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Prior to deployment of COVID-19 vaccines in the European Union (EU) in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports and real-world evidence, was anticipated. The European Medicines Agency (EMA) implemented specific activities to ensure enhanced monitoring of emerging vaccine safety information, including intensive monitoring of reports of adverse events of special interest (AESIs) and the use of observed-to-expected (O/E) analyses. EMA also commissioned several independent observational studies using a large network of electronic healthcare databases and primary data collection via mobile and web-based applications. This preparedness was key for two high-profile safety signals: thrombosis with thrombocytopenia syndrome (TTS), a new clinical entity associated with adenovirus-vectored vaccines, and myocarditis/pericarditis with messenger RNA (mRNA) vaccines. With no existing case definition nor background rates, the signal of TTS posed particular challenges. Nevertheless, it was rapidly identified, evaluated, contextualised and the risk minimised thanks to close surveillance and an efficient use of available evidence, clinical expertise and flexible regulatory tools. The two signals illustrated the complementarity between spontaneous and real-world data, the former enabling rapid risk identification and communication, the latter enabling further characterisation. The COVID-19 pandemic has tremendously enhanced the development of tools and methods to harness the unprecedented volume of safety data generated for the vaccines. Areas for further improvement include the need for better and harmonised data collection across Member States (e.g., stratified vaccine exposure) to support signal evaluation in all population groups, risk contextualisation and safety communication. |
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