# 4866
GSK (Glaxo Smith-Kline), manufacturers of the adjuvanted Pandemrix vaccine that has been linked by media reports to a small number of cases of narcolepsy in children – has released a statement today for journalists and investors.
Reports of narcolepsy in Europe following vaccination with Pandemrix™
WEBWIRE – Friday, September 03, 2010
London UK - GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland.
Information on the individual cases remains limited at present, but GSK is conducting its own investigation in an effort to gather as much additional data as possible regarding the reported cases, and is working closely with key regulatory authorities, including the European Medicines Agency (EMA).
Although some media reports – particularly those by anti-vaccination activists – have worded stories to suggest that a `probable link’ between the vaccine and these cases of narcolepsy has been established . . . right now, there is no proof of causation.
With further investigation, a link may be established. Flu vaccines have a good safety record, but on rare occasions serious side effects have been noted.
That said, the background rates of narcolepsy are poorly understood, and the condition is generally believed to be under-diagnosed.
It will take time to know whether the vaccine was responsible for this upsurge in reported cases.
But other possibilities exist.
Greater scrutiny, better reporting systems, and the public’s concern over the vaccine’s safety might well account for a greater number of diagnoses of narcolepsy in children over the past 6 months.
Essentially, the harder we look for diseases, the more we are likely to find.
We’ll simply have to wait to see where these investigations lead.
