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AMSTERDAM. The EU has received the first applications from pharmaceutical companies for conditional approval of corona vaccines. Both the Mainz-based company Biontech and its US partner Pfizer, as well as the US company Moderna, independently submitted the corresponding applications to the European Medicines Agency (EMA) in Amsterdam.
The move was widely anticipated after companies had previously presented promising efficacy and safety data from clinical trials. Biontech and Pfizer, as well as Moderna, are testing their active ingredients in large-scale test series and have been sharing data with regulatory authorities for weeks to speed up the approval and testing process. A final application has not yet been made in the EU. In the US, Biontech and Pfizer applied for emergency approval a week and a half ago. Moderna filed the application there in parallel to that of the EU.
After evaluating clinical studies, Biontech and Pfizer, as well as Moderna, reported in November that each of their active ingredients prevented the corona disease outbreak by about 95 percent and that there were no serious side effects. According to the EMA, a special meeting of its expert group on the Biontech and Pfizer candidate is scheduled for December 29 at the latest. A special session on the active ingredient Moderna should follow no later than January 12.
