From the Guidelines
Shingrix is highly effective in preventing shingles, with clinical trials showing approximately 97% efficacy in adults 50 years and older and about 90% efficacy in adults 70 years and older. The vaccine is administered as a two-dose series, with the second dose given 2-6 months after the first dose 1. Both doses are necessary to achieve optimal protection. Shingrix provides strong protection that remains high for at least four years after vaccination, with studies suggesting continued effectiveness beyond this period, maintaining above 83.3% for up to 8 years, and decreasing to 73% at 10 years 1. This recombinant vaccine works by boosting the immune system's response to the varicella-zoster virus (the virus that causes chickenpox and shingles), specifically targeting the glycoprotein E component of the virus. Unlike the older Zostavax vaccine, Shingrix is non-live and contains an adjuvant that enhances the immune response, making it particularly effective in older adults whose immune systems typically respond less robustly to vaccines.
Key Points
- Shingrix is recommended for adults 50 years and older, including those who previously received Zostavax or had shingles in the past 1.
- The vaccine is preferred over Zostavax due to its higher efficacy and longer duration of protection 1.
- Shingrix has a significantly higher rate of injection-site and systemic reactions compared to Zostavax, but no differences in serious adverse events (SAEs) between the two vaccines 1.
Administration
- The vaccine is administered as a two-dose series, with the second dose given 2-6 months after the first dose 1.
- The minimum interval between doses is 4 weeks, and the repeat dose should be administered if the second dose is given too soon 1.
From the FDA Drug Label
The efficacy of SHINGRIX in the prevention of HZ in subjects with confirmed HZ could not be demonstrated. Efficacy against Herpes Zoster: Compared with placebo, SHINGRIX significantly reduced the risk of developing HZ in auHSCT recipients aged 18 years and older Age Group (Years) SHINGRIX Placebo % Efficacy (95% CI) N n Incidence Rate of HZ per 1,000 Person-Years N n Incidence Rate of HZ per 1,000 Person-Years auHSCTb Overall (≥18)c 870 49 30.0 851 135 94.3 68.2 (55.5,77. 6)
The efficacy of Shingrix in preventing shingles is 68.2% (95% CI: 55.5,77.6) in immunocompromised adults aged 18 years and older, as demonstrated in the auHSCT study 2.
- Key findings:
- Shingrix significantly reduced the risk of developing HZ in auHSCT recipients aged 18 years and older.
- The incidence rate of HZ per 1,000 person-years was 30.0 versus 94.3 in the SHINGRIX and placebo groups, respectively.
- In the hematologic malignancy study, Shingrix was 87.2% (95% CI: 44.2,98.6) effective against development of HZ 2.
From the Research
Shingrix Efficacy
- The efficacy of Shingrix (zoster vaccine recombinant) in preventing shingles has been studied in several clinical trials and real-world observational studies 3, 4, 5, 6.
- A cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6-71.5) for 2 doses and 56.9% (95% CI, 55.0-58.8) for 1 dose of Shingrix 3.
- The 2-dose vaccine effectiveness was not significantly lower for beneficiaries aged >80 years, for second doses received at ≥180 days, or for individuals with autoimmune conditions 3.
- Shingrix has also been shown to be effective in preventing postherpetic neuralgia, with a 2-dose vaccine effectiveness of 76.0% (95% CI, 68.4-81.8) 3.
- Clinical trials have demonstrated the efficacy of Shingrix in preventing herpes zoster, with a protective efficacy that wanes minimally over 4 years and is well preserved in adults aged ≥70 years 4.
Comparison with Other Vaccines
- Shingrix has been compared to Zostavax, a live attenuated shingles vaccine, and has been shown to have significantly better efficacy 5, 6.
- Shingrix is preferred over Zostavax in immunocompetent individuals, according to the US and Canadian guidelines, and is not contraindicated in immunocompromised individuals 4.