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.”

Source: Sanofi