A recent publication questioned the public health concern about swine flu and raised issues on vaccine safety and must be corrected. Pandemic 2009 (H1N1) or swine flu is a public health emergency with good reason. Since the WHO declared a pandemic in June 2009, swine flu is reported now in more than 199 countries approaching half a million confirmed cases and over 6,000 deaths. In Ireland we are clearly now in the first wave of the pandemic and last week alone it was estimated that there were 30,000 new cases of the infection. It is true that the disease has been mild in the majority of people, however significant complications can and do arise among people who are otherwise healthy. Children and young adults remain the most affected group with over 80% being less than 35 years of age. 665 cases have been hospitalised and 54 admitted to ICU and to date, regrettably, there have been 14 deaths. This wave of infection is impacting not only on the health system but the broader functioning of society.
Issues are raised about vaccine safety with comparisons made with the different vaccine administered in the USA in 1976. This is misleading. In 2003 the European Commission and the European Medicines Agency (EMEA) in conjunction with the Irish Medicines Board and other European regulatory authorities introduced a procedure to prepare for future vaccines that could be used in a pandemic. These used 'mock-up' pandemic influenza vaccine which mimicked the future vaccine that would be used in terms of its composition, manufacturing and control and considered as identical to this vaccine except that it did not contain the material from the actual viral strain responsible for the pandemic. Since then there has been continuous review of animal and human studies with these mock-up vaccines on their safety and effectiveness. This has allowed for timely development of vaccines that are considered safe and effective for use in a pandemic without advanced knowledge of the viral strain responsible. Non-clinical and clinical testing is being done on an ongoing basis to provide information on immune response and safety. Outcomes from these studies completed to date indicate that the pandemic vaccine is as safe as the seasonal influenza vaccine, which is used every year in Ireland.
The article makes reference to Thiomersal which is a commonly used vaccine preservative. The safety of Thiomersal has been rigorously reviewed by national and international scientific groups including the World Health Organisation who conclude that there is no evidence of toxicity in infants, children or adults, including pregnant women exposed to thiomersal in vaccines. The article also makes reference to adjuvants which are used in vaccines to make them more effective. Once again careful consideration of the scientific data clearly supports the safety of adjuvants in pandemic influenza vaccine.
Studies have not shown harmful effects from the pandemic vaccine with respect to pregnancy, the developing foetus, the birthing or post-natal development. In fact, recent studies indicate that infected pregnant women have a 10 times higher chance to require hospitalisation in intensive care units than for infected persons in the general population. In Ireland more than 6% of our swine flu hospitalised cases are women in pregnancy. The benefits of vaccination far outweigh any risk.
Both Celvapan and Pandemrix, the vaccines available for use in Ireland, are considered equally safe and effective for use in everyone aged over 6 months, based on the available scientific evidence. People's concerns about taking a new vaccine are understandable, however the overwhelming medical and scientific advice is that benefits far outweigh any possible risks associated with the vaccine. Vaccination provides protection and the best means by which we can limit the impact of swine flu in individuals, their families and the broader community.
Source
Department of Health and Children, Ireland
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