Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: Nationwide population based cohort study

BMJ (Online)

Volumn 345, Issue 7878, 2012, Pages

  Rasmussen, Thomas A ^a   Jørgensen, Martin R S ^b   Bjerrum, Stephanie ^c   Jensen Fangel, Søren ^a   Støvring, Henrik ^d   Østergaard, Lars ^a   Søgaard, Ole S ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b AALBORG UNIVERSITY HOSPITAL   (Denmark)

^c HVIDOVRE HOSPITAL   (Denmark)

^d AARHUS UNIVERSITY   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS VACCINE; DIPHTHERIA POLIOMYELITIS TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; MEASLES MUMPS RUBELLA VACCINE; PERTUSSIS VACCINE; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; VACCINE; WART VIRUS VACCINE;

ADOLESCENT; ADVERSE OUTCOME; AGE DISTRIBUTION; ANAPHYLACTIC SHOCK; ARTICLE; AUTOIMMUNE THROMBOCYTOPENIA; CHILD; CHILD DEATH; CHILD HEALTH CARE; CHILDHOOD MORTALITY; COHORT ANALYSIS; DENMARK; DIPHTHERIA; DRUG SAFETY; FACIAL NERVE PARALYSIS; FEBRILE CONVULSION; FEMALE; FOLLOW UP; GUILLAIN BARRE SYNDROME; HAEMOPHILUS INFECTION; HOSPITAL ADMISSION; HUMAN; INFANT; INSULIN DEPENDENT DIABETES MELLITUS; JUVENILE RHEUMATOID ARTHRITIS; MAJOR CLINICAL STUDY; MALE; MASS IMMUNIZATION; MEASLES; MIGRATION; MORBIDITY; MULTIPLE SCLEROSIS; MUMPS; MYELITIS; NARCOLEPSY; OPTIC NERVE DISEASE; OPTIC POLYNEURITIS; OUTCOME ASSESSMENT; PERTUSSIS; PNEUMOCOCCAL INFECTION; POLIOMYELITIS; POPULATION RESEARCH; PRESCHOOL CHILD; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; RUBELLA; SCHOOL CHILD; SEASONAL VARIATION; SEIZURE; TETANUS; UNSPECIFIED SIDE EFFECT; VERRUCA VULGARIS;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; DENMARK; FOLLOW-UP STUDIES; HUMANS; INFANT; INFANT, NEWBORN; MASS VACCINATION; VACCINES;

EID: 84867417845     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.e5823     Document Type: Article

References (45)

1. Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. Am J Public Health 2008;98:1366-71.
2. Wijnans L, de Bie S, Dieleman J, Bonhoeffer J, Sturkenboom M. Safety of pandemic H1N1 vaccines in children and adolescents. Vaccine 2011;29:7559-71.
3. Destefano F, Tokars J. H1N1 vaccine safety monitoring: beyond background rates. Lancet 2010;375:1146-7.
4. Lieu TA, Kulldorff M, Davis RL, Lewis EM, Weintraub E, Yih K, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007;45(10 suppl 2):S89-95.
5. Salmon DA, Akhtar A, Mergler MJ, Vannice KS, Izurieta H, Ball R, et al. Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program. Pediatrics 2011;127(suppl 1):S78-86.
6. Siegrist CA, Lewis EM, Eskola J, Evans SJ, Black SB. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infect Dis J 2007;26:979-84. (Pubitemid 350287577)
7. Black S, Eskola J, Siegrist CA, Halsey N, Macdonald N, Law B, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009;374:2115-22.
8. Huang WT, Chuang JH, Kuo SH. Monitoring the safety of pandemic H1N1 vaccine. Lancet 2010;375:1164.
9. Wakefield AJ. MMR vaccination and autism. Lancet 1999;354:949-50.
10. Jansen VA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ. Measles outbreaks in a population with declining vaccine uptake. Science 2003;301:804. (Pubitemid 36962614)
11. Statens Serum Institut. DTaP-IPV/Hib vaccination coverage 2010. 2011. www.ssi.dk/English/News/EPI-NEWS/2011/No%2020%20-%202011.aspx.
12. Statens Serum Institut. HPV vaccination, coverage 2010. 2011. www.ssi.dk/English/News/EPI-NEWS/2011/No%2018%20-%202011.aspx.
13. Statens Serum Institut. MMR vaccination coverage 2010. 2011. www.ssi.dk/English/News/EPI-NEWS/2011/No%2021%20-%202011.aspx.
14. Statens Serum Institut. PCV coverage and invasive pneumococcal disease 2010. 2011. www.ssi.dk/English/News/EPI-NEWS/2011/No%2019%20-%202011.aspx.
15. Hviid A, Melbye M. Measles-mumps-rubella vaccination and asthma-like disease in early childhood. Am J Epidemiol 2008;168:1277-83.
16. Sun Y, Christensen J, Hviid A, Li J, Vedsted P, Olsen J, et al. Risk of febrile seizures and epilepsy after vaccination with diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Haemophilus influenzae type B. JAMA 2012;307:823-31.
17. Nørgaard M JJ, Gradus J, Lash TL, Sørensen HT. Problems with onset of multiple sclerosis based on hospital discharge data (abstract). Pharmacoepidemiol Drug Saf 2007;16:S220-1.
18. Christiansen CF, Christensen S, Farkas DK, Miret M, Sorensen HT, Pedersen L. Risk of arterial cardiovascular diseases in patients with multiple sclerosis: a population-based cohort study. Neuroepidemiology 2010;35:267-74.
19. Vestergaard M, Obel C, Henriksen TB, Christensen J, Madsen KM, Ostergaard JR, et al. The Danish National Hospital Register is a valuable study base for epidemiologic research in febrile seizures. J Clin Epidemiol 2006;59:61-6. (Pubitemid 41797476)
20. Thomsen RW, Hundborg HH, Lervang HH, Johnsen SP, Sorensen HT, Schonheyder HC. Diabetes and outcome of community-acquired pneumococcal bacteremia: a 10-year population-based cohort study. Diabetes Care 2004;27:70-6. (Pubitemid 38196712)
21. Norgaard M, Jensen AO, Engebjerg MC, Farkas DK, Thomsen RW, Cha S, et al. Long-term clinical outcomes of patients with primary chronic immune thrombocytopenia: a Danish population-based cohort study. Blood 2011;117:3514-20.
22. Statens Serum Institut. [Vaccination surveillance]. www.ssi.dk/ Smitteberedskab/Sygdomsovervaagning/VaccinationSurveillance.aspx?vaccination= 14&season=2009%7C2011&sex=3&agegroup=10&landsdel= 100&kommune=1000&xaxis=AgeGroup&yaxis=Total&show= Table&datatype=Vaccination#HeaderText.
23. Svanstrom H, Callreus T, Hviid A. Temporal data mining for adverse events following immunization in nationwide Danish healthcare databases. Drug Saf 2010;33:1015-25.
24. Klein NP, Ray P, Carpenter D, Hansen J, Lewis E, Fireman B, et al. Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies. Vaccine 2010;28:1062-8.
25. Madsen KM, Vestergaard M. MMR vaccination and autism: what is the evidence for a causal association? Drug Saf 2004;27:831-40. (Pubitemid 39331682)
26. Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, et al. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med 2002;347:1477-82. (Pubitemid 35257586)
27. Honda H, Shimizu Y, Rutter M. No effect of MMR withdrawal on the incidence of autism: a total population study. J Child Psychol Psychiatry 2005;46:572-9. (Pubitemid 40778959)
28. Institute of Medicine. Adverse effects of vaccines-evidence and causality. The National Academies Press, 2010.
29. Lower J. [Two unclear cases of death. Can we still recommend HPV vaccination?]. MMW Fortschr Med 2008;150:6.
30. Kokia ES, Silverman BG, Green M, Kedem H, Guindy M, Shemer J. Deaths following influenza vaccination - background mortality or causal connection? Vaccine 2007;25:8557-61. (Pubitemid 350192043)
31. Deeks SL, Lim GH, Simpson MA, Rosella L, Mackie CO, Achonu C, et al. Estimating background rates of Guillain-Barre Syndrome in Ontario in order to respond to safety concerns during pandemic H1N1/09 immunization campaign. BMC Public Health 2011;11:329.
32. Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, Sturkenboom M. Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 2011;343:d3908.
33. Williams SE, Pahud BA, Vellozzi C, Donofrio PD, Dekker CL, Halsey N, et al. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination. Vaccine 2011.
34. Choe YJ, Cho H, Bae GR, Lee JK. Guillain-Barre syndrome following receipt of influenza A (H1N1) 2009 monovalent vaccine in Korea with an emphasis on Brighton Collaboration case definition. Vaccine 2011;29:2066-70.
35. Arcondo MF, Wachs A, Zylberman M. [Transverse myelitis associated with anti-influenza A (H1N1) vaccination]. Medicina (B Aires) 2011;71:161-4.
36. Sato N, Watanabe K, Ohta K, Tanaka H. Acute transverse myelitis and acute motor axonal neuropathy developed after vaccinations against seasonal and 2009 A/H1N1 influenza. Intern Med 2011;50:503-7.
37. Adjuvant-containing H1N1 influenza vaccine pandemrix: narcolepsy in children. Prescrire Int 2011;20:154.
38. Bardage C, Persson I, Ortqvist A, Bergman U, Ludvigsson JF, Granath F. Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden. BMJ 2011;343:d5956.
39. Haba-Rubio J, Rossetti AO, Tafti M, Heinzer R. [Narcolepsy with cataplexy associated with H1N1 vaccination]. Revue neurologique 2011;167:563-6.
40. Mitrakrishnan S, Ranjanie G, Thirunavakarasu T, Manjula C, Nayananjani K. Seizures and retrograde amnesia with cerebrospinal fluid changes following H1N1 influenza vaccination. Vaccine 2011;29:6369-70.
41. Wu J, Xu F, Lu L, Lu M, Miao L, Gao T, et al. Safety and effectiveness of a 2009 H1N1 vaccine in Beijing. N Engl J Med 2010;363:2416-23.
42. Yin JK, Khandaker G, Rashid H, Heron L, Ridda I, Booy R. Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis. Influenza Other Respi Viruses 2011;5:299-305.
43. Larson HJ, Cooper LZ, Eskola J, Katz SL, Ratzan S. Addressing the vaccine confidence gap. Lancet 2011;378(9790):526-35.
44. Folkenberg M, Callreus T, Svanstrom H, Valentiner-Branth P, Hviid A. Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010. Vaccine 2011;29:1180-4.
45. Jiang GX, Cheng Q, Link H, de Pedro-Cuesta J. Epidemiological features of Guillain-Barre syndrome in Sweden, 1978-93. J Neurol Neurosurg Psychiatry 1997;62:447-53.