Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

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.

Procedimiento de autorización de las vacunas contra la COVID-19: Estados Unidos de América, Unión Europea y América Latina

“…(49) La mayoría de ARNs de América Latina, especialmente las que no son consideradas de referencia regional, utilizaron este mecanismo, tal como se muestra en la Tabla 2. Esta observación es similar a lo señalado en el estudio de Van der Zee et al (50) Además, en este punto debemos señalar que países como Brasil, Chile y Honduras, que antes de la pandemia no aceptaban ninguna forma de dependencia para la emisión de una autorización de comercialización (51) , emitieron normativas relacionadas a este mecanismo de autorización en el contexto de pandemia de la COVID-19 (ver Tabla 2).…”

“…En cuanto al tiempo de evaluación empleado para este mecanismo (reliance) por parte de las ARNs, se tiene un valor medio de 15 días. (50) Es importante destacar que las ARNs que recurren a las decisiones de otra siguen siendo responsables de las decisiones adoptadas y debe rendir cuenta de ellas. (43) Tabla 2.…”