Subject to a final contract, the UK government will receive the doses of a vaccine candidate developed by the two companies in partnership and based on the recombinant protein-based technology Sanofi used to produce an influenza vaccine, along with GSK’s pandemic adjuvant technology, according to a news release.
Sanofi expects a Phase 1/2 study for the vaccine candidate to begin in September, followed by a Phase 3 study by the end of 2020. If the sudies report positive data, regulatory approval could be garnered by the first half of 2021, while the two companies are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
“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,” Sanofi Pasteur EVP & global head Thomas Triomphe said in the release. “We greatly appreciate the UK government’s support of this shared vision.”
Last week, the two companies announced that they received a $1.2 billion award from the U.S. government for the development of the vaccine. The award was the largest among the more than $8 billion that the federal government, under its Operation Warp Speed program, has pledged to different companies for COVID-19 vaccine development.
“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,” GSK vaccines president Roger Connor added. “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.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease