1. Tozinameran (BNT162b2) COVID-19 vaccine is the first to hit the U.S. market
Description: Proposed indication is the prevention of COVID-19 in individuals 16 years of age and older. The vaccine uses an mRNA platform to targets the P2-mutated full spike protein of the SARS-COV-2 virus. The final analysis from a Phase 3 trial suggests that the vaccine is 95% effective at preventing COVID-19 symptoms and is generally well tolerated.
The vaccine’s current formulation must be stored between –80 and –60° C. Pfizer is currently evaluating whether the vaccine is stable at 2 to 8°C. The company is working on a new formulation that could be stable at room temperature.
Development status: Tozinameran became the first COVID-19 vaccine to win emergency use authorization from the FDA on Dec. 11. Pfizer plans to file a Biologics License Application (BLA) with FDA and anticipates full regulatory approval in 2021.
Pfizer intends to produce 1.3 billion doses of the vaccine by the end of 2021.
Filed Under: clinical trials, Drug Discovery, Infectious Disease