CARPHA Member States include low- and middle- income economies that have been hard hit by the global pandemic. With the receipt and deployment of various COVID-19 vaccines, regulators are faced with questions about the speed of vaccine development, and safety of vaccines received through various procurement mechanisms. The WHO’s process for the assessment of COVID-19 vaccines is summarized in a report of its technical advisory group, and shared publicly via the Emergency Use Listing (EUL) website. The CARPHA Caribbean Regulatory System (CRS) reviews the dossier shared by WHO, and produces a technical report to its regulatory focal points and Chief Medical Officers to help expedite decisions of registration and/or procurement. As of 26th April, the CARPHA CRS reviewed and recommended 4 of the 5 vaccines listed for emergency use by the WHO, and has recognized the need to help Member States navigate the technical summaries of the recommended COVID-19 vaccines, along with safety and efficacy information provided to WHO.
The WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization periodically reviews information from clinical trials, post-marketing studies, and observational studies to update its recommendations for the use of COVID-19 vaccines, primarily those approved for EUL by the WHO. These recommendations are periodically updated as new evidence emerges. This webinar aims to help regulatory focal points and other stakeholders understand the indicators of quality, safety and efficacy assessed by the WHO and reviewed by the CRS for COVID-19 vaccines by AstraZeneca and Pfizer-BioNTech, and the related SAGE recommendations that will assist health administrators in the deployment and monitoring of the vaccines.