France and UK Co-Develop COVID-19 Vaccine Advances to Late Stage Study
Paris-based Sanofi and its UK-based collaborator GSK announced the initiation of a Phase 2 study with 720 volunteers to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
Announced on February 22, 2021, three different antigen doses with a fixed dose of adjuvant will be tested in this new study in the USA, Honduras, and Panama.
In December 2020, a Phase 1/2 study's results showed an immune response comparable to patients who had recovered from COVID-19 in adults aged 18 to 49 years but a lower immune response in older adults, likely due to an insufficient concentration of the antigen.
If data from the new Phase 2 trial are positive, a global Phase 3 study is planned for Q2 2021. Positive results from the Phase 3 study would lead to regulatory submissions in the second half of 2021, with the vaccine expected to be available in late 2021, if approved.
Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur, commented in a press statement, “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.”
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions worldwide.