Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America
Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determine...
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ftdoajarticles:oai:doaj.org/article:1da238bafa3f4166b3fe1a754b4fa907 2023-05-15T15:08:15+02:00 Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America Ivar T. van der Zee Rick A. Vreman Lawrence Liberti Mario Alanis Garza 2022-08-01T00:00:00Z https://doi.org/10.26633/RPSP.2022.115 https://doaj.org/article/1da238bafa3f4166b3fe1a754b4fa907 EN ES PT eng spa por Pan American Health Organization https://iris.paho.org/handle/10665.2/56287 https://doaj.org/toc/1020-4989 https://doaj.org/toc/1680-5348 1020-4989 1680-5348 doi:10.26633/RPSP.2022.115 https://doaj.org/article/1da238bafa3f4166b3fe1a754b4fa907 Revista Panamericana de Salud Pública, Vol 46, Iss 115, Pp 1-7 (2022) regulatory frameworks covid-19 health priorities latin america global health drug approval covid-19 vaccines drug utilization review Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2022 ftdoajarticles https://doi.org/10.26633/RPSP.2022.115 2022-12-30T22:13:35Z Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Revista Panamericana de Salud Pública 46 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English Spanish Portuguese |
topic |
regulatory frameworks covid-19 health priorities latin america global health drug approval covid-19 vaccines drug utilization review Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
regulatory frameworks covid-19 health priorities latin america global health drug approval covid-19 vaccines drug utilization review Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Ivar T. van der Zee Rick A. Vreman Lawrence Liberti Mario Alanis Garza Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
topic_facet |
regulatory frameworks covid-19 health priorities latin america global health drug approval covid-19 vaccines drug utilization review Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency. |
format |
Article in Journal/Newspaper |
author |
Ivar T. van der Zee Rick A. Vreman Lawrence Liberti Mario Alanis Garza |
author_facet |
Ivar T. van der Zee Rick A. Vreman Lawrence Liberti Mario Alanis Garza |
author_sort |
Ivar T. van der Zee |
title |
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
title_short |
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
title_full |
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
title_fullStr |
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
title_full_unstemmed |
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America |
title_sort |
regulatory reliance pathways during health emergencies: enabling timely authorizations for covid-19 vaccines in latin america |
publisher |
Pan American Health Organization |
publishDate |
2022 |
url |
https://doi.org/10.26633/RPSP.2022.115 https://doaj.org/article/1da238bafa3f4166b3fe1a754b4fa907 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista Panamericana de Salud Pública, Vol 46, Iss 115, Pp 1-7 (2022) |
op_relation |
https://iris.paho.org/handle/10665.2/56287 https://doaj.org/toc/1020-4989 https://doaj.org/toc/1680-5348 1020-4989 1680-5348 doi:10.26633/RPSP.2022.115 https://doaj.org/article/1da238bafa3f4166b3fe1a754b4fa907 |
op_doi |
https://doi.org/10.26633/RPSP.2022.115 |
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Revista Panamericana de Salud Pública |
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46 |
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