Sanofi and GSK Initiate Late-Stage COVID-19 Vaccine Study
Sanofi and GlaxoSmithKline have begun enrollment in a global phase 3 trial of their COVID-19 vaccine candidate that could potentially lead to a regulatory approval in the fourth quarter of 2021.
The drugmakers said they tailored their vaccine development strategy to the ever-changing coronavirus, and the pivotal trial is using a two-stage design that will evaluate the vaccine candidate against both the original virus and the South African variant.
The Sanofi/GSK shot can remain stable at temperatures used for routine vaccines, making it potentially viable as a global option for COVID-19 vaccination.
The phase 3 trial, which will enroll more than 35,000 patients aged 18 years and up in the U.S., Africa, Asia and Latin America, will be supplemented by a booster study set to start in the coming weeks. That program will assess how well the adjuvanted vaccine candidate serves as a booster dose regardless of the initial vaccine administered.