Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine
31 Juli 2020 - 09:20PM
Sanofi and GSK in advanced discussions with European Union to
supply up to 300 million doses of COVID-19 vaccine
Sanofi and GSK in advanced discussions with European
Union to supply up to 300 million doses of COVID-19
vaccine
- Discussions relate to vaccine candidate using Sanofi’s
recombinant protein-based technology combined with GSK’s pandemic
adjuvant system
- Both companies are committed to making their COVID-19 vaccine
affordable and available globally
PARIS and LONDON – July 31,
2020 – Sanofi and GSK are in advanced discussions, with
the European Commission (EC) for the supply of up to 300 million
doses of a COVID-19 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 adjuvant technology. The doses would
be manufactured in European countries including France, Belgium,
Germany and Italy. This marks a key milestone in protecting and
serving the European population against COVID-19.
“Today’s announcement helps to ensure that
millions of Europeans will have access to a potential vaccine
protecting against COVID-19, once proven safe and effective. It has
been our steadfast commitment to provide a vaccine that is
affordable and accessible to everyone, and we are grateful to the
European Commission for their ongoing engagement and shared support
of this effort,” said Thomas Triomphe, Executive Vice President and
Global Head of Sanofi Pasteur. “Together with GSK, we are working
relentlessly to develop and produce a vaccine to address this
global health crisis.”
Roger Connor, President of GSK Vaccines added
"GSK is proud to be working in partnership with Sanofi to make this
vaccine available as soon as possible in Europe. Both companies
have significant R&D and manufacturing capability in Europe and
are already working hard to scale up production across our
networks. This announcement from the EC supports our ongoing
efforts”
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 data are positive, regulatory approval could be achieved
by 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 overall.
Sanofi and GSK are committed to making
the vaccine available globally
Sanofi and GSK recently signed agreements with
the United States where they have longstanding partnerships with
the Biomedical Advanced Research and Development Authority, and
also with the UK Government. The partners 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 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 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 Jean-Baptiste
Froville Tél. : +33 (0)1 53 77 46 46 mr@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
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Forward-looking statements are generally identified by the words
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“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
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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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