In parallel, a Emergency approval to be submitted to the US Food and Drug Administration.
With the application for admission to Ema, a Corona vaccination also closer in Germany. Last week had the EU Commission chief Ursula von der Leyen communicated that there was a framework agreement with Moderna 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, the agent could already be used in December delivered, provided it receives approval.
Rapid approval of Moderna vaccine possible
A so-called rolling review process is already running at Ema for the RNA vaccine from Moderna Admission process should accelerate. Manufacturers can submit individual parts on the quality, safety and effectiveness of a preparation even before the complete application for approval.
Also the Mainz manufacturer Biontech has together with the US group Pfizer such a procedure is ongoing. Biontech and Pfizer have already applied for emergency approval in the USA, but not yet in the EU. Moderna’s preparation is comparatively similar to the Biontech / Pfizer vaccine in terms of its mode of action and its effectiveness.
In the case of conditional marketing authorization, the Ema can, under certain conditions, authorize a product on the basis of less comprehensive data if the product is urgently needed.
The Moderna vaccine mRNA-1273 has one Effectiveness of 94.1 Percent, as the company announced. That emerges from the latest analysis of data from the Phase III clinical trial, in which 30,000 people in the US are participating. Half of the participants receive the vaccine, the other half a placebo. For full vaccination protection are two cans necessary at intervals.
A total of 196 cases of the Covid-19 disease have been confirmed among the test subjects. 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 Moderna published in mid-November.
In addition, Moderna announced that the total of 30 severe Covid 19 courses in the study only affected the placebo group. The effectiveness of mRNA-1273 was similar across all age groups, according to Moderna.
RNA vaccine is said to stimulate the body to make antibodies
Like that from Pfizer and Biontech, the Moderna preparation is a so-called one RNA vaccine. It contains genetic information about the pathogen, from which the body then produces a virus protein. The aim of vaccination is to stimulate the immune system to produce antibodies in order to intercept the viruses. There is still no approved vaccine of this type.
Countries such as Russia, China and recently Bahrain have already released vaccines with restrictions and are already vaccinating parts of the population with them. But how well these vaccinations actually protect and what side effects they can have is currently largely open.