Contract Pharma Staff07.29.20
Sanofi and GSK have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
“With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK government’s support of this shared vision,” said Thomas Triomphe, executive vice president and global head, Sanofi Pasteur.
Roger Connor, president, GSK Vaccines, said, "We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world. We thank the UK Government for confirmation of purchasing intent, which supports the significant investment we are already making as a company to scale up development and production of this vaccine.”
Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
“Our scientists and researchers are racing to find a safe and effective vaccine at a speed and scale never seen before. While this progress is truly remarkable, the fact remains that there are no guarantees,” said Alok Sharma, UK business secretary. “In the meantime, it is important that we secure early access to a diverse range of promising vaccine candidates, like GSK and Sanofi, to increase our chances of finding one that works so we can protect the public and save lives.”
Active discussions on supply of the vaccine are ongoing with global organizations, the U.S. and the EU Commission, with France and Italy on the negotiation team. The partners plan to provide a significant portion of total worldwide available supply capacity in 2021/22 to the global initiative, “Access to COVID‐19 Tools (ACT) Accelerator”, a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising. Sanofi expects a Phase 1 study to start by the end of the year, and, if the data are positive, an approval at the earliest 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.
“With our partner GSK, we are pleased to cooperate with the UK government as well as several other countries and global organizations as part of our ongoing efforts to develop a safe and effective vaccine and make it available as quickly as possible. We greatly appreciate the UK government’s support of this shared vision,” said Thomas Triomphe, executive vice president and global head, Sanofi Pasteur.
Roger Connor, president, GSK Vaccines, said, "We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world. We thank the UK Government for confirmation of purchasing intent, which supports the significant investment we are already making as a company to scale up development and production of this vaccine.”
Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
“Our scientists and researchers are racing to find a safe and effective vaccine at a speed and scale never seen before. While this progress is truly remarkable, the fact remains that there are no guarantees,” said Alok Sharma, UK business secretary. “In the meantime, it is important that we secure early access to a diverse range of promising vaccine candidates, like GSK and Sanofi, to increase our chances of finding one that works so we can protect the public and save lives.”
Active discussions on supply of the vaccine are ongoing with global organizations, the U.S. and the EU Commission, with France and Italy on the negotiation team. The partners plan to provide a significant portion of total worldwide available supply capacity in 2021/22 to the global initiative, “Access to COVID‐19 Tools (ACT) Accelerator”, a global collaboration of leaders of governments, global health organizations, businesses and philanthropies to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is also developing a messenger RNA vaccine candidate in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising. Sanofi expects a Phase 1 study to start by the end of the year, and, if the data are positive, an approval at the earliest 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.
