Home Business Sanofi-GSK Covid-19 Vaccine Set for Large-Scale Trials After Positive Results

Sanofi-GSK Covid-19 Vaccine Set for Large-Scale Trials After Positive Results

by Bioreports
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Sanofi SA and GlaxoSmithKline PLC said their Covid-19 vaccine candidate showed positive interim trial results and is expected to move into large-scale human trials soon, putting the long-delayed shot on track for potential regulatory approval later this year.

France’s Sanofi and GSK, based in the U.K., said Monday the two-dose shot produced strong antibody responses in phase-two trials with 722 volunteers. A single dose generated high levels of antibodies in volunteers with evidence of prior Covid-19 infection, the companies said, suggesting the vaccine could be useful as a booster for people already vaccinated with other shots.

Now the companies plan to begin pivotal phase-three trials, which will involve more than 35,000 people, and use two formulations: one targeting the original Covid-19 strain that circulated last year, and the second aimed at the strain that was originally detected in South Africa.

Sanofi and GSK fell behind other vaccine makers last year when they abandoned previous human trials after a miscalculation in the manufacturing process resulted in erroneously lower doses.

Their partnership combines a Sanofi-owned antigen—a protein from the coronavirus that triggers an immune response—and a GSK-owned adjuvant, a molecule used in some vaccines to boost the level of protection. The mis-dosing required the vaccine to be reformulated for new clinical trials.

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