The European Medicines Agency is investigating a possible link between the swine flu vaccine Pandemrix and cases of narcolepsy.
The review comes after a limited number of cases of narcolepsy were reported in Sweden and Finland, although the agency said at present it is unclear if the vaccine caused the disorder. The EMEA's Committee for Medicinal Products for Human Use (CHMP) will examine the evidence for a causal link between the vaccine and narcolepsy at its September meeting.
UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it was aware of the case reports and will assist the evaluation process. However, a spokesperson stressed that "after use of more than six million doses of swine flu vaccine in the UK, no cases of narcolepsy have been reported following vaccination in the UK. Pandemrix vaccine remains available for use as recommended."
A spokesperson from GSK, the manufacturer of pandemrix, said the company was aware of the reported link. "GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the observed cases and is working closely with the regulatory authorities, including the European Medicines Agency," they said.
"Global experience with previous large-scale immunisation programmes has shown that it is likely that a certain level of adverse events will be reported. Having reviewed the currently available data and information, as well as GSK’s own safety database, the company has concluded that the currently available information is insufficient to assess the likelihood of a causal relationship between Pandemrix and narcolepsy."
