SYNOPSIS
Pandemrix vaccine contributed to the onset of narcolepsy among those 4 to 19 years old during the pandemic influenza in 2009–2010 in Finland. Further studies are needed to determine whether this observation exists in other populations and to elucidate potential underlying immunological mechanism. The role of the adjuvant in particular warrants further research before drawing conclusions about the use of adjuvanted pandemic vaccines in the future.
TITLE
AS03 Adjuvanted AH1N1 Vaccine Associated with an Abrupt Increase in the Incidence of Childhood Narcolepsy in Finland
CITATION
Nohynek H, Jokinen J, Partinen M, Vaarala O, Kirjavainen T, et al. (2012) AS03 Adjuvanted AH1N1 Vaccine Associated with an Abrupt Increase in the Incidence of Childhood Narcolepsy in Finland. PLoS ONE 7(3): e33536. doi:10.1371/journal.pone.0033536
SUMMARY
To protect the population from death and serious forms of disease caused by the pandemic AH1N1 infection, the ASO3 adjuvanted vaccine Pandemrix was introduced nation-wide in Finland from October 2009 onwards. Following recommendation of the European Medicines Agency (EMA), enhanced passive surveillance of vaccine related adverse
events was initiated. Excess number of narcolepsy-cataplexy among children and adolescents was observed a few months after the A(H1N1) epidemic and pandemic vaccination. No increase was observed in other age groups. The incidence of narcolepsy was 9.0/100,000 person years in the vaccinated as compared to 0.7/100,000 person years in the unvaccinated individuals.
Pandemrix vaccine contributed to the onset of narcolepsy among those 4 to 19 years old during the pandemic influenza in 2009–2010 in Finland. Further studies are needed to determine whether this observation exists in other populations and to elucidate potential underlying immunological mechanism. The role of the adjuvant in particular warrants further research before drawing conclusions about the use of adjuvanted pandemic vaccines in the future.
