ArticleRevista panamericana de salud publica = Pan American journal of public health2022
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.
Article in Revista panamericana de salud publica = Pan American journal of public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Article
- Strengthening Vaccine Regulation: Insights from COVID-19 Vaccines, Best Practices, and Lessons for Future Public Health Emergencies.Vaccines · 2025Article
- A scoping review of authorisation pathway for COVIDJournal of pharmaceutical policy and practice · 2025Article
- [The role of regulatory agencies within health systems during emergencies in BrazilPapel de los organismos regulatorios en los sistemas de salud en situaciones de emergencia en Brasil].Revista panamericana de salud publica = Pan American journal of public health · 2024Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
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