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5 INFLUENZA AND THE ROLE OF IMMUNISATION 5.1 Influenza Influenza is a contagious disease of the respiratory tract caused by influenza viruses which generally circulate in the winter in temperate countries, but year-round in tropical areas. The virus is constantly changing. Most people who get influenza have a self-limiting illness, lasting from a few days to several weeks, but for some people—the elderly, those with poor immune systems and those with certain pre-existing chronic diseases— influenza can be a significant disease, requiring hospitalisation and resulting in death. Serious disease and death can also occur in healthy adults and children. High rates of influenza resulting in hospitalisation occur in infants and young children. Vaccines are available to protect against seasonal influenza infection (see 5.8 Seasonal influenza vaccine). 5.2 Pandemic influenza Influenza pandemics occur when a new subtype of influenza virus, which most people have not previously been exposed to, emerges in humans. The virus spreads easily and rapidly in the highly susceptible population, infecting large numbers of people worldwide (Australian Government Department of Health and Ageing 2008). Some pandemics cause severe disease and many deaths but others are mild in the illness and death they cause. The severity of a pandemic can change over its course (WHO 2011). Pandemics have occurred at irregular intervals throughout history. During the 20th century, the world experienced three pandemics—in 1918–19, 1957–58 and 1968–70. Pandemics have been of varying severity. The 1918–19 pandemic was extremely severe with at least 50 million deaths worldwide, with an unusually high number of deaths in young otherwise healthy people. The other two pandemics were less severe with 2 million and 1 million deaths respectively around the world. The timing and severity of pandemics are unpredictable; even at the beginning of a pandemic it is not possible to predict its overall severity. Pandemics also have the potential to overwhelm national health systems and cause economic and societal disruption. A high level of preparedness is needed globally to enable rapid and flexible responses to reduce the impact of the pandemic. 5.3 Australia’s preparation for a pandemic Australia has prepared for an influenza pandemic over the past decade, with the development of plans for both whole of government and health sector responses. For the 2009 H1N1 influenza Influenza and the role of immunisation 17
pandemic (see 5.4 The 2009 H1N1 influenza pandemic), national guidance for the health sector response was provided by the Australian Health Management Plan for Pandemic Influenza 2008 (AHMPPI) (Department of Health and Ageing 2008). This document, which built on two previous iterations and the outcomes of Exercise Cumpston in 2006, was developed following extensive consultation with peak bodies, advisory groups and eminent experts in pandemic influenza. The AHMPPI was endorsed by all Australian Health Ministers in December 2008. The purpose of Australia’s pandemic planning has been to ensure that we are ready to assess the situation, make decisions quickly and take action whenever a pandemic occurs. Without such planning, Australia would not have been able to act as quickly and effectively as it did in response to the 2009 H1N1 pandemic and the impact of the pandemic could have been a lot more serious. Pandemic planning and preparation is ongoing. The AHMPPI was updated in December 2009 to reflect the lessons learnt from the response to the 2009 H1N1 pandemic. The updated AHMPPI was endorsed by the Australian Health Ministers’ Council (AHMC) in October 2010. This is an interim revision—a more comprehensive revision will be undertaken once a formal review of the health sector response to the 2009 H1N1 pandemic has been finalised. A key objective of the AHMPPI is to reduce the transmission of the pandemic virus to decrease the number of people who become infected. The AHMPPI identifies the development and widespread use of a specific customised pandemic vaccine as the best method of protecting individuals against infection and the development of severe illness as well as reducing the spread of the virus in the community. Candidate pandemic (pre-pandemic) vaccines, based on viral strains thought to have pandemic potential, also have a role within the AHMPPI. This is in keeping with World Health Organization (WHO) advice that influenza vaccines are “one of the most effective ways to protect people from contracting illness during influenza epidemics and pandemics” (WHO 2011). Customised pandemic vaccines can only be developed once the new pandemic viral strain emerges. As production timelines for influenza vaccine using a standard egg-based method are several months long and global production capacity is limited, the AHMPPI recommends that arrangements be made early for future production and purchase of customised pandemic vaccine. To ensure the government has priority access to pandemic influenza vaccine, the Australian Government has put Influenza Deeds of Agreement in place for the supply of seasonal, candidate pre-pandemic and customised pandemic influenza vaccines. The current Influenza Deeds of Agreement are with both CSL Limited and Sanofi Pasteur. They were initially signed in 2004 following an open tender procurement process conducted by the Department of Health and Ageing. Interim deeds are in place with CSL and Sanofi Pasteur in 2010 and a tender process is nearing completion for supply after 2011. The Office of Health Protection in the Department of Health and Ageing manages the Influenza Deeds. 5.4 The 2009 H1N1 influenza pandemic The 2009 H1N1 influenza pandemic was the first human influenza pandemic in 40 years and caused significant human infection and mortality globally. The pandemic (H1N1) 2009 virus combines genetic components from swine, avian and human influenza virus strains. This genetic form was new and there was very little immunity in the largely naïve Australian population, although 18 Review of the management of adverse events associated with Panvax and Fluvax
Page 1 and 2: Review of the management of adverse
Page 3 and 4: Review of the management of adverse
Page 5 and 6: 5.9 Seasonal influenza vaccination
Page 7 and 8: MedDRA Medsafe NCIRS NIBSC NIC NIS
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Page 11 and 12: Recommendation 4 Raising Community
Page 13 and 14: WA Minister for Health, the Hon Dr
Page 16 and 17: 3 THE AUSTRALIAN REGULATORY SYSTEM
Page 18 and 19: • the health professionals who ad
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Page 32 and 33: TGA published summary reports on th
Page 34 and 35: 6 THE FINDINGS OF THE REVIEW 6.1 Ra
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Page 46 and 47: 7 RECOMMENDATIONS OF THE REVIEW Rec
Page 48 and 49: 8 REFERENCES Australian Government
Page 50 and 51: APPENDICES Appendix I: Documents an
Page 52 and 53: Appendix II: People interviewed •
Page 54 and 55: Country Canada Regulatory Agency an
Page 56 and 57: Regulatory Agency and Country Relev
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