaccination.^{2, 3, 4, 5}  Approximately 80 percent of influenza-related deaths and 50 to 70 percent of influenza-related hospitalizations occur among adults 65 years and older, according to the CDC.⁶ 

FLUAD is proven to be safe and effective and has an extensive clinical legacy, with more than 225 million doses distributed and licensure in over 30 countries since it was first approved in 1997.^{7, 8} 

More than 20 years of real-world evidence supports the clinical value of FLUAD in reducing influenza-related clinical outcomes in adults 65 years and older across different influenza seasons with different study designs, clinical outcomes, and study limitations.⁴ Seqirus will offer this enhanced seasonal vaccine option for pharmacy partners, healthcare providers and their patients during the upcoming 2022/23 Northern Hemisphere influenza season in the U.S. to better help protect this population from influenza and severe influenza-related outcomes. 

“This preferential recommendation sends a clear message that FLUAD QUADRIVALENT is an important treatment option for people 65 years of age and older,” said Dave Ross, Vice President, North America Commercial Operations, Seqirus. “A preferential recommendation for adults 65 and older helps to provide guidance to both healthcare providers and patients on the standard of care for this at-risk population.” 

Seqirus’ differentiated portfolio of seasonal influenza vaccines for the U.S. also includes FLUCELVAX^® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine for people six months of age and older in the U.S.⁹  Cell-based influenza vaccines are designed to produce an exact match to the World Health Organization (WHO)-selected influenza virus strains by avoiding egg-adapted changes and therefore have the potential to lead to greater vaccine effectiveness.¹⁰ 

According to the ACIP, if one of the preferentially recommended influenza vaccines is not available to adults 65 years and older, then any other age-appropriate influenza vaccine should be used.² 

About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.¹¹  Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.¹¹ 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.¹¹ Estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.¹²  The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.¹³  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.¹³ The CDC recommends that people get vaccinated by the end of October.¹³ 

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; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving 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 lifesaving products to patients in more than 100 countries and employs more than 25,000 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 inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.   
 
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. 

USA-aQIV-22-0039

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MEDIA CONTACT
Maria Tortoreto 
+1 (201) 248-5208
Maria.Tortoreto@Seqirus.com

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

What is FLUAD® QUADRIVALENT? 
FLUAD QUADRIVALENT is a vaccine that helps protect against flu. FLUAD QUADRIVALENT is for people age 65 years and older. Vaccination with FLUAD QUADRIVALENT may not protect all people who receive the vaccine. 
 
Who should not get FLUAD QUADRIVALENT? 
You should not get FLUAD QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine. 
 
Before receiving FLUAD QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you: 

• Have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu shot. The decision to give FLUAD QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
• Have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine.
• Have ever fainted when receiving a vaccine. 

What are the most common side effects of FLUAD QUADRIVALENT? 

• Pain or tenderness where the shot was given 
• Headache 
• Tiredness

These are not all of the possible side effects of FLUAD QUADRIVALENT. You can ask your healthcare provider for a complete list of possible side effects. 
 
What do I do if I have side effects? 
Ask your healthcare provider for advice about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 
 
Before receiving vaccine, please see the full Prescribing Information for FLUAD QUADRIVALENT. The information provided here is not comprehensive. To learn more, talk about FLUAD QUADRIVALENT with your healthcare provider or pharmacist. 
 
FLUAD® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.  

FLUCELVAX® QUADRIVALENT (Influenza Vaccine) 
IMPORTANT SAFETY INFORMATION 
 

What is FLUCELVAX® QUADRIVALENT (Influenza Vaccine)? 
FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine. 
 
Who should not get FLUCELVAX QUADRIVALENT? 
You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine. 
 
Before receiving FLUCELVAX QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you: 

• Have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks of getting a flu vaccine. The decision to give FLUCELVAX QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks. 
• Have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine. 
• Have ever fainted when receiving a vaccine. 

 
What are the most common side effects of FLUCELVAX QUADRIVALENT? 

• Pain, redness, swelling, or a raised hardened rea where the vaccine was given 
• Headache 
• Overtiredness with low energy 
• Muscle aches
• Feeling unwell (malaise) 

 
Additional side effects seen in children include: 

• Tenderness or bruising where vaccine was given 
• Sleepiness 
• Irritability 
• Diarrhea 
• Changes in eating habits  

 
These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.  
 
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus 1 855 358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.  

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¹National Center for Immunization & Respiratory Diseases. Advisory Committee on Immunization Practices. Influenza Vaccines for Older Adults: GRADE Summary. Accessed June 2022.
²FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2019.
³O’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.
⁴Frey 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.
⁵Banzhoff 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. 
⁶Centers for Disease Control and Prevention (CDC). Adults 65 & Over. Retrieved from: https://www.cdc.gov/flu/highrisk/65over.htm. Accessed June 2022. 
⁷Data on file. (2022). Seqirus USA Inc.
⁸Centers for Disease Control and Prevention (CDC). Adjuvanted Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm. Accessed June 2022. 
⁹FLUCELVAX® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: Seqirus Inc, 2021. 
¹⁰Rajaram, S., Boikos, C., Gelone, D.K., Gandhi, A. Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036483/. Accessed June 2022. 
¹¹Centers for Disease Control and Prevention (CDC). Key Facts about Influenza. Retrieved from https://www.cdc.gov/flu/about/keyfacts.htm. Accessed June 2022.
¹²Centers for Disease Control and Prevention (CDC). 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 June 2022. 
¹³Centers for Disease Control and Prevention (CDC). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed June 2022.