Official Update: Senofi Vaccine Reaction against Covid-19.
In December 2020, initial results from a phase 1/2 clinical trial showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults, likely due to an insufficient concentration of the antigen. A total of 441 healthy adults participated in the study in the US which evaluated safety, tolerability and immune response.
Sanofi is planning to launch a phase 2b study with an optimized candidate vaccine in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA) in the US. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global phase 3 study could start in Q2 2021. If the vaccine meets clinical requirements on safety and efficacy, and once approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021.
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