EMA reports on coronavirus (COVID-19) trial efficacy

Article summary

The European Medicines Agency (EMA) has published a report, adopted by the Committee for Medicinal Products for Human Use, on considerations for coronavirus (COVID-19) vaccine trials. The EMA considers that the vaccine developers should aim to provide ‘convincing demonstration of efficacy in the population studied’ through the use of well-planned pivotal efficacy trials with rigorous success criteria. The EMA considers following up with participants to be important for safety and efficacy after market authorisation, as well as assessing the safety of coronavirus vaccines during vaccination campaigns. EU regulators will consider, during the clinical assessment, the precision of the developers’ point estimate of vaccine efficacy and the point estimate’s accuracy, and the safety profile.