A vaccine for the prevention of shingles in adults aged 50 and over and those aged 18 and over at increased risk

KUALA LUMPUR,Malaysia,Sept. 13,2024 -- GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK)today announced the launch of its Herpes Zoster vaccine,Shingrix (MAL24056002ARZ),also known as Recombinant Zoster Vaccine,Adjuvanted (RZV) in Malaysia for the prevention of shingles (herpes zoster,HZ) and post-herpetic neuralgia (PHN) in adults aged 50 years and over.i RZVis a non-live,recombinant subunit adjuvanted vaccine given intramuscularly in two doses.

(from left to right) Dr Alap Gandhi,Country Medical Director of GSK Malaysia and Brunei; Ruxandra Nastasa,Vice President & General Manager of GSK Malaysia & Brunei; and Dr Peter Ch’ng,Consultant Dermatologist from Gleneagles Hospital Kuala Lumpur & Honorary Secretary of Dermatological Society of Malaysia at the launch of GSK’s Shingles vaccine.

RZV will initially be available in Malaysia to adults aged 50 and over and those aged 18 and over who are at increased risk of HZ.

Shingles is caused by the reactivation of the varicella zoster virus (VZV),the same virus that causes chickenpox.ii As people age,the cells in the immune system lose the ability to mount a strong and effective response to infection,increasing the risk of developing shingles.iii The disease can cause unbearable pain and,in some cases,people can also develop post-herpetic neuralgia (PHN) a long-lasting nerve pain following shingles.iv

RZV is a vaccine designed to prevent shingles in adults aged 50 years and over and 18 years and over who are at increased risk in countries where the indication for this population has been approved.i RZV is also approved for adults aged 18 and over who are at increased risk of HZ.i Immunocompromised individuals are at greater risk of shingles and associated complications and RZV is a shingles vaccine approved for this at-risk patient population.

In an analysis of the pivotal efficacy studies,ZOE-50,RZV demonstrated vaccine efficacy of up to 97%i in adults 50 years and above,over a follow-up period of approximately three years.iRecent interim data demonstrated overall vaccine efficacy of RZV of greater than 80% over the primary follow-up period approximately six to 10 years after initial vaccination in people 50 years and over.v

Dr. Alap Gandhi,Country Medical Director of GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK) Malaysia said: "Shingles is a disease that can cause excruciating pain and is caused by the reactivation of the varicella zoster virus. RZV has been designed to boost the immune response to the virus in people aged 50 and over or in those with immunocompromised conditions." He concluded,"We are pleased that people in Malaysia will now have access to the RZV vaccine to help reduce the burden of this painful disease."

RZV is an approved shingles vaccine to combine a non-live antigen with GSK's adjuvant and may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting adults aged 50 and over from this disease.vi,vii

RZV has resulted in positive vaccination recommendations.In Malaysia,RZV is recommended by Guideline for Adult Immunization by Malaysia Society of Infectious Diseases and Chemotherapy for persons who are 50 years and above and for immunosuppressed patients 18 years and above.xi

With the launch of RZV in Malaysia,GSK hopes to continue to play a part in the betterment of public health in Malaysia.

PM-MY-SGX-COCO-240003 09/24 Date of Approval: Sept 2024

KKLIU 2560 / EXP 29.01.2025

Trademarks are owned by or licensed by GSK.

Notes to editors

About Shingles

Shingles is caused by varicella zoster virus (VZV),the same virus that causes chickenpox. Adults aged 50 and over may have the VZV dormant in their nervous system,that may reactivate with advancing age.viii As people age,increasing the risk of developing shingles.iii

Shingles typically presents as a rash,with painful blisters across the chest,abdomen or face.ix The pain is often described as aching,burning,stabbing or shock-like.Following the rash,a person can also experience post-herpetic neuralgia (PHN),pain lasting from at least three months up to several years. PHN is the most common complication of shingles,occurring in up to 10-20 percent of all shingles cases depending on their age.

