International Network of Special Immunization Services (INSIS)
Rare adverse events following immunization (AEFIs) occurring in <1 per 10,000 vaccine recipients may not be detected in prelicensure clinical trials. The success of mass COVID-19 immunization programs depends upon establishing and maintaining confidence in the safety of COVID-19 vaccines through augmented surveillance and research.
The purpose of INSIS is to address knowledge gaps in our understanding of the causes of adverse events of special interest (AESIs), risk factors for developing AESIs, and determine the best way to immunize individuals with prior AESIs or risk factors for developing AESIs. While the initial focus will be on AESIs following COVID-19 vaccination, INSIS’s mandate can be broadened to other vaccines in the future. INSIS has three main objectives:
- Develop a platform of international experts to advise stakeholders and support the response to AESIs after COVID-19 vaccines
- Develop harmonized, evidence-based guidelines for the investigation and management of patients with AESIs after COVID-19 vaccines
- To establish a research platform to interrogate the pathogenesis of, and identify biomarkers for AESIs following COVID-19 vaccination.
As of January 2021 INSIS is working to determine the mechanism and allergens associated with immediate hypersensitivity following SARS-CoV-2 vaccination and define criteria for patients at low risk of recurrent hypersensivity reactions after revaccination. Understanding how SARS-CoV-2 vaccines trigger severe immediate hypersensitivity or anaphylaxis is critical to improving the safety and tolerability of future SARS-CoV-2 vaccines.