As the basis for their applications for regulatory approval, Sanofi and GSK plc intend to submit data from their booster and Phase 3 efficacy trials. The data they plan to submit is expected to include the full results of their Phase 3 efficacy trial of the vaccine, as well as data from their booster trial, which is designed to assess the efficacy of the vaccine after a booster dose.
GSK plc and SK Bioscience have submitted an application for a biologics license to the Korean Ministry of Food and Drug Safety for their SKYCovione after receiving positive Phase III clinical results. It is a candidate COVID-19 vaccine based on recombinant protein that has been adjuvant with GSK's pandemic adjuvant.
Author Credits: Radhika Gupta, Shivam Bhutani