Vaccine Candidate Shows Efficacy Against Omicron with COVID-19 Beta-Containing Vaccine

The Sanofi-GSK vaccine demonstrated a favorable safety and tolerability profile throughout stage 1 and stage 2 of the VAT08 trial, according to the researchers.

Data from a recent trial showed efficacy with an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate against the Omicron COVID-19 variant, according to GSK and Sanofi. This vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation, showing a favorable safety and tolerability profile, according to a GSK press release.

Prior to these data, positive results from 2 trials conducted with the new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSK’s pandemic adjuvant were reported. The research strongly indicates the potential of Sanofi-GSK’s next-generation Beta-based booster to be a relevant response to the ongoing pandemic, according to the investigators.

“These positive data show efficacy of our protein-based, bivalent adjuvanted vaccine candidate in an environment of high Omicron variant circulation,” Roger Connor, president of GSK Vaccines, said in a press release. “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.”

The stage 2 of the phase 3 COVID-19 vaccine trial VAT08 included more than 13,000 participants 18 years of age and older showed an efficacy of 64.7% against symptomatic COVID-19 and 72% efficacy in Omicron-confirmed symptomatic cases.

In previous seropositive populations, the Sanofi-GSK vaccine candidate showed an overall efficacy of 75.1% against symptomatic infection and 93.2% in Omicron-confirmed symptomatic cases, according to a sequencing analysis performed.

The Sanofi-GSK vaccine demonstrated a favorable safety and tolerability profile throughout stage 1 and stage 2 of the VAT08 trial, according to the researchers.

“Today’s results reinforce the strong potential for the Beta antigen to confer broad protection against multiple strains that cause COVID-19. 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, executive vice president, Vaccines at Sanofi, in a press release. “mRNA has proven speed to market; we are demonstrating here the efficacy that our recombinant protein platform can provide to the world. We look forward to completing our submissions to regulatory authorities and are ready to contribute to ongoing vaccination campaigns with our next-generation booster.”

REFERENCE

Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine. GSK. June 24, 2022. Accessed June 24, 2022. https://www.gsk.com/en-gb/media/press-releases/sanofi-gsk-first-to-report/