Pandemic influenza vaccine & narcolepsy: simulations on the potential impact of bias.

Abstract:

:Several studies have identified an association between Pandemrix(TM), an AS03 adjuvanted pandemic influenza A(H1N1) vaccine, and narcolepsy, a rare and under-diagnosed sleep disorder with a median onset-to-diagnosis interval of ten years. This paper reviews potential sources of bias in published studies and aims to provide, through simulation, methodological recommendations for assessment of vaccine safety signals. Our simulation study showed that in the absence of an association between the vaccine and the outcome, presence of detection bias and differential exposure misclassification could account for elevated risk estimates. These may play a major role, particularly in alert situations when observation times are limited and the disease has a long latency period. Estimates from the case-control design were less inflated than those from the cohort design when these biases were present. Overall, these simulations provide useful insights for the design and interpretation of future studies.

journal_name

Expert Rev Vaccines

authors

Wijnans L,Dodd C,de Ridder M,Romio S,Weibel D,Overeem S,Lammers GJ,Bonhoeffer J,Black S,Sturkenboom M

doi

10.1586/14760584.2016.1164045

subject

Has Abstract

pub_date

2016-05-01 00:00:00

pages

573-84

issue

5

eissn

1476-0584

issn

1744-8395

journal_volume

15

pub_type

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