Feb. 22 — GlaxoSmithKline and Sanofi pharmaceutical companies announced Monday that they have launched a second-stage clinical trial for their COVID-19 protein-based vaccine, which was postponed in December after testing. More than 700 volunteers are interested in the Stage 2 trials for their protein-based adjuvant coronavirus vaccine, the drugmakers said.In December, GSK and Sanofi postponed trials after discovering that the vaccine did not adequately stimulate an immune response in older people.
Monday’s announcement said developers have improved the formulation of the vaccine and older adults are included in the latest research process. The companies suggested that the new phase would examine the potential for three volunteer doses of antigens in the United States, Panama and Honduras.If the results are good, between April and July, the companies expect the Phase 3 analysis to begin. They plan to make the vaccine available sometime between October and January if the final stage is successful.
In a statement, Sanofi Executive Vice President Thomas Triomphe said, “We are confident our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,”. “This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages.”The developmental vaccine at GSK and Sanofi differs from those developed by Pfizer and Moderna (mRNA) and Johnson & Johnson (adenovirus) in that it is considered to be more experimental and uses a protein adjuvant to facilitate a stronger coronavirus immune response.
“The world needs multiple vaccines and we are confident that combining our proven pandemic adjuvant system with this improved antigen formulation will have significant potential as the pandemic evolves,” GSK Vaccines President Roger Connor said.Sanofi also said Monday that when it is approved, it would help Johnson & Johnson formulate and fill 12 million doses of its one-shot vaccine every month. With Translate Bio, Sanofi is also developing an mRNA vaccine and says it has seen “encouraging preclinical data.” This spring, an early-phase study is expected.