Health Canada’s Approval of FOCLIVIA ® (An Adjuvanted, Egg-Based A Strain H5N1 Pandemic Influenza Vaccine) Meets Key Requirement as Pandemic Partner
MONTREAL , March 23, 2021 /CNW/ — Seqirus, a world leader in influenza vaccines and pandemic response, announced today that following Health Canada’s approval of FOCLIVIA ® (adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine), the Company is ready to fulfil its role in Canada’s influenza pandemic preparedness plans.
Seqirus Canada is an influenza pandemic vaccine partner to the Canadian Government through the Public Health Agency of Canada (PHAC). The contract requires Seqirus to be on standby to rapidly manufacture and deliver a large number of vaccine doses to help protect Canadians against the influenza strain identified by the World Health Organization (WHO) when an influenza pandemic is declared.
Health Canada’s approval of FOCLIVIA is a key requirement of this contract and further exemplifies Seqirus’ position as the only global vaccine company singularly focused on influenza. FOCLIVIA is approved for use in individuals six months of age and older if the WHO declares an influenza pandemic. 1
“The approval of FOCLIVIA demonstrates our commitment to Canadians by providing a vaccine that can be used in the event of an influenza pandemic,” said Gillian Stafford , Canada Commercial Director, Seqirus. “If the WHO declares an influenza pandemic, Seqirus will produce the FOCLIVIA vaccine to be delivered throughout the country as approved by Health Canada. The approval of FOCLIVIA means we can help protect more people in an influenza pandemic.”
Seqirus is a leading contributor to influenza prevention and preparation. 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. 2 The 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 financial burdens on affected citizens and communities. 3
FOCLIVIA includes Seqirus’ MF59 ® adjuvant technology, which can help enhance and broaden the body’s immune response by inducing antibodies with broader affinity. 4,5,6 This adjuvant is an integral part of pandemic preparedness planning. It reduces the amount of antigen required to produce an immune response, increasing the number of doses of the vaccine developed so that many people can be protected as quickly as possible. 7,8
About Pandemic Influenza
As with seasonal influenza, pandemic influenza is a contagious airborne respiratory disease that is unpredictable and can occur in any age group or population worldwide. 3 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. 9 According to the World Health Organization (WHO), A (H5N1) influenza strain can cause severe disease and has a high mortality rate. If an influenza virus of pandemic potential were to become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be severe, causing significant morbidity and mortality. 10
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers globally, Seqirus is a significant contributor to influenza prevention 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.
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 enable 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 .
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 that 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 concerning 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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1 FOCLIVIA ® Product Monograph, January 7, 2021 .
2 World Health Organization (WHO). (2010). What is a pandemic? Retrieved from: https://www.who.int/csr/disease/swineflu/frequently_asked_questions/pandemic/en/ . Accessed January 2021 .
3 WHO. (2019). Global Influenza Strategy. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/311184/9789241515320-eng.pdf?ua=1 . Accessed January 2021 .
4 Frey SE, Aplasia-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
5 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
6 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
7 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 .
8 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 .
9 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 2021 .
10 WHO. (2011). FAQs: H5N1 influenza. Retrieved from: https://www.who.int/influenza/human_animal_interface/avian_influenza/h5n1_research/faqs/en/ . Accessed January 2021 .
SOURCE Seqirus Canada
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