Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines

Kathleen L. Dooling, MD; Angela Guo, MPH; Manisha Patel, MD; Grace M. Lee, MD; Kelly Moore, MD; Edward A. Belongia, MD; Rafael Harpaz, MD

Disclosures

Morbidity and Mortality Weekly Report. 2018;67(3):103-108. 

In This Article

Summary of the Quality of Evidence Across Outcomes

The body of evidence for benefits of RZV (prevention of herpes zoster and postherpetic neuralgia and duration of protection against herpes zoster) was primarily informed by one high quality RCT that studied vaccine efficacy through 4 years postvaccination. The GRADE evidence type was judged as 1, the strongest level of evidence.[22] The evidence for possible harms (serious adverse events and reactogenicity) was reported in the same RCT and was consistent across additional smaller, less rigorous studies. Overall, the estimates of possible harms were supported by GRADE evidence type 1.[22]

The body of evidence for benefits of ZVL (prevention of herpes zoster and postherpetic neuralgia, and duration of protection against herpes zoster) was large, including a high quality prelicensure RCT as well as a postlicensure RCT and observational studies of effectiveness. The level of vaccine effectiveness for the prevention of herpes zoster and postherpetic neuralgia was supported by GRADE evidence type 1.[22] The duration of protection beyond 4 years was supported by GRADE evidence type 2 because the studies lacked blinding, and beyond 6 years, lacked randomization and a true control group. The evidence for possible harms of ZVL (serious adverse events and reactogenicity) was supported by GRADE evidence type 1 from multiple RCTs and supported by observational studies and a decade of experience.[22,29]

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