Shots:

• The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2- 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2
• The P-II/III study follows the US FDA’s guidance on clinical trial design- will evaluate up to 30-000 participants in a ratio (1:1)  aged 18 – 85yrs. started in the US and is expected to include ~120 sites globally 
• Assuming clinical success- companies expect to seek regulatory approval as early as Oct’2020. Following the approval- the companies currently aim to supply globally up to 100M doses by the end of 2020 and ~1.3B doses by the end of 2021. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S)- which is the target of virus-neutralizing Abs and has received the US BT designation

­ Ref: Pfizer | Image: StraitTimes

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