Licensing Process Begins for Vaccine Developed by GSK and Sanofi

GSK and Sanofi announced they will submit their adjuvanted recombinant COVID-19 vaccine for regulatory approval to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). GSK and Sanofi announced the start of the regulatory approval process for the COVID-19 vaccine developed through their collaboration. The vaccine regulatory submission will be based on data from Phase 3 trials that began earlier last year and from the booster dose results.

Vaccine Efficacy Deemed Appropriate

The adjuvanted recombinant COVID-19 vaccine, which was found to generate strong immune responses and has an appropriate safety profile, can be stored at refrigerator temperatures. Another significant development regarding GSK and Sanofi's COVID-19 vaccine, which is ready for regulatory approval, is that when administered as a booster dose to participants who received mRNA or adenovirus vaccines as primary doses, neutralizing antibody levels increased by 18 to 30-fold. When GSK and Sanofi's vaccine is administered as two primary doses followed by a booster dose, neutralizing antibody levels showed an increase of 84 to 153-fold compared to levels before the booster dose.

Efficacy Rates Established Through Studies

According to current Phase 3 study results, the GSK-Sanofi vaccine administered as 2 doses showed: 100% efficacy against severe COVID-19 cases and hospitalizations; 75% efficacy against moderate-to-severe cases; and approximately 58% efficacy against any symptomatic COVID-19 case. Roger Connor, Head of GSK Global Vaccine Business Unit, stated: "The evolving epidemiology of COVID-19 demonstrates the need for diverse vaccines. Our protein-based adjuvanted vaccine candidate was developed using our established approach, which has been used in combating other viral infections, including pandemic influenza. This vaccine will play an important role not only in our fight against the pandemic, but also in preparing us for the post-pandemic period."