Under a new agreement with the European Commission, Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union in exchange for manufacturing scale-up support.
The vaccine in question is based on a mix of Sanofi’s recombinant protein-based technology — formerly used to create an influenza vaccine — and GSK’s pandemic adjuvant technology. It is currently being assessed in a phase 1/2 clinical study, with a phase 3 study planned to begin by year’s end. The companies intend to seek regulatory approval beginning in the first half of 2021 if all goes well.
Under the agreement, Sanofi and GSK will scale up manufacturing of both the antigen and adjuvant, with an end goal of producing as many as 1 billion doses per year. This will be supported by upfront funding from the EU. The antigen and final vaccine doses will also be produced in European countries, at industrial sites in Belgium, Italy, Germany, and France. All member states of the EU will be eligible to purchase the vaccine, and reserved doses may be donated to lower and middle-income countries.
While an agreement was reached in principle back in July, this latest announcement finalizes that agreement for Europe.
Separate arrangements with GSK and Sanofi are also in place with the United States and the United Kingdom, as well as with the global endeavor known as the Access to COVID-19 Tools Accelerator, which the companies intend to provide with a significant portion of total worldwide available supply capacity.