Issued: 6 February 2024, London
UK
GSK's regulatory application for
Shingrix for the
prevention of shingles in at-risk adults aged 18 and over accepted
for review by China National Medical Products
Administration
· Shingrix
already approved in China for adults aged 50 years
and over
· Application could expand populations eligible to benefit from
protection against shingles to include adults with an increased
risk of the disease
· Approximately six million cases of shingles in China each
year, with the incidence over three times higher for adults at
increased risk compared to the general population
GSK plc (LSE/NYSE: GSK) today
announced that the Center for Drug Evaluation (CDE) of the China
National Medical Products Administration (NMPA) has accepted for
review the regulatory application of Shingrix (Recombinant Zoster Vaccine
or RZV) for the prevention of shingles (herpes zoster) in adults
aged 18 years and over at increased risk.
Recombinant Zoster Vaccine (RZV) is a
non-live, recombinant subunit adjuvanted vaccine given
intramuscularly in two doses and was initially approved in 2019 by
the NMPA to prevent shingles in adults aged 50 years and
over.1-3
Globally, shingles will affect up to
1 in 3 people in their lifetime.4-7 A variety of factors can increase the risk of developing
shingles, including advancing
age and immunodeficiency or
immunosuppression,8
as well as other chronic conditions such as COPD,
diabetes, and asthma.9 It is
estimated that there are approximately 6 million cases of shingles
in China each year,10 with the incidence in people who
are at increased risk, including people who are immunocompromised
either due to disease or therapeutic treatment, being over three
times higher than the general population.11
The NMPA application is informed by six
clinical trials in patients aged 18 years and over who had
undergone recent blood-forming cells (stem cell) transplantation,
kidney transplant, or have blood cancer, solid tumour, or
HIV.12-17
About shingles
Shingles is caused by the
reactivation of the varicella-zoster virus (VZV), the same virus
that causes chickenpox.4
A variety of factors can increase the risk of
developing shingles, including advancing age and immunodeficiency
or immunosuppression,8
as well as other chronic conditions such as COPD,
diabetes, and asthma.9
Shingles typically presents as a
rash, with painful blisters across the chest, abdomen, or
face.18 The pain is often described as aching, burning,
stabbing or shock-like.4 Following the rash, a person
can also experience post‑herpetic neuralgia (PHN), a long-lasting
nerve pain that can last weeks or months and can occasionally
persist for several years.4 PHN is the most common
complication of shingles, occurring in 5-30% of all shingles cases
from findings in various studies.19
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.1,2 RZV
is not indicated to prevent primary varicella infection
(chickenpox). In some 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.
Please refer to the Product
Information (PI) for important dosage, administration and safety
information in China available at this link:
https://www.gsk-china.com/media/6506/4-说明书-pdf-145m-ppc-0025427-v3-clean.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.
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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 Q4 Results for 2023.
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References
1. Cunningham, A.L., 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):1019-1032.
2. 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.
3. GSK. GSK announces approval of
Shingrix in China for prevention of shingles in adults aged 50 and
over. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-announces-approval-of-shingrix-in-china-for-prevention-of-shingles-in-adults-aged-50-and-over/.
Last accessed: January 2024.
4. Harpaz, R., et al. Prevention of
herpes zoster: recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR Recomm
Rep 2008;57(Rr-5):1-30.
5. Shingles in Australia. Australian
Institute of Health and Welfare [Available from:
https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx
Last Accessed: November 2023
6. Lee, C., et al. Lifetime risk of
herpes zoster in the population of Beijing, China. Public health in
practice (Oxford, England). 2023;5:100356.
7. Curran, D., et al.
Meta-Regression of Herpes Zoster Incidence Worldwide. Infectious
diseases and therapy. 2022;11(1):389-403.
8. Chen S-Y, et al. Incidence of
herpes zoster in patients with altered immune function. Infection.
2014; 42: 325-334.
9. Marra F, et al. Risk Factors for
Herpes Zoster Infection: A Meta-Analysis. Open Forum Infect Dis
2020;7(1):ofaa005.
10. Zhang, Z., et al. The incidence
of herpes zoster in China: A meta-analysis and evidence quality
assessment. Human vaccines & immunotherapeutics.
2023;19(2):2228169.
11. Zhenwei L, et al. Study on the
risk of recurrence of herpes zoster in adults based on a
retrospective cohort design. Zhejiang University of Traditional
Chinese Medicine Conference.
12. Bastidas, A., et al. Effect of
Recombinant Zoster Vaccine on Incidence of Herpes Zoster After
Autologous Stem Cell Transplantation: A Randomized Clinical Trial.
JAMA. 2019;322(2):123-33.
13. Vink, P., et al. Immunogenicity
and safety of the adjuvanted recombinant zoster vaccine in patients
with solid tumors, vaccinated before or during chemotherapy: A
randomized trial. Cancer. 2019;125(8):1301-12.
14. Dagnew, A.F., et al.
Immunogenicity and safety of the adjuvanted recombinant zoster
vaccine in adults with haematological malignancies: a phase 3,
randomised, clinical trial and post-hoc efficacy analysis. The
Lancet Infectious Diseases. 2019;19(9):988-1000.
15. Stadtmauer, E.A., et al. A phase
1/2 study of an adjuvanted varicella-zoster virus subunit vaccine
in autologous hematopoietic cell transplant recipients. Blood.
2014;124 (19):2921-2929.
16. Berkowitz, E.M., et al. Safety
and immunogenicity of an adjuvanted herpes zoster subunit candidate
vaccine in HIV-infected adults: a phase 1/2a randomized,
placebo-controlled study. The Journal of infectious diseases.
2015;211(8):1279-1287.
17. GSK. Abstract on
file.
18. Mueller, N.H., et al. Varicella
zoster virus infection: clinical features, molecular pathogenesis
of disease, and latency. Neurologic clinics.
2008;26(3):675-697.
19. Kawai, K., et al. Systematic
review of incidence and complications of herpes zoster: towards a
global perspective. BMJ open. 2014;4(6).