Press Release: Sanofi-GSK first to report a successful efficacy study against Omicron with COVID-19 Beta-containing vaccine
June 24 2022 - 1:28AM
Press Release: Sanofi-GSK first to report a successful efficacy
study against Omicron with COVID-19 Beta-containing vaccine
Sanofi-GSK first to report a successful efficacy
study against Omicron with COVID-19 Beta-containing vaccine
- Primary vaccination with
Beta-containing vaccine candidate delivers 64.7% efficacy against
symptomatic infection in adults, and 75.1% efficacy in participants
previously infected with COVID-19
- Against Omicron, sequencing
analysis performed to date shows 72% efficacy in all adults and
93.2% in seropositives
- Favorable safety and tolerability
profile
- First ever reported efficacy data
in an Omicron environment support relevance of a Beta-containing
vaccine
Paris, June 24, 2022. Sanofi
and GSK today announce positive data from their vaccine trial which
evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine
candidate. Sanofi-GSK’s vaccine is the first candidate to
demonstrate efficacy in a placebo-controlled trial in an
environment of high Omicron variant circulation. The vaccine
candidate showed 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 modelled on the Beta variant antigen and including GSK’s
pandemic adjuvant. The data supporting this next-generation booster
vaccine will be submitted to regulatory authorities and indicate
the potential of Sanofi-GSK’s next-generation Beta-based booster to
be a relevant response to public health needs.
Thomas
TriompheExecutive Vice President Vaccines,
Sanofi“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. 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.”
Roger ConnorPresident
of GSK Vaccines“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.”
In Stage 2 of the Phase 3 COVID-19 vaccine trial
VAT08 of more than 13,000 participants 18 and above years of age,
the Sanofi-GSK Beta-containing vaccine candidate demonstrated an
efficacy of 64.7% (95% confidence interval [CI, 46.6, 77.2])
against symptomatic COVID-19 and 72% efficacy (95% confidence
interval [CI, 45.8, 86.6]) in Omicron-confirmed symptomatic cases
(sequencing was 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.
Throughout Stage 1 and Stage 2 of the VAT08
trial (~23,000 participants in total), 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 at the U.S.
Department of Health and Human Services in collaboration with the
U.S. Department of Defense Joint Program Executive Office 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 partnershipIn the
collaboration between the two companies, Sanofi provides its
recombinant antigen and will be the marketing authorization holder.
GSK contributes with its pandemic adjuvant, both established
vaccine platforms that have proven successful against
influenza.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.comEvan Berland | +1 215
432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comPriya Nanduri | +1
617 764 6418 | priya.nanduri@sanofi.com Nathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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StatementsThis press release contains forward-looking
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