FDA Approves New Herpes Zoster Vaccine

The FDA has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted)— a non-live, recombinant subunit vaccine given intramuscularly—for the prevention of herpes zoster in adults aged 50 years and older.

Approval of the vaccine was based upon the results of a Phase III clinical trial program including over 38,000 individuals. In the program, Shingrix demonstrated efficacy against herpes zoster that was over 90% in all age groups, and sustained its efficacy over a 4-year follow-up period.

The most common side effects with Shingrix were pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.

—Michael Potts

Reference:

Shingrix approved in the US for prevention of shingles in adults aged 50 and over [press release]. GSK. London, UK. 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/.