The French company Sanofi and its British partner GSK announced Thursday that they are starting a late-stage human trial for a coronavirus vaccine.
The trial will also include studies for boosters and the vaccine’s efficacy against a string of variants and comes after phase two trials showed a high efficacy rate for the shot.
Earlier tests showed the vaccine produced high levels of antibodies in patients with evidence of a prior coronavirus infection, suggesting “strong potential for development as a booster vaccine” and the possibility of “broad cross-protection against other more transmissible variants.”
The trial will include over 35,000 adults in the United States, Asia, Africa and Latin America.
“We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase 3 study, as we believe that our unique technology platform will provide a clinically-relevant vaccine option,” Thomas Triomphe, executive vice president, global head of Sanofi Pasteur, said in a statement. “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.”
“Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine. 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,” added Roger Connor, president of GSK Global Vaccines.
Clinical studies on the efficacy of the shot as a booster will also be done on participants regardless of whether they already received a vaccine from another manufacturer.
The two companies said they are looking to possibly get approval of their vaccine in the fourth quarter of 2021.