EMA’s reaction and communication initiatives throughout the pandemic - COVID-19 vaccines as an example

9:55 AM - 10:30 AM

The COVID-19 pandemic has placed sustained and intense demands on the EMA's resources, with multiple medicinal products subject to fast-track evaluation and additional safety monitoring. This session will look at how the EMA responded to the challenges, including putting in place exceptional measures to satisfy public demand for greater transparency and understanding of COVID-19 vaccines and therapeutics. The pace and extent of research on COVID-19 disease and on medicines development are both unprecedented. As a result, one of the EMA’s greatest challenges has been to constantly adapt to emerging scientific data and respond with appropriate actions and guidance. Communicating uncertainty in real time while evaluations are ongoing and COVID-19 vaccines uptake is global has not always been plain sailing. Public trust in regulators remains critical in the fight against COVID-19; achieving public confidence and thus a high vaccination uptake with vaccines developed at ‘pandemic speed’ demands going beyond regular communication and engagement. To achieve this, the EMA has been relying heavily on its scientific committees, and the COVID-19 pandemic task force (COVID-19 ETF), and working closely with the EU Network of Member State medicines regulatory authorities and the European Commission, with other EU agencies such as the ECDC, and with its international partners. The EMA’s mandate in providing information and support for public health positions beyond classical regulatory procedures has also been extended by the European Commission in the light of early lessons learned in this health crisis. The COVID-19 pandemic has been a powerful booster for development of tools, methods, and enhanced frameworks for communication and collaboration.