TIDMGSK
RNS Number : 4497D
GlaxoSmithKline PLC
28 October 2020
Issued: GlaxoSmithKline plc, 28 October 2020, London, UK and
Paris, France
Sanofi and GSK to support COVAX with 200 million doses of
adjuvanted, recombinant protein-based COVID-19 vaccine
-- COVAX Facility is led by Gavi and aims to secure successful
and equitable access to COVID-19 vaccines worldwide
Sanofi and GSK have signed a Statement of Intent with Gavi, the
legal administrator of the COVAX Facility, a global risk-sharing
mechanism for pooled procurement and equitable distribution of
eventual COVID-19 vaccines.
Sanofi and GSK intend to make available 200 million doses of
their adjuvanted recombinant protein-based COVID-19 vaccine, if
approved by regulatory authorities and subject to contract, to the
COVAX Facility. Both Companies intend to contribute to COVAX's
ambition to ensure successful COVID-19 vaccines reach those in
need, whoever they are and wherever they live, once they obtain
appropriate approvals.
Thomas Triomphe, Executive Vice President and Global Head of
Sanofi Pasteur, said:
"To address a global health crisis of this magnitude, it takes
unique partnerships. The commitment we are announcing today for the
COVAX Facility can help us together stand a better chance of
bringing the pandemic under control. This moment also reflects our
long-term commitment to global health and ensures our COVID-19
vaccines are affordable and accessible to those most at risk,
everywhere in the world."
Roger Connor, President of GSK Vaccines said:
"Since we started working on the development of COVID-19
vaccines, GSK has pledged to make them available to people around
the world. We are proud to be working with Sanofi to make this
adjuvanted recombinant protein-based vaccine available to the
countries signed up to the COVAX Facility as soon as possible -
this has the potential to be a significant contribution to the
global fight against COVID-19."
The COVAX Facility is part of COVAX, a global collaboration of
governments, global health organizations, businesses and
philanthropic organizations working to accelerate development,
production, and equitable access to COVID-19 vaccines. COVAX is
co-led by Gavi, the Coalition for Epidemic Preparedness Innovations
(CEPI) and WHO and forms the vaccines pillar of the Access to
COVID-19 Tools (ACT) Accelerator. More than 180 countries and
economies recently signed onto the COVAX Facility to get timely and
cost-effective access to vaccines to meet the global scale of the
COVID-19 pandemic.
Through the COVAX Facility's efforts, vaccines will be
distributed in participating countries through the WHO's recently
published Allocation Framework, and the WHO's Strategic Advisory
Group of Experts on Immunization (SAGE) Values Framework which has
begun to frame future guidance on vaccine use. These allocation
principles aim to ensure that people in all parts of the world will
get access to COVID-19 vaccines once they are available.
Status of the adjuvanted recombinant protein-based vaccine
development
Sanofi and GSK initiated a Phase 1/2 study on September 3 with a
total of 440 subjects enrolled, and anticipate first results in
early December 2020, to support the initiation of a pivotal Phase 3
study before the end of the year. If these data are sufficient for
licensure application, it is planned to request regulatory approval
from the first half of 2021. In parallel, the Companies are scaling
up manufacturing of the antigen and adjuvant respectively.
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:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Danielle Smith +44 (0) 20 8047 (London)
0932
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
GSK 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 as set out in GSK's "Principal risks and uncertainties" section
of the Q2 Results and any impacts of the COVID-19 pandemic.
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