Background: Current real-world evidence (RWE) of vaccines, both pre- and post-licensing, is mainly produced in high income countries despite many vaccine-preventable infectious diseases primarily being represented in low and middle-income countries (LMICs). Consequently, RWE on safety and effectiveness of vaccines for these diseases needs to be generated in LMICs where there is disease burden. In LMICs, RWE generation has been restricted by limited guidance, diversity of health care systems and regulators, and the lack of established systems to collect real-world data (RWD) in some settings. This symposium focuses on pharmacoepidemiology and the critical global issue of RWE generation in LMIC settings
Objectives: Describe the existing state of RWE and RWD generation for vaccines and antibody product development in LMICs and provide recommendations for future RWE research for vaccines in LMICs.
Description: 1. Introduction & Background – Speaker: Suzanna Francis
Current vaccine challenges, World Health Organization priorities for research and development with a concentration in LMICs. Providing a high level overview of current real-world research in LMIC. Reflection on RWE generation for COVID-19 vaccines in LMIC.
2. Overview of study designs for vaccine development and post-licensure – Speaker: Karin de Haart
Present study designs to generate evidence on vaccines pre-licensure and post-licensure; for both safety and effectiveness.
3. Overview of current RWD and RWE in LMIC (select countries) – Speaker: Carly Rodriguez
For selected (African) counties, describe the current available regulatory guidance and available RWD sources. Reflecting on challenges and opportunities with RWD. Describe examples of RWE on vaccines from LMIC (e.g. MPOX, Marburg, Ebola). Highlight health care provider and patient perspectives on vaccine research, both observational and interventional. Present Challenges and opportunities for primary data collection for RWE generation in LMIC.
4. Opportunities for RWE in LMIC for vaccines – Speaker: Suzanna Francis
Present considerations for future study designs and operational approaches to RWE generation to optimize success in LMIC. Highlight existing collaborations with regulators and government authorities (public engagement, infrastructure, Improving data and research quality)
