License Process for Vaccine Developed by GSK and Sanofi Begins

GSK and Sanofi announced that they will apply to the American Medicines Administration (FDA) and the European Medicines Agency (EMA) to initiate the licensing process of their adjuvanted recombinant COVID-19 vaccine. The licensing process of the COVID-19 vaccine developed in cooperation with GSK and Sanofi has begun. The registration application of the vaccine will be based on data obtained from Phase 3 studies that started last year and booster dose findings. The adjuvanted vaccine appears to induce potent immune responses and has a favorable safety profile. The recombinant COVID-19 vaccine can be stored at refrigerator temperature. Another significant development regarding the COVID-19 vaccine ready for registration by GSK and Sanofi is that an 18-30 fold increase in neutralizing antibodies was observed when mRNA or adenovirus vaccines were administered as a booster dose to participants who received them as primary doses. When GSK and Sanofi's vaccine was administered as a two-dose primary series and subsequently as a booster dose, the neutralizing antibody level increased between 84 and 153 times compared to pre-booster levels.