1,910
Views
3
CrossRef citations to date
0
Altmetric
Research Paper

How were DTP-related adverse events reduced after the introduction of an acellular pertussis vaccine in Chile?

ORCID Icon, ORCID Icon &
Pages 4225-4234 | Received 23 Apr 2021, Accepted 02 Aug 2021, Published online: 08 Sep 2021

References

  • World Health Organization Global Vaccine Safety. AEFI detection. Geneva (Switzerland): WHO; 2020 [accessed 2021 January 10]. Available from: https://www.who.int/vaccine_safety/initiative/detection/en/.
  • European Medicines Agency. CH E2E Pharmacovigilance planning (Pvp). European Medicines Agency; 2004.
  • CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Definition and application of terms for vaccine pharmacovigilance. CIOMS/WHO, editor. Geneva; 2012. p. 193.
  • World Health Organization Global Vaccine Safety. Core variables for AEFI Switzerland: WHO; 2020 [accessed 2021 January 10] https://www.who.int/vaccine_safety/news/HL_1/en/.
  • Ministerio de Salud de Chile, Subsecretaría de Salud Pública. Inmunización programatica contra la Difteria, Tétanos, Tos convulsiva, Hepatitis B, Poliomelitis y las enfermedades invasoras causadas por Haemophilus Influenzae tipo B en niños y niñas menores de 2 años; 2018.
  • Ministerio de Salud de Chile. Guía de Sistema de Notificación, Evaluación y Seguimiento de Eventos Supuestamente Atribuidos a Vacunación e Inmunización y Error Programático. Chile Subdepartamento de Farmacovigilancia. Agencia Nacional de Medicamentos. Instituto de Salud Pública de Chile. Departamento de Inmunizaciones. Subsecretaría de Salud Pública. División de Planificación Sanitaria, editors; 2013.
  • Departamento Agencia Nacional de Medicamentos Instructivo Para La Notificación De Sospechas De Reacciones Adversas A Medicamentos 2020. ISP, editor; 2020.
  • Thomsen O, Saldaña A, Cerda J, Abarca K. Seguridad en vacunas: descripción de los eventos adversos notificados al sistema de vigilancia en Chile, 2014 a 2016. Rev Chil Infectol. 2019;36(4):461–68. doi:10.4067/S0716-10182019000400461.
  • Departamento de estadísticas e Información de Salud, Ministerio de Salud. Gobierno de Chile Cobertura de vacunación programática: departamento de estadísticas e Información de Salud. Ministerio de Salud. Gobierno de Chile; 2020 [accessed 2020 July 20] http://www.deis.cl/estadisticas-inmunizaciones/.
  • World Health Organization. Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification. Second ed. Geneva; 2018.
  • Ministerio de Salud. Subsecreataría de Salud Pública. Decreto 7 Aprueba el Reglamento sobre Notificación de Enfermedades Transmisibles de Declaracion Obligatoria y su Vigilancia; 2019.
  • Zhou W, Ellenberg S. Surveillance for safety after immunization: vaccine adverse event reporting system (VAERS). Morbidity and Mortality Weekly Report: MMWR. Surveillance Summaries; 2003.
  • PuenteGómez I, Verheust C, Hanssens L, Dolhain J. Safety profile of Infanrix hexa – 17 years of GSK’s passive post-marketing surveillance. Expert Review of Vaccines. 2020;19(8):771–79. doi:10.1080/14760584.2020.1800458.
  • Hawken S, Manuel D, Deeks S, Kwong J, Crowcroft N, Wilson K. Underestimating the safety benefits of a new vaccine: the impact of acellular pertussis vaccine versus whole-cell pertussis vaccine on health services utilization. American Journal of Epidemiology. 2012;1(176(11)):1035–42. doi:10.1093/aje/kws167.
  • Klein N, Abu-Elyazeed R, Cheuvart B, Janssens W, Mesaros N. Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States. Human Vaccines & Immunotherapeutics. 2019;3(15):809–21. doi:10.1080/21645515.2018.1549449.
  • Sebastian J, Gurumurthy P, Ravi M, Ramesh M. Active surveillance of adverse events following immunization (AEFI): a prospective 3-year vaccine safety study. Therapeutic Advances in Vaccines and Immunotherapy. 2019;7:251513551988900. doi:10.1177/2515135519889000.
  • Prymula R, Kieninger D, Feroldi E, Jordanov E, B’Chir S, DaCosta X. Immunogenicity and safety of primary and booster vaccinations of a fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine in healthy infants and toddlers in Germany and the Czech Republic. The Pediatric Infectious Disease Journal. 2018;37(8):823–30. doi:10.1097/INF.0000000000002109.
  • Gidengil C, Chen C, Parker A, Nowak S, Matthews L. Beliefs around childhood vaccines in the United States: a systematic review. Vaccine. 2019;37(3):6793–802. doi:10.1016/j.vaccine.2019.08.068.
  • Patel P, Al-Rawahi B, Al-Jawari A, Al-Abaidani I, Al-Abri S. Surveillance of adverse events following immunization in Oman, 2006-2015. East Mediterr Health J. 2018;24(2):119–26. doi:10.26719/2018.24.2.119.
  • Lopes S, Perin J, Prass T, Carvalho S, Lessa S, Dórea J. Adverse events following immunization in Brazil: age of child and vaccine-associated risk analysis using logistic regression. International Journal of Environmental Research and Public Health. 2018;15(6):1149. doi:10.3390/ijerph15061149.
  • DuVernoy TS, Braun MM, Group tVW. Hypotonic–hyporesponsive episodes reported to the vaccine adverse event reporting system (VAERS), 1996–1998. Pediatrics. 2000;106(4):52. doi:10.1542/peds.106.4.e52.
  • Sittlejohn L, Clothier H, Perrett K, Danchin M. Surveillance of adverse events following the introduction of 13-valent pneumococcal conjugate vaccine in infants, and comparison with adverse events following 7-valent pneumococcal conjugate vaccine, in Victoria, Australia. Human Vaccines & Immunotherapeutics. 2015;11(7):1828–35. doi:10.1080/21645515.2015.1048937.
  • Moro P, Perez-Vilar S, Lewis P, Bryant-Genevier M, Kamiya H, Cano M. Safety surveillance of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines. Pediatrics. 2018;1:142.
  • Department of Vaccines and Biologicals. Supplementary information on vaccine safety. Part 2 background rates of adverse events following immunization. WHO, editor; 2000.
  • Eichenwald E. Apnea of prematurity. Pediatrics. 2016 Jan 1;137(1):e20153757. doi:10.1542/peds.2015-3757.
  • Hoffman KB, Dimbil M, Erdman CB, Tatonetti NP, Overstreet BM, Weber T. Effect and the United States food and drug administration’s adverse event reporting system (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. Drug Saf. 2014;37(4):283–94. doi:10.1007/s40264-014-0150-2.