EMA's Committee for Medicinal Products for Human Use (CHMP) issues opinion on narcolepsy and vaccination with Pandemrix®Archived

On 21 July 2011 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued its opinion on the review of Pandemrix® and reports on narcolepsy. The CHMP recommended that in persons under 20 years of age Pandemrix® may only be used if the recommended seasonal trivalent influenza vaccine is not available and if immunisation against H1N1 is still needed (e.g. in persons at risk of the complications of infection).

The CHMP based its decision on a number of scientific studies coming from various countries; some of them are currently ongoing. At European level, ECDC has funded a study with the Vaccine Adverse Events Surveillance and Communication (VAESCO) network in a number of European countries where pandemic influenza vaccines have been used. The interim VAESCO study results show that the number of cases of narcolepsy in children who had been vaccinated with Pandemrix is limited outside of the signalling countries for which VAESCO has currently reported data (Finland and Sweden).

VAESCO is a network entirely funded by ECDC that includes pharmacovigilance researchers from Public Health Institutes, Regulatory Agencies and Universities. Through supporting VAESCO, ECDC is building capacity for similar studies in the future, to inform decision-making in the EU Member States, the European Commission and EMA. Since the very first signal in Finland, VAESCO has been undertaking studies to test whether a true association between Pandemrix® and narcolepsy is being seen in Europe. The interim results have now been presented to the EMA’s CHMP meeting on 18-21 July. Further validation of interim results may be needed and further results are expected towards the end of 2011.