Sanofi COVID 19 vaccine development update.

Sanofi and BioNTech have entered into an agreement under which Sanofi will support manufacturing and supply of BioNTech’s COVID-19 vaccine which is being co-developed with Pfizer. Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021. Sanofi is collaborating with GSK on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of Sanofi’s seasonal influenza vaccines, combined with GSK’s established pandemic adjuvant platform. Phase 1/II study results of the vaccine candidate 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. The Companies plan to initiate a new Phase II study in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), that will evaluate the vaccine candidate with an improved antigen formulation in order to achieve high-level immune response across all age groups. If data are positive, a global Phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with potential availability of doses in the fourth quarter of 2021. In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/II study to start in Q1 2021.