Sanofi, GSK launch Phase III trial for COVID-19 shot
France’s Sanofi and Britain’s GlaxoSmithKline launched a late-stage human trial for a recombinant COVID-19 vaccine candidate on Thursday, which they hope to get approved by the end of 2021.
The two drugmakers, reported early this month that, 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.
The study initiated by Sanofi and GSK is one of the first late-stage trials that combines tests for boosters and variants.
“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.
“Recent scientific evidence shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants,” Sanofi said.
The French drugmaker added in a statement that, the design of the Phase III, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.
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, regardless of what vaccine a subject may have received first.
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