Sanofi-GSK is the first to report success

Sanofi-GSK is the first to report a successful efficacy study against Omicron with a vaccine containing COVID-19 beta

  • Primary vaccination with Beta container the candidate vaccine delivers 64.7% efficacy against symptomatic infection in adults, and 75.1% efficiency in participants previously infected with COVID-19
  • Against Omicronsequencing analysis to date shows 72% efficacy in all adults and 93.2% in HIV positives
  • Favorable safety and tolerability profile
  • First time reported efficacy data in an Omicron environment support the relevance of a vaccine containing beta

Paris, June 24, 2022. Sanofi and GSK today announce the positive results of their vaccine trial which evaluated a bivalent vaccine candidate D614 and Beta (B.1.351) with adjuvant. Sanofi-GSK’s vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in a high circulation environment of the Omicron variant. The candidate vaccine has shown a favorable safety and tolerability profile. Earlier this month, Sanofi reported positive data from two trials conducted with its new next-generation COVID-19 booster vaccine candidate modeled on the beta variant of the antigen and including GSK’s pandemic adjuvant. The data supporting this next-generation booster vaccine will be submitted to regulatory authorities and indicates the potential of Sanofi-GSK’s beta-based next-generation booster as a relevant response to public health needs.

Thomas Triumph
Executive Vice President Vaccines, Sanofi
Today’s results reinforce the strong potential of beta antigen to confer broad protection against the multiple strains that cause COVID-19. Together with the immunogenicity data from our beta-booster vaccine, they support our belief that, in a largely HIV-positive world, a next-generation beta-booster vaccine could provide protection against variants like Omicron. mRNA has proven its speed to market; here we demonstrate the efficiency that our recombinant protein platform can bring 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..”

Roger Connor
President of GSK Vaccines
These positive data show the efficacy of our adjuvanted bivalent protein-based vaccine candidate in a high circulation environment of Omicron variants. Our vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves. We look forward to discussions with regulatory authorities with the aim of making our vaccine candidate available later this year..”

In stage 2 of the phase 3 vaccine trial against COVID-19 VAT08 on more than 13,000 participants aged 18 and over, the candidate vaccine containing beta from Sanofi-GSK has demonstrated an efficacy of 64.7% (95% confidence interval [CI, 46.6, 77.2]) against symptomatic COVID-19 and an efficacy of 72% (95% confidence interval [CI, 45.8, 86.6]) in symptomatic cases confirmed by Omicron (sequencing has been 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 symptomatic cases confirmed by Omicron, according to sequencing analysis performed to date.

Throughout phases 1 and 2 of the VAT08 trial (~23,000 total participants), the Sanofi-GSK vaccine demonstrated a favorable safety and tolerability profile.

These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services, in conjunction with the Executive Office of the U.S. Department of Defense joint program for Chemical, Biological, Radiological, and Nuclear Defense under contract # W15QKN-16-9-1002 and the National Institute of Allergy and Infectious Diseases (NIAID).

About the Sanofi and GSK partnership
As part of the collaboration between the two companies, Sanofi is supplying its recombinant antigen and will hold the marketing authorization. GSK contributes with its pandemic adjuvant, two established vaccine platforms that have been proven against influenza.

About Sanofi
We are an innovative global healthcare company driven by one purpose: we pursue the miracles of science to improve people’s lives. Our team, present in over 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially game-changing treatment options and life-saving vaccine protection to millions of people around the world, while placing sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bath | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Nicholas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

Investor Relations
Eva Schäfer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Priya Nanduri | +1 617 764 6418 | priya.nanduri@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi forward-looking statements
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