Sanofi and GSK to seek regulatory authorization for COVID-19
vaccine
Sanofi and GSK to seek regulatory authorization
for COVID-19 vaccine
* Final analysis of the global VAT02 booster
trial confirms universal ability to boost neutralizing antibodies
18- to 30-fold across vaccine platforms (mRNA, adenovirus)
* In the VAT08 Phase 3 primary series trial, two
doses of the Sanofi-GSK vaccine in seronegative populations
demonstrated:* 100% efficacy against severe COVID-19 disease and
hospitalizations * 75% efficacy against moderate or severe COVID-19
disease* 57.9% efficacy against any symptomatic COVID-19 disease,
in line with expected vaccine effectiveness in today’s environment
dominated by variants of concern
* Favorable safety profile following both
primary series and booster vaccinations
Paris,
February 23, 2022. Sanofi and GSK today announce
that they intend to submit data from both their booster and Phase 3
efficacy trials as the basis for regulatory applications for a
COVID-19 vaccine.
The public health relevance of the refrigerator
temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is
strongly supported by the induction of robust immune responses and
a favorable safety profile in multiple settings. In participants
who had received a primary series of an already authorized mRNA or
adenovirus vaccine, the Sanofi-GSK booster vaccine induced a
significant increase in neutralizing antibodies of 18- to 30-fold
across vaccine platforms and age groups. When the Sanofi-GSK
vaccine was used as a two-dose primary series followed by a booster
dose, neutralizing antibodies increased 84- to 153-fold compared to
pre-boost levels (see Figures 1a and 1b for details).
Thomas TriompheExecutive Vice
President, Sanofi Vaccines“We’re very pleased with these data,
which confirm our strong science and the benefits of our COVID-19
vaccine. The Sanofi-GSK vaccine demonstrates a universal ability to
boost all platforms and across all ages. We also observed robust
efficacy of the vaccine as a primary series in today’s challenging
epidemiological environment. No other global Phase 3 efficacy study
has been undertaken during this period with so many variants of
concern, including Omicron, and these efficacy data are similar to
the recent clinical data from authorized vaccines.”
Roger ConnorPresident of GSK
Vaccines“The evolving epidemiology of COVID-19 demonstrates the
need for a variety of vaccines. Our adjuvanted protein-based
vaccine candidate uses a well-established approach that has been
applied widely to prevent infection with other viruses including
pandemic flu. We are confident that this vaccine can play an
important role as we continue to address this pandemic and prepare
for the post-pandemic period.”
When used as a two-dose primary series, the
Sanofi-GSK vaccine delivered robust levels of neutralizing
antibodies, with GMTs reaching 3711 units. For comparison, a panel
of sera from volunteers in the same age range who received two
doses of an already approved and highly effective mRNA vaccine
displayed a GMT of 1653 units, measured simultaneously in the same
laboratory.
Data from the VAT08 efficacy study showed that
two doses of Sanofi-GSK vaccine generated an efficacy of 57.9% (95%
confidence interval [CI, 26.5, 76.7]) against any symptomatic
COVID-19 disease in the seronegative population. The Sanofi-GSK
vaccine provided 100% protection (0 vs 10 cases post-dose 1, 0 vs 4
cases post-dose 2) against severe disease and hospitalizations and
75% (3 vs 11 cases) efficacy against moderate-to-severe disease in
seronegative populations. While sequencing is still in progress,
early data indicate 77% efficacy against any Delta
variant-associated symptomatic COVID-19 disease, in line with
expected vaccine effectiveness.
Across both studies, the Sanofi-GSK vaccine was
well-tolerated in younger and older adults with no safety
concerns.
The companies are in discussions with regulatory
authorities, including the US FDA and European Medicines Agency
(EMA), and plan to submit the totality of the data generated with
this vaccine candidate to support regulatory authorizations.
Figure 1a - Pre- vs post-booster
neutralizing antibody titers in 18-55-yr old participants.
Geometric Mean Titers (GMT) (95% CI).
Figure 1b - Pre- vs post-booster
neutralizing antibody in ≥56-yr old participants. Geometric Mean
Titers (GMT) (95% CI).
To evaluate the immunogenicity of the Sanofi-GSK
vaccine as a booster, human immune sera samples were tested by
Monogram Biosciences [San Francisco, CA] using an FDA-approved
standardized pseudovirus neutralization test (pVNT) against the
D614G prototype virus.
About VAT08 and VAT02The Phase
3 trial, VAT08 is evaluating a 10µg antigen formulation of the
SARS-CoV-2 adjuvanted recombinant protein-based vaccine for
efficacy, immunogenicity and safety compared to a placebo. Stage
one of the trial is assessing the efficacy of a vaccine formulation
containing the spike protein against the original D614 (parent)
virus in more than 10,000 participants >18 years of age,
randomized to receive two doses of 10µg vaccine or placebo at day 1
and day 22 across sites in the US, Asia, Africa and Latin America.
Enrolment recently completed for a second stage in the trial,
evaluating a second bivalent formulation, including the spike
protein of the B.1.351 (Beta) variant. The Phase 3 trial follows
positive initial results from a Phase 2 clinical trial (VAT00002).
In that trial, the COVID-19 vaccine candidate was administered to
722 adults to assess the safety, reactogenicity and immunogenicity
of 2 doses and to identify an optimal dosing for use as a booster.
Results showed strong rates of neutralizing antibody response with
95% to 100% seroconversion following a second injection in all age
groups (18 to 95 years old), across all doses.
Full study results for both VAT08 and VAT02 will
be published later this year.
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 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 RelationsNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comKate
Conway | + 1 508 364 4931
| kate.conway@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
908 981 5560 | priya.nanduri@sanofi.com Nathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
Sanofi Forward-Looking
StatementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that COVID-19 will have
on us, our customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well
as on our employees and on the global economy as a whole. Any
material effect of COVID-19 on any of the foregoing could also
adversely impact us. This situation is changing rapidly and
additional impacts may arise of which we are not currently aware
and may exacerbate other previously identified risks. The risks and
uncertainties also include the uncertainties discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in Sanofi’s annual
report on Form 20-F for the year ended December 31, 2020. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements
Sanofi (BIT:1SAN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sanofi (BIT:1SAN)
Historical Stock Chart
From Sep 2023 to Sep 2024