UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of July 2020
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 31 July 2020, London, UK and Paris, France - LSE
announcement
GlaxoSmithKline plc
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, manufacturing,
scale-up and delivery of an initial 100 million
doses
● Ongoing discussions with European Commission -
with France and Italy on the negotiation team - and other
governments to ensure global access to a novel coronavirus
vaccine
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 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
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."
GSK commitment to tackling COVID-19
GSK is collaborating with companies and research groups across the
world working on promising COVID-19 vaccine candidates through the
use of our innovative vaccine adjuvant technology. The use of an
adjuvant is of particular importance in a pandemic situation since
it may reduce the amount of vaccine protein required per dose,
allowing more vaccine doses to be produced and therefore
contributing to protecting more people. GSK does not expect
to profit from COVID-19 vaccines during the pandemic phase and will
invest any short-term profit in coronavirus related research and
long-term pandemic preparedness, either through GSK internal
investments or with external partners.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us.
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.
GSK enquiries:
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Media enquiries:
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Simon Steel
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+44 (0) 20 8047 5502
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(London)
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Simon Moore
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+44 (0) 20 8047 5502
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(London)
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Kristen Neese
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+1 804 217 8147
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(Philadelphia)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Analyst/Investor enquiries:
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Sarah Elton-Farr
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+44 (0) 20 8047 5194
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(London)
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Sonya Ghobrial
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+44 (0) 7392 784784
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(Consumer)
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Danielle Smith
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+44 (0) 20 8047 0932
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 4855
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(Philadelphia)
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Cautionary
statement regarding forward-looking statements
GSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
Registered
in England & Wales:
No. 3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: July
31, 2020
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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