Adverse reactions associated to VA-MENGOCC-BC antimeningococcal vaccine
Keywords:
BC MENINGOCOCCAL VACCINEAbstract
Background. The first massive vaccination campaign with VA-MENGOCC-BCR antimeningococcal vaccine in Uruguay was set up in December 2001. In Santa Lucía city (Canelones) 5 366 children and youths were vaccinated. The vaccine is thought to be harmless, main adverse reactions recorded are local.
Objective. To determine the prevalence and types of adverse reactions associated to VA-MNGOCC-BCR antimeningococcal vaccines in this population.
Method. A sample of 744 children were randomly assigned to the study. Adverse reactions were recorded after the first and the second dosage by personal interview or by phone 30 days later than dosages.
Results. Among the 744 children, 728 were assessed (98%). Adverse reactions were seen in 53% (IC95 53% + 3,6): 30% after the first intake, 5% after the second and 18% between the first and the second dosage. Adverse reactions were not seen in 47% (IC95 47% + 3,6). Among the 659 recorded adverse reactions, 71% were local and 29% systemic. Pain was the most frequent local adverse reaction, fatigue was the most frequent systemic adverse reaction.
Conclusion. The prevalence of adverse reactions in this population was 53% (IC95 53% + 3,6). There were no severe adverse reactions. Results are coincident with other series.
References
2) González Sierra G. Informe Instituto Finlay. La Habana: Instituto Finlay, 1993.
3) Martínez Torres E, Leguén Castillo F. La enfermedad meningocócica: un problema mundial que comienza a tener solución. Rev Cub Pediatr 1993; 65(1): 63-72.
4) Pírez MC, Picón T, Galazka J, Quian J, Gutiérrez S, Ferrari AM et al. Enfermedad meningocócica en Uruguay. Informe epidemiológico y recomendaciones, mayo 2002. Rev Med Urug 2002; 18(1): 83-8.
5) Gaivironsky R, Polack N. Reacciones secundarias a la administración de la primera dosis de vacuna antimeningocóccica BC. Resultados de una encuesta sobre 2000 niños. Rev Hosp Niños Bs As 1994; 34: 255.
6) Díaz Legaspe A. Informe sobre el Programa de Vacunación Antimeningocóccica de la Provincia de Buenos Aires. Rev Hosp Niños Bs As 1994; 36(158/159): 257-9.
7) Debbag R, Rüttimann R, Stamboulian D. Evaluación de las reacciones adversas asociadas con la vacuna antimeningocóccica BC. Informe preliminar sobre 8.177 vacunados. Rev Hosp Niños Bs As 1994; 36(158/159):249-54.
8) De Cicco LT, Kataife F, Bernardez V, Talamoni H, Altuna D, Musante G, et al. Efectos adversos asociados a la administración de la vacuna antimeningocóccica BC. Arch Arg Pediatr 1995; 93: 245-53.
9) Karch FE, Lasagna L. Adverse drug reactions: a critical review. JAMA 1975; 234: 1236-41.
10) Lepow ML, Perkins BA, Hughes PA, Poolman JT. Meningococcal Vaccines. In: Plotkin SA, Oreintein WA. Vaccines, 3ª ed. Philadelphia: Saunders, 1999.
11) Asociación Americana de Infectología. Asociación Española de Pediatría. Sociedad Latinoamericana de Pediatría. Vacunación contra el meningocco. In: Manual de Vacunas en Pediatría. 2ª ed. Méxocp: Latinoamericana, 2000: 165-77.
12) Esteban Calvo C, Francés Foz M, Frías Iniesta J. Farmacovigilancia. Medicine 1995; 6(91): 4037-44.
13) Uppsala Monitoring Centre, World Health Organiza-tion. Collaborating Centre for International Drug Monitoring. Vigilancia de la seguridad de los medicamentos. Guía para la instalación y puesta en funcionamiento de un Centro de Farmacovigilancia. Geneva: UMC, 2001.
14) Organización Panamericana de la Salud. Oficina Regional de la Organización Mundial de la Salud. División de Vacunas e Inmunización. Vacunación segura: Cómo enfrentar los eventos supuestamente atribuidos a la vacunación o inmunización. Washington: OPS, 2002.
15) Halsey NA. The Science of Evaluation of Adverse Events Associated with Vaccination. Semin Pediatr Infect Dis 2002; 13(3): 205-14.