About Shingrix

Shingrix [Herpes Zoster vaccine (recombinant,AS01Bixadjuvanted)] is a non-live,recombinant subunit vaccine indicated for the prevention of shingles (herpes zoster) and,in some markets,for post-herpetic neuralgia (PHN),in adults 50 years of age and over.

Approval of RZV follows a comprehensive Phase III clinical trial program evaluating its efficacy,safety,and immunogenicity in more than 30,000 people. The most common local side effects reported in the clinical trials were pain,redness and swelling at the injection site. The majority were mild to moderate in intensity and transient,generally lasting less than three days.

The indication for RZValso includes the prevention of HZ in adults aged 18 and over who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.x

RZV,given intramuscularly in two doses,was designed to enhance the immune response of a declining or compromised immune system.i

Important Safety Information

The following is based on the Malaysia Prescribing Information for Recombinant Zoster Vaccine (RZV). Please consult the full Prescribing Information for all the labelled safety information.

RZV is contraindicated in anyone who is hypersensitive to the active substances or to any of the excipients of RZV.

As with all injectable vaccines,appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

RZV should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.

In a post marketing observational study,an increased risk of Guillain-Barré syndrome was observed in the 42 days following vaccination with RZV.

Syncope (fainting) can be associated with the administration of vaccines,including RZV. Procedures should be in place to avoid falling injury.

In adults aged 50 years and over,the most frequently reported adverse reactions were pain at the injection site,myalgia,fatigue and headache. Most of these reactions were not long-lasting.

In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy,the safety profile was consistent with that observed in adults 50 years and over.

There are no safety,immunogenicity or efficacy data to support replacing a dose of RZV with a dose of another HZ vaccine. There are limited data to support the use of RZV in individuals with a history of HZ. Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.

There are no data from the use of RZV in pregnant women. As a precautionary measure,it is preferable to avoid the use of RZV during pregnancy.

The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether RZV is excreted in human milk.

As with any vaccine,a protective immune response may not be elicited in all vaccines.

About GSK

GSK is a global biopharma company with the ambition and purpose to unite science,technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people over the next 10 years. Our bold ambitions for patients are reflected in new commitments to growth and a step-change in performance. We have been operating in Malaysia for over 65 years,since starting our first operations in October 1958. In the last six decades,GSK Malaysia has grown substantially both in its infrastructure,business operations as well as talent base. Currently operating with over 400 employees spread across our two business entities – Pharmaceuticals & Vaccines and Business Service Centre. Find out more at Malaysia | GSK.

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 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2019.

PM-MY-SGX-COCO-240003 09/24 Date of Approval: Sept 24

Trademarks are owned by or licensed by GSK.

References

i Herpes zoester (HZ,or shingles) vaccine (non-live recombinant,AS01B adjuvanted). https://assets.gskinternet.com/pharma/GSKpro/Malaysia/Shingrix/shingrix_v01_28_mar_2024_clean.pdf

ii Harpaz R,Ortega-Sanchez IR,Seward JF; 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 Jun;57(RR-5):1-30.

iii Bowsher D. Acute Herpes Zoster and Postherpetic Neuralgia: effects of acyclovir and outcome of treatment with amitriptyline. British Journal of General Practice; 1992; 42; 244-246.

iv Bricout H et al. "Herpes zoster-associated mortality in Europe: a systematic review." BMC Public Health 15:466 (2015). Available at: https://doi.org/10.1186/s12889-015-1753-y Last accessed: February 2023.

v Strezova A et al. Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy,Immunogenicity,and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infectious Diseases. 2022;9:10.

vi 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.

vii Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32.

viii 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.

ix Mueller,NH et al. Varicella Zoster Virus Infection: Clinical Features,Molecular Pathogenesis of Disease and Latency. Neurologic Clinics,2008; 26;675-697.

x Lecrenier et al. EXPERT REVIEW OF VACCINES 2018,VOL. 17,NO. 7,619–634.

xi Guideline for Adult Immunization – 3rd Edition,Malaysia Society of Infectious Diseases and Chemotherapy (Published in October 2020,Revised in November 2023),Page 187