Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system

JAMA - Journal of the American Medical Association

Volumn 313, Issue 1, 2015, Pages 54-61

  Scheller, Nikolai Madrid ^a   Svanström, Henrik ^a   Pasternak, Björn ^a   Arnheim Dahlström, Lisen ^b   Sundström, Karin ^c   Fink, Katharina ^b,c   Hviid, Anders ^a  

^a STATENS SERUM INSTITUT   (Denmark)

^b KAROLINSKA INSTITUTE   (Sweden)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

WART VIRUS VACCINE;

ADOLESCENT; ADULT; ARTICLE; CHILD; CONTROLLED STUDY; DEMYELINATING DISEASE; DENMARK; DISEASE ASSOCIATION; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; MULTIPLE SCLEROSIS; OUTCOME ASSESSMENT; PAPILLOMAVIRUS INFECTION; PATIENT IDENTIFICATION; RISK ASSESSMENT; SWEDEN; COHORT ANALYSIS; DEMYELINATING DISEASES; INCIDENCE; PAPILLOMAVIRUS INFECTIONS; RISK; VACCINATION; YOUNG ADULT;

ADOLESCENT; ADULT; CHILD; COHORT STUDIES; DEMYELINATING DISEASES; DENMARK; FEMALE; HUMANS; INCIDENCE; MULTIPLE SCLEROSIS; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; RISK; SWEDEN; VACCINATION; YOUNG ADULT;

EID: 84920544183     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.16946     Document Type: Article

References (34)

1. Global Advisory Committee on Vaccine Safety, 11-12 December 2013. Wkly Epidemiol Rec. 2014;89 (7):53-60
2. Eisenstein M. Public health: An injection of trust. Nature. 2014;507(7490):S17-S19
3. Trim K, Nagji N, Elit L, Roy K. Parental knowledge, attitudes, and behaviours towards human papillomavirus vaccination for their children: A systematic review from 2001 to 2011. Obstet Gynecol Int. 2012;2012:921236
4. Laz TH, Rahman M, Berenson AB. An update on human papillomavirus vaccine uptake among 11-17 year old girls in the United States: National Health Interview Survey, 2010. Vaccine. 2012;30(24): 3534-3540
5. Laz TH, Rahman M, Berenson AB. Human papillomavirus vaccine uptake among 18- to 26-year-old women in the United States: National Health Interview Survey, 2010. Cancer. 2013;119(7): 1386-1392
6. Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009;15(1):116-119
7. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2011;82(11):1296-1298
8. Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology. 2009;72(24):2132-2133
9. DiMario FJ Jr, HajjarM, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010;25(3):321-327
10. Menge T, Cree B, Saleh A, et al. Neuromyelitis optica following human papillomavirus vaccination. Neurology. 2012;79(3):285-287
11. European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC):Minutes of the Meeting on 6-9 January 2014. http://www.ema .europa.eu/docs/en-GB/document-library/Minutes/2014/02/WC500161892.pdf. Accessed November 18, 2014
12. Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune disease: what is the evidence? Lancet. 2003;362(9396):1659-1666
13. Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: Cohort study. BMJ. 2013;347:f5906
14. Chao C, Klein NP, Velicer CM, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271(2):193-203
15. Grimaldi-Bensouda L, Guillemot D, Godeau B, et al; PGRx-AID Study Group. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014;275(4):398-408
16. Pedersen CB, Gøtzsche H, Møller JO, Mortensen PB. The Danish Civil Registration System: A cohort of eight million persons. Dan Med Bull. 2006;53(4):441-449
17. Ludvigsson JF, Otterblad-Olausson P, Pettersson BU, Ekbom A. The Swedish personal identity number: possibilities and pitfalls in healthcare and medical research. Eur J Epidemiol. 2009;24(11):659-667
18. European Medicines Agency. European Public Assesment Report-Summary of Product Characteristics. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product -Information/human/000703/WC500021142.pdf. Accessed November 18, 2014
19. European Medicines Agency. European Public Assessment Report: Gardasil and Silgard. http://www.ema.europa.eu/docs/en-GB/document -library/EPAR-Assessment-Report-Variation/human/000703/WC500167949.pdf. February 20, 2014. Accessed November 18, 2014
20. Hviid A. Postlicensure epidemiology of childhood vaccination: The Danish experience. Expert Rev Vaccines. 2006;5(5):641-649
21. Kildemoes HW, Sørensen HT, Hallas J. The Danish National Prescription Registry. Scand J Public Health. 2011;39(7)(suppl):38-41
22. Leval A, Herweijer E, Ploner A, et al. Quadrivalent human papillomavirus vaccine effectiveness: A Swedish national cohort study. J Natl Cancer Inst. 2013;105(7):469-474
23. Wettermark B, Hammar N, Fored CM, et al. The new Swedish Prescribed Drug Register- opportunities for pharmacoepidemiological research and experience from the first six months [published correction appears in Pharmacoepidemiol Drug Saf. 2008;17(5):533]. Pharmacoepidemiol Drug Saf. 2007;16(7):726-735
24. Lynge E, Sandegaard JL, ReboljM. The Danish National Patient Register. Scand J Public Health. 2011;39(7)(suppl):30-33
25. Ludvigsson JF, Andersson E, Ekbom A, et al. External review and validation of the Swedish national inpatient register. BMC Public Health. 2011; 11:450
26. Zipp F,Weil JG, Einhäupl KM. No increase in demyelinating diseases after hepatitis B vaccination. Nat Med. 1999;5(9):964-965
27. Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001;344(5):327-332
28. Farrington CP. Relative incidence estimation from case series for vaccine safety evaluation. Biometrics. 1995;51(1):228-235
29. Whitaker HJ, Farrington CP, Spiessens B, Musonda P. Tutorial in biostatistics: The self-controlled case seriesmethod. Stat Med. 2006; 25(10):1768-1797
30. Mason K, Thygesen LC, Stenager E, Brønnum-Hansen H, Koch-Henriksen N. Evaluating the use and limitations of the Danish National Patient Register in register-based research using an example of multiple sclerosis. Acta Neurol Scand. 2012;125(3):213-217
31. Chao C, Jacobsen SJ. Evaluation of autoimmune safety signal in observational vaccine safety studies. Hum Vaccin Immunother. 2012;8(9):1302-1304
32. Marrie RA, Cutter G, Tyry T, Hadjimichael O, Campagnolo D, Vollmer T. Changes in the ascertainment of multiple sclerosis. Neurology. 2005;65(7):1066-1070
33. Lutringer-Magnin D, Kalecinski J, Barone G, et al. Human papillomavirus (HPV) vaccination: perception and practice among French general practitioners in the year since licensing. Vaccine. 2011;29(32):5322-5328
34. Macartney KK, Chiu C, GeorgousakisM, Brotherton JM. Safety of human papillomavirus vaccines: A review. Drug Saf. 2013;36(6):393-412.