GSK and Sanofi Advance to Phase 3 Trials for COVID-19 Vaccine

GSK and Sanofi's COVID-19 vaccine completes Phase 2 clinical trial with positive results. Following positive outcomes from the Phase 3 study to begin in the coming weeks and regulatory approvals, the vaccine is expected to receive authorization in the fourth quarter of 2021. Sanofi and GSK's adjuvanted recombinant COVID-19 vaccine completed its Phase 2 clinical trial with positive results involving 722 volunteers. This vaccine development by the two major companies holds significant importance due to its stability advantage at standard vaccine storage temperatures, ease of administration, and simple distribution capability as it can be stored at standard refrigerator temperatures. The vaccine under development also stands out for its potential to generate high and durable immune response and prevent virus transmission. Phase 2 results demonstrated that the vaccine showed 95 to 100 percent success in generating relevant antibodies against COVID following the second injection across all age groups ranging from 18 to 95 years and all doses. The vaccine was observed to generate strong neutralizing antibody formation at high levels comparable to those produced by natural infection, with higher levels in young adults aged 18 to 59. Additionally, in participants showing symptoms of SARS-CoV-2 infection, the achievement of high neutralizing antibody levels following a single injection was interpreted as indicating that the vaccine carries strong potential for strengthening the immune system. In line with these positive Phase 2 interim results, a global Phase 3 study is planned to be initiated in the coming weeks as a randomized, double-blind trial involving more than 35,000 adult participants from various countries. As part of the collaboration in which Sanofi contributes with its Protein-S COVID-19 antigen based on recombinant DNA technology and GSK provides adjuvant technology, the Phase 3 clinical study is targeted to begin in the coming weeks. Following the Phase 3 study expected to yield positive results and the relevant regulatory approvals, the vaccine is expected to receive authorization in the fourth quarter of 2021.