Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America
Rev Panam Salud Publica
; 46, ago. 2022
Article
em En
| PAHOIRIS
| ID: phr-56287
Biblioteca responsável:
US1.1
ABSTRACT
[ABSTRACT]. 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.
Texto completo:
1
Coleções:
04-international_org
Base de dados:
PAHOIRIS
Assunto principal:
Saúde Global
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Aprovação de Drogas
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Revisão de Uso de Medicamentos
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Marcos Regulatórios em Saúde
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Vacinas contra COVID-19
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COVID-19
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Prioridades em Saúde
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América Latina
Tipo de estudo:
Observational_studies
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Prognostic_studies
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article