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Sanofi and GSK confirm agreement with European Union to supply up to 300 million doses of adjuvanted COVID-19 vaccine

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Sanofi and GSK finalised and signed today an advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. 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 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 COVID‐19 Tools), a global collaboration of leaders of governments, global health organisations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

GSK commitment to tackling COVID-19
GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase, and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.