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Moderna was the first company to apply for approval for a corona vaccine in the EU.
Moderna wants approval for a corona vaccine in the EU.
via REUTERS
US biotech group Moderna wants to apply for emergency approval in the United States on Monday after the study’s positive results with its corona vaccine.
via REUTERS
Moderna’s vaccine is said to be 94% effective.
REUTERS
US pharmaceutical company Moderna wants to be the first company to apply for approval for a corona vaccine in the EU. The conditional approval application is expected to be submitted to the European Medicines Agency Ema on Monday, the company announced on the same day. At the same time, an application for emergency approval must be submitted to the United States FDA.
With the request for approval from EMA, a corona vaccination is also approaching in Germany. Last week, the head of the European Commission, Ursula von der Leyen, announced that a framework contract for up to 160 million vaccine doses has been concluded with Moderna. As a result, 80 million cans will initially be delivered, with the option of 80 million more units. According to Moderna, the product could be delivered to the EU as early as December, provided it receives approval.
Further proceedings are ongoing
A so-called progressive review process is already underway at Ema for Moderna’s RNA vaccine, which aims to speed up the approval process. Manufacturers can submit individual parts on the quality, safety and efficacy of a preparation even before the full application for approval.
The Mainz-based manufacturer Biontech also carried out this procedure together with the US company Pfizer. Biontech and Pfizer have already applied for emergency approval in the US, but not yet in the EU. Moderna’s preparation is relatively similar to the Biontech / Pfizer vaccine in terms of mode of action and efficacy.
In the case of a conditional marketing authorization, EMA can, under certain conditions, approve a product based on less complete data if the product is urgently needed.
Moderna mRNA-1273 vaccine is 94.1 percent effective, the company announced. The effectiveness of the vaccine in severe cases of COVID-19 is 100%. This emerges from the latest data analysis 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 complete vaccine protection, two doses are required at intervals.
The severe courses were in the placebo group
A total of 196 cases of Covid-19 disease were confirmed among the test subjects. 11 of these cases were in the vaccine group and 185 in the placebo group. This translates into an effectiveness of 94.1 percent. The new results roughly correspond to the preliminary data that Moderna published in mid-November.
Additionally, Moderna announced that the total of 30 severe Covid 19 cycles in the study only affected the placebo group. The efficacy of mRNA-1273 was similar across all age groups, according to Moderna.
Like Pfizer and Biontech, the Moderna preparation is a so-called RNA vaccine. It contains genetic information about the pathogen, from which the body then produces a viral protein. The purpose of vaccination is to stimulate the immune system to produce antibodies to intercept viruses. There is still no approved vaccine of this type.
Countries like Russia, China, and recently Bahrain have already released restricted vaccines 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 widely open.
Viral protein vaccines: Some research groups are working on a viral protein-based vaccine in which the protein – and not the entire virus – triggers the immune response. Vaccinations against tetanus, hepatitis B and influenza, for example, work according to this principle.
Vaccines with virus transport: A second group is researching vaccines with so-called vector viruses. This means: They plant the gene for the Sars-CoV-2 spike protein in the genome of harmless viruses such as the established vaccinia virus. They mask it in a way. If this is then injected as a vaccine, the immune system reacts as if it were the real coronavirus and forms antibodies against it.
Vaccines from genetic material: A genetic construction manual for the novel coronavirus spike protein must be injected, whereby the immune system must be induced to create the virus molecule itself for a limited time in order for antibodies to Sars-CoV-2 to form. One of the advantages of this approach, which both Biontech and Moderna have chosen: unlike classical vaccines (with a long cultivation of the virus), mRNA vaccines can be produced quickly and at low cost in large quantities.
(SDA)
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