Clinical Development and Operations - Maternal Imm.
SWAT Team Description: The Clinical Development and Operations SWAT team collaborates on initiatives related to clinical operations (incl. supporting trial site readiness and setting up a clinical trial site network, providing information on COVID-19 CTA and EC requirements for specific regions), vaccine safety (incl. AESIs / case definitions, post roll-out vaccine safety surveillance), vaccine science (incl. development of strategic documents on key topics such as standard CT elements, adaptive trial design, Correlate of Protection, alternative/supportive evidence, optimization options) and maternal immunization.
The COVAX MI WG, co-chaired by Drs. Flor M. Munoz (Baylor College of Medicine, USA) and Ros Hollingsworth (Bill & Melinda Gates Foundation, USA) includes a group of professionals with expertise in various aspects pertinent to maternal immunization, who represent diverse organizations, geographies, and settings. The aim of the MIWG is to enable the evaluation and utilization of COVID-19 vaccine candidates in pregnant and lactating women.