Risk of Narcolepsy after AS03 Adjuvanted Pandemic A/H1N1 2009 Influenza Vaccine in Adults: A Case-Coverage Study in England.+

Stowe J1, Andrews N2, Kosky C3, Dennis G4, Eriksson S5, Hall A6, Leschziner G7, Reading P8, Shneerson JM9, Donegan K10, Miller E11.

Author information

  • 1Research Fellow, Public Health England, London, UK.
  • 2Senior Statistician, Public Health England, London, UK.
  • 3Consultant Physician, Guy’s and St Thomas’ NHS Trust, London, UK.
  • 4Consultant Neurologist, Royal Hallamshire Hospital, Sheffield, UK.
  • 5Consultant Neurologist, National Hospital for Neurology and Neurosurgery, London, UK.
  • 6Consultant in Anaesthesia, Intensive Care and Sleep Disorders Medicine, University Hospitals of Leicester NHS Trust, Leicester, UK.
  • 7Consultant Neurologist/Clinical Lead – Sleep, Guy’s and St Thomas’ NHS Trust, London, UK.
  • 8Consultant Neurologist, South Tees NHS Trust, Middlesborough, UK.
  • 9Consultant Physician, Papworth Hospital NHS Foundation, Cambridge, UK.
  • 10Pharmacoepidemiology Research and Intelligence Unit, Medicines and Healthcare Products Regulatory Agency, UK.
  • 11Consultant Epidemiologist, Public Health England, London, UK.

Abstract

STUDY OBJECTIVES:

An increased risk of narcolepsy has been observed in children following ASO3-adjuvanted pandemic A/H1N1 2009 (Pandemrix) vaccine. We investigated whether this risk extends to adults in England.

METHODS:

Six adult sleep centers in England were visited between November 2012 and February 2014 and vaccination/clinical histories obtained from general practitioners. Suspected narcolepsy cases aged older than 17 y were selected. The risk of narcolepsy following Pandemrix was calculated using cases diagnosed by the time of the center visits and those with a diagnosis by November 30, 2011 after which there was increased awareness of the risk in children. The odds of vaccination in cases and in matched population data were compared using a case-coverage design.

RESULTS:

Of 1,446 possible cases identified, most had onset before 2009 or were clearly not narcolepsy. Of the 60 remaining cases, 20 were excluded after expert review, leaving 40 cases with narcolepsy; 5 had received Pandemrix between 3 and 18 mo before onset. All the vaccinated cases had cataplexy, two received a diagnosis by November 2011 and two were aged 40 y or older. The odds ratio for vaccination in cases compared to the population was 4.24 (95% confidence interval 1.45-12.38) using all cases and 9.06 (1.90-43.17) using cases with a diagnosis by November 2011, giving an attributable risk of 0.59 cases per 100,000 doses.

CONCLUSIONS:

We found a significantly increased risk of narcolepsy in adults following Pandemrix vaccination in England. The risk was lower than that seen in children using a similar study design.

© 2016 Associated Professional Sleep Societies, LLC.

KEYWORDS:

Pandemrix; adult; case-coverage; narcolepsy; vaccination

 

http://www.ncbi.nlm.nih.gov/pubmed/26856903

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