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FDA Approves Shingles Vaccine With More Than 90% Efficacy
The FDA has approved a vaccine that has shown efficacy of more than 90% in the prevention of shingles, a painful and potentially serious problem that will affect one in three Americans.
Zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline) is a non-live, recombinant subunit vaccine given intramuscularly in two doses for the prevention of herpes zoster in adults 50 years of age and older.
“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,” said Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines. “Shingrix was developed specifically to overcome the age-related decline in immunity.”
Approval of Shingrix is based on a comprehensive phase 3 clinical trial program evaluating its efficacy, safety, and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated sustained efficacy over a follow-up period of four years. By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia, a form of chronic nerve pain and the most common complication associated with shingles.
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 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 its meeting on October 25, 2017. Pending a recommendation from ACIP, Shingrix will be available shortly.
Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age. As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation.
Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting, or stabbing.
There are an estimated one million cases of shingles in the United States each year. More than 99% of those older than 50 years of age are infected with VZV, and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults 85 years of age and older.
Source: GlaxoSmithKline; October 20, 2017.