Seqirus Presents New Data at ESWI 2020 Demonstrating Safety and Immunogenicity of Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

SUMMIT, N.J., Dec. 7, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and influenza pandemic response, today announced the presentation of new data at the European Scientific Working Group on Influenza (ESWI) virtual conference, demonstrating the immunogenicity and safety of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine.^1,2

Immunogenicity of two doses of the vaccine was presented, demonstrating that they elicited a strong immune response in pediatric (6 months to 17 years old), adult (≥ 18 years to 64 years old) and older adults (≥ 65 years old).¹ A separate safety analysis was also presented in pediatric (6 months to 17 years old), adult (≥ 18 years to 64 years old) and older adults (≥ 65 years old), demonstrating that the vaccine was well tolerated in these age groups.²

An influenza pandemic is a global epidemic caused by the emergence of a new influenza virus to which there is little or no pre-existing immunity in the human population.³ Influenza viruses are constantly circulating and abrupt and major mutations in Type A viruses (such as when a human flu virus crosses with an avian flu virus to create a new subtype not seen in humans) can cause a pandemic.⁴ Similar to the ongoing COVID-19 pandemic, an influenza pandemic can spread quickly from person to person, as the majority of the population will not have pre-existing immunity.⁵ The influenza A (H5N1) virus continues to circulate and has high pandemic potential due to its ability to transmit from birds to humans.⁶ According to the World Health Organization (WHO), the mortality rate is about 60% when humans do become infected with influenza A (H5N1).⁷

“As seen with the ongoing COVID-19 crisis, infectious diseases can be deadly and cause a significant burden on our healthcare infrastructure. For viruses with strong pandemic potential like influenza, it’s critical that we do everything we can to prepare for a possible outbreak,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “The data being presented at ESWI underscore our commitment to developing advanced technologies that are safe and effective for rapid use in the event of an influenza pandemic.”

The vaccine included in this study is the first-ever adjuvanted, cell-based pandemic influenza vaccine in the U.S.⁸ The novel vaccine combines two leading-edge technologies—MF59^® adjuvant and cell-based antigen manufacturing. The adjuvanted, cell-based pandemic influenza A (H5N1) vaccine is designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of an influenza pandemic.^9,10

“By combining our cutting-edge cell-based and adjuvant technologies, we are proud to help provide protection in the event of an influenza pandemic emergency,” said Marc Lacey, Executive Director, Pandemic Response Solutions at Seqirus. “In the event of an influenza pandemic, it will be critical to have vaccines that have a positive safety profile, are effective and are able to be rapidly produced to protect against a pandemic influenza virus.”

Influenza vaccines using the MF59^® adjuvant may enhance and broaden the body’s immune response by inducing antibodies against virus strains that have mutated.^11,12 This adjuvant is also important in pandemic response, as it can reduce the amount of antigen required per dose, allowing production of a larger number of doses to respond to a public health need.^13,14 The cell-based vaccine antigen, MF59^® adjuvant and formulated prefilled syringes used in the pandemic influenza vaccine are all produced in the state-of-the-art Seqirus production facility in Holly Springs, N.C., built and supported through a multi-year public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.¹⁵ Seqirus is uniquely positioned to manufacture cell-based influenza vaccines on a pandemic scale as a result of its public-private partnership with BARDA.¹⁶

About the Studies

Immunogenicity of a Mammalian Cell Culture-Derived, MF59^®-Adjuvanted, A/H5N1 Influenza Vaccine in Children, Adults, and Older Adults¹
This study assessed immunogenicity data from four clinical trials of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine in children (6 months to 17 years), adults (18-64 years), and older adults (≥ 65 years).¹ The four clinical trials comprised 7,484 participants who received two doses of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine administered on Days 1 and 22.¹

Results indicate that across all age groups studied (6 months to ≥ 65 years old), two doses of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine induced antibody responses that met both the Center for Biologics Evaluation and Research (CBER) and former Committee for Medicinal Products for Human Use (CHMP) criteria for licensure.¹ Overall, an age-related immunological response was evident; the highest responses were observed in children 6 months to < 3 years of age, with almost 100% of this population achieving HA Inhibition titers ≥ 1:40 after two doses.¹ Immune responses in the those ≥ 65 years of age were lower than in adults 18-64 years of age, consistent with the principle of age-related immune decline.¹

Overview of Safety Data from Four Clinical Trials of a Mammalian Cell Culture-Derived, MF59^®-Adjuvanted, A/H5N1 Influenza Vaccine in Children, Adults and Older Adults²
This study assessed safety data over a year from four clinical trials of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine in children (6 months to 17 years), adults (18-64 years) and older adults (≥ 65 years).²

