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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 April 2024
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:
17 April 2024, London UK
New long-term data show Shingrix continues to provide high
protection against shingles in adults aged 50 and over for more
than a decade
●
End-of-trial data
show 79.7% efficacy in participants
aged 50 years and over, six to 11 years
after vaccination1
●
Vaccine efficacy remains high at 82.0% at year 11
after initial vaccination[1]
●
No new safety concerns were identified during the
follow-up period1
GSK plc
(LSE/NYSE: GSK) today announced positive data from the ZOSTER-049
long-term follow-up phase III trial which followed participants for
up to approximately 11 years following initial vaccination
with Shingrix (Recombinant Zoster
Vaccine or RZV). The final trial data demonstrate that RZV
maintains efficacy against shingles for more than a decade in
adults over 50. The data will be presented at ESCMID Global
(European Society of Clinical Microbiology and Infectious Diseases)
2024, formerly known as ECCMID in Barcelona, Spain (27-30 April
2024).1
The
results from ZOSTER-049, an extension from two phase III clinical
trials in adults aged 50 and over (ZOE-50 and ZOE-70),
include:1
●
79.7% vaccine
efficacy (VE) in adults aged ≥50 cumulatively within the
period from year six to year 11 after vaccination (95% CI
73.7-84.6)
●
82.0% VE in adults ≥50 at year 11 (95% CI
63.0-92.2), showing VE remains high in each year after
vaccination
●
73.1% VE in adults
aged ≥70 cumulatively from six to 11 years after vaccination
(95% CI 62.9-80.9) showing high VE rates across all age
groups
Dr Javier Díez-Domingo, Principal Investigator, FISABIO
(Foundation for the Promotion of Health and Biomedical Research of
the Valencian Community, Spain) said: "These final data demonstrate continued
protection over more than a decade with high efficacy maintained in
both the 50+ and 70+ age groups. Infectious diseases like shingles pose a significant risk to
adults due to the natural decline in our immune
system, and these data represent remarkable advancement
in our understanding of what can be achieved long-term for
effective protection against shingles."
Phil Dormitzer, Senior Vice President, Head of Vaccines R&D,
said: "These
data go far beyond the typical long-term
follow-up period for a trial, tracking
the efficacy of vaccination for some participants as they aged into
their 70s, 80s and 90s. With the vaccine now included in many national
immunisation programmes around the world, these
data add to
the body of evidence on the extended long-term protection against
shingles and provide further confidence to inform public
immunisation strategies."
Globally, shingles will affect up to 1 in 3 people in their
lifetimes.[2],[3],[4],[5] A variety of factors can increase the risk of
developing shingles, including advancing age and immunodeficiency
or immunosuppression,[6] as well as other chronic conditions such as
COPD, diabetes mellitus, and asthma.[7] Shingles typically presents as a rash, with
painful blisters across the chest, abdomen or
face,[8] with the pain often described as aching,
burning, stabbing or shock-like.2 Following the rash, up to 30% of people
experience post-herpetic neuralgia (PHN),[9] a long-lasting nerve pain that can last weeks or
months and can occasionally persist for several
years.2 Shingles
is also associated with significant healthcare and human cost, with
57% of people with shingles reported
missing work for an average of 9.1 days.[10]
We will continue to evaluate long-term data and conduct real-world
evidence studies related to vaccine efficacy, immunogenicity, and
safety across indicated populations, including those at highest
risk of shingles to assess a potential need for revaccination in
future.
About ZOSTER-0491
ZOSTER-049 is a phase III open-label, long-term
follow-up trial from two pivotal phase III randomised clinical
trials (ZOE-50, ZOE-70). The trial evaluated the efficacy, safety, and
immunogenicity in adults 50 years and over at time of vaccination,
for six additional years after completion of the ZOE-50 and ZOE-70
trials, up to approximately 11 years of
follow-up.
ZOSTER-049
included over 7,000 participants from 18 countries across five
continents, with vaccine recipients compared to historical
controls.
No new safety concerns were identified during the follow-up period
in ZOSTER-049. No serious adverse events were considered
causally related to RZV vaccination by the investigators. In adults
aged 50 years and over, the most frequently reported adverse
reactions with RZV are pain at the injection site, myalgia, fatigue
and headache. Most of these reactions were mild to moderate in
intensity and generally lasted less than three
days.[11]
About shingles
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.2 By age 50, VZV is present in most
adults[12] and may reactivate with advancing
age.8 As people age, the strength of the immune system
response to infection wanes, increasing the risk of developing
shingles.2
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.[13],[14] RZV is not indicated to prevent primary
varicella infection (chickenpox). In several countries, RZV is also
approved for adults aged 18 years or over at increased risk for
shingles. The use of RZV should be in accordance with official
recommendations and local product label.
Please refer to the Product Information (PI) for important dosage,
administration, and safety information in Europe available at this
link: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
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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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
2023.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8
9GS
References
[1] Diez-Domingo J, et
al. Adjuvanted
recombinant zoster vaccine (RZV) is the first vaccine to provide
durable protection against herpes zoster (HZ) in all age ranges
≥50 years: final analysis of efficacy and safety after 11
years (Y) of follow-up. Abstract presented at European Society of
Clinical Microbiology and Infectious Diseases (ESCMID); 27-30 April
2024, Barcelona, Spain.
[2] 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.
[3] Australian Institute of Health and Welfare.
Shingles in Australia. Available at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx Last
Accessed: April 2024.
[4] Lee C, et al.
Lifetime risk of herpes zoster in the population of Beijing, China.
Public Health Pract (Oxf). 2023;5:100356.
[5] Curran D, et al.
Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis
Ther. 2022;11(1):389-403.
[6] Chen S-Y, et al.
Incidence of herpes zoster in patients with altered immune
function. Infection. 2014; 42: 325-334.
[7] Marra F, et al. Risk
Factors for Herpes Zoster Infection: A Meta-Analysis. Open Forum
Infect Dis 2020;7(1):ofaa005.
[8] Mueller, N.H., et
al. Varicella zoster
virus infection: clinical features, molecular pathogenesis of
disease, and latency. Neurologic
clinics.
2008;26(3):675-97.
[9] Kawai, K., et al.
Systematic review of incidence and complications of herpes zoster:
towards a global perspective. BMJ open. 2014;4(6).
[10] Rampakakis E, Stutz M, Kawai K, Tsai TF, Cheong
HJ, Dhitavat J, et al. Association between work time loss and
quality of life in patients with Herpes Zoster: a pooled analysis
of the MASTER studies. Health and Quality of Life
Outcomes. 2017;15(1).
[11] Grading of
Recommendations, Assessment, Development, and Evaluation (GRADE):
Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged
≥19 Years. Centers for Disease Control and Prevention (CDC).
Available from: https://www.cdc.gov/vaccines/acip/recs/grade/recombinant-zoster-immunocompromised.html.
Last Accessed: April 2024
[12] Johnson, R.W., et
al. Herpes zoster epidemiology, management, and disease and
economic burden in Europe: a multidisciplinary perspective.
Therapeutic advances in vaccines.
2015;3(4):109-20.
[13] Cunningham, AL, et
al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70
Years of Age or Older. New England Journal of
Medicine.
2016;375(11):1019-32.
[14] 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: April
17, 2024
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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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