Building capacity for systems biology analysis of adverse events following COVID-19 vaccination in low- and middle-income countries

The development of safe and effective vaccines is helping to control COVID-19. Though benefits of vaccination outweigh risks, rare, serious adverse events have been reported after vaccine introduction in North America and Europe. One example is thrombosis with thrombocytopenia syndrome (TTS) associated with COVID-19 vaccines produced by AstraZeneca and Janssen. Patients develop blood clots, low platelets and bleeding that can be fatal. Safety concerns may slow vaccine uptake, particularly in low- and middle-income countries (LMICs) where these vaccines may be the only option available. It is important to understand what causes serious adverse events like TTS and who might be at risk to ensure the safety of COVID-19 vaccines. Systems biology involves detailed analysis of DNA, RNA, proteins and other molecules. Patterns in these molecules can be compared between patients with adverse events and healthy people to provide information into how vaccination may cause adverse events. A challenge to applying system biology technologies to study very rare adverse events like TTS (which occurs in 1-2 per 100,000 people) is identifying enough patients from different backgrounds with the condition. This study aims to address this gap by building partnerships with physicians and public health in LMICs to identify and recruit patients with rare adverse events, collect data and samples. This will allow us to apply systems biology to learn about the causes of adverse events from patients around the world. This research will help to make vaccines even safer in the future. The study lead, Dr. Top is a physician and expert in vaccine safety who co-leads an international network of experts in vaccine safety and systems biology. She will work with the Brighton Collaboration, a global organization focused on vaccine safety evaluation on this project. Dr. Top's expertise, experience, and collaborations with systems biology experts will ensure the success of this project.