Sanofi and GSK plan to make available to the Gavi lead COVAX Facility 200 million doses of their adjuvanted recombinant protein-based vaccine for COVID-19 if authorized by the regulatory authorities and have signed a Statement of Intent.
Sanofi and GSK sign Statement of Intent to supply their adjuvanted recombinant protein-based vaccine for COVID-19 worldwide trough the COVAX Facility
The COVAX Facility is led by Gavi and strives to secure successful and equitable access to COVID-19 vaccines worldwide. Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, which is a global risk-sharing mechanism for pooled procurement and equitable distribution of potential COVID-19 vaccines.
Both pharma companies intend to contribute to the COVAX aim to ensure that a safe and efficient COVID-19 vaccine becomes globally accessible for those in need, regardless of where on this planet they live, once the investigational adjuvanted, recombinant protein-based COVID-19 vaccine gets approved.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, stated:
“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. 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 commented:
“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.”
People in all parts of the world to have access to COVID-19 vaccines
The COVAX Facility is part of COVAX, a global collaborative partnership between governments, health organisations, companies and charity organizations making an effort together to advance the development, manufacturing, fair distribution and access to COVID-19 vaccines. COVAX is co-founded by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO forming the vaccines backbone of the Access to COVID-19 Tools (ACT) Accelerator. Through the COVAX Facility activities, vaccines will be delivered to member countries through the newly released by WHO Allocation Scheme and the WHO’s Strategic advisory board of Experts on Immunization (SAGE) Values Framework, which has started to include prospective guidelines on vaccine use. The goal of these allocation principles is to ensure that people in all parts of the world can have access to COVID-19 vaccines once they are available.
Status of the adjuvanted recombinant protein-based COVID-19 vaccine development
Sanofi and GSK launched a Phase 1/2 trial on the 3rd of September with a total of 440 subjects participating and are expecting the first results in early December 2020 to support the start of a pivotal Phase 3 study before the end of the year. If the data is eligible to be submitted as an application for authorisation, it is intended that regulatory approval will be requested in the first half of 2021. At the same time, the businesses are increasing the production of antigens and adjuvant respectively.
Sanofi, on the front lines in the fight against COVID-19
In addition to the recombinant protein-based vaccine developed in collaboration with GSK, Sanofi is also working on a messenger RNA vaccine in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the pharmaceutical and biotechnology industries, mRNA is thought of as one of 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 Q4 of 2020, with the earliest possible approval in the second half of 2021. Massachusetts-headuartered clinical-stage therapeutics company Translate Bio has an established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.
GSK’s commitment to tackling COVID-19
GSK, in partnership with companies and scientific research groups around the world, works on developing promising COVID-19 vaccine candidates using its ground-breaking adjuvant vaccine technology platform. Adjuvant use is of special significance in a pandemic situation as it could minimize the amount of vaccine protein needed per dose, leading to an increased capacity for more vaccine doses to be manufactured in order to protect more people. GSK does not plan to make a profit from COVID-19 vaccines during the pandemic and will spend all short-term income on coronavirus-related studies and long-term pandemic preparedness, either through GSK’s internal contributions or through external partners.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better and live longer. For further information please visit www.gsk.com.
Sanofi is a multinational biopharmaceutical organization dedicated to human health. Sanofi remains committed to empowering people through their health challenges and aims to prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. The pharma giant stands by the few who suffer from rare diseases and the millions with long-term chronic conditions. Through more than 100,000 employees in 100 countries, Sanofi is transforming scientific innovation into global healthcare solutions.
Sanofi Press Release: https://www.sanofi.com/en/media-room/press-releases/2020/2020-10-28-07-00-00