Coronavirus: Questions and answers on conditional marketing authorisation of vaccines

The Commission is negotiating intensely to build a diversified portfolio of vaccines at fair prices and has secured agreements with six promising vaccine developers so far. In response to public health threats such as the current pandemic, the EU has a specific regulatory tool in place to allow early availability of medicines for use in emergency situations. In such emergency situations, the Conditional Marketing Authorisation procedure is specifically designed to enable marketing authorisations as quickly as possible, as soon as sufficient data becomes available. It provides the EU with a robust framework for accelerated approval and post-authorisation safety and safeguards and controls. So far, the European Medicines Agency (EMA) has received applications for a conditional marketing authorisation from two vaccine developers: BioNTech and Pfizer, and Moderna. The EMA is assessing the safety, efficacy and quality of the vaccines. If the EMA gives a positive recommendation, the Commission can proceed with the authorisation of the vaccine on the EU market. A full Questions and Answers explains the process of the conditional marketing authorisation and is available here. More information is available on the new Commission website on safe and effective vaccination in the EU and on treatments and vaccines for COVID-19 on EMA’s website.