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Pfizer with its Partner BioNTech Receives the US FDA's Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

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Pfizer with its Partner BioNTech Receives the US FDA's Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

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  • The designation is based on preliminary data from P-I/II study assessing BNT162b1 including animal immunogenicity studies results that were released on Jul 01- 2020. Additionally- the early results of German trial evaluating BNT162b1 are expected in Jul 2020
  • The companies BNT162 mRNA-based vaccine program involves the evaluation of 4 investigational candidates developed to target SARS-CoV-2 while BNT162b1 & BNT162b2 being assessed in P-I/II clinical studies in the US and Germany. The Project Lightspeed vaccine development program is based on BioNTech’s mRNA-based technology platforms
  • BNT162b1 encodes optimized SARS-CoV-2 RBD antigen and BNT162b2 encodes an optimized SARS-CoV-2 spike protein antigen while both are nucleoside modified RNAs formulated in lipid nanoparticles. In Jul 2020- the companies are expected to initiate P-IIb/III trial enrolling 30-000 patients with expected manufacturing of ~100M doses by the end of 2020 and 1.2B doses by the end of 2021

Click here to read full press release/ article | Ref: Pfizer | Image: PharmaWorld


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