FDA Approves Shingrix for Prevention of Shingles
The Food and Drug Administration (FDA) has approved Shingrix (zoster vaccine recombinant, adjuvanted; GlaxoSmithKline) for the prevention of shingles (herpes zoster) in adults aged ≥50 years.
Shingrix is a non-live, recombinant subunit vaccine intended for intramuscular injection in 2 doses. It consists of glycoprotein E, an antigen, and AS01B, an adjuvant system, intended to induce a strong and sustained immune response to help overcome reduced immunity that comes with age.
The FDA approval was supported by data from the Phase 3 clinical trial program that assessed its safety, efficacy, and immunogenicity in over 38,000 individuals. Findings from a pooled analysis showed >90% efficacy against shingles for all age groups and sustained efficacy over a 4-year follow-up.
The use of Shingrix also decreased the overall incidence of postherpetic neuralgia (PHN).
Shingrix received unanimous support by the FDA's Vaccines and Related Biological Products Advisory Committee in September 2017. It is expected to be available shortly; the Center for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practice (ACIP) will vote on a recommendation for the use of Shingrix this week.
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