Global Vaccine Safety

Statement on narcolepsy and Pandemrix

In August 2010, the Swedish authorities reported an unexpected increase of cases of juvenile narcolepsy following immunization with Pandemrix. The Finnish authorities subsequently suspended the use of the vaccine as a similar signal was seen in that country. Since then, GACVS has closely monitored investigations ongoing in countries where the vaccine was used. In April 2011, GACVS indicated that an increased risk of narcolepsy had not been observed in association with the use of any vaccines in the past and that it did not appear that narcolepsy following vaccination against pandemic influenza was a general worldwide phenomenon.

On 21 July 2011, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) published its conclusion following a review of findings on Pandemrix and narcolepsy from Finland and Sweden. EMA, on a precautionary basis, recommends restricting use of Pandemrix in persons under 20 years of age but indicates that overall the benefit-risk of the vaccine remains positive.

GACVS concurs with the recommendation, which states 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).

GACVS acknowledges also that the benefit-risk balance of Pandemrix remains positive where H1N1 influenza is prevalent. Currently data are limited on the association between juvenile narcolepsy and Pandemrix; additional epidemiological studies are underway.

GACVS will continue to monitor the situation closely and updates will be provided as further information becomes available.

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