Source: European Parliament
The authorisation of COVID-19 vaccines is based on a thorough scientific assessment by the European Medicines Agency (EMA) about the vaccine quality, safety, and efficacy[1].
Initially, COVID-19 vaccines were granted a conditional marketing authorisation (CMA)[2], a pathway used to expedite access to medicines addressing unmet needs, particularly during public health emergencies. A CMA requires the marketing authorisation holder to provide further data post-authorisation to confirm the benefit-risk balance.
Following authorisation, all medicinal products authorised in the EU, are subject to continuous and rigorous safety monitoring, which was further enhanced for COVID-19 vaccines.
The EU pharmacovigilance system detects, assesses, and addresses potential side effects[3], with the EMA’s safety Committee (PRAC)[4] analysing new risks that may emerge from various sources, including clinical practice, clinical studies, and medical literature.
Current scientific data from over 13 billion COVID-19 vaccine doses administered worldwide shows a very good safety profile. Most adverse drug reactions are mild and short-lived.
Serious effects are very rare[5] and thoroughly assessed. In 2022, PRAC concluded that there was no evidence supporting a causal link between mRNA COVID-19 vaccines and AIH[6].
Each vaccine has published product information and an assessment report detailing all examined aspects[7]. If a reasonable possibility exists that a side effect is linked to the vaccine, it is included in the product information to ensure transparency for healthcare professionals and patients.
- [1] Approval of vaccines in the EU: https://vaccination-info.europa.eu/en/about-vaccines/approval-vaccines-eu; COVID-19 vaccines: development, evaluation, approval and monitoring: https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-development-evaluation-approval-monitoring.
- [2] Conditional marketing authorisation: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation.
- [3] Pharmacovigilance: Overview: https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview.
- [4] Pharmacovigilance Risk Assessment Committee (PRAC): https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac.
- [5] Safety of COVID-19 vaccines: https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines#suspected-side-effects-13834.
- [6] Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-april-2022.
- [7] COVID-19 medicines: https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines.