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# FDA Approves Glaxo’s Shingrix Shingles Vaccine
- URL: https://www.fdaweb.com/fda-approves-glaxos-shingrix-shingles-vaccine/
- Published: 2017-10-23T12:00:00.000Z
- Updated: 2026-09-14T22:57:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139934

FDA has approved a GlaxoSmithKline BLA for its Shingrix (zoster vaccine recombinant, adjuvanted) for preventing shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.

Approval was based on data from a Phase 3 clinical trial program evaluating its 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 four years,” the company says. “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.”