FDA approves GSK shingles vaccine

GSK News Release (10/20/17)

FDA has approved zoster vaccine recombinant, adjuvanted (Shingrix—GlaxoSmithKline) for the prevention of shingles in adults aged 50 years and older. The non-live, recombinant subunit vaccine is administered intramuscularly in two doses. Noting the vaccine was developed with an eye toward overcoming the age-related decline in immunity, Thomas Breuer—senior vice president and chief medical officer of GSK Vaccines—said: "Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States." Approval of the vaccine was based on a Phase III clinical trial program involving more than 38,000 individuals. In a pooled analysis of these studies, the vaccine demonstrated efficacy against shingles greater than 90% across all age groups and also sustained efficacy during a 4-year follow-up period. The most common adverse effects from the vaccine are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach. CDC's Advisory Committee on Immunization Practices is expected to vote on a recommendation for the use of Shingrix at its October 25 meeting.

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