It announced that it will carry out late-stage manufacturing at its German plant in Frankfurt, from July, to supply over 125 million doses of the vaccine for the EU.
“Since our main vaccine is a few months late, we asked ourselves how we could be of assistance now,” Sanofi CEO, Paul Hudson, told Le Figaro newspaper yesterday [January 26].
Last month, Sanofi and GSK said a COVID-19 vaccine they are jointly developing had showed an insufficient immune response in older people, likely due to an insufficient concentration of the antigen, with that outcome delaying its launch to later this year.
Today, Hudson commented further: “We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. Although vaccination campaigns have started around the world, the ability to get shots into arms is being limited by lower than expected supplies and delayed approval timelines owing to production shortages. We have made the decision to support BioNTech and Pfizer in manufacturing their COVID-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so.”
Improved antigen formulation in Sanofi-GSK vaccine
Separately, Sanofi remains committed to its two COVID-19 vaccine candidates. The jab it is developing with GSK is based on the same recombinant protein-based manufacturing technology as one of its seasonal influenza vaccines, combined with GSK’s established pandemic adjuvant platform.
The partners said they plan to initiate a new Phase 2 study in February with support from the US agency, the Biomedical Advanced Research and Development Authority (BARDA). That study 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 3 study could start in Q2 2021. If this study meets objectives then they would file regulatory submissions in the second half of this year, with potential availability of doses in Q4 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 1/2 study to start in Q1 2021.