GlaxoSmithKline and Sanofi plan to submit data to the FDA that shows two doses of their protein-based COVID-19 vaccine provided 100 percent protection against severe disease and hospitalization.
In a phase 3 clinical trial, the vaccine demonstrated 75 percent efficacy against moderate to severe disease and 58 percent efficacy against symptomatic disease, "in line with expected vaccine effectiveness in today's environment dominated by variants of concern," the companies said in a Feb. 23 news release.
When used as a booster following two doses of mRNA vaccine, the shot boosted neutralizing antibody levels by 18- to 30-fold, laboratory studies showed.
The companies said the study results will be published later this year. They plan to submit the data as the basis for regulatory applications to the FDA and European Medicines Agency.