Monitoring adverse events following immunisation in developing countries: experience from human papillomavirus vaccination demonstration projectsKriti M. Jain A , Proma Paul B and D. Scott LaMontagne B C
A Johns Hopkins School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, USA.
B PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
C Corresponding author. Email: firstname.lastname@example.org
Sexual Health 10(1) 57-63 https://doi.org/10.1071/SH11161
Submitted: 15 November 2011 Accepted: 20 August 2012 Published: 14 December 2012
Background: Surveillance of adverse events following immunisation (AEFIs) is important for maintaining trust in vaccination. This paper discusses retrospective reports by parents and guardians of girls experiencing AEFIs during human papillomavirus (HPV) vaccine demonstration projects in Uganda and Vietnam. Methods: A secondary analysis of data from a population-based survey measuring HPV vaccine coverage of eligible girls and acceptability among parents and guardians was conducted. Survey data from parents were analysed for frequency and type of AEFI and actions taken. Results: Of the 1700 eligible households contacted, all responded to the survey; of those, 1313 respondents had an eligible child who had received at least one dose of the HPV vaccine. Data were missing from 49 respondents, resulting in 1264 surveys. Twenty-five percent reported an AEFI, with fever (29.1%) and pain or swelling at the injection site (62.0%) being the most common. Events totalled 386 (10.5%) of the 3684 doses administered. Most parents reported that they took no action (63.9%) or cared for girls at home (16.1%) following an AEFI. Thirty-three parents sought advice from health workers or attended a clinic for 46 events (0.8% of all doses). Frequency of reporting varied by respondent identity, geographic location and vaccination location. Conclusions: AEFIs reported were similar to Phase III vaccine trials. Most parents reporting AEFIs took no action or treated the girl at home, suggesting that most AEFIs were not serious enough to contact the health system. AEFI reports were more frequent when solicited in surveys compared with reports from routine monitoring.
Additional keywords: bivalent, quadrivalent, Uganda, vaccination, Vietnam.
References Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127 2893–917.
| Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008.CrossRef | 1:CAS:528:DC%2BC3cXhtlWhs7fO&md5=dc247f8e1e21d86871c6b5a9817f4c13CAS | 21351269PubMed |
 Ginsberg GM, Edejer TTT, Lauer JA, Sepulveda C. Screening, prevention and treatment of cervical cancer – a global and regional generalized cost-effectiveness analysis. Vaccine 2009; 27 6060–79.
| Screening, prevention and treatment of cervical cancer – a global and regional generalized cost-effectiveness analysis.CrossRef | 19647813PubMed |
 Brabin L, Greenberg DP, Hessel L, Hyer R, Ivanoff B, Van Damme P. Current issues in adolescent immunization. Vaccine 2008; 26 4120–34.
| Current issues in adolescent immunization.CrossRef | 1:CAS:528:DC%2BD1cXoslenurk%3D&md5=38255bb535f1b961498d311775a2be73CAS | 18617295PubMed |
 Fowler GL, Kennedy A, Leidel L, Kohl KS, Khromava A, Bizhanova G, et al Vaccine safety perceptions and experience with adverse events following immunization in Kazakhstan and Uzbekistan: a summary of key informant interviews and focus groups. Vaccine 2007; 25 3536–43.
| Vaccine safety perceptions and experience with adverse events following immunization in Kazakhstan and Uzbekistan: a summary of key informant interviews and focus groups.CrossRef | 17293012PubMed |
 Agorastos T, Chatzigeorgiou K, Brotherton JML, Garland SM. Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Vaccine 2009; 27 7270–81.
| Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far.CrossRef | 1:CAS:528:DC%2BD1MXhsFShur3M&md5=4c3be852b81ee8adbabade49abb4294eCAS | 19799849PubMed |
 Duclos P. A global perspective on vaccine safety. Vaccine 2004; 22 2059–63.
| A global perspective on vaccine safety.CrossRef | 15121323PubMed |
 Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, et al Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001; 344 564–72.
| Intussusception among infants given an oral rotavirus vaccine.CrossRef | 1:STN:280:DC%2BD3M7ksVegug%3D%3D&md5=5e5f39720b074e5c0fc9984822fdd388CAS | 11207352PubMed |
 Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration. Vaccine adverse event reporting system. Rockville: CDC. Available online at: http://vaers.hhs.gov/index [verified August 2010].
 Medicines and Healthcare products Regulatory Authority (MHRA). Yellow Card: helping to make medicines safer. London: MHRA. Available online at: http://yellowcard.mhra.gov.uk/the-yellow-card-scheme/ [verified April 2012].
 World Health Organization (WHO), Department of Immunization, Vaccines and Biologicals. GIVS: global immunization vision and strategy (2006–2015). Geneva: WHO; 2005.
 World Health Organization (WHO). The work of the WHO in the Western Pacific Region, 1 July 2011–30 June 2012. Geneva: WHO, 2010. Available online at: http://www.wpro.who.int/regional_director/regional_directors_report/en/index.html[verified 1 October 2012].
