French and British pharmaceutical companies announced on Friday that they will initiate global phase 3 clinical efficacy studies of a coronavirus vaccine candidate.
The clinical study will assess the safety, efficacy and immunogenicity, according to a statement from Sanofi and GSK.
The efficiency study will include more than 35,000 participants who are older than 18 years old from America, Asia, Africa and Latin America.
The statement said that in a Phase 2 study, the candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates.
If Phase 3 results are positive, the vaccine is expected to be approved in the last quarter of 2021.
To ensure rapid access to the vaccine, the two companies plan to start production of their COVID-19 vaccine candidates in the weeks following positive clinical results.
“We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting,” said Executive Vice President and global head of Sanofi, Thomas Triomphe. “This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.”
GSK Vaccines President Roger Connor said he believes further solutions are needed for COVID-19 to help reach people around the world, especially as the pandemic develops and variants continue to emerge.
“Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine,” he said. “We are grateful to the volunteers who will take part in the trials and hope the results will add to the encouraging data we’ve seen so far so we can make the vaccine available as quickly as possible.”
The first stage of the study aims to prevent symptomatic COVID-19 in adults who were not exposed to the virus. Secondly, to prevent patients from having severe symptoms and to prevent asymptomatic infection.
Sanofi also provides production support to other vaccine manufacturers. The company recently announced it would manufacture up to 200 million doses of Moderna’s vaccine for the US starting in September.
It announced at the beginning of the year that it would provide 125 million doses of production support to BioNTech for the European Union, announcing last February that Johnson & Johnson will support the company with about 12 million doses per month for the production of the vaccine.