Regulatory reliance pathways during health emergencies
Enabling timely authorizations for Covid-19 vaccines in Latin America
Dados Bibliográficos
| ID | 14968166 |
|---|---|
| Autores | Ivar T van der Zee (0000-0003-1149-8177, Utrecht University, autor correspondente), Rick A Vreman (0000-0002-2076-322X, Utrecht University), Lawrence Liberti (0000-0003-3815-1165, [email protected]), Mario Alanis Garza (Centre for Innovation in Regulatory Science) |
| Ano | 2022 |
| Volume | 46 |
| Páginas | 1 |
| Data de publicação | 2022-08-30 |
| Peer Reviewed | Sim |
| Open Access | Sim |
| Tipo | ARTICLE |
| Periódico | Revista Panamericana de Salud Pública (JOURNAL) |
| Identificadores do periódico | ISSN: 1020-4989 • E-ISSN: 1680-5348 |
| Editora | Pan American Health Organization (PUBLISHER • US) |
| DOI | 10.26633/rpsp.2022.115 |
| PMID | 36060200 |
| OpenAlex | W4293579595 |
| Idioma | EN |
| Citações recebidas | 1 |
| Referências citadas | 9 |
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
Authorization · Business · Computer security · Coronavirus disease 2019 (COVID-19 · Latin Americans · Political science · Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 · Computer Science · COVID-19 epidemiological studies · Law · Medicine · SARS-CoV-2 and COVID-19 Research · Vaccine Coverage and Hesitancy · Internal Medicine
| Obras citantes distintas | 1 |
|---|---|
| Citações por ano | 0,5 |
| Intervalo de citações | 2024 - 2024 (1) |
| Velocidade de citação | recent |
| Altamente citado | Não |
| Tipos de citação | Neutras: 1 |