Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced the renewal of a five-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).1
The agreement further strengthens the U.S. government’s pandemic preparedness and response capability by ensuring ready production of medical countermeasures (MCMs). This allows BARDA to request that Seqirus provide influenza vaccines and adjuvants for pre-pandemic stockpiling or for manufacture to support rapid response to an influenza pandemic or other public health emergency. Seqirus and BARDA have held similar agreements since 2006.
Seqirus stands ready to provide BARDA with:
- Supply of AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.2 The vaccine combines Seqirus’ proprietary MF59® adjuvant technology with its cell-based manufacturing platform. Cell-based manufacturing, an alternative to traditional egg-based manufacturing, avoids egg-adapted changes, one source of possible strain mismatch between the vaccine and circulating influenza virus.3,4 AUDENZ™ was approved in 2020 and received a supplemental FDA approval in 2021.
- Supply of its proprietary MF59® adjuvant, which when added to an influenza vaccine, is designed to enhance and broaden the body’s immune response by creating broad, cross-reactive antibodies.5,6,7 This adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine produced. This ensures that a large number of people can be vaccinated as quickly as possible, as directed by the U.S. National Influenza Vaccine Modernization Strategy and the White House American Pandemic Preparedness Plan.8,9,10,11
- Access to pre-pandemic vaccines using either cell- or egg-based manufacturing technologies from Seqirus’ global network of production facilities, including Holly Springs, North Carolina; Liverpool, United Kingdom; and Parkville, Australia. In a pandemic, BARDA would source vaccines from the Holly Springs facility.
“As a global leader in seasonal influenza prevention and pandemic influenza preparedness, Seqirus remains committed to working with BARDA and other global partners on the front line of public health in mitigating the potentially devastating effects of another influenza pandemic,” said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus. “With our proven ability to provide a differentiated portfolio of seasonal influenza vaccines across the globe, Seqirus is well-positioned to apply our pandemic influenza vaccine expertise, flexible platform technologies and innovative research capabilities to meet the needs of the U.S. government in such a critical capacity. We are proud to be a trusted partner in support of BARDA’s pandemic preparedness objectives.”
Seqirus and BARDA Build on Longstanding, Successful Partnership
Seqirus has a longstanding partnership with BARDA. The company’s manufacturing facility in Holly Springs, North Carolina, the largest cell-based influenza vaccine producer in the world and the first such domestic facility, was built through a public-private partnership established in 2009 with BARDA. The partnership utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response, in addition to its seasonal influenza vaccine production. Seqirus has made many investments in the facility in recent years, including the expansion of a new fill-finish line, which is currently underway. These investments serve to strengthen the company’s continuous efforts to increase manufacturing capacity and decrease production time.
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.12 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.9 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.9 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.13 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.14 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.15 The CDC recommends that people get vaccinated by the end of October.12
About Pandemic Influenza
Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity.16 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.17 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.18 According to the CDC, a novel influenza A virus such as the highly pathogenic avian A(H5N1) strain can cause severe disease and have a high mortality rate.19 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 severe.16
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.
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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.
CONTRAINDICATIONS
Do not administer AUDENZ to anyone with a 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 severe allergic reactions (e.g., anaphylaxis) 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.
- Vaccination with AUDENZ may not protect all recipients. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AUDENZ.
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 18553588966 or VAERS at 18008227967 or www.vaers.hhs.gov.
Before administration, please see the full Prescribing Information for AUDENZ.
AUDENZ and MF59® are registered trademarks of Seqirus UK Limited or its affiliates.
USA-H5N1-22-0001
MEDIA CONTACT
Maria Tortoreto
+1 (201) 248-5208
Maria.Tortoreto@Seqirus.com
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1 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50122D00002.
2 AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2021.
3 CDC. (2021). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed November 2021.
4 Rajaram, S., Boikos, C., Gelone, et al. (2020). Influenza Vaccines: The Potential Benefits of Cell-Culture Isolation and Manufacturing.
5 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
6 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
7 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
8 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/. Accessed February 2022.
9 Reed, SG, Orr, MT, Fox, CB. (2013). Key roles of adjuvants in modern vaccines. Retrieved from: https://www.nature.com/articles/nm.3409. Accessed February 2022.
10 U.S. Department of Health & Human Services. (2020). National Influenza Vaccine Modernization Strategy (NIVMS) 2020-2030. Retrieved from https://www.phe.gov/Preparedness/planning/nivms/Pages/default.aspx. Accessed February 2022.
11 American Pandemic Preparedness: Transforming Our Capabilities. (2021). Retrieved from https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29. Accessed February 2022.
12 CDC. (2021). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed February 2022.
13 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 February 2022.
14 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 February 2022.
15 CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed February 2022.
16 CDC. (2016). Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. Accessed February 2022.
17 WHO. (2021). How pandemic influenza emerges. Retrieved from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/pandemic-influenza/how-pandemic-influenza-emerges. Accessed February 2022.
18 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 February 2022.
19 CDC. (2015). Highly Pathogenic Asian Avian Influenza A(H5N1) in People. Retrieved from: https://www.cdc.gov/flu/avianflu/h5n1-people.htm. Accessed February 2022.