The US pharmaceutical company Moderna wants to apply for approval for its corona vaccine in the EU on Monday. At the same time, an emergency license is to be applied for in the USA.
- The US pharmaceutical company Modern has a vaccine against that Coronavirus* developed.
- On Monday the company wants the Admission in the I request.
- The Corona vaccine* has one, according to Moderna Effectiveness of 94.1 percent.
New York – The US pharmaceutical company Modern wants to be the first company Approval for a corona vaccine in the I request. The company announced that the application for conditional approval should be submitted to the European Medicines Agency EMA on Monday. In parallel, a Emergency approval with the US Medicines Agency FDA be requested.
Corona vaccine: Moderna wants to apply for approval in Europe
With the application for approval at the EMA, a Corona*-Vaccination also in Germany closer. Last week had the EU Commission chief Ursula von der Leyen communicated with Modern is a framework agreement for up to 160 million vaccine doses been completed. Accordingly, 80 million cans are to be delivered initially, with the option of 80 million more units. In the EU, according to Moderna already in December delivered, provided it receives approval.
We just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, our COVID-19 vaccine candidate and that today, we plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA. Read more: https://t.co/90FbcVHdWN pic.twitter.com/36tpY0QeFl
– Modern (@moderna_tx) November 30, 2020
To that Corona vaccine* from Modern a so-called is already running at the EMA Rolling review process, which is supposed to speed up the approval process. Manufacturers can submit individual parts on the quality, safety and effectiveness of a preparation even before the complete application for approval.
Moderna corona vaccine: 94.1 percent effectiveness
The Moderna vaccine mRNA-1273 has a Effectiveness of 94.1 percentas the company announced. That goes from the latest analysis of the data phase III clinical trial of 30,000 people in the USA take part. Half of the participants receive the vaccine, the other half a placebo. For full vaccination protection, two doses are necessary at intervals.
Overall, therefore, have been among the subjects so far 196 cases illness Covid-19* approved. 11 of these cases were in the vaccine group and 185 in the placebo group. From this one can be calculated Effectiveness of 94.1 percent. The new results roughly correspond to the preliminary data that Modern Published in mid-November. The company also announced that the total 30 severe Covid-19 courses in the study only the placebo group concerned. The effectiveness of mRNA-1273 was similar across all age groups, according to Moderna. (ph / dpa) * Merkur.de is part of the Ippen-Digital editors network