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

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

Shots:

  • 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

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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