In an effort to meet global supply demands, Sanofi has agreed to support the manufacturing of a COVID-19 vaccine made by Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., both of which are part of Johnson & Johnson.
The Janssen candidate has been submitted to the U.S. Food and Drug Administration (FDA) for potential Emergency Use Authorization, as well as to the European Medicines Agency for conditional marketing authorization. The single-dose vaccine will mark Sanofi’s second manufacturing support offer, following an agreement to aid Pfizer-BioNTech to manufacture and supply more than 125 million doses of their own vaccine.
“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,” Paul Hudson, Sanofi CEO, said. “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.”
Once the Janssen candidate has been authorized, Sanofi intends to open its vaccine manufacturing plant in Marcy l’Etoile, France, to Johnson & Johnson for use, formulating and filling vials throughout the year. The pair expect to reach a rate of approximately 12 million doses per month.
Still, Sanofi doesn’t mince words: its priority remains its own pair of COVID-19 vaccine candidates. Both are the result of collaborations: one with GSK and one with Translate Bio. The GSK candidate uses the same recombinant protein-based manufacturing technology as one of Sanofi’s seasonal influenza vaccines combined with GSK’s pandemic adjuvant platform. A phase two study of that candidate is currently underway for all age groups, with a phase three study expected to begin in the second quarter.
The candidate being pursued with Translate Bio is earlier in development, having only passed preclinical data so far. Another mRNA vaccine, it has so far been shown to induce high neutralizing antibody levels after two doses, at around the upper range of those seen in infected humans. A phase 1/2 study is expected to begin later this quarter.