The four clinical trials comprised 7,484 participants given two doses of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine administered on Days 1 and 22.² Results indicate in subjects ≥ 18 years of age, pain was the most frequently reported solicited local adverse event (AE) and fatigue the most frequent solicited systemic AE.² In subjects 6 months to 17 years of age, pain (68%) was the most frequent solicited local AE, and myalgia (30%) the most frequent solicited systemic AE; fever ≥ 38.0°C occurred in 4% subjects, with no incidence ≥ 40.0°C.² Overall, two doses of an adjuvanted, cell-based pandemic influenza A (H5N1) vaccine were well tolerated with no safety concerns in all age groups studied.²

About Pandemic Influenza
Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity.³ The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the virus in the human population.⁴ Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.¹⁶ According to the WHO, influenza A (H5N1) strain can cause severe disease and has a high mortality rate. If the influenza A (H5N1) virus were to change and become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be catastrophic, with an estimated 60% mortality rate.⁷

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.

AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
Important Safety Information

INDICATION AND USAGE
AUDENZ is an inactivated vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.

AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.

Use in persons 6 months through 17 years of age is approved under accelerated approval based on the immune response elicited by AUDENZ. Continued approval for use in this age group may be contingent upon verification and description of clinical benefit in a confirmatory trial.

CONTRAINDICATIONS
History of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, or after a previous dose of an influenza vaccine.

WARNINGS AND PRECAUTIONS

• Hypersensitivity reactions can occur. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give AUDENZ should be based on careful consideration of potential benefits and risks.

ADVERSE REACTIONS

• In adults 18 through 64 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (64%), fatigue (25%), headache (25%), malaise (22%), myalgia (14%), arthralgia (10%), and nausea (10%).
• In adults 65 years of age and older, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (36%), fatigue (20%), malaise (16%), headache (16%), and arthralgia (10%).
• In infants and children, 6 months through 5 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were tenderness (56%), irritability (30%), sleepiness (25%), change in eating habits (18%), and fever (16%).
• In children 6 through 17 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (68%), myalgia (30%), fatigue (27%), malaise (25%), headache (22%), loss of appetite (14%), nausea (13%), and arthralgia (13%).

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 Prescribing Information for AUDENZ.

AUDENZ and MF59^® are trademarks of Seqirus UK Limited or its affiliates.

US/CORP/1120/0320

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

REFERENCES

¹ Immunogenicity of a mammalian cell culture-derived, MF59-adjuvanted, A/H5N1 influenza vaccine in children, adults, and older adults. Presented at ESWI 2020.

² Overview of safety data from four clinical trials of a mammalian cell culture-derived, MF59-adjuvanted, A/H5N1 influenza vaccine in children, adults, and older adults. Presented at ESWI 2020.

³ World Health Administration (WHO). (2010). What is a pandemic? Retrieved from: https://www.who.int/csr/disease/swineflu/frequently_asked_questions/pandemic/en/. Accessed November 2020.

⁴ (WHO). (2020). How pandemic influenza emerges. Retrieved from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/pandemic-influenza/how-pandemic-influenza-emerges#:~:text=Influenza%20viruses%20constantly%20change%20through,pronounced%20in%20influenza%20A%20viruses. Accessed November 2020.

⁵ CDC. (2017). Pandemic Influenza: Questions and Answers. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/faq.html#:~:text=When%20a%20pandemic%20influenza%20virus%20emerges%2C%20the%20virus%20can%20spread,available%20to%20offer%20immediate%20protection. Accessed November 2020.

⁶ CDC. (2018). Highly Pathogenic Asian Avian Influenza A(H5N1) Virus. Retrieved from: https://www.cdc.gov/flu/avianflu/h5n1-virus.htm. Accessed November 2020.

⁷ (WHO). (2012). Influenza: H5N1. Retrieved from: https://www.who.int/news-room/q-a-detail/influenza-h5n1. Accessed November 2020.

⁸ Data on file. (2019). Seqirus USA Inc.

⁹ AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2020.

¹⁰ Reisinger, KS, Holmes, SJ, Pedotti, P, et al. (2014). A dose-ranging study of MF59^®-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896790/. Accessed November 2020.

¹¹ 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

¹² 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

¹³ Khurana, S, Verma, N, Yewdell, JW, et al. (2011) MF59 adjuvant enhances diversity and affinity of antibody-mediated immune response to pandemic influenza vaccines. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501657/.

¹⁴ Reed, SG, Orr, MT, Fox, CB. (2013). Key roles of adjuvants in modern vaccines. Retrieved from: https://www.nature.com/articles/nm.3409. Accessed November 2020.

¹⁵ This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C and HHSO100200900101C.

¹⁶ WHO. (2017). Pandemic Influenza Risk Management: A WHO guide to inform and harmonize national and international pandemic preparedness and response. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/259893/WHO-WHE-IHM-GIP-2017.1-eng.pdf;jsessionid=4421F16879D2F8B96481F8D0C745C7F3?sequence=1. Accessed November 2020.

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