Through these rolling reviews, EMA can start evaluating data while the development is still ongoing, and before the vaccine developer has submitted a request for marketing authorisation. The rolling review assesses data on the vaccine's quality as well as results from laboratory studies. EMA also looks at results on the vaccine's efficacy and initial safety data emerging from large-scale clinical trial as they become available. This significantly shortens the normal assessment times while maintaining the principles of quality, safety and efficacy.
In the context of the rolling reviews, a dedicated group of experts, the COVID-19 EMA pandemic Task Force, has been established on the development, authorisation and safety monitoring of COVID-19 vaccines and is responsible for thoroughly assessing the scientific data. Hence, when a marketing authorisation is requested, the formal assessment can proceed much more quickly, as the data have already been scrutinised during the rolling review.
Moreover, EMA assesses the data with a view to issue a Conditional Marketing Authorisation (CMA). Such an authorisation ensures that the safety, efficacy and quality of the vaccine is demonstrated and that the benefits of the vaccine outweigh its risks, whilst at the same time allowing the vaccine developers to submit additional data also after the marketing authorisation (contrary to a normal marketing authorisation where all data are submitted before the authorisation is granted).
The European Commission is also ensuring that the process leading to the marketing authorisation can take place as quickly as possible by shortening administrative steps, such as the period for consulting Member States and by allowing for the translation of the product information in all official languages to take place in the first instance in electronic form to save time.
Whilst the average standard process for the authorisation of medicinal products takes 67 days, including 22 for the consultation of Member States, by making use of the provisions specifically provided for under EU legislation for emergency situations, the Commission will be able to proceed with a marketing authorisation within 3 days following a positive recommendation from EMA.
