Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.
Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.
Both Companies intend to contribute to COVAX's ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals.
"To address a global health crisis of this magnitude, it takes unique partnerships. The commitment we are announcing today for the COVAX Facility can help us together stand a better chance of bringing the pandemic under control," said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.
"This moment also reflects our long-term commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world."
Roger Connor, President of GSK Vaccines added, "Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world. We are proud to be working with Sanofi to make this adjuvanted recombinant protein-based vaccine available to the countries signed up to the COVAX Facility as soon as possible - this has the potential to be a significant contribution to the global fight against COVID-19."
The COVAX Facility is part of COVAX, a global collaboration of governments, global health organisations, businesses and philanthropic organisations 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 WHO and forms the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator. More than 180 countries and economies have 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 the 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 1/2 study on September 3 with a total of 440 subjects enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, it is planned to request regulatory approval from the first half of 2021. In parallel, the Companies are scaling up manufacturing of the antigen and adjuvant respectively.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising.
Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in the fourth quarter of 2020, with earliest potential approval in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.