Sanofi and GSK to Seek Regulatory Authorization for COVID-19 Vaccine

Sanofi and GlaxoSmithKline (GSK) announced on Feb. 23, 2022 that they intend to submit data from both their booster and Phase 3 efficacy trials to support regulatory authorizations applications to FDA and the European Medicines Agency (EMA) for a COVID-19 vaccine.

The Sanofi-GSK vaccine is refrigerator temperature-stable and protein-based. The Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies across vaccine platforms and age groups in participants who had already received an authorized mRNA or adenovirus vaccine. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralizing antibodies increased significantly compared to pre-boost levels.

“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine,” stated Thomas Triomphe, executive vice president of Sanofi Vaccines, in the press release. “The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages. We also observed robust efficacy of the vaccine as a primary series in today’s challenging epidemiological environment. No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines.”