Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

Late comers to coronavirus vaccine development, pharma majors France’s Sanofi (Euronext: SAN) and the UK’s GlaxoSmithKline (LSE: GSK) today announced that they intend to submit data from both their booster and Phase III efficacy trials as the basis for regulatory applications for a COVID-19 vaccine.

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings.

In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels.