Sanofi and GSK have announced positive results from the trial of their adjuvanted bivalent D614 and Beta (B.1.351) Covid-19 vaccine candidate.
In the placebo-controlled trial, which was carried out in a high Omicron variant circulation environment, the Beta-containing vaccine candidate demonstrated a favourable safety and tolerability profile.
Earlier this month, Sanofi reported positive data from two studies that were conducted with its new next-generation Covid-19 booster vaccine candidate modelled on the Beta variant antigen and including the pandemic adjuvant of GSK.
The company will submit the data supporting this booster vaccine to regulatory authorities.
GSK Vaccines president Roger Connor said: “These positive data show efficacy of our protein-based, bivalent adjuvanted vaccine candidate in an environment of high Omicron variant circulation.
“Our vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves further. We are looking forward to the discussions with regulatory authorities with the aim of making our vaccine candidate available later this year.”
Stage two of the Phase III Covid-19 vaccine trial VAT08 enrolled more than 13,000 subjects aged 18 years and older to evaluate the Sanofi-GSK vaccine candidate.
Throughout the trial’s Stage 1 and Stage 2, the Sanofi-GSK vaccine showed a favourable safety as well as tolerability profile.
Sanofi Vaccines executive vice-president Thomas Triomphe said: “With the immunogenicity data from our Beta-booster vaccine, they support our belief that, in a largely seropositive world, a next-generation Beta booster vaccine could provide protection against variants like Omicron.”
As part of a partnership between the two companies, Sanofi provides its recombinant antigen and will be the holder of the marketing authorisation while GSK contributes with its adjuvant.