Incidence rates of Guillain Barré (GBS), chronic fatigue/systemic exertion intolerance disease (CFS/SEID) and postural orthostatic tachycardia syndrome (POTS) prior to introduction of human papilloma virus (HPV) vaccination among adolescent girls in Finland, 2002–2012

Papillomavirus Research

Volumn 3, Issue , 2017, Pages 91-96

  Skufca, J ^a,b   Ollgren, J ^a   Ruokokoski, E ^a   Lyytikainen O ^a   Nohynek, H ^a  

^a NATIONAL PUBLIC HEALTH INSTITUTE   (Finland)

^b EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL ECDC   (Sweden)

Author keywords

Chronic fatigue syndrome Systemic exertion intolerance disease; Finland; Guillain Barr syndrome; Incidence rates; Papillomavirus vaccines; Postural orthostatic tachycardia syndrome; Vaccination adverse effects

Indexed keywords

WART VIRUS VACCINE;

ADOLESCENT; AGE; ARTICLE; CHILD; CHRONIC FATIGUE SYNDROME; DISEASE ASSOCIATION; DRUG SAFETY; FEMALE; FINLAND; GENDER; GUILLAIN BARRE SYNDROME; HUMAN; ICD-10; INCIDENCE; MAJOR CLINICAL STUDY; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; REGISTER;

EID: 85015404942     PISSN: None     EISSN: 24058521     Source Type: Journal    
DOI: 10.1016/j.pvr.2017.03.001     Document Type: Article

References (37)

