In persons under 20 years of age Pandemrix is to used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people. The overall benefit-risk remains positive.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that in persons under 20 years of age Pandemrix should only be used if the recommended seasonal trivalent influenza vaccine was not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection).
What is Pandemrix?
Pandemrix is an influenza vaccine which has been authorised since September 2009, and was used during the 2009 H1N1 influenza pandemic in at least 30.8 million Europeans. The H1N1 influenza strain continues to be the predominant strain in this season.
The review of Pandemrix was initiated to investigate a possible link between the Pandemrix vaccination and narcolepsy following an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden. The reported cases of narcolepsy occurred following the H1N1 pandemic vaccination campaign in late 2009 and early 2010.
What is Narcolepsy?
Narcolepsy is a rare sleep disorder characterised by excessive day time sleepiness, sometimes accompanied by cataplexy. Its precise cause is still unclear but it is generally considered to be triggered by a combination of genetic and environmental factors. Narcolepsy occurs naturally at a rate of one new case per 100,000 people every year.
The CHMP considered all available data on the possible association between Pandemrix and narcolepsy and the impact on the overall benefit-risk balance of Pandemrix. These included the results of epidemiological studies carried out in Finland and Sweden, analysis of safety surveillance data performed in several member states and case reports from across the European Union.
The CHMP considered that the epidemiological studies relating to Pandemrix in Finland and Sweden were well designed and the results showed an association between Pandemrix vaccination and narcolepsy in children and adolescents in those countries. The results indicated a six to thirteen fold increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated children and adolescents, corresponding to about an additional three to seven cases in every 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). A similar risk has not been confirmed but cannot be ruled out in other countries.
The review of Pandemrix and narcolepsy was initiated at the requested of the European Commission under Article 20 of Regulation (EC) No 726/2004 in August 2010 following an increased number of reports of Narcolepsy in Finland and Sweden.
If you have used Pandemrix and have suffered side effects you may be entitled to claim compensation. To find out if you have a case, you should immediately contact Liam Moloney, product liability Solicitor Naas at 045 898000 or simply log onto www.moloneysolicitors.ie for further information concerning your rights.
