Coronavirus: Biontech ready to deliver the first vaccine doses in the EU
Source: Heise.de added 21st Dec 2020The Mainz company Biontech and the US pharmaceutical company Pfizer are in the starting blocks for the delivery of the first vaccines to the EU. “We are ready to start delivering the first vaccine doses in the EU as soon as we get the green light,” said Biontech boss and co-founder Ugur Sahin on Monday.
The European Medicines Agency (EMA) had previously recommended the approval of the first corona vaccine, which is to be sold under the trade name Comirnaty, in the EU. As the EMA announced, sufficient reliable data on the quality, safety and efficacy of Comirnaty are available to recommend a formally conditional authorization for placing it on the market. The round 44. 000 Participant in a comprehensive clinical trial would have demonstrated the effectiveness of the vaccine in humans for 16 years at an efficiency of 95 percent shown.
In line with the EU Safety Monitoring Plan for Covid – 19 – Vaccines are being monitored comirnaty to pursue possible side effects in vaccinating millions of people. Additional studies on the vaccine are also planned. The EMA sees the vaccine as a milestone in combating the coronavirus pandemic. At the same time, however, the EMA restricted the fact that this was not yet a turning point in the pandemic.
Approval of the vaccine still expected today In a next step, the EU Commission must now decide on the approval of the vaccine for all member countries. However, this is a matter of form. According to the EU Commission President Ursula von der Leyen, the decision will be made on Monday, she said on Twitter. A vaccination start with Comirnaty could already be on 21. 12. 2020.
“Today’s decision is a particularly personal one and emotional for all of us at Biontech, “explained Sahin. “As a company based in the heart of the EU, we are particularly pleased to be one step closer to possibly delivering the first vaccine against this devastating pandemic in Europe.”
: As announced by EU Commission President Ursula von der Leyen, the EU Commission has approved the vaccine from Biontech / Pfizer. Comirnaty should therefore be available in all EU countries at the same time and at the same conditions.
( With material from dpa ) / (olb)
brands: Boss media: Heise.de
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