Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine

This news release is intended for medical and pharmaceutical trade media and financial media only

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Seqirus, a global leader in influenza prevention, today announced that its adjuvanted quadrivalent influenza vaccine (aQIV) - launching as FLUAD® TETRA - has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of the marketing authorisation application (MAA) for use in people aged 65 years and above.1

The CHMP positive opinion is a scientific recommendation for marketing authorisation which is referred to the European Commission for a final decision on the Company’s MAA.  Subject to final approval, the decision will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein.2

The European Commission MAA approval is also applicable in the UK.  During the Brexit transition period the UK is still subject to EU legislation and regulatory decisions.

Seqirus’ adjuvanted trivalent vaccine (aTIV) - FLUAD® - offers protection against three strains of influenza.  The aQIV vaccine includes an additional B strain, offering protection against four seasonal influenza virus strains – A(H3N2), A(H1N1) and two B virus strains.

“This positive CHMP opinion takes us one step closer to fulfilling our commitment to bring our adjuvanted quadrivalent vaccine to Europe,” said Dr Raja Rajaram, Head of EMEA Medical Affairs for Seqirus.  “Our current adjuvanted trivalent vaccine is supported by a large body of evidence - generated from both clinical trials and real world studies - and is recommended for use in patients over 65 years of age in many countries across the globe.

“We know that influenza causes a significant burden each year and that vaccination is the best method of prevention. The impact of the current coronavirus emergency underscores the importance of influenza vaccination in protecting those most at risk and reducing pressure on vital health services.3

Influenza vaccine effectiveness tends to be low in the 65 and over population due to age-related immune decline, which reduces the body’s ability to produce a sufficient, protective immune response to the vaccine.4  The aQIV vaccine utilises the same adjuvant found in the aTIV vaccine - MF59® - which is designed to create a strong, broad and durable immune response.5,6,7

The aQIV vaccine will be produced in the UK at Seqirus’ Speke, Liverpool, manufacturing site.

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Job ID: UK/FLUD/0320/0147

Date of Preparation: March 2020

Adverse reporting

To report an adverse event to any Seqirus product please phone +44 (0) 1748 828816 or email seqirus@eu.propharmagroup.com

About seasonal influenza

Seasonal influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. The European Centre for Disease Prevention and Control (ECDC) estimates that 15,000 – 70,000 people in Europe die from influenza-related complications each year, and encourages annual vaccination as the most effective way to prevent influenza.8

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. Seqirus operates state-of-the-art production facilities in the US, 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.  For more information visit www.seqirus.com.

Adjuvant Technology

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

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 visit www.csl.com.

Forward-Looking Statements

This news release contains 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.

References

1. EMA. Fluad Tetra Opinion. Retrieved from https://www.ema.europa.eu/en/medicines/human/summaries-opinion/fluad-tetra (accessed March 2020) 

2. EMA. Human Regulatory, Marketing Authorisation. Retrieved from https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation (accessed March 2020)

3. American College of Cardiology. Coronavirus Disease 2019 (COVID-19) Provides Potent Reminder of the Risk of Infectious Agents. Retrieved from https://www.acc.org/latest-in-cardiology/articles/2020/03/01/08/42/feature-coronavirus-disease-2019-covid-19-provides-potent-reminder-of-the-risk-of-infectious-agents (accessed march 2020)

4. 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. 

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):13-30

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. ECDC. Factsheet about seasonal influenza. Retrieved from https://www.ecdc.europa.eu/en/seasonal-influenza/facts/factsheet (accessed March 2020)