Positive data – BioNTech plans to file for approval of corona vaccine

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Frankfurt/New York, Nov 09 (Reuters) – The Mainz-based biotech company BioNTech is close to a breakthrough with its potential corona vaccine. BioNTech and its US partner Pfizer presented positive efficacy data from the pivotal study with the vaccine on Monday. According to these data, the risk of contracting Covid-19 was more than 90 percent lower for study participants who received the vaccine than without the vaccination. BioNTech and Pfizer are thus the first companies worldwide to present successful data from the study with a corona vaccine, which is crucial for approval. “This is the first evidence that Covid-19 can be prevented by a vaccine in humans,” BioNTech CEO Ugur Sahin told Reuters.

The two partners plan to apply for emergency approval for the vaccine in the U.S. later this month. If sufficient data on the safety of the vaccine is available, which is expected in the third week of November, the application should be filed soon thereafter. So far, no serious safety concerns have been raised in the study.

Numerous governments have already secured millions of doses of the vaccine in advance, including the US, Japan and the UK. The European Commission has also concluded exploratory talks with the companies to purchase up to 300 million doses.