Moderna was the first company to apply for approval for a corona vaccine in the EU.
The American pharmaceutical company Moderna wants to be the first company to apply for approval for a corona vaccine in the EU. The application for conditional approval must be submitted to the European Medicines Agency Ema on Monday, the company announced the same day. At the same time, an application for emergency approval must be filed with the US FDA.
With the application for approval at Ema, a corona vaccination is also approaching in Germany. Last week, Ursula von der Leyen, head of the European Commission, announced a framework contract with Moderna for up to 160 million vaccine doses. Accordingly, 80 million cans will be delivered initially, with the option of an additional 80 million units. According to Moderna, the product could be delivered to the EU as early as December, subject to approval.
Further proceedings are underway
For the Moderna RNA vaccine, a so-called rolling review process is already underway at Ema, intended to speed up the approval process. Manufacturers can already submit individual parts about the quality, safety and effectiveness of a preparation before the complete application for approval.
The Mainz-based manufacturer Biontech has also carried out such a process together with the American company Pfizer. Biontech and Pfizer have already applied for an emergency permit in the US, but not yet in the EU. Moderna’s preparation is relatively similar to the Biontech / Pfizer vaccine in terms of mechanism of action and effectiveness.
In the case of conditional marketing authorization, the Ema can under certain conditions authorize a product on the basis of less extensive data if the product is urgently needed.
The Moderna vaccine mRNA-1273 has a 94.1 percent effectiveness, as the company announced. The effectiveness of the vaccine in severe COVID-19 cases is 100 percent. This is evident from the most recent analysis of data from the Phase III clinical trial, involving 30,000 people in the US. Half of the participants will receive the vaccine, the other half a placebo. Two doses are required at intervals for complete vaccination protection.
Severe courses were in the placebo group
A total of 196 cases of Covid-19 have been confirmed in the subjects. 11 of these cases were in the vaccine group and 185 in the placebo group. This results in an effectiveness of 94.1 percent. The new results are roughly in line with preliminary data published by Moderna in mid-November.
In addition, Moderna announced that the total of 30 severe courses of Covid 19 in the study only affected the placebo group. The effectiveness of mRNA-1273 was comparable in all age groups according to Moderna.
Like that of 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 virus protein. The purpose of the vaccination is to stimulate the immune system to produce antibodies to intercept the viruses. There is no approved vaccine of this type yet.
Countries like Russia, China and recently Bahrain have 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 largely open.
Virus Protein Vaccines: Some research teams are working on a vaccine made from viral protein in which the protein – and not the entire virus – triggers the immune response. The tetanus, hepatitis B and flu vaccinations, for example, work according to such a principle.
Vaccines with virus transport: A second group is researching vaccines with so-called vector viruses. That means, they plant the gene for the spike protein of Sars-CoV-2 into the genome of harmless viruses such as the established vaccinia virus. They disguise it in a way. When this is then injected as a vaccine, the immune system reacts as if it were the real coronavirus and forms antibodies against it.
Vaccines of genetic material: A genetic engineering manual for the spike protein of the novel coronavirus is injected, whereby the immune system must be triggered to make the virus molecule itself for a limited time so that antibodies against Sars-CoV-2 are built up. One of the advantages of this approach, chosen by both Biontech and Moderna: Unlike traditional vaccines (with long-term virus culture), mRNA vaccines can be produced quickly and cheaply in large quantities.