Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model

Autores
Marin, Gustavo Horacio; Medrano, L.; Marin, Gustavo Horacio; Rolla, J. B.; Marin, L.; Carlson, S.; Martínez, F.; Nelson, A.
Año de publicación
2022
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: To measure vaccination`s risks it exists the term “events supposedly attributed to vaccination or immunization”(ESAVI). ESAVI monitoring usually consist in passive surveillance based on voluntary notifications done either by beneficiariesor by health professionals. The spontaneous reports are scarce compared with active surveillance. Unfortunately; activemethods performed by health service are expensive, laborious and unfeasible due to the few health personnel available.Objective: to evaluate the efficacy of an active method for ESAVI reports associated to COVID19- vaccines performed byuniversity students.Methods: a research comparing two Pharmacovigilance methods for COVID-19-ESAVI was performed (passive vs activesurveillance with participation of university students) from May to September 2021.Results: At the end of the study period, in Argentina 52.786.324 anti-COVID-19 vaccines were applied (1st dose 56, 86%; 2nddose 43, 14%), and 102.358 ESAVIs were validated (1st dose 74, 75%; 2nd dose 23, 96%; other dose 0, 5%; No data 1, 24); 2,16% among them were considered severe. Although female/male vaccination/ratio was similar (50.31% vs 49.67%), ESAVIwere much more reported by females (72.8%). The active pharmacovigilance experience was performed by 933 students-volunteers. They contacted 56,824 vaccinated people; obtaining 39,952 “positive” calls (either “no events” or “potential ESAVI”results). The monthly contacts performed by students were 14,206±1124; among them, 1186±436 calls were “refused”, whilein 3,032±741 cases existed wrong phone number. From 6.652 potential ESAVI reported; 1,037 were validated, which means1.82% of vaccinated people contacted, certainly a better result than the 0.121%obtained by passive reports (p <0.0001).Conclusion: An active method of pharmacovigilance performed by health students was able to increase 15 times the validatedESAVI reports after COVID-19 vaccination.
Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
Fil: Medrano, L.. No especifíca;
Fil: Marin, Gustavo Horacio. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina
Fil: Rolla, J. B.. No especifíca;
Fil: Marin, L.. No especifíca;
Fil: Carlson, S.. No especifíca;
Fil: Martínez, F.. No especifíca;
Fil: Nelson, A.. No especifíca;
Materia
COVID-19
Vaccines
ESAVI
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/241054

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network_acronym_str CONICETDig
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network_name_str CONICET Digital (CONICET)
spelling Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance ModelMarin, Gustavo HoracioMedrano, L.Marin, Gustavo HoracioRolla, J. B.Marin, L.Carlson, S.Martínez, F.Nelson, A.COVID-19VaccinesESAVIhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3Background: To measure vaccination`s risks it exists the term “events supposedly attributed to vaccination or immunization”(ESAVI). ESAVI monitoring usually consist in passive surveillance based on voluntary notifications done either by beneficiariesor by health professionals. The spontaneous reports are scarce compared with active surveillance. Unfortunately; activemethods performed by health service are expensive, laborious and unfeasible due to the few health personnel available.Objective: to evaluate the efficacy of an active method for ESAVI reports associated to COVID19- vaccines performed byuniversity students.Methods: a research comparing two Pharmacovigilance methods for COVID-19-ESAVI was performed (passive vs activesurveillance with participation of university students) from May to September 2021.Results: At the end of the study period, in Argentina 52.786.324 anti-COVID-19 vaccines were applied (1st dose 56, 86%; 2nddose 43, 14%), and 102.358 ESAVIs were validated (1st dose 74, 75%; 2nd dose 23, 96%; other dose 0, 5%; No data 1, 24); 2,16% among them were considered severe. Although female/male vaccination/ratio was similar (50.31% vs 49.67%), ESAVIwere much more reported by females (72.8%). The active pharmacovigilance experience was performed by 933 students-volunteers. They contacted 56,824 vaccinated people; obtaining 39,952 “positive” calls (either “no events” or “potential ESAVI”results). The monthly contacts performed by students were 14,206±1124; among them, 1186±436 calls were “refused”, whilein 3,032±741 cases existed wrong phone number. From 6.652 potential ESAVI reported; 1,037 were validated, which means1.82% of vaccinated people contacted, certainly a better result than the 0.121%obtained by passive reports (p <0.0001).Conclusion: An active method of pharmacovigilance performed by health students was able to increase 15 times the validatedESAVI reports after COVID-19 vaccination.Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; ArgentinaFil: Medrano, L.. No especifíca;Fil: Marin, Gustavo Horacio. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; ArgentinaFil: Rolla, J. B.. No especifíca;Fil: Marin, L.. No especifíca;Fil: Carlson, S.. No especifíca;Fil: Martínez, F.. No especifíca;Fil: Nelson, A.. No especifíca;MedWin Publishers2022-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/241054Marin, Gustavo Horacio; Medrano, L.; Marin, Gustavo Horacio; Rolla, J. B.; Marin, L.; et al.; Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model; MedWin Publishers; Epidemiology International Journal; 6; 1; 2-2022; 225-2292639-2038CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://medwinpublishers.com/EIJ/covid-19-vaccination-advantages-of-opting-for-an-active-pharmacovigilance-model.pdfinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:55:21Zoai:ri.conicet.gov.ar:11336/241054instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:55:21.96CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
title Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
spellingShingle Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
Marin, Gustavo Horacio
COVID-19
Vaccines
ESAVI
title_short Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
title_full Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
title_fullStr Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
title_full_unstemmed Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
title_sort Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model
dc.creator.none.fl_str_mv Marin, Gustavo Horacio
Medrano, L.
