GSK Singapore announces availability of Shingrix in Singapore for shingles prevention

SINGAPORE, Jan. 10, 2022 /PRNewswire/ -- GlaxoSmithKline (GSK) Singapore announced that a new vaccine to help protect against shingles, Shingrix, is now available in Singapore. Shingrix is a non-live, recombinant subunit adjuvanted vaccine, given intramuscularly in two doses, for the prevention of shingles (herpes zoster). The vaccine was initially approved for adults aged 50 years and over, with the indication expanded recently to adults aged 18 years and over who are at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy^[1].

Shingles is triggered by the reactivation of the varicella zoster virus, the same virus that causes chickenpox. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age^[2]. As one's immunity system declines with age, the risk and severity of shingles increases, putting older adults in Singapore at a higher risk of shingles and its complications^[2].

Shingles affects 1 in 3 people across the Asia-Pacific region^[3]. It can cause lasting pain and other complications which can severely impact the quality of people's lives, such as postherpetic neuralgia (PHN), that can result in persistent nerve pain for months or years after.

Dr. Asok Kurup, Infectious Disease Physician at the Mount Elizabeth Hospital, said, "Shingles can be a very painful rash. Many patients describe the pain as a burning, shooting or stabbing sensation. Some suffer from serious complications and chronic pain for months. If you've had chickenpox, the virus that causes shingles is already inside your body, which means it can reactivate anytime. Even the healthiest lifestyle cannot stop your immune system from declining as you age."

He concluded, "As doctors we never like to see our patients in pain. Shingles can be difficult to treat once the symptoms break out, so vaccination can play an important role in helping to reduce the burden of this painful disease."

"We are truly proud to make GSK's shingles vaccine available in Singapore," said Priya Kudva Menon, VP and General Manager, GSK Singapore. "We are pleased to be able to support healthy ageing for Singaporeans through our Vaccines portfolio and in particular, to be able to play a part in shingles prevention for the 50+ population, who are at increased risk for the shingles disease." 

Shingrix is the first approved shingles vaccine to combine a non-live antigen with a specifically designed adjuvant to trigger a targeted, strong and sustained immune response. Shingrix provides over 90% protection against shingles across all age groups over 50, with robust and sustained efficacy^[1],[4]. It is also the first shingles vaccine indicated for use in those who are at increased risk of the disease due to immunodeficiency or immunosuppression caused by known disease or therapy^[1].

Shingrix was initially approved by the Singapore Health Sciences Authority (HSA) in January 2021, followed by its expanded indication for immunodeficient or immunosuppressed patients aged 18 and over in December 2021. Vaccination against shingles is also recommended in the Society of Infectious Disease (Singapore) Handbook (2020 edition)^[5].

*Note to media: Additional background information*

*About Shingles*

Shingles typically presents as a painful, itchy rash that develops on one side of the body. Complications from shingles can include post-herpetic neuralgia (PHN – persistent neuropathic pain, the most common complication occurring in up to 30% of shingles cases)^[6], herpes zoster ophthalmicus (HZO – occurring in up to 25% of shingles cases)^[2] including vision loss, scarring, stroke, secondary infection and nerve palsies^[7],[8].

Shingles is caused by the reactivation of latent chickenpox virus (varicella zoster virus, VZV). The individual lifetime risk of developing shingles is approximately 1 in 3 people^[2]*.* The risk of shingles and its complications increases with age and is most common in those aged 50 and over^[2]. People with immunosuppressive diseases or therapies are also at increased risk^[9]. 

*About Shingrix*

Shingrix is a non-live, recombinant subunit vaccine indicated in Singapore to help prevent shingles and PHN in adults aged 50 years and over, as well as for adults aged 18 years and over who are at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. It combines an antigen, glycoprotein E, and an adjuvant system, AS01[B], intended to generate an immune response of a declining or compromised immune system^[10].

Shingrix provides over 90% protection against shingles across all age groups over 50, with robust and sustained efficacy for at least 7 years^[1],[4].

Shingrix is to be given intramuscularly in two doses, 2 to 6 months apart^[1]. However, for adults who are immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.

*Important Safety Information for Shingrix*^[1]

The following is based on the Singapore Prescribing Information for Shingrix. Please refer to the full Prescribing Information for all the full safety information.

· *Contraindications*: Shingrix is contraindicated in anyone who is allergic (hypersensitive) to the active substances or to any component of the vaccine.
· *Warnings and Precautions*:

· Shingrix should not be administered intravascularly, intradermally or subcutaneously.
· Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
· Syncope (fainting) can occur following or before any vaccination as a psychogenic response to the needle injection.
· Vaccination with Shingrix may not result in the protection of all individuals.
· In a post-marketing observational study in individuals aged ≥65 years, an increased risk of Guillain-Barré syndrome (estimated 3 excess cases per million doses administered) was observed during the 42 days following vaccination. Available information is insufficient to determine a causal relationship with Shingrix.

· *Adverse Reactions*: Most frequently reported adverse reactions include pain at injection site, myalgia, fatigue, headache, chills, fever, gastrointestinal symptoms, and malaise. Please refer to the full prescribing information for more details.
· Shingrix is not indicated for the prevention of chickenpox.
· A healthcare professional should be consulted for more information about the benefits and risks of Shingrix prior to administration.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are encouraged to report any suspected adverse reactions.

*A**bout GSK*

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

*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 in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

*References*

[1] Singapore Local Prescribing Information for Shingrix Herpes zoster vaccine. Available at: https://gskpro.com/content/dam/global/hcpportal/en_SG/products/PDF/shingrix/pdf/shingrix-pi-gdsv06si-approved-13dec2021.pdf. Last accessed: January 2022.

[2] 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;57(RR-5): 1-30.

[3] Chen L.K., Pinchinat S, et al. Looking Back To Move Forward: A Twenty-Year Audit Of Herpes Zoster In Asia-Pacific. BMC Infectious Diseases, 2017; 17: 213.

[4] Boutry et al. The Adjuvanted Recombinant Zoster Vaccine Confers Long-term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase III Clinical Trials (ZOE-50 and ZOE-70). Clin Infect Dis. 2021: ciab629.

[5] Society of Infectious Diseases, College of Family Physicians Singapore, Chapter of Infectious Disease Physicians. Handbook on Adult Vaccination in Singapore 2020. Available at: https://static1.squarespace.com/static/55a367f6e4b0ab3ab048c147/t/5ee73b41945e9b489ae933f9/1592212309077/SIDS+Adult+Vaccine+Handbook+2020.pdf. Last accessed: December 2021.

[6] Kawai K, Gebremeskel BG, Acosta CJ. Systematic Review Of Incidence And Complications Of Herpes Zoster: Towards A Global Perspective. BMJ Open. 2014;4(6): e004833.

[7] Tseng HF et al. The Epidemiology of Herpes Zoster in Immunocompetent, Unvaccinated Adults ≥50 Years Old: Incidence, Complications, Hospitalization, Mortality, and Recurrence. J Infect Dis. 2020;222(5): 798-806.

[8] Sreenivasan N, Basit S, Wohlfahrt J, Pasternak B, Munch TN, Nielsen LP, et al. The Short- And Long-Term Risk Of Stroke After Herpes Zoster— A Nationwide Population-Based Cohort Study. PLoS One. 2013;8: e69156.

[9] Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A Population-Based Study Of The Incidence And Complication Rates Of Herpes Zoster Before Zoster Vaccine Introduction. Mayo Clin Proc. 2007;82(11): 1341-9.

[10] Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372: 2087-96.