Sanofi and GSK to support COVAX with 200 million doses of COVID-19 vaccine

The companies anticipate first results of Phase I/II in early December 2020, to support the initiation of a pivotal Phase III study before the end of the year.

The two companies have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility.

“To address a global health crisis of this magnitude, it takes unique partnerships,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

The COVAX Facility is part of COVAX, a global collaboration of governments, global health organizations, businesses and philanthropic organizations working to accelerate development, production, and equitable access to COVID-19 vaccines.

COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organisation and forms the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator.

More than 180 countries and economies recently signed onto the COVAX Facility to get timely and cost-effective access to vaccines to meet the global scale of the COVID-19 pandemic.

Through the COVAX Facility’s efforts, vaccines will be distributed in participating countries through the WHO’s recently published Allocation Framework, and WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) Values Framework, which has begun to frame future guidance on vaccine use. These allocation principles aim to ensure that people in all parts of the world will get access to COVID-19 vaccines once they are available.

Sanofi and GSK initiated a Phase I/II study on 3 September with a total of 440 subjects enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase III study before the end of the year.

If these data are sufficient for licensure application, the companies plan to request regulatory approval from the first half of 2021. In parallel, the companies are scaling up manufacturing of the antigen and adjuvant respectively.