The vaccine candidate is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established adjuvant technology. This final agreement confirms the announcement made on July 31 by both companies and marks a key milestone in protecting European populations against COVID-19.
The contract will allow the purchase of a vaccine against COVID-19 for all Member States of the European Union (EU), which may donate reserved doses to lower- and middle-income countries. The EU will provide upfront funding to support the scale-up of Sanofi and GSK manufacturing capabilities on European soil. The antigen and final vaccine doses will be manufactured in European countries, leveraging Sanofi and GSK’s industrial sites in Belgium, Italy, Germany, and France.
The companies announced the launch of a Phase 1/2 clinical study in support of the vaccine’s development on September 3rd. A Phase 3 study is planned to begin by the end of 2020 and regulatory approval could be requested in the first half of 2021. Thanks in part to the agreement signed today, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the intent to produce up to one billion doses per year overall to help meet the high and urgent demand for vaccines worldwide.
Sanofi and GSK are committed to making the vaccine available globally
Sanofi and GSK also recently signed agreements with the United States and UK governments. The partners plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX, the vaccines pillar of the ACT-Accelerator (Access to COVIDâ€19 Tools), a global collaboration of leaders of governments, global health organizations, businesses, and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.