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The Mainz-based Biopharma company Biontech and its US Partner Pfizer have started with the crucial Tests of their vaccine candidates.
“Today we are launching our global study, which will include up to 30,000 participants,” said Biontech-CEO Ugur Sahin on Tuesday, according to a message.
With the clinical study of Phase II/III will be shown, among other things, whether the active ingredient BNT162b2 is actually protecting against infection with Sars-CoV-2.
In a similarly advanced stage of the trial, only four other projects, according to a Summary of the WHO currently.
On Monday, the US manufacturer Moderna announced the launch of its Phase III study. First results may be available in November.
So far, it could be demonstrated for several of the vaccine candidates that stimulate the immune response. The proof that one of the means protects really is but still.
Corona vaccine still be in 2020?
The Tests of Biontech and Pfizer should be carried out on subjects between the ages of 18 and 85 years of age in 120 study centres worldwide, including in Germany, as Biontech announced on Tuesday in Mainz.
With the success of the study, Pfizer and Biontech want to apply to their own information, in October 2020, the authorisation procedure and, in the case of a permit by the end of the year, up to 100 million doses of Vaccine manufacture until the end of 2021, it could be then doses of more than 1.3 billion Vaccine.
Both the candidates of Moderna as well as the funding of Biotech/Pfizer, it is a so-called RNA vaccine, which contains genetic information of the pathogen.
The body cells of the vaccinated volunteers to connect with their help, surface proteins of the Coronavirus against the the immune system defence skills are developed.
However, so far approved no genbasierter vaccine for people.
The results of Tests on 120 subjects in studies of the Phase I/II studies have BNT162b2 a “favorable tolerability profile” shown, declared, Biontech, and Pfizer.
So side effects such as fever, fatigue and chills had been “mild to moderate” in severity and only one to two days occurred.
For the further financing of the research, Biontech has obtained a capital increase of about a half a billion dollars on the stock market. Biontech and Pfizer have said the United States in a first step, in the Presence of a corresponding emergency authorisation first 100 million doses of the Vaccine, and up to 500 million doses as an optional Nachorderung the course.
Also with the UK, there is an initial supply agreement.
Deutsche Presse-Agentur (dpa)
*The article “Coronavirus: Further vaccine trial will start with up to 30,000 people,” published by FitForFun. Contact with the executives here.