Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.
Rev Panam Salud Publica
; 46: e115, 2022.
Article
in English
| MEDLINE | ID: covidwho-2026378
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Type of study:
Observational study
/
Prognostic study
Topics:
Vaccines
Language:
English
Journal:
Rev Panam Salud Publica
Journal subject:
Public Health
Year:
2022
Document Type:
Article
Affiliation country:
RPSP.2022.115
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