Sanofi, GSK tout 72% Omicron efficacy in PhIII trial of next-gen, bivalent shot — with an eye to year-end rollout
Sometimes, being late can give you an advantage.
That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.
“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,” said Thomas Triomphe, Sanofi’s EVP of vaccines, in a statement. “mRNA has proven speed to market; we are demonstrating here the efficacy that our recombinant protein platform can provide to the world.”
The companies are hoping to make this candidate available by the end of the year, added Roger Connor, president of GSK Vaccines.
Separately, Sanofi and GSK are wrapping up their regulatory submissions on a Beta-only booster candidate and, armed with data unveiled recently, say they will stand ready to roll out a booster campaign.
In Stage 2 of the Phase III VAT08 trial, which enrolled 13,000 adult participants, the bivalent vaccine candidate demonstrated an efficacy of 64.7% overall against symptomatic Covid-19.
The 72% efficacy in Omicron-confirmed symptomatic cases was calculated based on sequencing performed for 71 cases out of 121 total cases to date.
In previously seropositive populations, the Sanofi-GSK vaccine candidate demonstrates an overall efficacy of 75.1% (95% confidence interval [CI, 56.3, 86.6]) against symptomatic infection, and 93.2% (95% confidence interval [CI, 73.2, 99.2]) in Omicron-confirmed symptomatic cases, according to the sequencing analysis performed to date.
Sanofi and GSK had hoped early on that a combination of their protein-based vaccine and adjuvant technologies could bring a more traditional, even if slightly slower, option to the table. But an early setback delayed their efforts, forcing them to shift strategies to focus on a world that’s already flooded with mRNA and adenovirus-based shots.