Shingrix Approved in Europe and Japan for Prevention of Shingles

Megan Brooks

March 23, 2018

Drug regulators in Europe and Japan have approved a recombinant, adjuvanted herpes zoster vaccine (Shingrix, GlaxoSmithKline) to prevent shingles (in Europe and Japan) and postherpetic neuralgia (in Europe only) in adults aged 50 years or older, the company has announced.

Shingles is caused when the same varicella zoster virus that causes chickenpox becomes reactivated. In most adults older than 50 years, shingles virus is dormant in the nervous system, and a person's risk for shingles rises sharply after age 50 years.

Shingrix is a nonlive vaccine that combines an antigen, glycoprotein E, and an adjuvant system, AS01B, designed to generate a strong and long-lasting immune response that can help overcome the decline in immunity that occurs as people age, the company said in a news release. The vaccine is administered intramuscularly in two doses.

Shingrixwas approved in the United States and Canada in October 2017 and has been recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years or older.

The approval of Shingrix was based on a phase 3 clinical trial program that evaluated the drug's efficacy, safety, and immunogenicity in more than 38,000 people.

In a pooled analysis of these studies, the vaccine demonstrated efficacy against herpes zoster of greater than 90% in adults aged 50 or older and in those aged 70 or older. Efficacy was sustained during the 4-year follow-up period. By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia, the most common complication associated with shingles, the company said.

The most common side effects reported in the clinical trials were pain, redness, and swelling at the injection site. Most reactions were transient and were mild to moderate in intensity, lasting fewer than 3 days.

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