Shingrix approved for Australians 18+ at high risk


Monday, 14 March, 2022

Shingrix approved for Australians 18+ at high risk

GSK Australia’s Shingrix is available on the private market for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in people aged 18 years and over who are at increased risk of shingles.1

People who are immune deficient or immunosuppressed, due to a disease and/or therapy, may be at increased risk of shingles, said GSK in a statement. People with a recent immunosuppressive condition may have a 50% higher risk of shingles than the general population.2 For people who are severely immunocompromised, the risk can be up to four times higher than the general population.3

In Australia, it is estimated that 120,000 new cases of shingles occur each year, accounting for approximately one in 1000 GP visits.4

The clinical trials of Shingrix in highly immunocompromised populations aged 18 years and older are said to have demonstrated a robust immune response and reported adverse reactions were consistent with those reported in adults aged 50 years and over.5-10

This new indication builds on Shingrix’s existing approval for Australian adults aged 50 years and over for the prevention of shingles and PHN.1

Both ATAGI and the National Centre for Immunisation Research and Surveillance (NCIRS) recommend Shingrix for the prevention of herpes zoster and associated complications in immunocompetent and immunocompromised adults aged 50 years and older.11,12

The availability of vaccines to help prevent shingles and PHN in people at increased risk is an “important milestone”, according to Professor Tony Cunningham, infectious disease physician, clinical virologist and Co-Director of the Centre for Virus Research at the Westmead Institute for Medical Research.

“Shingles can be very painful and is often described as burning, shooting or stabbing pain. This acute pain can last for two to four weeks, with some people potentially experiencing complications and chronic pain for months,” Professor Cunningham said.

“People who are at increased risk of shingles, due to underlying conditions or treatments, are significantly more likely to experience severe disease and hospitalisation than the general population. For these patients, vaccines can play an important role in helping reduce the impact of the infection.”

Shingrix is a non-live, recombinant Varicella Zoster Virus adjuvanted vaccine given intramuscularly in two doses.1

References

1. Shingrix Approved Product Information GSK Australia

2. Liu B, Heywood AE, Reekie J, et al. Risk factors for herpes zoster in a large cohort of unvaccinated older adults: a prospective cohort study. Epidemiology and Infection 2015;143:2871-81

3. Qian J, Heywood AE, Karki S, et al. Risk of Herpes Zoster Prior to and Following Cancer Diagnosis and Treatment: A Population-Based Prospective Cohort Study. Journal of Infectious Diseases 2019;220:3-11

4. Jayasinghe S, Sheridan S, Macartney K. Herpes zoster vaccination in Australia: what's available and who benefits?. Aust Prescr. 2020;43(1):2-6. doi:10.18773/austprescr.2020.001

5. Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, Lopez-Jimenez J, 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

6. Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, 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. Lancet Infect Dis. 2019;19(9):988-1000

7. Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, 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.

8. Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, et al. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020;70(2):181-90.

9. Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, et al. A phase 1/2 study of an adjuvanted varicellazoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014;124(19):2921-9.

10. Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll 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. J Infect Dis. 2015;211(8):1279-87.

11. Australian Technical Advisory Group on Immunisation (ATAGI). Statement of clinical use of zoster vaccines in older adults in Australia. October 2021. Available at: https://www.health.gov.au/sites/default/files/documents/2021/07/statement-on-the-clinical-use-of-zoster-vaccine-inolder-adults-in-australia-statement-on-the-clinical-use-ofzoster-vaccine-in-older-adults-in-australia.pdf [Accessed January 2022]

12. National Centre for Immunisation Research and Surveillance (NCIRS) Zoster vaccine for Australian adults fact sheet, updated November 2021. Available at: https://ncirs.org.au/ncirs-fact-sheets-faqs/zoster-vaccine-australian-adults [Accessed January 2022]

13. Forbes HJ, Thomas SL, Langan SM. The Epidemiology and prevention of Herpes Zoster. Epidemiology. 2012. Available at https://link.springer.com/article/10.1007/s13671-011-0004-4 [Accessed January 2022]

14. Centers for Disease Control and Prevention. Prevention of herpes zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2008 May;57(RR-5):1-30

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