COVID-19 vaccines: Post-authorisation safety surveillance

Though the COVID-19 pandemic is now over, work remains ongoing to monitor vaccine effectiveness against genetic variants, the evolving safety profile and the long-term safety of vaccine use by way of post-authorisation safety surveillance (PASS). A key challenge relating to these studies is the acquisition, interrogation and assessment of the vast volumes of data to ensure the most accurate and up-to-date information is available so conclusions can be reached, and appropriate actions taken.

With several PASS studies underway in the US and Europe, we are generating a clearer picture of the long-term health impacts posed by the COVID-19 pandemic, including the nuances between long COVID and potential vaccine side effects.

Download our whitepaper to learn more about:

• The challenges associated with monitoring COVID-19 (COVID) vaccine safety in light of the accelerated approval, and the difficulty in distinguishing between vaccine side effects and long COVID symptoms
• Available assessment methods and numerous post-authorisation safety surveillance methods employed to capture good quality data, as well as the challenge of assessing the large volume of associated data to generate critical insights
• How business intelligence tools like ICON’s SIGNET can benefit improved data visualisation and reporting, faster processing and analysis, and improved decision-making
• The clinician’s perspective based on experience with the types of side effects reported by patients and the complications of long COVID in determining what is a true vaccine side-effect