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The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns.
Vaccine. 2013 Feb 06; 31(8):1246-54.V

Abstract

BACKGROUND

In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification.

METHODS

We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom.

RESULTS

Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women>men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time.

CONCLUSIONS

The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail.

Authors+Show Affiliations

Erasmus University Medical Center, Rotterdam, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23246544

Citation

Wijnans, Leonoor, et al. "The Incidence of Narcolepsy in Europe: Before, During, and After the Influenza A(H1N1)pdm09 Pandemic and Vaccination Campaigns." Vaccine, vol. 31, no. 8, 2013, pp. 1246-54.
Wijnans L, Lecomte C, de Vries C, et al. The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine. 2013;31(8):1246-54.
Wijnans, L., Lecomte, C., de Vries, C., Weibel, D., Sammon, C., Hviid, A., Svanström, H., Mølgaard-Nielsen, D., Heijbel, H., Dahlström, L. A., Hallgren, J., Sparen, P., Jennum, P., Mosseveld, M., Schuemie, M., van der Maas, N., Partinen, M., Romio, S., Trotta, F., ... Sturkenboom, M. C. (2013). The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. Vaccine, 31(8), 1246-54. https://doi.org/10.1016/j.vaccine.2012.12.015
Wijnans L, et al. The Incidence of Narcolepsy in Europe: Before, During, and After the Influenza A(H1N1)pdm09 Pandemic and Vaccination Campaigns. Vaccine. 2013 Feb 6;31(8):1246-54. PubMed PMID: 23246544.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns. AU - Wijnans,Leonoor, AU - Lecomte,Coralie, AU - de Vries,Corinne, AU - Weibel,Daniel, AU - Sammon,Cormac, AU - Hviid,Anders, AU - Svanström,Henrik, AU - Mølgaard-Nielsen,Ditte, AU - Heijbel,Harald, AU - Dahlström,Lisen Arnheim, AU - Hallgren,Jonas, AU - Sparen,Par, AU - Jennum,Poul, AU - Mosseveld,Mees, AU - Schuemie,Martijn, AU - van der Maas,Nicoline, AU - Partinen,Markku, AU - Romio,Silvana, AU - Trotta,Francesco, AU - Santuccio,Carmela, AU - Menna,Angelo, AU - Plazzi,Giuseppe, AU - Moghadam,Keivan Kaveh, AU - Ferro,Salvatore, AU - Lammers,Gert Jan, AU - Overeem,Sebastiaan, AU - Johansen,Kari, AU - Kramarz,Piotr, AU - Bonhoeffer,Jan, AU - Sturkenboom,Miriam C J M, Y1 - 2012/12/16/ PY - 2012/12/03/received PY - 2012/12/05/accepted PY - 2012/12/19/entrez PY - 2012/12/19/pubmed PY - 2013/7/19/medline SP - 1246 EP - 54 JF - Vaccine JO - Vaccine VL - 31 IS - 8 N2 - BACKGROUND: In August 2010 reports of a possible association between exposure to AS03 adjuvanted pandemic A(H1N1)pdm09 vaccine and occurrence of narcolepsy in children and adolescents emerged in Sweden and Finland. In response to this signal, the background rates of narcolepsy in Europe were assessed to rapidly provide information for signal verification. METHODS: We used a dynamic retrospective cohort study to assess the narcolepsy diagnosis rates during the period 2000-2010 using large linked automated health care databases in six countries: Denmark, Finland, Italy, the Netherlands, Sweden and the United Kingdom. RESULTS: Overall, 2608 narcolepsy cases were identified in almost 280 million person years (PY) of follow up. The pooled incidence rate was 0.93 (95% CI: 0. 90-0.97) per 100,000 PY. There were peaks between 15 and 30 year of age (women>men) and around 60 years of age. In the age group 5-19 years olds rates were increased after the start of pandemic vaccination compared to the period before the start of campaigns, with rate ratios (RR) of 1.9 (95% CI: 1.1-3.1) in Denmark, 6.4 (95% CI: 4.2-9.7) in Finland and 7.5 (95% CI: 5.2-10.7) in Sweden. Cases verification in the Netherlands had a significant effect on the pattern of incidence over time. CONCLUSIONS: The results of this incidence study provided useful information for signal verification on a population level. The safety signal of increased narcolepsy diagnoses following the start of the pandemic vaccination campaign as observed in Sweden and Finland could be observed with this approach. An increase in narcolepsy diagnoses was not observed in other countries, where vaccination coverage was low in the affected age group, or did not follow influenza A(H1N1)pdm09 vaccination. Patient level analyses in these countries are being conducted to verify the signal in more detail. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23246544/The_incidence_of_narcolepsy_in_Europe:_before_during_and_after_the_influenza_A_H1N1_pdm09_pandemic_and_vaccination_campaigns_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)01782-3 DB - PRIME DP - Unbound Medicine ER -