P-13 A Systematic Comparison of COVID-19 Products with Regulatory Endorsement in the Caribbean Community and Major Markets
Author(s):
T. R. Austin, J. L. Austin
Year of Presentation:
2023
Objective: This work was intended to examine the products with regulatory endorsement in major pharmaceutical markets in comparison to the Caribbean Community (CARICOM) for the treatment or prevention of Coronavirus Disease (COVID-19).
Methods: For this analysis, major pharmaceutical markets were represented by the 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)-founding entities (European Union, Japan, and the United States). Recommendation by the Caribbean Public Health Agency (CARPHA)-Caribbean Regulatory System (CRS) was selected as the representation of regulatory endorsement in CARICOM. A systematic review of public listings was conducted to quantitate, chronologically assess, and classify COVID-19 vaccines and medicines approved by these ICH-founding entities in comparison to those recommended by the CARPHA-CRS for CARICOM Member States.
Results: Japan approved 17 COVID-19 products; 16 products were approved in the EU and 11 products in the US. In contrast, there were 6 distinct products with CRS recommendations for CARICOM. On average for vaccine products, the CARICOM regulatory endorsement occurred approximately 83 days after the earliest ICH endorsement.
Conclusion: The total number of distinct COVID-19 products with regulatory endorsement in CARICOM represented a reasonable portion of the total number of products approved in ICH countries. Overall, CARPHA-CRS made timely recommendations for CARICOM during the COVID-19 pandemic, signifying its value for preparing the region for future public health emergencies.