Reference:
Pfizer. (2020). PF-07302048 (BNT162 RNA-Based COVID-19 vaccines) protocol C4591001.
Summary:
The document outlines the Phase 1/2/3 clinical trial to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162 RNA-based COVID-19 vaccines, developed by Pfizer and BioNTech. The trial investigates two vaccine candidates: BNT162b1, encoding the receptor-binding domain (RBD), and BNT162b2, encoding the prefusion spike glycoprotein. The study involves healthy participants aged 12 to 85, assessing the safety and immune response after one or two doses. It includes a randomised, placebo-controlled design, with primary objectives focusing on safety profiles and immune responses at various intervals post-vaccination. The document also discusses the rationale for rapid vaccine development in response to the COVID-19 pandemic, the need for effective immunisation strategies, and the expected benefits versus risks associated with the trials.