FDA Approves Herpes Zoster Vaccine

Officials with the FDA have approved the zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline) for the prevention of herpes zoster in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.¹

The approval was based on a phase 3 clinical trials that evaluated the vaccine's efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years.^2,3 By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at its meeting later this week.

Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly.

References

1 Shingrix approved in the US for prevention of shingles in adults aged 50 and over [news release]. London. GlaxoSmithKline press office. October 20, 2017. https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-us-for-prevention-of-shingles-in-adults-aged-50-and-over/. Accessed Oct. 21, 2017.

2 Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.

3 Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32.