PARIS (Reuters) – France’s Sanofi and Britain’s GlaxoSmithKline on Thursday launched a late-stage human trial for their recombinant COVID-19 vaccine candidate that they hope to get approved by the end of this year.
The two companies, which earlier this month reported positive interim results, confirmed their double-blind, placebo-controlled, phase III study would include more than 35,000 adults in the United States, Asia, Africa, and Latin America.
“In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus, while a second stage will evaluate a second formulation targeting the B.1.351 virus,” Sanofi said.
The virus lineage known as B.1.351 was first detected in South Africa.
Sanofi also confirmed it would begin clinical studies in the coming weeks to assess the efficacy of the vaccine as a booster shot regardless of what vaccine a subject may have received in first intention.
Pending positive phase III outcome, the vaccine could be approved in the fourth quarter after having initially been targeted for the first half of this year before a setback.
Sanofi and GSK last December were forced to restart their trial when the vaccine showed a low immune response in older adults as a result of a weak antigen formulation.