Thursday, 28 March 2019
Department of Health
Vaccination Programme Data
134. To ask the Minister for Health the steps being taken to ascertain the number of persons diagnosed with narcolepsy as a result of receiving Pandemrix in 2011; and when it was reissued for use as the winter flu vaccine. [14640/19]
The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines, including vaccines, that are licensed in Ireland. The HPRA has advised that, of the reports received to date with clinical information confirming a diagnosis of narcolepsy in relation to individuals vaccinated with Pandemrix, none of the reports where information on the date of vaccination was provided indicate a date of vaccination in 2011. However, there are a small number of reports which do not include information on the date of vaccination. Likewise, no medically confirmed cases of narcolepsy have been reported in association with the winter flu trivalent vaccine that contained a H1N1 component.
For information, the HPRA operates the national adverse reaction reporting system which relies on submission of reports by members of the public, healthcare professionals and Marketing Authorisation Holders (i.e. pharmaceutical companies that hold the licenses for medicines (MAHs)), with members of the public and healthcare professionals encouraged to report when they consider a medicine may have contributed to the effects experienced.
The composition of seasonal influenza vaccines is updated annually, if appropriate, to include relevant vaccine strains to provide appropriate protection against circulating influenza viruses. The strains included in the seasonal influenza vaccines are recommended by the World Health Organisation (WHO) each year and the HSE liaises with the manufacturers in relation to procurement of vaccines for use in Ireland based on this advice.
Vaccination continues to remain the most effective means of preventing infection caused by seasonal influenza viruses and can reduce severe disease that can lead to hospitalisation and even death.