Loading...
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America
can der Zee, Ivar T. Vreman, Rick A. Alanis Garza, Mario
can der Zee, Ivar T.
Vreman, Rick A.
Alanis Garza, Mario
Citations
Altmetric:
Genre
Journal article
Date
2022-08-18
Advisor
Committee member
Group
Department
Pharmaceutical Sciences
Permanent link to this record
Collections
Research Projects
Organizational Units
Journal Issue
DOI
https://doi.org/10.26633/rpsp.2022.115
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.
Description
Citation
van der Zee IT, Vreman RA, Liberti L, Garza MA. Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America. Rev Panam Salud Publica. 2022;46:e115. https://doi.org/10.26633/ RPSP.2022.115
Citation to related work
World Health Organization
Has part
Pan American Journal of Public Health, Vol. 46
ADA compliance
For Americans with Disabilities Act (ADA) accommodation, including help with reading this content, please contact scholarshare@temple.edu