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 June 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 . . . . . . . .
Issued:
26 June 2023, London UK
Japan's Ministry of Health, Labour and Welfare
approves Shingrix for the prevention of
shingles in at-risk adults aged 18 and over
● Approval expands the number of people who can be
protected against shingles, now including all adults considered at
increased risk by their healthcare provider
● Shingrix (Recombinant Zoster Vaccine - RZV) is already
approved in Japan for adults aged 50 and over
GSK plc
(LSE/NYSE: GSK) today announced that the Japanese Ministry of
Health, Labour and Welfare (MHLW) has approved an updated
indication for Shingrix (Recombinant Zoster
Vaccine, Adjuvanted - RZV) for the prevention of shingles (herpes
zoster) in adults aged 18 years and over who are at increased risk
of the condition.[1],[2]
RZV, a
non-live, recombinant sub-unit adjuvanted vaccine, was first
approved in 2018 by the Japanese MHLW for shingles prevention in
adults aged 50 years and over. This week's approval represents a
significant expansion of RZV's availability in Japan, now including
all adults aged 18 and over considered to be at increased risk of
shingles by their healthcare provider.
Nearly all older adults have VZV dormant in their nervous system,
waiting to reactivate with advancing age.2,[3],[4] As
people age, the strength of the immune system response to infection
decreases, increasing the risk of developing
shingles.1,2,4,13 People
with a suppressed or compromised immune system, are also at high
risk of shingles.[5],4 It
is estimated that about 600,000 people in Japan develop shingles
every year.[6]
The MHLW approval was granted based on data from six clinical
trials involving adults aged 18 years and over who were among those
at increased risk for shingles, including those who had undergone
recent stem cell transplantation or kidney transplant, or who had
blood cancer, solid tumours or HIV.5,[7],[8],[9],[10],[11],[12]
About shingles
Shingles, also known as herpes zoster, is caused by a reactivation
of the varicella-zoster virus (VZV) - the same virus that causes
chickenpox.1
Globally, most people over the age of 50 have dormant VZV in their
nervous system and are at risk of developing
shingles.2,[13] Shingles
typically presents as a rash, with painful blisters across the
chest, abdomen or face.1 The
pain is often described as aching, burning, stabbing or
shock-like.4 Following
the rash, a person can also experience PHN, a long-lasting nerve
pain that can continue for weeks or months and occasionally
persists for several years.4 PHN
is the most common complication of shingles, occurring in up to
10-18% of all shingles cases depending on the individual's
age.4
About Shingrix
RZV is a non-live, recombinant sub-unit vaccine approved by
the Japanese MHLW on 23 March 2018 to prevent shingles in adults 50
years and over.
It combines an antigen, glycoprotein E, with an adjuvant system,
AS01B,
and may help overcome the natural age-related decline in responses
to immunisation that contribute to the challenge of protecting
older adults from shingles.[14],[15] RZV
is not indicated to prevent primary varicella infection
(chickenpox).
RZV has launched in more than 30 countries for the prevention of
shingles in adults aged 50 years and over, and adults aged 18 or
over who are or will be at increased risk of shingles. RZV is the
only shingles vaccine specifically indicated for those aged 18 or
over at increased risk of shingles due to certain underlying
diseases, conditions or treatments.[16]
Important Information for Shingrix in Japan
Shingrix (Recombinant Zoster Vaccine -
RZV) is a non-live, recombinant sub-unit vaccine indicated for the
prevention of herpes zoster (HZ) in adults aged 50 and over, and is
the only shingles vaccine specifically indicated for those aged 18
or over at increased risk of HZ due to certain underlying diseases,
conditions or treatments.16
Please refer to the updated Product Information (PI) for
important dosage, administration, and safety information in Japan
which will shortly be updated at this link:
https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html
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 https://www.gsk.com/en-gb/company/
GSK enquiries
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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
2022, and Q1 Results for 2023 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] Mueller, NH et al. Varicella Zoster Virus
Infection: Clinical Features, Molecular Pathogenesis of Disease and
Latency. Neurologic Clinics, 2008;
26;675-697.
[2] Bollaerts K et al. Epidemiol Infect
2017;145:2666-2677
[3] Johnson RW et al. Herpes zoster epidemiology, management, and
disease and economic burden in Europe: a multidisciplinary
perspective. Therapeutic Advances in Vaccines.
2015;3(4):109-120.
[4] Harpaz R et al. Advisory Committee on
Immunization Practices (ACIP), Centers for Disease Control and
Prevention (CDC). Prevention of herpes zoster: recommendations of
the Advisory Committee on Immunization Practices (ACIP). MMWR
Recomm Rep. 2008;57(RR-5):1-30.
[5] Huang C-T et al. J Clin Endocrinol Metab
2022;107:586-597
[6] IASR.
Epidemiology of herpes zoster in Miyazaki Préfecture 2013;
34;298-300. Available at: https://www.niid.go.jp/niid/ja/iasr-sp/2256-related-articles/related-articles-404/4014-dj4048.html.
Last Accessed May 2023.
[7] Bastidas
A, et al. JAMA 2019;132:123-133.
[8] Berkowitz
EM, et al. J Infect Dis 2015;211:1279-1287.
[9] Vink
P, et al. Cancer 2019;125:1301-1312.
[10] Dagnew
AF, et al. Lancet Infect Dis 2019;19:988-1000.
[11] Stadtmauer
E, et al. Blood.
2014;124(19):2921-2929
[12] Imafuku S et al. Risk of herpes
zoster in the Japanese population with immunocompromising and
chronic disease conditions: Results from a claims database cohort
study, from 2005 to 2014. Journal of Dermatology. 2020; 47:
236-244.
[13] Bricout
H et al. "Herpes zoster-associated mortality in Europe: a
systematic review." BMC Public Health 2015,
15:466. Available at:
https://doi.org/10.1186/s12889-015-1753-y Last accessed: April
2023.
[14] Cunningham et al. Vaccine profile of herpes
zoster (HZ/su) subunit vaccine. Expert Review of
Vaccines. 2017; 16:7;661-670.
[15] The GSK proprietary AS01 adjuvant system contains
QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a
wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and
liposomes.
[16] Centers for Disease Control and Prevention (CDC).
Shingles vaccination. Available at:
https://www.cdc.gov/vaccines/vpd/shingles/public/shingrix/. Last
accessed: June 2023.
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: June
26, 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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