London/Paris: Drugmakers Sanofi and GlaxoSmithKline on Wednesday said they plan to make available 200 million doses of their Covid-19 vaccine to the World Health Organisation-led COVAX international initiative which aims to ensure equitable global access to vaccines against the novel coronavirus.
The two companies said that they have signed a pact with Gavi, the legal administrator of the COVAX Facility, for their adjuvanted, recombinant protein-based Covid-19 vaccine.
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 the appropriate approvals are obtained.
“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,” Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said in a statement.
“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.”
Sanofi and GSK initiated a Phase-1/2 study on September 3 with a total of 440 participants, 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.
“Since we started working on the development of Covid-19 vaccines, GSK has pledged to make them available to people around the world,” said Roger Connor, President of GSK Vaccines added.
“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 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.