License Process for Vaccine Developed by GSK and Sanofi Begins

License Process for Vaccine Developed by GSK and Sanofi Begins
  • 26.04.2022
GSK and Sanofi with adjuvant developed announced that they will apply to the American Medicines Administration (FDA) and the European Medicines Agency (EMA) to initiate the licensing process of the recombinant COVID-19 vaccine. It has been announced that 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 the data obtained as a result of the Phase 3 studies that started last year and the booster dose. Adjuvanted , which appears to induce potent immune responses and has a favorable safety profile. The recombinant COVID-19 vaccine can be stored at refrigerator temperature. Another important development regarding the COVID-19 vaccine, which is 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 were administered 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 before the booster dose.

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