RESEARCH TRIANGLE PARK – GlaxoSmithKline has received good news on two fronts in the battle against COVID-19, reporting the launch of a Phase 3 clinical trial for a COVID-19 vaccine and also emergency authorization for use of its antibody drug from the FDA.
GSK is partnering with Sanofi on the vaccine. While other vaccines have already won approval, GSK and Sanofi are moving ahead with a global trial including some 35,000 volunteers ages 18 and over across the US as well as Asia, Africa and Latin America.
“Following encouraging interim results from the recent Phase 2 study, the companies will also begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the initial vaccine platform received,” GSK said in a statement.
Roger Connor, president of GSK Vaccines, noted: “We believe further solutions for COVID-19 are very much needed to help reach people around the world, especially as the pandemic evolves 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. 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.”
On Wednesday, GSK and partner Vir Biotechnology received emergency use authorization for its investigational single-dose monoclonal antibody for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients 12 years of age and older meeting minimum weight requirements.
“The new treatment may offer an advantage as concerns rise about new virus variants that may evade some antibody drugs,” The New York Times reported.
Adrienne E. Shapiro, an infectious disease specialist at Fred Hutchinson Cancer Research Center, said in a statement: “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk – allowing them to avoid hospitalisation or worse.”
GSK maintains a significant operation in RTP and has a manufacturing plant in Zebulon.