 World Health Organization (WHO). Expanded Programme on Immunization (EPI) review. Indonesia, 19–30 October 2009. Geneva: WHO; 2010. Available online at: http://188.8.131.52/PDS_DOCS/B4547.pdf [verified September 2010].
 Singh Y, Shah A, Singh M, Verma S, Shrestha BM, Vaidya P, et al Human papilloma virus vaccination in Nepal: an initial experience. Asian Pac J Cancer Prev 2010; 11 615–7.
| 21039025PubMed |
 LaMontagne DS, Barge S, Le NT, Mugisha E, Penny ME, Gandhi S, et al Delivery strategies for HPV vaccination programs that achieved high coverage in low and middle-income countries. Bull World Health Organ 2011; 89 821–830B.
| Delivery strategies for HPV vaccination programs that achieved high coverage in low and middle-income countries.CrossRef | 22084528PubMed |
 van’t Klooster TM, Kemmeren JM, van der Maas NA, de Melker HE. Reported adverse events in girls aged 13–16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands. Vaccine 2011; 29 4601–7.
| Reported adverse events in girls aged 13–16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands.CrossRef |
 Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, et al Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009; 374 301–14.
| Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women.CrossRef | 1:CAS:528:DC%2BD1MXovF2kt78%3D&md5=c3c8e95b22a5f692e611f0f84b9241c7CAS | 19586656PubMed |
 Bingham A, Drake JK, LaMontagne DS. Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource settings. Arch Pediatr Adolesc Med 2009; 163 455–61.
| Sociocultural issues in the introduction of human papillomavirus vaccine in low-resource settings.CrossRef | 19414692PubMed |
 Gust DA, Campbell S, Kennedy A, Shui I, Barker L, Schwartz B. Parental concerns and medical-seeking behavior after immunization. Am J Prev Med 2006; 31 32–5.
| Parental concerns and medical-seeking behavior after immunization.CrossRef | 16777540PubMed |
 Mbonye AK. Prevalence of childhood illnesses and care-seeking practices in rural Uganda. ScientificWorldJournal 2003; 3 721–30.
| Prevalence of childhood illnesses and care-seeking practices in rural Uganda.CrossRef | 12941972PubMed |
 Mohan P, Iyengar S, Agarwal K, Martines JC, Sen K. Care-seeking practices in rural Rajasthan: barriers and facilitating factors. J Perinatol 2008; 28 S31–7.
| Care-seeking practices in rural Rajasthan: barriers and facilitating factors.CrossRef | 19057566PubMed |
 Jain KM, Paul P, LaMontagne DS. Monitoring adverse events following immunization in developing countries. Global Health Council 2011 Conference, Washington, DC, June 14-17, 2011.
 Netterlid E, Månsson ME, Håkansson A. Surveillance of vaccine safety: comparison of parental reports with routine surveillance and a clinical trial. Vaccine 2009; 27 2042–7.
| Surveillance of vaccine safety: comparison of parental reports with routine surveillance and a clinical trial.CrossRef | 19428828PubMed |
 Fletcher A. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991; 84 341–4.
| 1:STN:280:DyaK3M3oslSltQ%3D%3D&md5=f537f87871ae4d938e86593d2e6b4b70CAS | 2061900PubMed |
 Isaacs D, Lawrence G, Boyd I, Ronaldson K, McEwen J. Reporting of adverse events following immunization in Australia. J Paediatr Child Health 2005; 41 163–166.
| Reporting of adverse events following immunization in Australia.CrossRef | 15813867PubMed |
 Gold MS, McIntyre P. Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance. Sex Health 2010; 7 320–4.
| Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance.CrossRef | 20719221PubMed |
 Griffin MR, Braun MM, Bart KJ. What should an ideal vaccine postlicensure safety system be? Am J Public Health 2009; 99 S345–50.
| What should an ideal vaccine postlicensure safety system be?CrossRef | 19797747PubMed |
 Duclos P, Delo A, Aguado T, Bilous J, Birmingham M, Kieny MP, et al Immunization safety priority project at the World Health Organization. Semin Pediatr Infect Dis 2003; 14 233–9.
| Immunization safety priority project at the World Health Organization.CrossRef | 12913836PubMed |
 Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J Low Genit Tract Dis 2004; 8 188–94.
| Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents.CrossRef | 15874862PubMed |
 Gellin BG, Maibach EW, Marcuse EK. Do parents understand immunizations? A national telephone survey. Pediatrics 2000; 106 1097–102.
| Do parents understand immunizations? A national telephone survey.CrossRef | 1:STN:280:DC%2BD3M%2FlvVGktA%3D%3D&md5=3e88e5ab290ed611233bd9911971decfCAS | 11061781PubMed |
 Stratton KR, Howe CJ, Johnston RB. Research strategies for assessing adverse events associated with vaccines: a workshop summary. Washington, DC: National Academies; 1994.