COVID-19: Sanofi, GSK launch clinical trial for protein-based vaccine candidate

French pharmaceutical giant Safi and British drugmaker GSK have started a clinical trial for protein-based COVID-19 vaccine candidate amid global vaccine race. Safi and GSK said in a joint statement on September 3 that y kicked-off “Phase ½” clinical trial for ir juvanted COVID-19 vaccine. 

According to pharma companies, vaccine candidate uses same recombinant protein-based techlogy as one of Safi’s seasonal influenza vaccines with GSK’s established pandemic juvant techlogy. clinical trial is a randomized, double-blind and placebo-controlled trial designed to evaluate safety, tolerability and immune response of COVID-19 vaccine candidate. 

A total of 440 volunteers have been enrolled in Phase ½ study across 11 investigational sites in United States and companies anticipate first results in early December. If results are positive, companies will initiate Phase 3 trial by end of year. y will n move for regulatory approval in first half of 2021 if y get sufficient data for licensure application.

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Phase 3 trial by year-end

Thomas Triomphe, Executive Vice President and Global He of Safi Pasteur, said in a statement that Safi and GSK bring proven science and techlogy to fight against global COVID-19 pandemic. Triomphe stated that initiation of clinical study is an important step and brings m closer to a potential vaccine which could help defeat COVID-19. 

“Our dedicated teams and partner continue to work around clock as we aim to deliver first results in early December. Positive data will enable a prompt start of pivotal phase 3 trial by end of this year,” he ded.

vaccine candidate has been developed in collaboration with Biomedical vanced Research and Development Authority, part of office of Assistant Secretary for Preparedness and Response at US Department of Health and Human Services. Roger Conr, president of GSK Vaccines said in a statement that clinical trial is an important moment in progress towards dressing pandemic.

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