Michelle Mulherin (Mayo, Fine Gael)
Link to this: Individually | In context

Question 499: To ask the Minister for Health the complaints of side effects he has received from recipients of the swine flu vaccine since 2009; and the nature of the complaints. [29938/11]

Michelle Mulherin (Mayo, Fine Gael)
Link to this: Individually | In context

Question 500: To ask the Minister for Health if any of the swine flu vaccines or winter flu vaccines have been withdrawn from use. [29940/11]

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

I propose to take Questions Nos. 499 and 500 together.

Throughout the H1N1 influenza pandemic of 2009/10, the Irish Medicines Board published regular updates on national monitoring experience with the vaccines used on its website. Since then, the IMB has received information on reports of suspected cases of Narcolepsy in some patients who received one of the vaccines, Pandemrix, in Ireland and is working in consultation with other national organisations including the Health Service Executive and the Health Protection Surveillance Centre in relation to this matter.

The IMB is also contributing to the evaluation of this issue at EU level through its participation at the European Medicines Agency and its scientific committees. An update on the outcome of the EU evaluation was published by the European Medicines Agency in July 2011 and is available on the EMA website. The EMA has advised that balance of risks/benefits still favour this vaccine being provided in a pandemic (which we are currently not in). Also, that it should only be used in persons under 20 years of age if the recommended annual seasonal trivalent influenza strain (which protects against three influenza strains) is not available and that immunisation against H1N1 is still needed. For instance, in people at risk of complications of infection. GP's have been advised to return any remaining stocks to the HSE for disposal. Any stock in Ireland is now out of date.

The seasonal influenza vaccine changes annually in accordance with the particular strain of influenza identified in that year and the vaccine is, therefore, only licensed and effective for that particular year. There have been no withdrawals or recalls of the current seasonal flu vaccine as it does not arise.