Shingles vaccine wins approval

November 13, 2017

FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.

FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.

The vaccine contains Agenus Inc.’s proprietary immune adjuvant QS-21 Stimulon, which helps improve the vaccine's effectiveness by boosting immune response in older adults who often experience age-related decline in immunity, according to a statement from Agenus.

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Shingles impacts as many as 1 in 3 older adults over aged 50 years, according to Agenus.

“Beyond shingles, our QS-21 Stimulon is under investigation in numerous vaccines and is a critical component of our neoantigen vaccine formulation, which is currently advancing in a Phase 1 clinical trial in patients with cancer,” said Garo Armen, PhD, chairman and CEO of Agenus, in the statement.

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FDA approval’s of Shingrix was based on data pooled from two phase 3 clinical trials in more than 37,000 people, which demonstrated an efficacy rate against shingles greater than 90% independent of age, as well as a sustained efficacy over the 4-year follow-up period.

Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), the most common and often debilitating chronic nerve pain associated with shingles.

The most common side effects reported in clinical trials of Shingrix were pain, redness and swelling at the injection site, the majority of which were transient and mild to moderate in intensity, lasting less than 3 days.

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