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 March 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: 1 March 2023, London UK
US FDA Advisory Committee votes to support effectiveness and safety
of GSK's respiratory syncytial virus older adult vaccine
candidate
● Committee
votes unanimously that the data support the effectiveness of the
vaccine, and 10-2 that the data support the safety of the
vaccine
● FDA
decision on US approval expected by 3 May 2023,
with the
potential for the vaccine to be the first approved for older
adults
● Evidence
reviewed by the Committee was supported by pivotal data recently
published in the New England
Journal of Medicine
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) Vaccines
and Related Biological Products Advisory Committee
(VRBPAC) voted
that the available data support the safety and effectiveness
of GSK's
respiratory syncytial virus (RSV) older adult vaccine candidate for
the prevention of lower respiratory tract disease (LRTD) caused by
RSV in adults aged 60 years and older. The Committee voted
unanimously 12-0 on effectiveness and 10-2 on
safety.
Phil Dormitzer, Global Head of Vaccines R&D, GSK
said: "Today's
vote brings us an important step closer to delivering one of the
world's first vaccines for RSV, a respiratory
virus that
causes potentially debilitating disease and imposes a major burden
on healthcare systems. Thousands
of older
adults in the US are impacted
by RSV and those
with underlying health conditions, like respiratory and heart
diseases and diabetes, are at increased risk of severe
complications. We're
delighted that the Advisory Committee recognised the strength of
our vaccine's data and its potential to make a positive
public health impact with a unanimous vote on the effectiveness of
the vaccine."
The Committee based its vote on the robust data package supporting
the vaccine candidate. This includes results from the pivotal
AReSVi-006 (Adult Respiratory Syncytial Virus)
phase III trial, recently published in the New
England Journal of Medicine. In addition, GSK presented
positive data on concomitant administration with seasonal
quadrivalent influenza vaccination previously shared at IDWeek
2022.
The role of the VRBPAC is to provide non-binding recommendations
for consideration by the FDA, with the final decision on approval
made by the FDA. In November 2022, the FDA accepted the
Biologics License Application (BLA) for GSK's RSV older adult
vaccine candidate under Priority Review and assigned a Prescription
Drug User Fee Act action date of 3 May 2023.
GSK's RSV older adult vaccine candidate is also under regulatory
review by the European Medicines Agency, Japan's Ministry of
Health, Labour and Welfare, and several other regulators, with
decisions expected in 2023. Additional regulatory submissions are
anticipated to continue throughout this year.
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 GSK's proprietary AS01E adjuvant.
Across multiple trials, the vaccine candidate was generally well
tolerated with an acceptable 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.
There are currently no RSV vaccines approved anywhere in the
world.
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 other conditions, including chronic obstructive
pulmonary disease, asthma and chronic heart failure and can lead to
severe complications, 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
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GSK enquiries
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Media:
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Tim Foley
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(London)
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Simon Moore
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Kathleen Quinn
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Alison Hunt
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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) 7796 707505
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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 February 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: March
02, 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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