1. [1] World Health Organization, Human papillomavirus vaccines: WHO position paper. Wkly. Epidemiol. Rec. 43:89 (2014), 465–492.
2. [2] Paavonen, J., Jenkins, D., Bosch, X., Naud, P., Salmeron, J., Wheeler, C., et al. Efficacy of a prophylactic adjuvanted L1 VLP vaccine against infection with HPV16 and 18 in young women: an interim analysis of a phase III double-blind, randomized controlled trial. Lancet 369 (2007), 2161–2170.
3. [3] Villa, L., Perez, G., Kjaer, S., Lehtinen, M., Paavonen, J., Muñoz, N., et al. Efficacy of a quadrivalent HPV types 8/11/16/18) L1 virus-like particle vaccine in the prevention of cervical intraepithelial neoplasia grades 2/3 and adenocarcinoma in situ: a randomized controlled trial. N. Engl. J. Med. 356 (2007), 1915–1927.
4. [4] National Institute for Health and Welfare (THL), Department of Vaccination and Immune Protection. HPV vaccination coverage in Finland; 2016. (Accessed 11 April 2016).
5. [5] Finnish Medicines Agency (Fimea). Question E 9/2015 from the Nordic Council regarding adverse reactions to HPV-vaccine. Contribution from Finland to the question from the Nordic Council; 3 Nov 2015.
6. [6] D. Descamps, K. Hardt, B. Spiessens, et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. 26th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID), Austria: Graz; 13–16 May, 2008.
7. [7] Block, S.L., Brown, D.R., Chatterjee, A., et al. Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. Pediatr. Infect. Dis. J. 29 (2010), 95–101.
8. [8] Angelo, M.G., Zima, J., Tavares Da Silva, F., Baril, L., Arellano, F., Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol. Drug Saf. 23 (2014), 456–465.
9. [9] Macartney, K.K., Chiu, C., Georgousakis, M., Brotherton, J.M., Safety of human papillomavirus vaccines: a review. Drug Saf. 36:6 (2013), 393–412.
10. [10] European Medicines Agency (EMA), Periodic safety update reports, 〈http://www.ema.europa.eu/ema/index.jsp*Curl=pages/regulation/document_listing/document_listing_000361.jsp〉 ; 2016. (Accessed 21 June 2016).
11. [11] European Medicines Agency (EMA), Assessment report. Human papillomavirus (HPV) vaccines, 〈http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use/WC500197129.pdf〉; Nov 11 2015. (Accessed 11 May 2016).
12. [12] 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. Br. Med. J., 347, 2013, f5906, 10.1136/bmj.f5906 (PMID: 24108159).
13. [13] Ministry of Social Affairs and Health, Finland. Communicable Diseases Act. No. 583/1986, 〈http://www.finlex.fi/fi/laki/kaannokset/1986/en19860583.pdf〉; 25 Jul 1986. (Accessed 25 May 2016).
14. [14] National Institute for Health and Welfare (THL), Department of Vaccination and Immune Protection. Register of adverse effects of vaccines. April 2016.
15. [15] Global Advisory Committee on Vaccine Safety (GACVS), Weekly epidemiological record. No. 7, 2014, 89, 53–60, 〈http://www.who.int/vaccine_safety/committee/reports/wer8907.pdf*ua=1〉; 11–12 December 2013. (Accessed 11 April 2016).
16. [16] Sejvar, J.J., Baughman, A.L., Wise, M., Morgan, O.W., Population incidence of Guillain-Barré syndrome: a systematic review and meta-analysis. Neuroepidemiology 36 (2011), 123–133.
17. [17] McGrogan, A., Madle, G.C., Seaman, H.E., de Vries, C.S., The epidemiology of Guillain-Barré syndrome worldwide. A systematic literature review. Neuroepidemiology 32 (2009), 150–163.
18. [18] Callréus, T., Svanström, H., Nielsen, N.M., Poulsen, S., Valentiner-Branth, P., Hviid, A., Human papillomavirus immunisation of adolescent girls and anticipated reporting of immune-mediated adverse events. Vaccine 27:22 (2009), 2954–2958.
19. [19] Cao-Lormeau, V.-M., Blake, A., Mons, S., et al. Guillain-Barré syndrome outbreak associated with Zika virus infection in French Polynesia: a case-control study. Lancet 387 (2016), 1531–1539.
20. [20] Alcalde-Cabero, E., Almazán-Isla, J., García López, F.J., et al. Guillain-Barré syndrome following the 2009 pandemic monovalent and seasonal trivalent influenza vaccination campaigns in Spain from 2009 to 2011: outcomes from active surveillance by a neurologist network, and records from a country-wide hospital discharge database. BMC Neurol., 16, 2016, 75, 10.1186/s12883-016-0598-z.
21. [21] Ghaderi, S., Gunnes, N., Bakken, I., Magnus, P., Trogstad, L., Håberg, S.E., Risk of Guillain-Barré syndrome after exposure to pandemic influenza A(H1N1)pdm09 vaccination or infection: a Norwegian population-based cohort study. Eur. J. Epidemiol. 31:1 (2016), 67–72.
22. [22] Committee to Review Adverse Effects of Vaccines, Institute of Medicine. Stratton, K., Ford, A., Rusch, E., et al. (eds.) Adverse Effects of Vaccines: Evidence and Causality, 2011, National Academies Press (US), Washington (DC).
23. [23] French medicines agency (ANSM), Vaccins anti-HPV et risque de maladies auto-immunes: étude pharmaco-épidémiologique - Rapport final - Septembre 2015, 〈file:///C:/Users/jkue/AppData/Local/Temp/Ansm_Gardasil-Hpv2_Rapport_Septembre-2015.pdf〉; 14 Sept 2015.
24. [24] Bakken, I.J., Tveito, K., Gunnes, N., Ghaderi, S., Stoltenberg, C., Trogstad, L., et al. Two age peaks in the incidence of chronic fatigue syndrome/myalgic encephalomyelitis: a population-based registry study from Norway 2008–2012. BMC Med., 12, 2014, 167.
25. [25] Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 〈 http://www.ncbi.nlm.nih.gov/books/NBK284897/〉; 10 Feb 2015.
26. [26] Magnus, P., Gunnes, N., Tveito, K., Bakken, I.J., Ghaderi, S., Stoltenberg, C., et al. Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/SEID/ME) is associated with pandemic influenza infection, but not with an adjuvanted pandemic influenza vaccine. Vaccine 33:46 (2015), 6173–6177, 10.1016/j.vaccine.2015.10.018.
27. [27] Donegan, K., Beau-Lejdstrom, R., King, B., et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK. Vaccine 31 (2013), 4961–4967.
28. [28] R. Wilson, P. Paterson, J. Chiu, W. Schulz, H. Larson, HPV Vaccination in Japan. The continuing debate and Global Impacts. A Report of the CSIS Global Health Policy Center 2015, 〈http://csis.org/files/publication/150422_Wilson_HPVVaccination2_Web.pdf〉; April 2015. (Accessed 16 May 2016).
29. [29] Kinoshita, T., Abe, R.T., Hineno, A., Tsunekawa, K., Nakane, S., Ikeda, S., Peripheral sympathetic nerve dysfunction in adolescent Japanese girls following immunization with the human papillomavirus vaccine. Intern. Med. 53:19 (2014), 2185–2200.
30. [30] Blitshteyn, S., Postural tachycardia syndrome following human papillomavirus vaccination. Eur. J. Neurol. 21:1 (2014), 135–139.
31. [31] Brinth, L.S., Pors, K., Theibel, A.C., Mehlsen, J., Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine 33:22 (2015), 2602–2605, 10.1016/j.vaccine.2015.03.098.
32. [32] European Medicines Agency, EMA to further clarify safety profile of human papillomavirus (HPV) vaccines. 〈http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/Procedure_started/WC500189476.pdf〉; 13 July 2015. (Accessed 16 April 2016).
33. [33] Global Advisory Committee on Vaccine Safety (GACVS). Statement on Safety of HPV vaccines, 〈http://www.who.int/vaccine_safety/committee/GACVS_HPV_statement_17Dec2015.pdf;17〉 December 2015. (Accessed 21 May 2016).
34. [34] Nordic Cochrane Centre. Complaint to the European Medicines Agency (EMA) over maladministration at the EMA, 〈http://nordic.cochrane.org/sites/nordic.cochrane.org/files/uploads/ResearchHighlights/Complaint-to-EMA-over-EMA.pdf〉; 26 May 2016. (Accessed 16 June 2016).
35. [35] Statens Serum Institute. Annual reports on the Danish childhood vaccination programme, 〈http://www.ssi.dk/English/News/EPI-NEWS/2016/No%2017%20-%202016.aspx〉; 27 April 2016. (Accessed 12 May 2016).
36. [36] Larson, H.J., et al. The state of vaccine confidence 2016: global insights through a 67-country survey. EBioMedicine 12 (2016), 295–301.
37. [37] Nohynek, H., Jokinen, J., Partinen, M., Vaarala, O., Kirjavainen, T., Sundman, J., et al. ASO3 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland. PLoS One, 7(3), 2012, e33536, 10.1371/journal.pone.0033536.