editor in the economy.F. A. Z.
An agreement with the American authorities, the two companies announced on Wednesday. Both shares are traded in the premarket trade in America.
In the framework of the agreement the American government to get first 100 million doses of the candidate BNT162, after the companies have received the vaccine, the approval of the U.S. food and drug administration FDA. Then the government will pay 1.95 billion dollars for the first 100 million doses, it said in the message. The government has secured, according to the companies the opportunity to buy up to 500 million additional doses. Just a few days ago, the development partners had announced, with great Britain an agreement on the supply of 30 million doses agreed, but without giving any financial Details.
"We are pleased to have this important agreement with the American government-signed, which provides for, after acceptance of the delivery of the first 100 million doses of the Vaccine as part of our commitment to addressing this global health crisis. This agreement is one of many steps to allow for a vaccine approval, a global access,“ said Biontech-founder and Chairman of the Board, Ugur Sahin. It is also "in advanced talks with a number of other governments" and hope to be able soon for more supply agreements to announce, he said.
the local clinical study is the first positive data
Biontechs vaccine program called BNT162 supplies includes four candidates. In April, the company was started in this country with the first clinical study. A short time later, a study in America followed. From the local testing recently, first results have been published. It is the candidate BNT162b1 was tested in a study of Phase I/II, 45 subjects in various dosages. Overall, the preliminary data showed that the doses administered were well tolerated and a dose-dependent efficacy was achieved based on the antibody concentration.
On Monday more positive initial data from the study, which is being carried out followed also. In July, the two companies had communicated recently, might start a large-scale efficacy study of the Phase IIb/III, with the most promising of the four candidates, with about 30,000 volunteers.
Recently, had granted the American FDA in addition, for two of the four vaccine candidates, the so-called Fast-Track Status, so a fast-track admission procedures. If the clinical trials are successful, the two companies expect to be able to in October 2020 to apply for authorisation. Depending on the dose amount Biontech and Pfizer plan, global by the end of the year, up to 100 million doses, and by the end of 2021 may be more than 1.3 billion doses to recover.Updated Date: 22 July 2020, 08:19