The Mainz biopharma company Biontech and its US partner Pfizer are now allowed to test their corona vaccine candidate in Germany. As Biontech announced on September 7, 2020, the Paul Ehrlich Institute has given permission for this. The global study on the possible vaccine with up to 30,000 participants began in late July.
For the clinical investigation of phases II / III – with the aim of checking the effectiveness and possible side effects and determining the appropriate dose – the active ingredient BNT162b2 was selected as the main candidate. According to the information, 25,000 test persons had already participated in the study by September 7.
“A large, controlled phase III study is an essential prerequisite for unequivocally demonstrating the safety and effectiveness of a vaccine,” said Biontech CEO Ugur Sahin. “The integration of study centers in Europe, and now also in Germany, has the specific aim of supporting local approval.” If the current clinical study on their possible corona vaccine is successful, Biontech and Pfizer are aiming for the application in October To provide market approval.
Vladimir Putin had announced the world’s first approval of a corona vaccine under the name “Sputnik V” and wants to have won the global race of vaccine developers. The first results actually look very promising.
But there are many other vaccine projects around the world, some of which are well advanced and are already carrying out large-scale studies on humans.
There are promising projects in China, the USA, England and Germany
In addition to the two Chinese projects Sinopharm and Sinovac, which have recently started conducting phase III studies in Brazil and Indonesia, scientists from Oxford University have been testing their vaccine candidates on humans together with the pharmaceutical company AstraZeneca since June. The US company Moderna is also well advanced in development.
But the biotech start-up Biontech from the Rhineland-Palatinate state capital Mainz is one of the world’s most promising candidates. The Mainz-based company is not alone, however, but has been able to win over the financially strong US pharmaceutical giant Pfizer as a supporter.
If the clinical studies run without complications, the application for marketing authorization should be submitted as early as October. Biontech managed to start the study “in record time”, said CEO Ugur Sahin on August 11th at a conference at which the quarterly figures were also announced.
These looked less rosy at first, however: The high research costs had pushed the losses up to 88.3 million euros – compared to 50.1 million minus in the same period of the previous year. Research and development costs this quarter totaled 160.3 million euros. But contract partner Pfizer is ready to provide a total of 573 million euros.
The WHO still expects the vaccine to be available in mid-2021
If the active ingredient should actually be approved, however, the investment in Biontech should be worthwhile for Pfizer: There are already supply agreements with the UK, the USA, Japan and Canada for more than 250 million vaccine doses. These could, however, be increased at will. These prospects are driving up the price of Biontech, which has been listed on the US tech stock exchange Nasdaq since October 2019.
If Biontech or one of the competitors actually received market approval in the next few months, this would not mean that the pandemic would have stopped. The next task would then be the production of millions or even billions of vaccine doses, which would take additional months. WHO chief researcher Soumya Swaminathan therefore assumes that “by mid-2021 we will have a vaccine that can be used on a broad basis”.