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

Methods

From March 2015 to October 2017, the ACIP Herpes Zoster Vaccines Work Group (Work Group; see acknowledgments for members and their affiliations) participated in monthly or bimonthly teleconferences to review herpes zoster epidemiology and the evidence for the efficacy, safety, and programmatic factors of RZV and ZVL. According to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the Work Group defined critical and important outcomes, conducted a systematic review of the evidence, and subsequently reviewed and discussed findings and evidence quality (https://www.cdc.gov/vaccines/acip/recs/grade/).[9]

A cost effectiveness analysis comparing RZV, ZVL, or no vaccine was conducted by CDC from a societal perspective, using an analytic horizon of time of vaccination through the end of life. Model inputs were based on published literature where available and relied on unpublished data and Work Group expert opinion when necessary. It was modeled that ZVL effectiveness against herpes zoster would wane to zero 4–12 years following vaccination, depending on age at vaccination.[4,10–13] In the absence of long-term effectiveness data, it was modeled that RZV effectiveness in adults aged 50–69 years or ≥70 years would wane to zero 19 years following vaccination based on the rate of waning observed during the first 4 years of clinical trials as well as expert opinion.[13–15] Economic analyses were also conducted for RZV in cohorts previously vaccinated with ZVL. In keeping with CDC practice,[16,17] the purpose of the economic analysis was to model the proposed recommendation; therefore, full adherence to a 2-dose RZV regime was assumed in baseline models. Lower rates of 2-dose adherence were evaluated in sensitivity analyses.

Since 2015, RZV was discussed at five ACIP meetings. In addition to the aforementioned data, several independent health economic studies,[18,19] (Merck, unpublished data, 2017), as well as immunogenicity data were presented. Long-term immunogenicity of RZV[20] and immunogenicity and safety of RZV in ZVL recipients[21] were considered, with recognition that there are no standard immunologic correlates of protection for prevention of herpes zoster.

At the October 2017 meeting, three proposed recommendations were presented to the committee, and, after a public comment period, were approved by the voting ACIP members as follows: 1) RZV is recommended for immunocompetent adults aged ≥50 years (14 voted in favor, 1 opposed*), 2) RZV is recommended for immunocompetent adults previously vaccinated with ZVL (12 voted in favor, 3 opposed), and 3) RZV is preferred over ZVL (8 voted in favor, 7 opposed). This report summarizes the data considered, the quality of evidence, and rationale for recommendations.

*Laura Riley submitted that her opposed vote was cast in error. This is reflected in the official minutes; however, because the disclosure occurred after the session was closed, the original vote remains unchanged.

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