GlaxoSmithKline (GSK) and Sanofi have entered into a statement of intent with Gavi to supply 200 million doses of their adjuvanted recombinant protein-based Covid-19 vaccine to the COVAX Facility.
Gavi is the legal administrator of the COVAX Facility, which is part of COVAX, a global collaboration of governments, global health organisations, businesses and philanthropic organisations working to advance 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 (WHO). COVAX is said to form the vaccines pillar of the Access to Covid-19 Tools (ACT) accelerator.
Recently, over 180 countries and economies signed onto the COVAX Facility to access vaccines to meet the global scale of the Covid-19 pandemic.
Sanofi Pasteur global head and executive vice president Thomas Triomphe said: “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.”
In September, both companies began phase 1/2 study and recruited 440 subjects. The results from the trials are expected to be revealed in early December, which will help to begin a pivotal phase 3 study before the end of this year.
The companies plan to apply for regulatory approval in the first half of 2021 if the data is sufficient for licensure application. They are also planning to scale up manufacturing of the antigen and adjuvant in parallel.
GSK Vaccines president Roger Connor said: “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.”
Recently, GSK and Vir Biotechnology have announced that they will expand the study of a VIR-7831 (GSK4182136) monoclonal antibody to treat Covid-19.