Objective
To evaluate the post-pandemic regulatory preparedness of countries of the Region of the Americas for emergency authorization of vaccines as of August 2024 and propose recommendations for future public health emergencies.
Methods
Special report describing the mechanisms for emergency use authorization of vaccines established in the regulatory frameworks of Latin American and English-speaking Caribbean countries.
Results
Most of the countries (64%) included in this analysis did not make any changes in their regulations for emergency situations following the COVID-19 pandemic. Special import permits constitute the most common established mechanism for emergency authorization (82%). Regulatory reliance-based mechanisms were found in a minority of countries (32%), as were emergency use authorization, provisional marketing authorization, or fast-track registration mechanisms (23%). Only reliance-based mechanisms were found to use risk criteria based on the source from which vaccines were obtained.
Conclusions
This analysis reflects the need to strengthen the Region’s regulatory systems to address future public health emergencies and facilitate access to necessary vaccines. Furthermore, regulatory systems should adopt a regulatory approach based on risk criteria, with distinct procedures and requirements, as well as strengthen cooperation with other National Regulatory Authorities (NRAs) at the regional and global levels, to achieve greater regulatory efficiency.