Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccin...
31 Julho 2020 - 8:00AM
Sanofi and GSK selected for Operation Warp Speed to supply United
States government with 100 million doses of COVID-19 vaccine
Sanofi and GSK selected for Operation Warp Speed to
supply United States government with 100 million doses of COVID-19
vaccine
- Promising vaccine candidate selected by U.S. government’s
Operation Warp Speed
- U.S. government to provide funding up to $2.1 billion for
development, including clinical trials and manufacturing scale-up,
and delivery of an initial 100 million doses
- Ongoing discussions with the European Commission, with France
and Italy on the negotiation team, and other governments to ensure
global access to a novel coronavirus vaccine
PARIS and LONDON – July 31,
2020 – Sanofi and GSK today announce a collaborative
effort with the U.S. government to accelerate the development and
manufacturing of a COVID-19 recombinant protein-based vaccine.
The vaccine candidate, developed by Sanofi in
partnership with GSK, is based on the recombinant protein-based
technology used by Sanofi to produce an influenza vaccine, and
GSK’s established pandemic adjuvant technology.
Collaborating with the U.S. Department of Health
and Human Services (HHS) and Department of Defense will help fund
the development activities and secure scale-up of Sanofi’s and
GSK’s manufacturing capabilities in the United States for the
recombinant protein-based, adjuvanted vaccine, resulting in a
significant increase in capacity.
The U.S. government will provide up to $2.1
billion, more than half of which is to support further development
of the vaccine, including clinical trials, with the remainder used
for manufacturing scale-up and delivery of an initial 100 million
doses of the vaccine. Sanofi will receive the majority of the U.S.
government funding. The U.S. government has a further option for
the supply of an additional 500 million doses longer term. This
helps the U.S. government’s Operation Warp Speed goals of providing
millions of doses of a safe and effective COVID-19 vaccine.
“The global need for a vaccine to help prevent
COVID-19 is massive, and no single vaccine or company will be able
to meet the global demand alone,” said Thomas Triomphe, Executive
Vice President and Global Head of Sanofi Pasteur. “From the
beginning of the pandemic, Sanofi has leveraged its deep scientific
expertise and resources to help address this crisis, collaborating
with the U.S. Department of Health and Human Services to unlock a
rapid path toward developing a pandemic vaccine and manufacturing
at large scale. With our partner GSK, we expect our Phase 1/2 study
for the recombinant adjuvanted approach to start in September.”
Roger Connor, President of GSK Vaccines added,
“GSK is proud to be working in partnership with Sanofi to make this
vaccine available at scale as soon as possible. We thank the
U.S. government for playing a very important role in providing
early, significant funding to enable the development and scale-up
of this potentially important vaccine.”
“The portfolio of vaccines being assembled for Operation Warp
Speed increases the odds that we will have at least one safe,
effective vaccine as soon as the end of this year,” said HHS
Secretary Alex Azar. “Today’s investment supports the Sanofi and
GSK adjuvanted product all the way through clinical trials and
manufacturing, with the potential to bring hundreds of millions of
safe and effective doses to the American people.”
Sanofi is leading the clinical development and
registration of the COVID-19 vaccine and expects a Phase 1/2 study
to start in September, followed by a Phase 3 study by the end of
2020. If the data are positive, the companies can request U.S.
regulatory approval in the first half of 2021. In parallel, Sanofi
and GSK are scaling up manufacturing of the antigen and adjuvant to
produce up to one billion doses per year globally.
Sanofi and GSK are committed to making
the vaccine available globally
Active discussions are ongoing with global
organizations and with the EU Commission – with France and Italy on
the negotiation team on supplying European countries from Sanofi’s
and GSK’s European industrial network. The partners also plan to
provide a significant portion of total worldwide available supply
capacity in 2021/22 to the global initiative, “Access to COVID‐19
Tools (ACT) Accelerator,” a global collaboration of leaders of
governments, global health organizations, businesses and
philanthropies to accelerate development, production, and equitable
access to COVID-19 tests, treatments, and vaccines.
On the front lines in the fight against
COVID-19
In addition to the recombinant protein-based
vaccine in collaboration with GSK, Sanofi is also developing a
messenger RNA vaccine candidate in partnership with Translate Bio.
With several innovative vaccine platforms currently being
investigated across the industry, mRNA is considered among the most
promising. Sanofi expects a Phase 1 study to start by the end of
the year, and, if the data are positive, an approval at the
earliest in the second half of 2021. Translate Bio has established
mRNA manufacturing capacity and Sanofi expects to be able to supply
annual capacity of 90 to 360 million doses.
About GSK
GSK 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 Contacts Ashleigh Koss Tel.: +1
908-981-8745 Ashleigh.Koss@sanofi.com Nicolas Kressmann Tel.:
+1 732-532-5318 Nicolas.Kressmann@sanofi.com |
Investor
Relations Contact Eva Schaefer-Jansen Tel.: +33 (0)1 53 77
45 45 ir@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. |
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