In view of the proven effectiveness and quality of the two mRNA vaccines against the coronavirus, the European Medicines Agency (EMA) has recommended converting their conditional approval into a standard approval.
For the vaccines Comirnaty from Biontech/Pfizer and Spikevax from Moderna, this means that the approval no longer has to be checked and renewed annually, the EMA announced on Friday in Amsterdam. The EU Commission is now responsible for issuing the permanent approval.
Both vaccines received conditional marketing authorization at the time of their approval, the EMA announced. The companies were thus obliged to present the results of the ongoing clinical studies and to provide additional data on the pharmaceutical quality of the vaccine in view of the planned expansion of production.
As the EMA has now explained, these trials and additional studies have provided reassuring data on important aspects such as the effectiveness of the vaccines in preventing serious corona diseases. In addition, the companies submitted any additional data requested on the pharmaceutical quality of the vaccines. Therefore, the way is now clear for a standard approval.
