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For the first time, an application for registration of a coronavirus vaccine has been submitted in Switzerland. Pharmaceutical authority Swissmedic announced on Tuesday that scientific evaluation of Astra Zeneca’s “Covid-19 Vaccine” had begun.
Astra Zeneca submitted the application for approval in early October 2020. They developed the vaccine in collaboration with the University of Oxford.
Application for approval also filed in Europe
The coronavirus active ingredient manufactured by AstraZeneca is based on the weakened version of a chimpanzee cold virus. It is supposed to activate the immune system so that it can make Sars-CoV-2 harmless in the event of an infection.
The AstraZeneca agent works in two ways: it is supposed to promote the formation of specific antibodies and T cells; both are important for the immune system.
Astra Zeneca submitted a similar application for approval to the European Medicines Agency (EMA) a few days ago. At BLICK’s request, Swissmedic said that this request would have no influence on the Swiss decision. Swissmedic decides “completely independently”.
However, the testing procedure in Switzerland and Europe is based on the same principles: scientific evaluation of the vaccine is carried out using the continuous submission procedure. This would allow pharmaceutical companies to submit applications for Covid-19 drugs before application development and documentation is completed.
In this way, the approval decision can be expedited.
The drug approval decision could be sped up in this way, as Swissmedic had already evaluated the first scientific evaluations of laboratory studies (non-clinical data) while ongoing clinical studies continued. Study results available in the coming weeks and months should be sent to Swissmedic for scientific evaluation as soon as they are available.
A decision on authorization can only be made when all the data necessary to prove the safety, quality and efficacy of a vaccine are available, according to the Swissmedic notification. The documents would have to show how safely and effectively the vaccine protects people from the Sars-CoV-2 coronavirus.
As also became known today, the European Medicines Agency (EMA) is testing another vaccine in an ongoing process. This is the candidate vaccine of the Mainz-based company Biontech in cooperation with the American company Pfizer. Switzerland has signed a cooperation agreement with the American biotech company Moderna. This vaccine candidate is also very promising. However, there is still no approval process in Europe.
Many candidates
There is an international race of scientists and pharmaceutical companies for corona vaccines. The Astra Zeneca agent has so far been one of the promising candidates among potential corona vaccines. Many countries have signed contracts with the group for a total of billions of cans.
The pharmaceutical company AstraZ eneca could be clear about the effectiveness of its corona vaccine by the end of the year. After the study continues, which was interrupted due to the unexplained illness of a test person, it should be known before the end of the year whether the vaccine protects against the virus, the chairman of the board of directors, Pascal Soriot, said in September.
In total, according to the WHO, there are now 41 potential Covid vaccines in clinical trials around the world. Additionally, there are ongoing trials with a further 151 projects that have not yet reached clinical trial level. (SDA / koh)
The corona virus is currently occupying the whole world and every day there are news. All current information on the subject is available on the coronavirus ticker.
