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News > Medscape Medical FDA Approvals
FDA Clears Shingles Vaccine Shingrix for Adults 50 and Older
October 23, 2017
GlaxoSmithKline's recombinant zoster vaccine (adjuvanted) (Shingrix) has been approved in the United States for the prevention of herpes zoster (shingles) in adults aged 50 years and older.
The approval follows a unanimous vote last month by the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) that the vaccine is effective and safe for adults aged 50 years and older.
Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age, the company explained in a news release. Shingrix is given in two doses, with a 2- to 6-month interval between doses.
"Shingrix represents a significant scientific advancement in the field of vaccinology," Thomas Breuer, MD, senior vice president and chief medical officer, GSK Vaccines, said in the release. "The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity," he said.
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 and older and in those aged 70 and older. Efficacy was sustained during the 4-year follow-up period.
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.
According to the company, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at a meeting scheduled for October 25, the company said. "Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly," the company said.
Shingrix was approved in Canada earlier this month for the prevention of herpes zoster in people aged 50 years or older. Regulatory filings in the European Union, Australia, and Japan are underway.
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