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New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults
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If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021
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In parallel, development work on new SARS-CoV-2 variants underway
Sanofi and GlaxoSmithKline (GSK) announced today the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
"Over the past few weeks, our teams have worked to refine the antigen formulation of our recombinant-protein vaccine, based on learnings from our initial Phase 1/2 study." said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. "We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data. This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages. We have demonstrated our commitment to focusing efforts and capabilities towards the global fight against the pandemic, and this new study takes us a step closer to achieving our primary goal of developing a COVID-19 vaccine with a good efficacy and safety profile."