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 February 2022
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:
24 February 2022, London UK
Medicago and GSK announce the approval by Health Canada of
COVIFENZ®, an
adjuvanted plant-based COVID-19 vaccine
●
A vaccine
manufactured in plants and developed in Canada
Medicago,
a biopharmaceutical company headquartered in Quebec City, and
GlaxoSmithKline (GSK) today announced that Health Canada has
granted approval for COVIFENZ®, COVID-19 vaccine,
(plant-based virus-like particles [VLP], recombinant, adjuvanted).
This vaccine is indicated for active immunization to prevent
coronavirus disease 2019 (COVID‑19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) in individuals 18
to 64 years of age.
“The
approval of our COVID-19 vaccine is a significant milestone for
Canada in the fight against the pandemic. We appreciate Health
Canada’s timely review,” said Takashi Nagao, President and CEO at
Medicago. “We’re also grateful for the
Government of Canada’s support in the development of this new
vaccine, and we are manufacturing doses to start fulfilling its
order.”
Roger Connor, President of GSK Vaccines, added, “This
first approval is an important milestone in our approach of pairing
GSK’s well-established pandemic adjuvant with promising
antigens to develop protein-based, refrigerator-stable COVID-19
vaccines to help protect people against COVID-19 disease. We look
forward to working with Medicago to make the vaccine available in
Canada and to progress further regulatory
submissions.”
The
Government of Canada has a contract with Medicago (the Marketing
Authorization Holder) to supply the COVID-19 vaccine. Medicago is
committed to fulfilling this order as soon as
possible.
“As
one of our government’s top priority has been to reverse the
40-year decline faced by Canada’s biomanufacturing sector, we
are pleased to see Medicago’s vaccine approval. It is a great
milestone for Canada’s biotechnology sector and for homegrown
innovation. We will continue to support companies that want to
produce vaccines in Canada and join the growing national
biomanufacturing sector.” said the Honourable François-Philippe
Champagne, Minister of Innovation, Science and
Industry.
Health
Canada based its decision on scientific data shared by Medicago as
part of their rolling submission that began in April 2021 under an
Interim Order, and concluded with the filing of a New Drug
Submission-CV.
“Today
is a great day for Medicago as COVIFENZ® becomes its first
approved vaccine. I’d like to thank the Clinical
Investigators involved in our trials as well as Medicago’s
passionate and curious team of over 500 scientific experts and
employees. Today only reinforces our commitment to using our
technology to provide rapid responses to emerging global health
challenges, and to advancing therapeutics against life-threatening
diseases worldwide.” said
Yosuke Kimura, Chief Scientific Officer at
Medicago.
About COVIFENZ®
COVIFENZ® uses Coronavirus-Like Particle (CoVLP)
technology with the vaccine composed of recombinant spike (S)
glycoprotein expressed as virus-like particles (VLPs)
co-administered with GSK’s pandemic adjuvant. The vaccination
regimen calls for two doses given intramuscularly 21 days apart
(3.75 micrograms of CoVLP antigen in combination with GSK pandemic
adjuvant in the same injection). The vaccine is stored at 2 °C
to 8 °C. COVIFENZ® antigen will be
manufactured in Canada and in North Carolina (US).
COVIFENZ® is not currently approved or authorized for
the prevention of COVID-19 or any other indication anywhere other
than Canada.
Authorized use in Canada
Medicago’s
COVIFENZ®, COVID-19
vaccine (plant-based virus-like particles [VLP], recombinant,
adjuvanted), approved by Health Canada, is indicated for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
individuals 18 to 64 years of age.
About Medicago
Medicago
is on a mission to help improve global public health using the
power of plants. Founded in 1999 with the belief that innovative
approaches and rigorous research would bring new solutions in
healthcare, Medicago is a pioneer in plant-based therapeutics. We
are proudly rooted in Quebec, with manufacturing capacity in both
Canada and the US. Our passionate and curious team of over 500
scientific experts and employees are dedicated to using our
technology to provide rapid responses to emerging global health
challenges, and to advancing therapeutics against life-threatening
diseases worldwide. Medicago is an affiliated company of Mitsubishi
Tanabe Pharma Corporation. For more information: www.medicago.com
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi
Tanabe Pharma Corporation (MTPC) Group, the majority parent company
of Medicago, is one of the large Japanese pharmaceutical companies,
with its headquarters in Osaka, Japan. It positions vaccines as one
of its key R&D areas under its Medium-Term Management Plan
21-25 and is also working to develop new modalities of
vaccines. MTPC Group will further contribute to the prevention
of infectious diseases which is one of the world’s important
social issues, by delivering a new option of plant-based VLP vaccine as a new
type of vaccine. For
further information please visit https://www.mt-pharma.co.jp/e/.
About GSK and its commitment to tackling COVID-19
GSK is
a science-led global healthcare company. For further information
please visit www.gsk.com/about-us.
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 enquiries:
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Media
enquiries:
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Tim
Foley
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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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Evan
Berland
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+1 215
432 0234
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(Philadelphia)
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Analyst/Investor
enquiries:
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Nick
Stone
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+44 (0)
7717 618834
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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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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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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 in the Company's
Annual Report on Form 20-F for 2020, GSK’s 2021 Q4 Results
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: February
24, 2022
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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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