Monitoring and assessing vaccine safety: A European perspective

Expert Review of Vaccines

Volumn 9, Issue 4, 2010, Pages 371-380

  Lopalco, Pier Luigi ^a   Johansen, Kari ^a   Ciancio, Bruno ^a   De Carvalho Gomes, Helena ^a   Kramarz, Piotr ^a   Giesecke, Johan ^a  

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

Author keywords

Adverse effects; European Union; Immunization program; Vaccination; Vaccine safety

Indexed keywords

BCG VACCINE; HEPATITIS B VACCINE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INFLUENZA VACCINE; MALARIA VACCINE; MEASLES MUMPS RUBELLA VACCINE; ROTAVIRUS VACCINE; WART VIRUS VACCINE; VACCINE;

AUTHORITY; AUTISM; BELL PALSY; CASE CONTROL STUDY; CLINICAL TRIAL; COMPUTER PROGRAM; CONTROLLED STUDY; DATA BASE; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EDUCATION PROGRAM; EUROPE; EUROPEAN UNION; GOVERNMENT; GUILLAIN BARRE SYNDROME; HEALTH CARE ORGANIZATION; HEALTH EDUCATION; HEALTH HAZARD; HEALTH PRACTITIONER; HUMAN; IMMUNIZATION; INFECTION; INFLUENZA; INFLUENZA VIRUS A H1N1; INFORMATION DISSEMINATION; INTERPERSONAL COMMUNICATION; INTUSSUSCEPTION; LEGAL ASPECT; MEDICAL INFORMATION; MULTIPLE SCLEROSIS; NATIONAL HEALTH ORGANIZATION; NEURITIS; OBSERVATIONAL STUDY; PANDEMIC; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK REDUCTION; SAMPLE SIZE; STANDARD; VACCINATION; VALIDATION PROCESS; ANIMAL; PREVENTIVE HEALTH SERVICE; RISK FACTOR; STANDARDS; TRENDS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; EUROPE; HUMANS; IMMUNIZATION PROGRAMS; PRODUCT SURVEILLANCE, POSTMARKETING; PUBLIC HEALTH; RISK FACTORS; VACCINATION; VACCINES;

EID: 77950624071     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/erv.10.20     Document Type: Review

References (16)

1. Edwards RI, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 356, 1255-1259 (2000).
2. Wakefield AJ, Murch SH, Anthony A et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 351(9103), 637-641 (1998). (Pubitemid 28098447)
3. DeStefano F, Thompson WW. MMR vaccine and autism: an update of the scientific evidence. Expert Rev. Vaccines 3(1), 19-22 (2004).
4. Ramsay S. UK starts campaign to reassure parents about MMR-vaccine safety. Lancet 357(9252), 290 (2001).
5. Wright JA, Polack C. Understanding variation in measles-mumps-rubella immunization coverage-a population-based study. Eur. J. Public Health 16(2), 137-142 (2006).
6. Muscat M, Bang H, Wohlfahrt J, Glismann S, Mølbak K; EUVAC.NET Group. Measles in Europe: an epidemiological assessment. Lancet 373(9661), 383-389 (2009).
7. Farrington CP, Miller E, Taylor B. MMR and autism: further evidence against a causal association. Vaccine 19(27), 3632-3635 (2001). (Pubitemid 32522760)
8. DeStefano F. Vaccines and autism: evidence does not support a causal association. Clin. Pharmacol. Ther. 82, 756-759 (2007).
9. Balinska MA. Hepatitis B vaccination and French society ten years after the suspension of the vaccination campaign: how should we raise infant immunization coverage rates? J. Clin. Virol. 46(3), 202-205 (2009).
10. Ascherio A, Zhang SM, Hernan MA et al. Hepatitis B vaccination and the risk of multiple sclerosis. N. Engl. J. Med. 344, 327-332 (2001). (Pubitemid 32107640)
11. Confavreux C, Suissa S, Saddier P, Bourdes V, Vukusic S; Vaccines in Multiple Sclerosis Study Group. Vaccinations and the risk of relapse in multiple sclerosis. N. Engl. J. Med. 344, 319-326 (2001). (Pubitemid 32107639)
12. Farrington CP. Control without separate controls: evaluation of vaccine safety using case-only methods. Vaccine 22(15-16), 2064-2070 (2004).
13. Chen RT, Glasser JW, Rhodes PH et al. Vaccine Safety Datalink Project: a new tool for improving vaccine safety monitoring in the United States. Pediatrics 99, 765-773 (1997).
14. Kohl KS, Gidudu J, Bonhoeffer J et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 25, 5671-5674 (2007). (Pubitemid 47043207)
15. Bonhoeffer J, Zumbrunn B, Heininger U. Reporting of vaccine safety data in publications: systematic review. Pharmacoepidemiol. Drug Saf. 14(2), 101-106 (2005). (Pubitemid 40253618)
16. Zanoni G, Berra P, Lucchi I et al. Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts Vaccine 27 3376-3384 (2009).