Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate
27 Mai 2021 - 7:30AM
Sanofi and GSK initiate global Phase 3 clinical efficacy study of
COVID-19 vaccine candidate
Sanofi and GSK
initiate global
Phase 3
clinical
efficacy study
of COVID-19 vaccine
candidate
- Two-stage design will evaluate
vaccine formulations targeting original D.614 virus as well as
B.1.351 variant, in diverse geographies with multiple circulating
variants
- A booster study program will begin
in the coming weeks to complement Phase 3 trial
- Pending positive Phase 3 outcomes
and regulatory reviews, the vaccine could be approved in Q4
2021
PARIS and
LONDON – May 27, 2021 – Today,
Sanofi and GSK started enrollment in their Phase 3 clinical study
to assess the safety, efficacy, and immunogenicity of their
adjuvanted recombinant-protein COVID-19 vaccine candidate. The
global, randomized, double-blind placebo-controlled Phase 3 study
will include more than 35,000 volunteers aged 18 and
older from several countries, including sites in the US, Asia,
Africa, and Latin America.
The primary endpoint of the study is the
prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with
secondary endpoints being the prevention of severe COVID-19 disease
and prevention of asymptomatic infection. In a two-stage approach,
the study will initially investigate the efficacy of a vaccine
formulation targeting the original D.614 virus (Wuhan), while a
second stage will evaluate a second formulation targeting the
B.1.351 (South African) variant. Recent scientific evidence1 shows
that antibodies created against the B.1.351 variant may provide
broad cross-protection against other more transmissible variants.
The design of the Phase 3, conducted across a broad diversity of
geographies, also allows evaluation of the efficacy of the
candidate against a variety of circulating variants.
Following encouraging interim results from the
recent Phase 2 study, the companies will also begin clinical
studies in the coming weeks to assess the ability of the adjuvanted
recombinant-protein COVID-19 vaccine candidate to generate a strong
booster response regardless of initial vaccine platform
received.
“We are encouraged to see first vaccinations
starting to take place in such an important, pivotal Phase 3 study,
as we believe that our unique technology platform will provide a
clinically-relevant vaccine option” said Thomas Triomphe, Executive
Vice President, Global Head of Sanofi Pasteur. “We have adapted our
vaccine development strategy based on forward-looking
considerations as the virus continues to evolve, as well as
anticipating what may be needed in a post-pandemic setting. This
trial is testament to the urgency and agility in our approach to
help overcome the ongoing impact of this pandemic.
Roger Connor, President of GSK Vaccines added,
“We believe further solutions for COVID-19 are very much needed to
help reach people around the world, especially as the pandemic
evolves and variants continue to emerge. Adjusting our technology
and study designs reflects this need and will further build the
potential of this adjuvanted protein-based vaccine. We are grateful
to the volunteers who will take part in the trials and hope the
results will add to the encouraging data we’ve seen so far so we
can make the vaccine available as quickly as possible.”
The Phase 3 study follows the interim Phase 2
results which showed that the adjuvanted recombinant COVID-19
vaccine candidate achieved high rates of neutralizing antibody
responses in all adult age groups, with 95 to 100% seroconversion
rates. After a single injection, high neutralizing antibody levels
were also generated in participants with evidence of prior
SARS-CoV-2 infection, suggesting strong potential for development
as a booster vaccine.
Pending positive Phase 3 outcomes and regulatory
reviews, the vaccine could be approved / authorized in Q4 2021.
Manufacturing will begin in the coming weeks to enable rapid access
to the vaccine should it be approved.
This effort is 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.
About the
Sanofi and GSK
partnershipIn the partnership 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. The recombinant technology
combined with GSK’s adjuvant is designed to offer the advantages of
stability at temperatures used for routine vaccines, making it
easily implementable and easier to distribute at a global scale
through existing infrastructures where vaccines are stored at
normal refrigerator temperature. It is also designed to offer the
potential to generate high and sustained immune responses, and the
potential to prevent virus transmission.
Shots on goal in the fight against the
COVID-19 pandemicIn addition to the adjuvanted recombinant
protein-based vaccine in collaboration with GSK, Sanofi is
developing a messenger RNA vaccine in partnership with Translate
Bio. In March 2021, Sanofi and Translate Bio initiated a Phase 1/2
clinical trial of their mRNA COVID-19 vaccine candidate, in order
to assess safety, immune response and reactogenicity, after
preclinical data showed high neutralizing antibody levels. First
results are expected in the third quarter of 2021.
Sanofi is also committed to providing
manufacturing support to other vaccine producers. The company
recently announced it will manufacture up to 200 million doses of
Moderna’s COVID-19 vaccine for the U.S., starting in September
2021. Earlier this year, Sanofi also announced the company will
provide support to BioNTech for 125 million doses for the European
Union. In February, Sanofi said it would support Johnson &
Johnson for the production of its COVID-19 vaccine at a rate of
approximately 12 million doses per month.
In addition to developing its two COVID-19
vaccines, Sanofi is the only company to leverage its manufacturing
capacity and expertise for three different COVID-19 vaccines to
support the global vaccines supply and help combat the
pandemic.
Find out more about our COVID-19 vaccine
candidates.
About GSKGSK is a science-led
global healthcare company with a special purpose: to help people do
more, feel better, live longer. GSK is the leading manufacturer of
vaccines globally. For further information please
visit www.gsk.com.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Media Relations ContactsAshleigh KossTel: +1 (908)
205-2572Ashleigh.Koss@sanofi.com Sandrine GuendoulTel.: +33
(0)6 25 09 14 25MR@sanofi.com Nicolas KressmannTel.: +1 (732)
532-5318Nicolas.Kressmann@sanofi.com |
Investor
Relations Contacts ParisEva Schaefer-JansenArnaud
Delepine Investor Relations Contacts North
AmericaFelix LauscherFara BerkowitzSuzanne Greco IR
main line:Tel.: +33 (0)1 53 77 45
45investor.relations@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, 2019. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements. |
1 Moyo-Gwete, T. et al. SARS-CoV-2 501Y.V2 (B.1.351) elicits
cross-reactive neutralizing antibodies. bioRxiv (2021)
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