REG - GSK PLC - Positive CHMP Opinion for GSK on Shingrix PFS

GSKAnnouncement

Tue 07:05

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RNS Number : 1149E  GSK PLC  21 October 2025

Issued: 21 October 2025, London UK

 

GSK's Shingrix new prefilled syringe presentation receives positive CHMP
opinion

 

·   Prefilled syringe offers a convenient ready-to-use administration
option to healthcare professionals

·   Marketing authorisation in EU expected in December 2025

·   Shingles affects approximately 1.7 million people in Europe each
year 1  (#_edn1)

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a
positive opinion to support the approval of Shingrix (GSK's Recombinant Zoster
Vaccine or RZV) in a prefilled syringe. Currently, the vaccine presentation
consists of two vials, a lyophilised powder antigen and a liquid adjuvant,
which are combined prior to administration. After approval by the European
Commission, expected in December 2025, the new prefilled syringe will remove
the need to reconstitute separate vials, simplifying the vaccine
administration process for healthcare professionals.

 

Tony Wood, Chief Scientific Officer, GSK, said: "At GSK, we are dedicated to
driving innovation to continually enhance our world-class vaccines. The CHMP
positive opinion on our new presentation of Shingrix reflects our commitment
to supporting the healthcare community, making it easier for healthcare
professionals to provide protection against shingles, a painful disease
affecting well over a million people in Europe each year."

 

GSK's shingles vaccine has been approved in the European Union for the
prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults
aged 50 years or older since 2018; and in adults 18 years or older at
increased risk of HZ, since 2020. GSK's RZV is specifically designed to
enhance the varicella-zoster virus (VZV)‑specific immune response of a
declining or compromised immune system. 2  (#_edn2) (, 3  (#_edn3) ) This
positive CHMP opinion is based on data confirming technical comparability
between the prefilled syringe and the existing vaccine presentation. 4 
(#_edn4)

 

About shingles

Shingles is caused by the reactivation of the varicella-zoster virus (VZV),
the same virus that causes chickenpox. 5  (#_edn5) Globally, up to 1 in 3
adults will develop shingles in their lifetime.(5, 6  (#_edn6) , 7  (#_edn7)
, 8  (#_edn8) ) Over 90% of adults have the varicella-zoster virus (VZV)
dormant in their nervous system, waiting to reactivate.(6, 9  (#_edn9) , 10 
(#_edn10) , 11  (#_edn11) ) In addition to advancing age, chronic conditions
like cardiovascular disease, chronic kidney disease, chronic obstructive
pulmonary disease, asthma, and diabetes are all linked to higher risk of
shingles.(5, 12  (#_edn12) )

 

Shingles typically presents as a rash, with painful blisters across the chest,
abdomen or face.(9) Following the rash, up to 30% of people experience
PHN, 13  (#_edn13) a long-lasting nerve pain that can last weeks or months and
can occasionally persist for several years.(5) Shingles is also associated
with significant healthcare and human cost, with one in three patients with
shingles taking an average of 12.5 days of sick leave and patients with PHN
taking sick leave for an average of two months. 14  (#_edn14)

 

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix combines an antigen, glycoprotein E, with an adjuvant system,
AS01(B), 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.(2,3) RZV is not indicated to prevent primary varicella
infection (chickenpox). 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.

 

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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 "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q2 Results for 2025.

 

Registered in England & Wales:

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Registered Office:

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WC1A 1DG

 

References

 1  (#_ednref1) Pinchinat et al. Similar herpes zoster incidence across
Europe: results from a systematic literature review. BMC Infect Dis.
2013;13:170.

 2  (#_ednref2) 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.

 3  (#_ednref3) 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.

 4  (#_ednref4) GSK. Data on file 2025.

 5  (#_ednref5) 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.

 6  (#_ednref6) 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
(https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx)
. Last Accessed: October 2025.

 7  (#_ednref7) Lee C, et al. Lifetime risk of herpes zoster in the population
of Beijing, China. Public Health Pract (Oxf). 2023;5:100356.

 8  (#_ednref8) Curran D, et al. Meta-Regression of Herpes Zoster Incidence
Worldwide. Infect Dis Ther. 2022;11(1):389-403.

 9  (#_ednref9) Mueller, N.H., et al. Varicella zoster virus infection:
clinical features, molecular pathogenesis of disease, and latency. Neurologic
clinics. 2008;26(3):675-97.

 10  (#_ednref10) 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.

 11  (#_ednref11) Bricout, H., et al. Herpes zoster-associated mortality in
Europe: a systematic review. BMC public health. 2015;15:466.

 12  (#_ednref12) Steinmann et al. Risk factors for herpes zoster infections:
a systematic review and meta-analysis unveiling common trends and
heterogeneity patterns. Infection. 2024;52(3):1009-1026. doi:
10.1007/s15010-023-02156-y. REF-224255

 13  (#_ednref13) Kawai, K., et al. Systematic review of incidence and
complications of herpes zoster: towards a global perspective. BMJ open.
2014;4(6).

 14  (#_ednref14) Ultsch B, Koster I, Reinhold T, et al. Epidemiology and cost
of herpes zoster and postherpetic neuralgia in Germany. Eur J Health Econ.
2013;14(6):1015-26.

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