“Data on the immune response after vaccination in humans is actually an important and encouraging step on the way to a vaccine,” said the President of the Paul Ehrlich Institute, Klaus Cichutek. This applies in particular to an RNA vaccine like this, because there are no such approved human vaccines yet, and there is little experience worldwide with “preventive RNA vaccines”.
Before Biontech and Pfizer, the biotech company Moderna from the United States announced the induction of an immune response in humans by an RNA vaccine candidate. So there has now been the second hint worldwide.
Biontech co-founder and boss Ugur Sahin said the preliminary data was very encouraging. They showed that the vaccine candidate “can induce an immune response with neutralizing antibodies in humans”. “We look forward to releasing additional data on BNT 162b1,” he said. Biontech is also testing potential vaccines in Germany. It was the first company in Germany to receive the approval of the Paul Ehrlich Institute. BNT 162b1 is the name of the vaccine candidate for which the US results are now available. Kathrin U. Jansen, senior vice president at Pfizer and responsible for vaccine research, said the first clinical data were encouraging.
Further tests necessary
With the tests that have already been carried out and are now to follow, Biontech and Pfizer want to find the right dose for a possible vaccine. A selection must also be made of which vaccine candidates will be used in a large-scale, global study involving over 30,000 healthy subjects. If approved by the authorities, it could start in late July 2020.
Biontech and Pfizer emphasized that BNT 162b1 has not yet been approved for use in any country in the world. However, should the vaccine be approved, the companies plan to produce up to 100 million doses of vaccine by the end of the year and possibly more than 1.2 billion doses by the end of next year.