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Tests in humans provide convincing data: Biontech will receive fast-track admission procedure for 2 Corona vaccines
Pfizer and BioNTech for two of the four in the developing mRNA-based vaccine candidate (BNT162b1 and BNT162b2) against SARS-CoV-2 the Fast-Track Status by the US food and drug administration FDA. BNT162b1 and BNT162b2 are the most advanced vaccine candidates from the BNT162 vaccine program, currently in ongoing Phase 1/2 studies in the USA and Germany are examined. “We will work closely with the FDA to expedite our clinical development,” added Özlem Türeci, Chief Medical Officer of BioNTech.
The Status was granted on the basis of preliminary data from Phase 1/2 studies currently being conducted in the United States and Germany, as well as on the basis of immunogenicity studies in animals. The two companies on 1. Published July 2020 first data for the vaccine candidate BNT162b1 from the in the USA ongoing Phase 1/2 study. The manuscript of these data is on the Preprint Server medRxiv available. First, data from the German study of BNT162b1 are expected to be published in July 2020.
Subject to regulatory approval, the company intend to start a Phase 2b/3 study by the end of this month, with up to 30,000 subjects. The study was successful and the vaccine will receive regulatory approval, plan to the two companies until the end of 2020, up to 100 million doses of the Vaccine and to be able to until the end of 2021 may be more than 1.2 billion doses of Vaccine to produce.
The Fast-Track process aims to support the development of new drugs and vaccines intended for the treatment or prevention of serious diseases and have the Potential to address a high unmet medical need.
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