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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 2023
Commission
File Number 001-15170
GSK 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: 15 February 2023, London UK
Landmark New England Journal of
Medicine publication
reinforces potential of GSK's respiratory syncytial virus older
adult vaccine candidate
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First
peer-reviewed publication of phase III respiratory syncytial virus
vaccine data in older adults, including those with comorbidities
who are most at risk
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Expert
perspective recognises a new era in vaccine design based on
progress in respiratory syncytial virus research
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Vaccine
on track to become available in 2023 pending regulatory decisions
in the US, EU, and other countries
GSK plc (LSE/NYSE: GSK) today announced the publication of positive
phase III trial results for its respiratory syncytial virus (RSV)
older adult vaccine candidate in the New
England Journal of Medicine. The publication summarises the
pivotal efficacy data (previously
presented at
IDWeek 2022), showing the vaccine candidate met the primary
endpoint of vaccine efficacy against RSV-lower respiratory tract
disease (LRTD) in adults aged 60 years and above, with a favourable
safety profile. In addition, positive vaccine efficacy was observed
in participants with comorbidities of interest who are at increased
risk of severe outcomes.
RSV is one of the major infectious diseases without a vaccine or
specific treatment available for older adults. The
accompanying New England Journal of
Medicine expert
perspective article recognises the significant progress that has
been made in RSV vaccine design. GSK is the first company to
publish positive peer-reviewed phase III data for an RSV older
adult vaccine candidate.
Tony Wood, Chief Scientific Officer, GSK, said:
"Our ambition is to protect the many older adults at risk from RSV
disease, including those with underlying health conditions, who
account for the majority of severe RSV outcomes. We are delighted
to publish these exceptional data in the New
England Journal of Medicine. We look forward to making the
vaccine available as quickly as possible, pending regulatory
decisions, and sharing more data from our ongoing clinical
development programme as we work to get ahead of this potentially
debilitating virus."
Professor Martinón-Torres, Co-ordinator of the Vaccine
Clinical Trials Unit, Instituto de Investigación Sanitaria de
Santiago, Spain, and
one of the authors on the New
England Journal of Medicine publication, added:
"Although RSV often results in mild symptoms, it can have
devastating consequences for older adults and has a global burden
that can approach that of seasonal influenza. The publication of
these important data shows that, for the first time, we are on the
cusp of having an effective vaccine that could meaningfully impact
public health."
GSK is on track to supply the vaccine candidate ahead of the
2023-24 northern hemisphere RSV season, pending regulatory
decisions in the US, EU, Japan, and other countries. A meeting of
the US Food and Drug Administration's Vaccines and Related
Biological Products Advisory Committee (VRBPAC) to review the
Biologics License Application will take place on 1 March
2023. There are currently no RSV
vaccines approved anywhere in the world.
RSV clinical development programme
GSK is conducting three additional phase III clinical trials that
aim to expand the population who may benefit from RSV vaccination
into adults aged 50-59 with underlying comorbidities and to provide
further evidence on co-administration with other older adult
vaccines.
These are fully recruited, and results are expected in 2023,
together with additional data from the AReSVi-006 (Adult
Respiratory Syncytial Virus) phase III efficacy trial and the
AReSVi-004 immunogenicity trial. These continue to evaluate an
annual revaccination schedule and protection/immunogenicity over
multiple seasons following one dose of the RSV vaccine
candidate.
●
NCT05590403 will
evaluate the immunogenicity and safety of the vaccine candidate in
adults 50-59 years of age, including adults at increased risk of
RSV-LRTD, compared to its immunogenicity and safety in adults
≥60 years of age.
●
NCT05568797 and NCT05559476 will
evaluate the vaccine candidate's immunogenicity, safety and
reactogenicity when co-administered with adjuvanted and high-dose
influenza vaccines in adults aged 65 years and above. These trials
build on positive data on the concomitant administration of GSK's
RSV older adult vaccine candidate with seasonal quadrivalent
influenza vaccination presented at IDWeek 2022.
About GSK's RSV older adult vaccine candidate
GSK's RSV older adult vaccine candidate contains a recombinant
subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined
with the Company's proprietary AS01E adjuvant. Across
multiple trials, the vaccine candidate was generally well tolerated
with a favourable safety profile. The most frequently observed
solicited adverse events were injection site pain, fatigue,
myalgia, and headache. These were typically mild to moderate and
transient. The GSK proprietary AS01 adjuvant
system contains QS-21 STIMULON adjuvant licensed from Antigenics
Inc, a wholly-owned subsidiary of Agenus Inc.
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages. It is one of the major remaining infectious diseases for
which there is currently no vaccine or specific treatment available
for adults. Older adults are at high risk for severe disease due in
part to age-related decline in immunity, and older adults with
underlying conditions are at even greater risk for severe disease.
RSV can exacerbate conditions, including chronic obstructive
pulmonary disease, asthma and chronic heart failure and can lead to
severe outcomes, such as pneumonia, hospitalisation, and death.
Each year RSV causes over 470,000 hospitalisations and 33,000
deaths in adults in high-income countries.1 Adults
with underlying conditions are more likely to seek medical services
and have higher hospitalisation rates than adults without these
conditions.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com/company.
GSK enquiries
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Media:
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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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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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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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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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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7736 063933
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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 2021, GSK's Q4 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1. Savic
M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus
disease burden in adults aged 60 years and older in high-income
countries: a systematic literature review and meta-analysis.
Influenza Other Respir Viruses 2022 November 11 (Epub ahead of
print). [PMID: 36369772]. Accessed 6 December 2022. Available
at: Respiratory
syncytial virus disease burden in adults aged 60 years and
older in high‐income
countries: A systematic literature review and
meta‐analysis
- Savic - Influenza and Other Respiratory Viruses - Wiley Online
Library
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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GSK plc
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(Registrant)
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Date: February
16, 2023
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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 GSK plc
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