Sanofi-GSK Prepare Regulatory Filings For COVID-19 Vaccine After Booster Data

Sanofi SA SNY and GlaxoSmithKline plc GSK are seeking regulatory approval for their COVID-19 vaccine to be used as a booster, as well as a standalone two-dose shot.

• In two separate trials, the companies said their adjuvanted protein-based vaccine demonstrated "universal ability" to boost neutralizing antibodies whether following mRNA or adenovirus shots, as well as 57.9% efficacy against any symptomatic COVID-19 disease. 
• Protection against moderate or severe disease was better at 75%, yet higher against severe disease and hospitalizations at 100%.
• The VAT08 study tested the vaccine as a two-dose primary series. Symptomatic COVID-19 cases in the vaccine and placebo cohorts were 0 vs. 10 cases of severe disease and hospitalization post-dose 1 and 0 vs. 4 cases post-dose 2.
• Related: Sanofi, Glaxo's COVID-19 Vaccine Candidate Works As Booster, But Data Readout Pushed Back.
• The 75% figure for protection against moderate-to-severe disease came from 3 vs. 11 cases among participants who had never been vaccinated or infected. 
• Preliminary sequencing data suggest it has 77% efficacy against Covid cases associated with the Delta variant.
• The companies said the final analysis of the booster trial, which included participants previously given shots based on mRNA technology or adenovirus viral vectors, showed it could increase neutralizing antibodies by 18 to 30 times. 
• When used as a booster to a two-dose Sanofi/GSK regimen, antibody levels shot up 84 to 153-fold.
• Price Action: SNY shares are up 1.39% at $52.80, and GSK stock is up 1.15% at $43.18 during the market session on the last check Wednesday.