Covid vaccine, Sanofi and Gsk start phase 3: approval by 2021

Sanofi and GSK announce the launch of the Phase 3 clinical trial that will evaluate the safety, efficacy and immunogenicity of their candidate Covid-19 adjuvanted recombinant protein vaccine It reads in a note that explains: “The phase 3 randomized, double-blind and placebo-controlled study will include more than 35,000 adult volunteers (aged 18 and over) from different countries in the United States, Asia, Africa and America. Latina “. The primary endpoint of the study is the prevention of symptomatic Covid-19 disease in Sars-Cov-2 naïve adults, while the secondary endpoints are the prevention of severe Covid-19 disease and the prevention of asymptomatic infection. In two distinct phases, the study will initially analyze the efficacy of a vaccine formulation targeting the native virus D.614 (Wuhan), while a second phase will evaluate a second formulation targeting variant B.1.351 (South African variant). Recent scientific evidence shows that antibodies created against variant B.1.351 can provide broad cross-protection against other more highly transmitted variants. The phase 3 design, conducted in different geographical areas, also allows to evaluate the efficacy of the candidate vaccine against a variety of circulating variants. Following the encouraging interim results of the recent phase 2 study, the companies will also begin a clinical trial in the coming weeks to evaluate the ability of the candidate Covid-19 adjuvanted vaccine based on recombinant proteins to induce a strong response. as a booster dose, regardless of the type of vaccine previously received. “We are confident in kicking off a Phase 3 study of this magnitude as we believe our unique technology platform can offer a truly clinically relevant opportunity – says Thomas Triomphe, executive vice president, global head of Sanofi Pasteur. – We have adapted our development strategy in consideration of the fact that the virus continues to mutate and trying to anticipate what may be necessary in a post-pandemic context. it is tangible proof of our willingness to implement a decisive and flexible approach ible in response to the pandemic “.” We believe that further solutions are needed for Covid-19 that can help reach people around the world, especially as the pandemic evolves and variants continue to emerge – adds Roger Connor, president of GSK Vaccines -. We have adapted our technology and the study design reflects this need. It will build the further potential of this adjuvanted recombinant protein vaccine. We are grateful to the volunteers who will take part in the trials and hope that the results add to the encouraging data we have seen so far, so that we can make the vaccine available as quickly as possible. “Waiting for the positive results of phase 3 and regulatory reviews , vaccine approval is expected in the fourth quarter of 2021. Production will begin in the coming weeks to allow quick access to the vaccine should it be approved.