Challenge
There is an urgent need to support the COVAX Vaccine Safety working Group (VSWG), supported by CEPI, and the WHO- Pharmacovigilance team (WHO-PV), in collating the studies evaluating the safety of COVID-19 vaccines globally to inform strategy and policy. Several rare severe adverse events have already been observed with commonly used Covid-19 vaccines. The ability to assess their occurrence in all Covid-19 vaccines and to detect other unknown and unexpected serious adverse events (SAEs) is critical to understanding the risks associated with Covid-19 vaccine use globally. A landscape assessment of safety studies is needed to understand all the potential sources of evidence and to identify gaps that may need to be filled by targeted assessments.
Approach
To create a repository of published, planned and ongoing COVID-19 vaccine safety studies, literature reviews and a survey are being conducted to identify efforts globally and to identify gaps in safety assessment. Observational studies of routine vaccine use are included (i.e., does not include clinical trials). Data tracked include the vaccine used, population, study design, study status, country. Results will be made publicly available on VIEW-Hub.org.
Results
The survey showed that efforts to assess safety are planned or underway in all regions globally and include a wide variety of populations (i.e., pregnant women, children, older adults, etc.). A parallel literature review of published vaccine safety assessments shows results from some of these.
