EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once these are authorised in the European Union. The Agency has signed a contract with Utrecht University as coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, a public-academic partnership of 22 European research centres, to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice. The ACCESS (vACcine Covid-19 monitoring readinESS) project will be led by the University Medical Center Utrecht (UMCU) and Utrecht University.
To authorise any COVID-19 vaccine, EMA will need to have strong evidence from clinical trials on the safety, efficacy and the quality of this vaccine. Once on the market, approved vaccines will be monitored closely, by the Agency and its Pharmacovigilance Risk Assessment Committee (PRAC), through planned and routine pharmacovigilance activities, including the spontaneous reporting of suspected side effects reported by patients and healthcare professionals through Eudravigilance, the European database of suspected adverse reactions to medicines. The infrastructure put in place by Utrecht University will provide additional information from clinical practice to complement data collected pre-authorisation through clinical trials and post-authorisation through spontaneous reporting...
Full text at GMPnews.Net