References
0
- 01
-
The GTN "Surveillance for Adverse Events Following Immunizations" training course has been held at: University of Cape Town in South Africa; National Pharmacovigilance Centre in Tunisia; Epidemiological Unit, Ministry of Health in Sri Lanka; and, Tarassevich Institute in Russia. For more information, see http://www.who.int/immunization_standards/vaccine_quality/gtn_aefi.
- 02
-
World Health Organization (WHO), United Nations Children's Fund (UNICEF), World Bank. State of the world's vaccines and immunization, 3rd ed, Geneva: WHO, 2009.
- 03
-
World Health Organization (WHO). "Progress in global measles control and mortality reduction, 2000–2007", Weekly Epidemiological Record, Geneva: WHO, 2008: 83(49):441–448.
- 04
-
Copenhagen Consensus 2008. Available at: http://www.copenhagenconsensus.com (Accessed 1 December 2009).
- 05
-
World Health Organization Immunization, Vaccines and Biologics (WHO/IVB) database. Database includes 193 WHO Member States. Data as of July 2009.
- 06
-
Plotkin SL, Plotkin SA. "A short history of vaccination," In: Plotkin S, Orenstein W, Offit PA. Vaccines, 5th edition, Philadelphia: Saunders, 2008.
- 07
-
Chen RT et al. "The Vaccine Adverse Event Reporting System (VAERS)," Vaccine, 1994: 12(6):542–550.
- 08
-
Wilson, CB, Marcuse, EK. "Vaccine safety – vaccine benefits: science and the public's perception," Nature Reviews Immunology, 2001: 1:160–165.
- 09
-
World Health Organization (WHO). Available at: http://www.who.int/vaccines/en/smallpox.shtml (Accessed 2 December 2009).
1
- 10
-
United Nations Children Fund (UNICEF). Available at: http://www.unicef.org (Accessed 2 December 2009).
- 11
-
Milstien, JB. "Regulation of vaccines: strengthening the science base," Journal Public Health Policy, 2004: 25(2):173–189.
- 12
-
Baylor NW, Midthun K. "Regulation and testing of vaccines," In: Plotkin S, Orenstein W, Offit PA. Vaccines, 5th edition, Philadelphia: Saunders, 2008.
- 13
-
Duclos P, Bentsi-Enchill AD, Pfeifer D. "Vaccine safety and adverse events: lessons learnt," In: Kaufmann SHE and Lamert PH. The Grand Challenge for the Future, Basel, Switzerland: 2005: 209–229.
- 14
-
Offit PA, David RL, Gust D. "Vaccine safety," In: Plotkin S, Orenstein W, Offit PA. Vaccines, 5th edition, Philadelphia: Saunders, 2008.
- 15
-
Malaria Vaccine Initiative, PATH. Fact Sheet: Clinical trials: Steps in malaria vaccine development, Seattle, Washington.
- 16
-
US Centers for Disease Control and Prevention (CDC). "Intussusception among recipients of rotavirus vaccine – United States, 1998–1999", Morbidity and Mortality Weekly Report, 1999: 48:577–581.
- 17
-
World Health Organization (WHO). Acute intussusception in infants and children: Incidence, clinical presentation and management: A global perspective, WHO/V&B/02.19, Geneva: WHO, 2002.
- 18
-
Ruiz-Palacios G, Pérez-Schael I, Velázquez F, et al. "Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis," New England Journal of Medicine, 2006: 354(1):11–22.
- 19
-
Vesikari T, Matson D, Dennehy P, et al. "Safety and efficacy of a pentavalent human-bovine (wc3) reassortant rotavirus vaccine," New England Journal of Medicine, 2006: 354(1):23–33.
2
- 20
-
Chen RT, Glasser J, Rhodes P et al. "Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States," Pediatrics, 1997: 99(6):765–773.
- 21
-
US Centers for Disease Control and Prevention. Website (Clinical Immunization Safety Assessment Network section) http://www.cdc.gov/vaccinesafety/Activities/CISA.html (Accessed 23 February 2010).
- 22
-
US Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices, February 21–22, 2007, Record of the Proceedings, Atlanta, Georgia: 2007.
- 23
-
US Centers for Disease Control and Prevention (CDC). "Prevention of rotavirus gastroenteritis among infants and children; recommendations of the Advisory Committee on Immunization Practices", Morbidity and Mortality Weekly Report, 2006: 55(RR-12).
- 24
-
Duclos P. "A global perspective on vaccine safety," Vaccine, 2004: 22:2059–2063.
- 25
-
European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use. CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine, EMEA/32706/2007: London, 19 January 2007.
- 26
-
Infant mortality and births from 2008 Immunization summary, WHO/UNICEF (The 2010 edition).
- 27
-
Uppsala Monitoring Centre. Available at: www.who-umc.org (Accessed 24 February 2010).
- 28
-
World Health Organization (WHO). "BCG vaccine: WHO position paper", Weekly Epidemiological Record, Geneva: 2004:79(4):25–40.
- 29
-
World Health Organization (WHO). "Introduction of inactivated poliovirus vaccine into oral poliovirus vaccine-using countries", Weekly Epidemiological Record, Geneva: 2003:78(28):241–252.
3
- 30
-
World Health Organization (WHO). "Pertussis vaccine: WHO position paper", Weekly Epidemiological Record, Geneva: 2005:80(4):29–40.
- 31
-
World Health Organization (WHO). "Measles vaccines: WHO position paper", Weekly Epidemiological Record, Geneva: 2009:84(35):349–360.
- 32
-
World Health Organization (WHO). Aide mémoire: To ensure the efficiency and safety of mass immunization campaigns with injectable vaccines, WHO/V&B/04.07, Geneva: WHO, 2007.
- 33
-
World Health Organization (WHO). "Module 4: Ensuring safe injections" In: Immunization in Practice, WHO/IVB/04.06, Geneva: WHO, 2004.
- 34
-
Black S, Eskola J, Siegrist C et al. "Importance of background rates of disease in assessment of vaccine safety during mass immunization with pandemic H1N1 influenza vaccines," Lancet, Published Online October 21, 2009. DOI:10.1016/S0140- 6736(09)61877–8.
- 35
-
World Health Organization (WHO). "Causality assessment of adverse events following immunization", Weekly Epidemiological Record, Geneva: WHO, 2001: 76(12):85–89.
- 36
-
World Health Organization (WHO). Aide Mémoire: Adverse Events Following Immunization (AEFI): Causality Assessment, WHO/IVB, Geneva: 2005.
- 37
-
World Health Organization Western Pacific Regional Office (WHO/WPRO), PATH. Third Biregional Meeting on Control of Japanese Encephalitis, Manila: WHO, 2007.
- 38
-
World Health Organization (WHO). "Global Advisory Committee on Vaccine Safety: Safety of Japanese encephalitis vaccination in India", Weekly Epidemiological Record, Geneva: WHO, 2007: 82(3):23–24.
- 39
-
Global Advisory Committee on Vaccine Safety (GACVS) and World Health Organization Secretariat. "Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS", Expert Review Vaccines, 2009:8(6) 705–716.
4
- 40
-
The Brighton Collaboration. Available at: http://www.brightoncollaboration.org (accessed 18 November 2009).
- 41
-
World Health Organization (WHO). Available at: www.who.int/immunization_standards/vaccine_quality/gtn_index (Accessed 18 March 2010).
- 42
-
The Uppsala Monitoring Centre. Available at: www.who-umc.org (accessed 18 November 2009).
- 43
-
Folb, PI, Bernatowska, W, Chen R, et al. "A Global Perspective on Vaccine Safety and Public Health: The Global Advisory Committee on Vaccine Safety", American Journal of Public Health, November 2004: 94(11):1926–1931.
- 44
-
World Health Organization (WHO). "Global Advisory Committee on Vaccine Safety, report of meeting held 17–18 June 2009", Weekly Epidemiological Record, Geneva: 2009: 84(40):330–332.
- 45
-
World Health Organization (WHO). Available at: www.who.int/immunization_safety/safety_quality/vaccine_safety_websites (Accessed 18 March 2010).
- 46
-
World Health Organization (WHO). The Importance of Pharmacovigilance: safety monitoring of medicinal products, Geneva: WHO, 2002.
- 47
-
WHO (2012). WHO vaccine reaction rates information sheets. www.who.int/vaccine_safety/initiative/tools/vaccinfosheets.
- 48
-
Uppsala Monitoring Centre (UMC). Available at: www.who-umc.org (Accessed 18 November 2009).
- 49
-
Council for International Organizations of Medical Sciences/World Health Organization (CIOMS/WHO) Working Group on Vaccine Pharmacovigilance. Vaccine Pharmacovigilance Definition. Available at: www.cioms.ch (Accessed 10 February 2010).
5
- 50
-
Global Advisory Committee on Vaccine Safety (GACVS) and World Health Organization Secretariat. "Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS," Expert Review Vaccines, 2009: 8(6),705–716.
- 51
-
Zanardi LR, Haber P, Mootrey GT, Niu MT, Wharton M and the VAERS Working Group. "Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System" Pediatrics, 2001: 107;e97 DOI:10.1542/peds.107.6.e97.
- 52
-
Robert Pless, Public Health Agency of Canada. (Personal communication January 2010).
- 53
-
World Health Organization (WHO). Available at: www.who.int/immunization_standards/national_regulatory_authorities/strengthening (Accessed 1 March 2009).
- 54
-
Burgess DC, Burgess MA, Leask J. The MMR vaccination and autism controversy in United Kingdom 1998–2005: inevitable community outrage or a failure of risk communication? Vaccine 24, 3912–3928 (2006).
- 55
-
World Health Organizaton Global Training Network. "Similarities and differences between vaccines and medicines," In: WHO Global Training Network: Adverse events following immunization (AEFI), Geneva: WHO, 2009.
- 56
-
World Health Organization (WHO). "Module 3: The cold chain" In: Immunization in Practice, Geneva: WHO/IVB/04/06, 2004.
- 57
-
World Health Organization (WHO). "Module 4: Ensuring safe injections" In: Immunization in Practice, Geneva: WHO/IVB/04/06, 2004.
- 58
-
World Health Organization (WHO). "Module 6: Holding an immunization session" In: Immunization in Practice, Geneva: WHO/IVB/04/06, 2004.
- 59
-
Gold R. Your Child's Best Shot: A parent's guide to vaccination 3rd edition, Canadian Paediatric Society, Canada, 2006.
6
- 60
-
Council for International Organizations of Medical Sciences (CIOMS). Guidelines for Preparing Core Clinical Safety Information on Drugs – Report of CIOMS Working Group III, Geneva: WHO, 1995.
- 61
-
World Health Organization (WHO). "Rotavirus vaccines: an update" Weekly Epidemiological Record, Geneva: 2009:84(51–52):533–538.
- 62
-
World Health Organization (WHO). "Yellow fever vaccine: WHO position paper" Weekly Epidemiological Record, Geneva: 2003:78(40):349–360.
- 63
-
World Health Organization (WHO). "Hepatitis B vaccines: WHO position paper", Weekly Epidemiological Record, Geneva: 2009:84(40):405–420.
- 64
-
Asian Development Bank. Immunization Financing in Developing Countries and the International Vaccine Market: Trends and Issues, Manila: Asian Development Bank, 2001.
- 65
-
World Health Organization (WHO). "WHO position paper on Haemophilus influenzae type b conjugate vaccines", Weekly Epidemiological Record, Geneva: 2006:81(47):445—452.
- 66
-
World Health Organization (WHO). "Pneumococcal conjugate vaccine for childhood immunization – WHO position paper", Weekly Epidemiological Record, Geneva: 2007:82(12):93–104.
- 67
-
Meningitis vaccine project. Available at: www.meningvax.org (Accessed 1 January 2010).
- 68
-
World Health Organization (WHO). "Tetanus vaccine: WHO position paper", Weekly Epidemiological Record, Geneva: 2006:81(20):197–208.
- 69
-
World Health Organization (WHO). "Diphtheria vaccine: WHO position paper", Weekly Epidemiological Record, Geneva: 2006:81(3):21–32.
7
- 70
-
Adapted from Martin Friede.
- 71
-
World Health Organization (WHO). Mass Measles Immunization Campaigns: Reporting and Investigating Adverse Events Following Immunization, Geneva: Revision May 2002.
- 72
-
World Health Organization (WHO). "Revised BCG vaccination guidelines for infants at risk for HIV infection", Weekly Epidemiological Record, Geneva: 2007:82(21):193–196.
- 73
-
World Health Organization (WHO). "Influenza Vaccines WHO Position Paper", Weekly Epidemiological Record, No. 33, 19 August 2005.
- 74
-
World Health Organization (WHO). Website (Vaccine-preventable diseases section). Available at: www.who.int/immunization_monitoring/diseases/MNTE_initiative (Accessed 19 May 2010).
- 75
-
World Health Organization (WHO). Website (Maternal and Neonatal Tetanus (MNT) elimination). Available at: www.who.int/immunization_monitoring/diseases/MNTE_initiative/en/index4.html (Accessed January 2012)
- 76
-
D. Baxter. (2007). Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond) 57 (8): 552–556. doi: 10.1093/occmed/kqm11.
- 77
-
World Health Organization (WHO). Website (Information related to influenza immunization). Available at: www.who.int/influenza/vaccines/SAGE_information (Accessed 25 May 2012).
- 78
- 79
-
WHO WER 2007; 82:17–24 and WER 2007; 82:181–96.
8
- 80
-
Siegrist CA, Lewis EM, Eskola J, Evans S, Black S. "Human Papilloma Virus Immunization in Adolescent and Young Adults: A Cohort Study to Illustrate What Events Might be Mistaken for Adverse Reactions." The Pediatric Infectious Disease Journal. Volume 26, Number 11, November 2007.
- 81
-
Expanded Programme on Immunization (EPI): www.who.int/immunization_delivery
- 82
-
WHO Programme for International Drug Monitoring (PIDM): www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map
- 83
-
Uppsala Monitoring Center (UMC): www.who-umc.org
- 84
-
Global Advisory Committee on Vaccine Safety (GACVS): www.who.int/vaccine_safety
- 85
-
Brighton Collaboration: brightoncollaboration.org
- 86
-
Standardized case definitions: https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/available-definitions.html
- 87
-
Global Vaccine Safety Resource Centre (GVS RC): www.who.int/vaccine_safety/initiative/tech_support
- 88
-
Global Learning Opportunities for Vaccine Quality: www.who.int/immunization_standards/vaccine_quality/gtn_index
- 89
-
WHO: Good information practices for vaccine safety web sites: www.who.int/vaccine_safety/good_vs_sites
- 90
-
More about the "History of Anti-vaccination Movements: College of Physicians of Philadelphia: The history of vaccines:www.historyofvaccines.org/content/articles/history-anti-vaccination-movements
- 91
-
Standard case definitions by the Brighton collaboration: https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions.html
- 92
-
The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 2007; 25(31):5671–5674. www.ncbi.nlm.nih.gov/pubmed/17400339
- 93
-
Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2007;25(31):5771–5792. www.ncbi.nlm.nih.gov/pubmed/17570566
- 94
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Adverse Effects of Vaccines: Evidence and Causality: www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx
- 95
-
Vaccine Safety Net: www.who.int/immunization_safety/safety_quality/vaccine_safety_websites
- 96
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UMC Pharmacovigilance Training Course: www.who-umc.org/DynPage.aspx?id=116849&mn1=7347&mn2=7252&mn3=7323&mn4=7632