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What Nurses Need To Know About Shingrix Herpes Zoster Vaccine

By: Darrell Hulisz, RPh, PharmD, Associate Professor
Case Western Reserve University, School of Medicine

Shingrix vaccine Shingrix is a novel herpes zoster vaccine approved by the Food and Drug Administration (FDA) for the prevention of herpes zoster (shingles) in adults 50 years of age and older. Shingrix joins Zostavax as the second vaccine available in the United States for shingles prevention. The effectiveness of Shingrix was established following two concurrent, multicenter, randomized, placebo-controlled, trials: ZOE-50 and ZOE-70. The primary objective of ZOE-50 was to evaluate the overall effectiveness of the Shingrix vaccine in reducing the risk of herpes zoster in adults 50 years of age and older compared to placebo (Lal, et al., 2015). ZOE-70 investigated the efficacy of the Shingrix vaccine in reducing the risk of herpes zoster in adults 70 years of age and older compared to placebo. A combined analysis was also performed, which included participants 70 years of age and older from ZOE-50 and ZOE-70. The primary objective of the pooled analysis was to evaluate the efficacy of the Shingrix vaccine in reducing the risk of herpes zoster and post-herpetic neuralgia compared to placebo (Cunningham et al., 2016).

ZOE-50
A total of 15,411 participants, at least 50 years of age, were randomized to receive two intramuscular doses of the Shingrix vaccine or placebo two months apart. Participants were excluded from the study if they had:
  •   A history of herpes zoster
  •   Previously received vaccination against varicella or herpes zoster
  •   Possessed an immunosuppressive condition.
Participants were then classified according to age group (50-59 years, 60-69 years, and ≥70 years). At the three year follow-up assessment, there were six confirmed cases of herpes zoster in the Shingrix vaccine group, compared to 210 cases in the placebo group. The vaccine’s overall efficacy in reducing risk of herpes zoster in participants 50 years of age and older was 97.2%.

ZOE-70
A total of 14,816 participants 70 years of age or older were randomized to receive two intramuscular doses of the Shingrix vaccine or placebo two months apart. Participants were classified according to age group (70-79 years, ≥80 years). The follow-up assessment conducted at 3.5 years, confirmed herpes zoster in 23 recipients of the Shingrix vaccine, compared to 223 placebo recipients. The vaccine’s overall efficacy was 89.8% in reducing risk of herpes zoster in participants 70 years or older. The analysis of participants 70 years of age or older from ZOE-50 and ZOE-70 revealed 25 confirmed cases of herpes zoster in Shingrix vaccine recipients, compared to 284 cases in placebo recipients. The Shingrix vaccine was 91.3% effective in reducing risk against herpes zoster, and 88.8% effective in reducing risk against post-herpetic neuralgia among participants 70 years of age or older when compared to placebo. Longer follow-up is needed to determine the continued effectiveness of Shingrix in protecting against herpes zoster.

The Centers for Disease Control and Prevention (CDC) reports the older shingles vaccine, Zostavax, provides immunity against shingles for approximately five years, and is 51.3% effective in reducing risk of herpes zoster, and 66.5% effective in reducing risk of post-herpetic neuralgia when compared to placebo (CDC, 2017). Shingrix is a non-live vaccine for intramuscular administration only, and is administered in two doses at 0 and two to six months (GlaxoSmithKline 2017). The current cost of one dose of Shingrix is $168, and the estimated total cost of the vaccine series is $336. This compares to Zostavax, a live vaccine administered subcutaneously in one dose, which is priced at $267.74 (Lexi-Comp, 2018). The most common adverse effects of both Shingrix and Zostavax include pain, redness, and swelling at the injection site. Fatigue, headache, fever, gastrointestinal adverse effects, and myalgia have also been reported with Shingrix.

The CDC reports the Advisory Committee on Immunization Practices (ACIP) voted for Shingrix as the preferred vaccine for preventing shingles and its complications, and recommends Shingrix for adults previously vaccinated with Zostavax to prevent shingles and its complications (Dooling, et al., 2018). According to the ACIP, shingles vaccines may be used in adults aged ≥50 years, regardless of prior receipt of varicella vaccine or Zostavax, and does not require screening for a history of chickenpox (varicella). The ACIP states that Zostavax is still an acceptable vaccine for prevention of herpes zoster in immunocompetent adults aged 60 and older.

Recently a new drug was approved by the FDA for the prevention of herpes zoster-shingles. The new drug, Shingrix, has shown promising results in clinical trials measuring its effectiveness in reducing the risk of shingles in adults 50 and older. For more information on Shingrix click here: Shingrix Vaccination.



References
Centers for Disease Control and Prevention [Internet]. Atlanta (GA). 2017 [cited 2018 Sept 25]. Available from: https://www.cdc.gov/vaccines/vpd/shingles/public/index.html

Cunningham, A., Lal, H., Kovac, M., Chlibek, R., Hwang, S., & Díez-Domingo, J. et al. (2016). Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. New England Journal Of Medicine, 375(11), 1019-1032. doi: 10.1056/nejmoa1603800

Dooling, K. L., Guo, A., Patel, M., Lee, G. M., Moore, K., Belongia, E. A., & Harpaz, R. (2018). Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR. Morbidity and Mortality Weekly Report, 67(3), 103-108. doi:10.15585/mmwr.mm6703a5

GlaxoSmithKline (2017). Shingrix (Zoster Vaccine Recombinant, Adjuvanted) [package insert on the Internet]. Research Triangle Park (NC): GlaxoSmithKline. 2017 [updated 2017 Oct; cited 2018 Sept 25]. Available from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf

Lal, H., Cunningham, A. L., Godeaux, O., Chlibek, R., Diez-Domingo, J., Hwang, S., et al. (2015). Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. New England Journal of Medicine, 372(22), 2087-2096. doi:10.1056/nejmoa1501184

Lexicomp [Internet]. Hudson (OH): Wolters Kluwer Clinical Drug Information. 2018 [cited 2018 Sept 25]. Available from: http://online.lexi.com.onu.ohionet.org/lco/action/doc/retrieve/docid/patch_f/6559291

Shimabukuro, T. T., Miller, E. R., Strikas, R. A., Hibbs, B. F., Dooling, K., Goud, R., & Cano, M. V. (2018). Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018. MMWR. Morbidity and Mortality Weekly Report, 67(20), 585-586. doi:10.15585/mmwr.mm6720a4

Shingrix approved in the US for prevention of shingles in adults aged 50 and over [Internet]. GlaxoSmithKline; 2001-2017 [cited 2018 Sept 25]. Available from: https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-adults-aged-50-and-over/

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