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The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.
Sanofi and GSK announced positive data from their vaccine trial evaluating an adjuvanted bivalent COVID-19 vaccine candidate on June 24, 2022. Designed for the D614 and Beta (B.1.351) variations, the Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high Omicron variant circulation.
The data comes from stage two of the Phase III COVID-19 vaccine trial VAT08, which was composed of more than 13,000 participants ages 18 or older. The Sanofi-GSK Beta-containing vaccine candidate demonstrated a 64.7% efficacy against symptomatic COVID-19 and 72% efficacy in Omicron-confirmed symptomatic cases. In previously seropositive populations, the efficacy was 75.1% against symptomatic infection and 93.2% in Omicron-confirmed symptomatic cases, according to the sequencing analysis performed to date. Thus far, sequencing has been performed for 71 out of 121 total cases.
“Today’s results reinforce the strong potential for the Beta antigen to confer broad protection against multiple strains that cause COVID-19,” said Thomas Triomphe, executive VP, vaccines, Sanofi, in a company press release. “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.”
According to the press release, the vaccine candidate showed a favorable safety and tolerability profile. The companies plan to submit the data to regulatory authorities to indicate the potential for Sanofi-GSK’s Beta-based vaccine candidate as a relevant response to public health needs.