Marin, Gustavo Horacio
Rolla, J. B.
Marin, L.
Carlson, S.
Martínez, F.
Nelson, A.
author Marin, Gustavo Horacio
author_facet Marin, Gustavo Horacio
Medrano, L.
Rolla, J. B.
Marin, L.
Carlson, S.
Martínez, F.
Nelson, A.
author_role author
author2 Medrano, L.
Rolla, J. B.
Marin, L.
Carlson, S.
Martínez, F.
Nelson, A.
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv COVID-19
Vaccines
ESAVI
topic COVID-19
Vaccines
ESAVI
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: To measure vaccination`s risks it exists the term “events supposedly attributed to vaccination or immunization”(ESAVI). ESAVI monitoring usually consist in passive surveillance based on voluntary notifications done either by beneficiariesor by health professionals. The spontaneous reports are scarce compared with active surveillance. Unfortunately; activemethods performed by health service are expensive, laborious and unfeasible due to the few health personnel available.Objective: to evaluate the efficacy of an active method for ESAVI reports associated to COVID19- vaccines performed byuniversity students.Methods: a research comparing two Pharmacovigilance methods for COVID-19-ESAVI was performed (passive vs activesurveillance with participation of university students) from May to September 2021.Results: At the end of the study period, in Argentina 52.786.324 anti-COVID-19 vaccines were applied (1st dose 56, 86%; 2nddose 43, 14%), and 102.358 ESAVIs were validated (1st dose 74, 75%; 2nd dose 23, 96%; other dose 0, 5%; No data 1, 24); 2,16% among them were considered severe. Although female/male vaccination/ratio was similar (50.31% vs 49.67%), ESAVIwere much more reported by females (72.8%). The active pharmacovigilance experience was performed by 933 students-volunteers. They contacted 56,824 vaccinated people; obtaining 39,952 “positive” calls (either “no events” or “potential ESAVI”results). The monthly contacts performed by students were 14,206±1124; among them, 1186±436 calls were “refused”, whilein 3,032±741 cases existed wrong phone number. From 6.652 potential ESAVI reported; 1,037 were validated, which means1.82% of vaccinated people contacted, certainly a better result than the 0.121%obtained by passive reports (p <0.0001).Conclusion: An active method of pharmacovigilance performed by health students was able to increase 15 times the validatedESAVI reports after COVID-19 vaccination.
Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
Fil: Medrano, L.. No especifíca;
Fil: Marin, Gustavo Horacio. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina
Fil: Rolla, J. B.. No especifíca;
Fil: Marin, L.. No especifíca;
Fil: Carlson, S.. No especifíca;
Fil: Martínez, F.. No especifíca;
Fil: Nelson, A.. No especifíca;
description Background: To measure vaccination`s risks it exists the term “events supposedly attributed to vaccination or immunization”(ESAVI). ESAVI monitoring usually consist in passive surveillance based on voluntary notifications done either by beneficiariesor by health professionals. The spontaneous reports are scarce compared with active surveillance. Unfortunately; activemethods performed by health service are expensive, laborious and unfeasible due to the few health personnel available.Objective: to evaluate the efficacy of an active method for ESAVI reports associated to COVID19- vaccines performed byuniversity students.Methods: a research comparing two Pharmacovigilance methods for COVID-19-ESAVI was performed (passive vs activesurveillance with participation of university students) from May to September 2021.Results: At the end of the study period, in Argentina 52.786.324 anti-COVID-19 vaccines were applied (1st dose 56, 86%; 2nddose 43, 14%), and 102.358 ESAVIs were validated (1st dose 74, 75%; 2nd dose 23, 96%; other dose 0, 5%; No data 1, 24); 2,16% among them were considered severe. Although female/male vaccination/ratio was similar (50.31% vs 49.67%), ESAVIwere much more reported by females (72.8%). The active pharmacovigilance experience was performed by 933 students-volunteers. They contacted 56,824 vaccinated people; obtaining 39,952 “positive” calls (either “no events” or “potential ESAVI”results). The monthly contacts performed by students were 14,206±1124; among them, 1186±436 calls were “refused”, whilein 3,032±741 cases existed wrong phone number. From 6.652 potential ESAVI reported; 1,037 were validated, which means1.82% of vaccinated people contacted, certainly a better result than the 0.121%obtained by passive reports (p <0.0001).Conclusion: An active method of pharmacovigilance performed by health students was able to increase 15 times the validatedESAVI reports after COVID-19 vaccination.
publishDate 2022
dc.date.none.fl_str_mv 2022-02
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/241054
Marin, Gustavo Horacio; Medrano, L.; Marin, Gustavo Horacio; Rolla, J. B.; Marin, L.; et al.; Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model; MedWin Publishers; Epidemiology International Journal; 6; 1; 2-2022; 225-229
2639-2038
CONICET Digital
CONICET
url http://hdl.handle.net/11336/241054
identifier_str_mv Marin, Gustavo Horacio; Medrano, L.; Marin, Gustavo Horacio; Rolla, J. B.; Marin, L.; et al.; Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model; MedWin Publishers; Epidemiology International Journal; 6; 1; 2-2022; 225-229
2639-2038
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://medwinpublishers.com/EIJ/covid-19-vaccination-advantages-of-opting-for-an-active-pharmacovigilance-model.pdf
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv MedWin Publishers
publisher.none.fl_str_mv MedWin Publishers
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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