GlaxoSmithKline’s full statement to W5 on Pandemrix
1. A. Studies in Sweden, Finland, Ireland, Norway and Britain have also shown the risk of developing narcolepsy is between seven and 13 times higher in children who were immunized with Pandemrix than in those who were not – What is your response to these findings?
B. Can Pandemrix trigger narcolepsy in children?
Epidemiological data currently available to GSK suggest an increased risk of narcolepsy following vaccination with Pandemrix™ (H1N1). Due to the methodological limitations of the studies, which are retrospective observational studies, further research is needed to determine whether the observed risk is related to the vaccine, environmental effects, genetic factors, other factors or a combination of them. Further research also is needed to evaluate whether there are biologically plausible mechanisms by which vaccination with Pandemrix™ (H1N1) may have triggered narcolepsy in some individuals as no such mechanism has been demonstrated to date.
2. In some jurisdictions Pandemrix is no longer used in people under 20 – what do you think of that decision? Is it justified? Why? Why Not?
