Press Release: Sanofi-GSK next-generation COVID-19 booster delivers
strong immune response against variants of concern, including
Omicron
Sanofi-GSK next-generation COVID-19 booster delivers strong
immune response against variants of concern, including Omicron
- Next-generation booster vaccine
candidate delivers immune boost in adults primed with mRNA
vaccines; with a stronger immune response compared to
Pfizer-BioNTech’s Comirnaty booster vaccine
- Next-generation booster vaccine
candidate demonstrates potential to protect against COVID-19
variants of concern, including Omicron BA.1 and BA.2, with a
favorable safety and tolerability profile
Paris
– June
13, 2022 –
Sanofi today reports data from two trials, VAT02 Cohort 2 and
COVIBOOST VAT013, conducted with its new next-generation COVID-19
booster vaccine
candidate modelled
on the Beta
variant antigen and including GSK’s pandemic
adjuvant.
In the Phase 3 VAT02 Cohort 2 study, the
Sanofi-GSK
next-generation
vaccine candidate
induced (at day 15 post-immunization)
a significant boost in
antibody titers above baseline
against multiple variants of concern (15-fold
increase against D614 parent virus, 30-fold increase against Beta
strain) in adults previously
primed with mRNA COVID-19
vaccines. In particular against Omicron,
preliminary data show a 40-fold increase against BA.1. The
Sanofi-GSK next-generation
booster candidate
generated double the
number of neutralizing antibodies against
Omicron BA.1 and BA.2
compared to the D614-based (original parent virus) booster.
In parallel, the independent COVIBOOST (VAT013)
study conducted by the Assistance Publique – Hôpitaux de Paris
(AP-HP) demonstrated that, following primary vaccination with two
doses of Pfizer-BioNTech’s Comirnaty vaccine, the
Sanofi-GSK next-generation booster
candidate generated a
higher immune
response (as measured by
neutralizing antibody
titers) than
Pfizer-BioNTech’s
booster or the Sanofi-GSK first-generation
booster, both of which target the original D614 parent strain. The
proportion of participants with at least a 10-fold increase in
neutralizing antibody titers for the original D614 SARS-CoV-2
strain between day 0 and day 15 was:
- 76.1% (95% CI 64.5–85.4) for the
Sanofi-GSK next-generation booster, vs
- 63.2% (95% CI 51.3–73.9) for the
Pfizer BioNTech D614 booster, and
- 55.3% (95% CI 43.4–66.7) for the
Sanofi-GSK D614 (first-generation parent booster candidate).
In this study, which included 247 subjects, all
the three vaccines also elicited neutralizing antibodies against
the Omicron BA.1 variant, with highest responses generated by the
Sanofi-GSK next-generation candidate. Results of COVIBOOST study
are available on a pre-print server, pending publication in a
peer-reviewed journal.
Across both studies, the Sanofi-GSK
next-generation vaccine candidate was well-tolerated, with a
favorable safety profile. In the VAT02 cohort 2 study, low numbers
(less than 4%) of Grade 3 reactions were reported, all transient
and non-severe.
Thomas Triomphe
Executive Vice President, Sanofi Vaccines
“COVID-19 keeps evolving and the combination of emergence of
variants and waning immunity is likely to lead to the need for
additional booster shots, at least in some populations. The
Beta variant expresses similar mutations across multiple variants
of concern, including Omicron, making it a strong vaccine candidate
to confer broad protection against multiple strains of COVID-19.
Seeing the cross-neutralization data from the independent AP-HP
study, we believe this next-generation booster could have an
important role to play for public health vaccination campaigns. We
look forward to submitting these data to global regulatory
authorities.”
Sanofi and GSK have developed their
next-generation booster candidate in parallel to ongoing regulatory
reviews of their first-generation vaccine candidate. The totality
of data supporting this next-generation booster vaccine will be
submitted to regulatory authorities in the upcoming weeks, with the
aim of making it available later this year.
About VAT02The VAT02 booster study is an
extension of the company’s phase 3 safety and immunogenicity study.
In Cohort 1 of this study, participants previously vaccinated with
the primary series of an authorized COVID-19 vaccine received a
booster dose of the Sanofi-GSK adjuvanted recombinant vaccine
candidate, using SARS-CoV-2 (D614) antigen. These data confirmed
the vaccine candidate’s universal potential to boost neutralizing
antibodies 18- to 30-fold across all vaccine platforms (mRNA,
protein, adenovirus). Cohort 2 included 1,500 participants. VAT02
results will be published in a peer-reviewed journal at a later
date.
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 by the National
Institute of Allergy and Infectious Diseases (NIAID). The NIAID
provides grant funding to the HIV Vaccine Trials Network (HVTN)
Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics
and Data Management Center (UM1 AI 68635), the HVTN Laboratory
Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership
and Operations Center (UM1 AI 68619), the AIDS Clinical Trials
Group Leadership and Operations Center (UM1 AI 68636), and the
Infectious Diseases Clinical Research Consortium (UM1 AI 148684,
UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574).
About COVIBOOST (VAT013) studyCOVIBOOST is an
independent study conducted by the Assistance Publique – Hôpitaux
de Paris (AP-HP). It is a randomized, single-blinded, multicenter
trial across 11 centers in France, which studies the immune
response of the Sanofi-GSK first- and next-generation booster
vaccine candidates (adjuvanted, recombinant protein) and that of a
3rd dose of the Pfizer-BioNTech vaccine Comirnaty, following two
doses of Comirnaty received as primary vaccination. The study was
funded by the French Ministry of Solidarity and Health and
Sanofi.
About the Sanofi and GSK partnership In the
collaboration between the two companies, Sanofi provides its
recombinant antigen and GSK contributes 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.comNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.comEvan Berland
| + 1 215 432 0234 | evan.berland@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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