Sanofi and BioNTech have entered into an agreement under which Sanofi will support the manufacture and supply of BioNTech’s COVID-19 vaccine, which is being co-developed with Pfizer.
Sanofi will provide BioNTech access to its infrastructure and expertise to produce more than 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will come from Sanofi’s production facilities in Frankfurt, Germany, starting in summer 2021. The vaccine must be filled in a sterile environment and at a very low temperature. The proximity of Sanofi’s production facility in Frankfurt to Biontech’s headquarters in Mainz is an advantage.
Sanofi is several months behind schedule with its own vaccine. The company 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 epandemic adjuvant platform.
Phase 1/2 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 2 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 to achieve high-level immune response across all age groups. If data are positive, a global Phase 3 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 this recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing an mRNA vaccine in partnership with Translate Bio. Preclinical data showed that two immunizations of the vaccine induced high neutralizing antibody levels. These are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in Q1 2021.
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