- CSL Seqirus to provide 665,000 pre-pandemic (zoonotic) vaccines to support fifteen EU and EEA Member States.
- Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and poultry have been reported in Europe.
- The decision by the Health Emergency Preparedness and Response Authority (HERA) demonstrates their commitment to support Member States’ pandemic preparedness in the face of these outbreaks.
Maidenhead, June 11, 2024 -- CSL Seqirus, a business of CSL (ASX: CSL), was selected by the Health Emergency Preparedness and Response Authority (HERA), part of the European Commission (EC), to provide 665,000 pre-pandemic vaccine doses for fifteen EU and EEA Member States as well as to the "Union Civil Protection Mechanism" (rescEU). This acquisition of pre-pandemic (zoonotic) vaccine will create a stockpile of vaccines available to support the EC’s outbreak and pre-pandemic response.
“While the ECDC assesses the risk of infection from avian influenza to be low for the general population, it considers people with activities that expose them to infected animals or a contaminated environment at low-medium risk.1” said Raja Rajaram, CSL Seqirus, Head of Global Medical Strategy. “This agreement will help in Europe’s resolve to maintain robust preparedness and rapid response capabilities for this potential threat.”
Under the terms of the agreement, CSL Seqirus will deliver 665,000 doses of pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain, to fifteen EU and EEA Member States, as well as the "Union Civil Protection Mechanism" (rescEU). In addition, the 4-year contract includes an option for participating authorities to purchase up to an additional 40 million doses of the pre-pandemic vaccine over the life of the contract.
The vaccines are being manufactured in CSL Seqirus’ European manufacturing sites in Amsterdam (for test and release) and Liverpool which utilises a scalable method of production and is one of the largest sites in Europe to manufacture seasonal influenza vaccines.
“CSL Seqirus is a global leader and proud champion of the pandemic preparedness efforts of over 30 governments, and we are pleased to work with the European Commission to deliver this zoonotic vaccine as part of their pandemic preparedness and outbreak response,” said Lorna Meldrum, CSL Seqirus, VP Commercial Operations, International & Pandemic Response. “Vaccine access, alongside surveillance and testing, is critical for pandemic preparedness and provides reassurance to governments and their populations alike. Together with our partners, we embrace this crucial aspect of public health protection.”
About Pandemic Influenza
Influenza is a contagious airborne respiratory disease.2,3 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 novel virus in the human population.4 The timing and severity of pandemic influenza is unpredictable.5 Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, with an estimated mortality of up to 50 million people worldwide.5 Strain-matched pandemic influenza vaccines are manufactured in response to the declaration of a pandemic.6 Pre-pandemic (also called zoonotic) influenza vaccines are available in the inter-pandemic period to help protect against influenza strains with pandemic potential; these vaccines can be deployed under government guidance to mitigate the risk of an outbreak or provide a first line of defense in advance of a pandemic vaccine if a pandemic were to be declared.6
About Avian Influenza
Avian influenza is an infectious type of influenza that spreads predominantly among birds.7 Avian influenza viruses do not normally infect humans, however, in rare cases humans have been infected with avian influenza viruses.8 Illness in humans from avian influenza has varied in levels of severity, from no symptoms or mild illness to severe disease and death.8 The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.8
The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1).9 CSL Seqirus recommends referring to the WHO statement, and CDC, ECDC or national guidance to gauge the levels of concern regarding the high levels of HPAI activity.9,10,11
About CSL Seqirus
CSL Seqirus is part of CSL (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus offers a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
About CSL
CSL (ASX: CSL) (USOTC:CSLLY) is a global biotechnology company with a portfolio covering haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. This enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
Intended Audience
This press release is issued from CSL Seqirus in Maidenhead, UK and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products.
GL-PAN-24-0001
Date of Preparation: June 2024
1 ECDC. ECDC Communicable Disease Threats Report 25-31 May 2024. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/Communicable-disease-threats-report-week-22-2024.pdf [Accessed June 2024]
2 CDC. Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. [Accessed June 2024]
3 CDC. Key Facts About Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. [Accessed June 2024]
4 WHO. How pandemic influenza emerges. Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/how-pandemic-influenza-emerges. [Accessed June 2024]
5 WHO. 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 June 2024]
6 European Medicines Agency (EMA). Vaccines for pandemic influenza. Retrieved from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/pandemic-influenza/vaccines-pandemic-influenza. [Accessed June 2024]
7 CDC. Avian Flu, Information on bird flu. Retrieved from: https://www.cdc.gov/flu/avianflu/index.htm. [Accessed June 2024]
8 CDC. Avian Flu, Bird Flu Virus Infections in Humans. Retrieved from: https://www.cdc.gov/flu/avianflu/avian-in-humans.htm. [Accessed June 2024]
9 Centers for Disease Control and Prevention (CDC). H5N1 Bird Flu: Current Situation Summary. Retrieved from: https://www.cdc.gov/flu/avianflu/avian-flu-summary.htm. [Accessed June 2024].
10 WHO. Ongoing avian influenza outbreaks in animals pose risk to humans. Retrieved from: https://www.who.int/news/item/12-07-2023-ongoing-avian-influenza-outbreaks-in-animals-pose-risk-to-humans. [Accessed June 2024]
11 European Centre for Disease Prevention and Control (ECDC). Avian influenza overview April – June 2023. Retrieved from: https://www.ecdc.europa.eu/en/publications-data/avian-influenza-overview-april-june-2023. [Accessed June 2024]