Sanofi, GSK Sign Pacts with EU, Canada To Supply Their COVID-19 VaccineBy
Sanofi and GlaxoSmithKline (GSK) have signed separate agreements with the European Commission (EC) and the Canadian government for the supply of their COVID-19 vaccine. The vaccine is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine and GSK’s adjuvant technology.
Sanofi and GSK have finalized and signed an advanced purchase agreement with the EC for the supply of up to 300 million doses of their COVID-19 vaccine, once the vaccine is approved. This companies had announced a proposed agreement in late July (July 2020).
The contract will allow the EC to purchase the COVID-19 vaccine for all European Union (EU) member states, which may donate reserved doses to lower- and middle-income countries. The EU will provide upfront funding to support the scale-up of manufacturing at European facilities. The antigen and final vaccine doses will be manufactured in Sanofi and GSK’s industrial sites in Belgium, Italy, Germany, and France.
In a separate development, Sanofi and GSK have signed agreements with the Canadian government to supply of up to 72 million doses of their COVID-19 vaccine, beginning in 2021. Both companies have vaccine manufacturing sites in Canada that are contributing to their overall global COVID-19 vaccine development. These sites, plus their global industrial networks,will play a role in the production of the COVID-19 vaccine doses for Canada.
The companies launched a Phase I/II clinical study for their vaccine candidate in early September (September 2020). The companies say that a Phase III study is planned to begin by the end of 2020, and regulatory approval could be requested in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the intent to produce up to one billion doses per year globally.
In addition to their supply pacts with the EU and Canada, Sanofi and GSK recently signed supply agreements for their COVID-19 vaccine with the US and the UK governments. In July 2020, Sanofi and GSK announced a collaborative effort with the US government to supply up to 100 million doses of their COVID-19 vaccine with a further option by the US government to discuss the purchase of up to 500 million doses longer term. Both companies also agreed (subject to final contract) with the UK government to supply up to 60 million doses of their COVID-19 vaccine. In addition, the companies say they also plan to provide a portion of their available global supply capacity to the Access to COVID‐19 Tools (ACT) Accelerator, a global collaboration of governments, global health organizations, businesses, and philanthropies organized to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.