Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020.
The deal between Sanofi provides BioNTech access to its infrastructure and expertise to produce over 125 million doses of the COVID-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt starting in the summer of 2021, according to a news release.
“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. Today’s announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic,” Sanofi CEO Paul Hudson said in the release. “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.
“As always, our top priority is to focus our efforts and capabilities on fighting this global pandemic. First and foremost, we will do this by continuing to develop our own COVID-19 vaccines candidates, in parallel with this industrial cooperation.”
Sanofi’s own vaccine candidate is being developed in collaboration with GlaxoSmithKline, with Phase 1/2 study results showing an immune response comparable to patients who recovered from COVID-19 in adults between 18 and 49 years old, but a low immune response in older adults, likely due to an insufficient concentration of the anitgen.
The two companies plan to start a Phase 2 study in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), to evaluate the candidate with an improved antigen formulation, with positive data potentially leading to a global Phase 3 study in the second quarter of 2021. They hope this would lead to regulatory submissions in the second half of 2021 with potential availability of doses in the fourth quarter.
Additionally, the company 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. The company initially said it expected a Phase 1/2 study in the fourth quarter of 2020, but now says it anticipates a first-quarter 2021 start.