a1343k
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 August 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: 23 August 2023, London UK
New Shingrix data demonstrate 100% vaccine efficacy in
the prevention of shingles in adults aged 50 and over in
China
●
No cases
of shingles (herpes zoster) reported among the participants who
received Shingrix (Recombinant
Zoster Vaccine or RZV) in the randomised clinical
trial[1]
● The data come from the first efficacy trial
of Shingrix in China
● The trial's safety and efficacy data were
consistent with GSK's pivotal phase III trials ZOE-50 and
ZOE-701
GSK plc (LSE/NYSE: GSK) today announced positive results from the
first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in
China. These results come from the post-license phase IV trial
(ZOSTER-076), which evaluated the efficacy and safety of RZV in
preventing shingles in adults aged 50 and over. The trial included
almost 6,000 participants randomised 1:1 to the RZV or placebo
group and followed in an observer-blind design. No cases of
shingles were reported among the participants who received RZV,
compared to 31 cases in the placebo arm.1
The results are in line with findings from the pivotal phase III
trials ZOE-50 and ZOE-70 investigating the efficacy and safety of
RZV, showing vaccine efficacy was up to 97%[2] in adults
aged 50 and over, over a follow-up period of approximately four
years.2,[3] The
safety profile observed in this trial was consistent with the
established safety profile of the vaccine.1 The
new data add to the growing body of evidence affirming the efficacy
and safety profile of RZV in preventing shingles in adults aged 50
and over.1
Globally, the varicella zoster virus (VZV) is present in over 90%
of adults.[4],[5] VZV
remains dormant in the nervous system, waiting to reactivate as
shingles with advancing age.8,9 The
population of people aged 65 and over in China is rapidly
increasing, with a predicted percentage increase from 6.8% in 2000
to 23.6% by 2050.[6] It
is estimated that there are approximately 6 million cases of
shingles in China each year6,
and this number is expected to increase in line with local
population ageing.
RZV was first licensed for use in China in 2019 for the prevention
of herpes zoster in adults aged 50 and over. This post-licence
trial was undertaken to fulfil the requirement of regulatory
authorities to evaluate the vaccine efficacy and safety of two
doses of RZV for the prevention of shingles in China. The trial
further demonstrates RZV's efficacy in preventing herpes zoster in
adults aged 50 and over irrespective of sex, geographic region and
ancestry/ethnicity.
Results from this phase IV trial will be submitted for publication
in a peer-reviewed scientific journal later this year.
About the ZOSTER-076 trial
ZOSTER-076 was a phase IV, randomised, observer-blind,
placebo-controlled, multi-centre trial to assess the prophylactic
efficacy against herpes zoster (HZ) and the immunogenicity and
safety of RZV when administered intramuscularly on a 2-dose
schedule in adults aged 50 and over in China.1
The trial was conducted between 2021 and 2023. It included almost
6,000 adults (n=5,956). Vaccine efficacy was 100% (95% CI:
89.82%-100%). HZ incidence rate of 0/1,000 person years in the RZV
arm versus an incidence rate of 8.2/1,000 person years in the
placebo arm, p<0.0001.1 The
safety profile observed in this trial was consistent with the
established safety profile of the vaccine.1
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.[7] Globally,
most people aged 50 and over have the dormant VZV in their nervous
system and are at risk of developing shingles.4,5 As
people age, the strength of the immune system wanes, leading to a
decreased response to infection and thus increasing the risk of
developing shingles.4,5,7,[8],[9] People
with
a suppressed or compromised immune system are also at risk of
shingles.[10]
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.7 The
pain is often described as aching, burning, stabbing or
shock-like.9 Following
the rash, a person can also experience post-herpetic neuralgia
(PHN), a long-lasting nerve pain that can continue for weeks or
months and in some cases can persists for several
years.9 PHN
is the most common complication of shingles, occurring in 5-30% of
all shingles cases depending on the individual's
age.[11]
About Shingrix
Shingrix (Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant subunit
vaccine indicated for the prevention of shingles in adults 50 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 contributes to the challenge of protecting
adults aged 50 and over from shingles.[12],[13] RZV
is not indicated to prevent primary varicella infection
(chickenpox). In some countries, RZV is also approved for adults
aged 18 years or over who are at increased risk for
shingles.
Please refer to the Product
Information (PI) for
important dosage, administration and safety information in China
available at this link:
https://portaldev2.igskapp.com/media/916483/欣安立适说明书.pdf
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.
GSK enquiries
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Investor
Relations:
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Nick
Stone
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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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Mick
Readey
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Williams
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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
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Frannie
DeFranco
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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 Q2 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] GSK
data on file.
[2] Lal
H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in
Older Adults. N Engl J Med. 2015;372:2087-96.
[3] Cunningham
AL, Lal H, Kovac M, et al. Efficacy of the Herpes Zoster Subunit
Vaccine in Adults 70 Years of Age or Older. N Engl J Med.
2016;375(11):1019-1032.
doi:10.1056/NEJMoa1603800
[4] Bollaerts
K et al. A systematic review of varicella seroprevalence in
European countries before universal childhood immunization:
deriving incidence from seroprevalence data. Epidemiol Infect
2017;145:2666-2677.
[5] Bricout
H et al. Herpes zoster-associated mortality in Europe: a systematic
review. BMC Public Health 2015;15:466.
[6] Zhang Z
et al. The incidence of herpes zoster in China: A meta-analysis and
evidence quality assessment. Hum
Vaccin Immunother. 2023;19(2):2228169.
[7] Mueller,
NH et al. Varicella Zoster Virus Infection: Clinical Features,
Molecular Pathogenesis of Disease and Latency. Neurologic Clinics,
2008; 26;675-697
[8] 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.
[9] 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.
[10] Huang
C-T et al. Association Between Diabetes Mellitus and the Risk of
Herpes Zoster: A Systematic Review and Meta-analysis. J Clin
Endocrinol Metab 2022;107:586-597.
[11] Kawai
K, Gebremeskel BG, Acosta CJSystematic review of incidence and
complications of herpes zoster: towards a global perspectiveBMJ
Open 2014;4:e004833. doi:
10.1136/bmjopen-2014-004833
[12] Cunningham
et al. Vaccine profile of herpes zoster (HZ/su) subunit vaccine.
Expert Review of Vaccines. 2017;16:7;661-670.
[13] 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.
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: August
23, 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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