February 22 2021: Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen´s COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs.
Janssen has submitted an application to the U.S.FDA requesting Emergency Use Authorization for its single-dose Janssen COVID-19 vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency.
Once authorized, Sanofi will provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Janssen’s COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month.
“Today’s agreement is the second of its kind and demonstrates Sanofi’s ongoing commitment to the collective effort to ending this crisis as quickly as possible,” said Paul Hudson, Chief Executive Officer, Sanofi.
“While our priority remains advancing our two COVID-19 vaccine programs, we recognize there are opportunities to increase supply and expand access to COVID-19 vaccines.
As such, without compromising other essential medicines and vaccines, and where we have the right manufacturing capabilities, we are stepping forward to show solidarity in the industry and continue doing our part in the fight against COVID-19.”
Sanofi earlier announced an agreement with Pfizer-BioNTech under which Sanofi will support the manufacturing and supply of more than 125 million doses their COVID-19 vaccine.
Sanofi’s priority is to continue to develop its two COVID-19 vaccine candidates
· 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.
The Companies initiated a new Phase 2 study in February 2021 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 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 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. A Phase 1/2 study is expected to start in Q1 2021.”