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Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure

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Author/s: 
Izurieta, H. S., Wu, X., Forshee, R., Lu, Y., Sung, H. M., Agger, P. E., Chillarige, Y., Link-Gelles, R., Lufkin, B., Wernecke, M., MaCurdy, T. E., Kelman, J., Dooling, K.
Date Added: 
September 23, 2021
Journal/Publication: 
Clinical Infectious Diseases
Publication Date: 
September 15, 2021
Issue: 
6
Volume: 
73
Pages: 
941-948
Type: 
Clinical Research Results
DOI (1): 
10.1093/cid/ciab125
MeSH 
Adult
aged
United States
Middle Aged
Aged, 80 and over
herpes zoster vaccine
Neuralgia, Postherpetic
cohort studies
Confidence Intervals
independent living
Medicare Part D
Herpes Zoster
herpesvirus 3, human
Vaccines, Synthetic
Probability
Algorithms
Models, Structural
Office Visits

RPR Commentary

Real world effectiveness of Shingrix (76%)

Abstract

Background
Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2–6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.

Methods
We conducted a cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia was identified using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance and marginal structural models to estimate hazard ratios.

Results
We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for 2 and 1 doses, respectively. 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. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4–81.8).

Conclusions
This large real-world observational study of the effectiveness of Shingrix demonstrates the benefit of completing the 2-dose regimen. Second doses administered beyond the recommended 6 months did not impair effectiveness. Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.