Which vaccines are FDA approved for the prevention of shingles and postherpetic neuralgia (PHN)?

Updated: Mar 06, 2018
  • Author: W Alvin McElveen, MD; Chief Editor: Robert A Egan, MD  more...
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Answer

In 2011, the Food and Drug Administration (FDA) lowered the approved age for use of Zostavax to 50-59 years. Zostavax was already approved for use in individuals aged 60 years or older. Annually, in the United States, shingles affects approximately 200,000 healthy people aged 50-59 years. Approval was based on a multicenter study, the Zostavax Efficacy and Safety Trial (ZEST). [9] The trial was conducted in the United States and 4 other countries in 22,439 people aged 50-59 years. Participants were randomized in a 1:1 ratio to receive either Zostavax or placebo. Participants were monitored for at least 1 year to see if shingles developed. Compared with placebo, Zostavax significantly reduced the risk of developing zoster by approximately 70%.

In 2017, the FDA approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in adults aged ≥50 years. Approval is based on findings from a Phase III clinical trial program assessing its efficacy, safety, and immunogenicity in 38,000 patients. Data from a pooled analysis of 2 clinical trials demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years. [10, 11]


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