Source: European Parliament
1. As the Commission noted in its reply to Question E-003117/2023[1], ‘the European Medicines Agency (EMA) and national authorities evaluate data on reported events in EudraVigilance[2] to determine if there is any signal indicating causality and take action as appropriate’. EMA and national authorities closely monitor emerging data and will take regulatory action if new evidence indicates any causal relationship.
2. The Commission relies on EMA to continuously monitor the COVID-19 vaccine safety assessing all available data, including EudraVigilance reports, scientific literature, and studies[3]. EMA has reviewed the study mentioned in the Honourable Member’s letter and concluded that, given the methodological limitations of the study- which was withdrawn from a scientific journal because of serious concerns about its quality- considers no action necessary at this stage.
3. The Commission considers safety a core requirement for all vaccines. COVID-19 vaccines used in the EU have undergone EMA’s rigorous scientific assessment. Information on risks, including rare side effects, are publicly available in resources such as product information[4], the European Public Assessment Reports[5], and periodic safety update reports (PSURs)[6], which are regularly updated to keep healthcare professionals and patients informed. When necessary to ensure vaccine safety regulatory actions are taken in accordance with the applicable legislation.
- [1] https://www.europarl.europa.eu/doceo/document/E-9-2023-003117-ASW_EN.html
- [2] https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance
- [3] https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pharmacovigilance-marketing-authorisation/risk-management/risk-management-plans
- [4] https://ec.europa.eu/health/documents/community-register/html/index_en.htm
- [5] https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when/european-public-assessment-reports-background-context
- [6] https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs