EMA Recommends Restricting Use of Pandemrix
EMA recommends 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.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (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 confirmed that overall the benefit-risk balance of Pandemrix remains positive.
The review of Pandemrix was initiated to investigate a possible link between 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
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