The European Medicines Agency Has Received Two Applications For Conditional Registration

The European Medicines Agency Has Received Two Applications For Conditional Registration

The European Medicines Agency has received two applications for conditional registration of a vaccine to prevent COVID-19. The first applicant is a consortium of BioNTech and Pfizer and the second is Moderna Biotech Spain, S.L. If the quality, efficacy and safety data submitted meet the requirements for vaccine registration, marketing authorizations may be issued in a few weeks. Magdaléna Jurkemíková, a spokeswoman for the State Institute for Drug Control, informed about it.

Dates may still change

Registration of vaccines to prevent COVID-19 is under an accelerated procedure. Both vaccines were included in the ongoing evaluation process. If the data submitted are sufficient, the Agency will issue an opinion on the vaccine registration from the BioNTech and Pfizer consortium on 29 December, an opinion on the vaccine registration from Moderna Biotech Spain, S.L. should be known on January 12. However, these deadlines may still change. "The date of issue of the opinion is mainly influenced by whether the submitted data will be sufficient or whether it will be necessary to ask manufacturers to provide additional data," Jurkemíková explained.