FDA Approves Audenz

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1).1 Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.2

The novel vaccine combines two leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing. Audenz is designed to be rapidly deployed to help protect the U.S. population1,3 and can be stockpiled for first responders in the event of pandemic.

"The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies," said Russell Basser, MD, Chief Scientist and Senior Vice President of Research and Development at Seqirus. "This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency."

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.4 Pandemics are impossible to predict and can cause catastrophic morbidity and mortality globally.3 The World Health Organization (WHO) Global Influenza Strategy for 2019-2030 states that a severe pandemic can result in widespread social and economic effects, including a loss of national economic productivity and severe economic burdens on affected citizens and communities.5

Influenza vaccines using the MF59® adjuvant may enhance and broaden the body's immune response by inducing antibodies against virus strains that have mutated.6,7,8 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 developed, so that a large number of people can be protected as quickly as possible.9,10 The cell-based vaccine antigen, MF59® adjuvant, and formulated prefilled syringes used in the Audenz 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.11

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said BARDA Director Rick Bright, Ph.D. "With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza – we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic."

Seqirus is uniquely positioned to manufacture cell-based vaccines on a pandemic scale as a result of its public-private partnership with the BARDA.11

About Pandemic Influenza

Pandemic influenza, as with seasonal influenza, is a contagious airborne respiratory disease which is unpredictable and can occur in any age group or any population worldwide.4 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because of little or no pre-existing immunity to the virus in the human population.3 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.12 According to the World Health Organization (WHO), A (H5N1) influenza strain can cause severe disease and has a high mortality rate. If the 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 very serious, with an approximate 60% mortality rate.13

About Audenz™

Audenz™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) is a pandemic influenza vaccine developed by Seqirus.1 This is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.2 Seqirus has combined two leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing—to create this pandemic influenza vaccine.2 The U.S. Food and Drug Administration granted Fast Track designation for the aH5N1c vaccine for prevention of illness related to pandemic influenza caused by A (H5N1) virus in December 2015.14 Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.15

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 22,000 people with operations in more than 60 countries.

Seqirus was established on 31 July 2015 following CSL's acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. 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.

Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

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.

Intended Audience

This press release is issued from Seqirus USA Inc. in Holly Springs, North Carolina, 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

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 is a trademark of Seqirus UK Limited or its affiliates.

MF59® is a registered trademark of Novartis International AG, Basel, Switzerland.

REFERENCES

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

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

3 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 January 2020.

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

5 (WHO). (2019). Global Influenza Strategy. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/311184/9789241515320-eng.pdf?ua=1. Accessed January 2020.

6 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

7 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

8 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

9 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 January 2020.

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

11 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.

12 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 January 2020.

13 WHO. (2011). FAQs: H5N1 influenza. Retrieved from: https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/. Accessed January 2020.

14 Data on file. (2015). Seqirus USA Inc.

15 U.S. Food and Drug Administration (FDA). (2018). Fast Track. Retrieved from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

SOURCE Seqirus

Posted: February 2020

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) FDA Approval History