FDA Panel Backs Herpes Zoster Vaccine Safety Data

The FDA's Vaccines and Related Biological Products Advisory Committee has unanimously backed the safety and efficacy data for GlaxoSmithKline's herpes zoster (shingles) vaccine, Shingrix, in adults 50 and over.

The candidate vaccine is a nonlive, recombinant subunit vaccine to help prevent herpes zoster and its complications, such as postherpetic neuralgia, in adults 50 years and older. The candidate vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate an immune response that can help overcome declines in immunity as people age.

The committee voted after hearing trial results from GlaxoSmithKline that indicated that rates of severe adverse effects, were similar between treatment and placebo groups.

Shingles is caused by the zoster virus (VZV), the same virus that causes chicken pox. Nearly all older adults have the VZV dormant in their nervous systems. Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. There are an estimated 1 million cases of shingles in the United States each year. Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99.5% of those over 50 are infected with VZV, and 1 in 3 Americans will develop shingles in their lifetime. The risk increases to 1 in 2 for adults 85 and older.

FDA advisory committees provide nonbinding recommendations for consideration by the agency, with the final decision on approval made by the FDA. The advisory panel's 11-0 vote of support for GlaxoSmithKline's Shingrix comes about one month before the treatment's October 24 FDA biologics license application expected decision date. Currently, Merck's Zostavax is the only marketed shingles prevention vaccine.

According to briefing documents filed by GlaxoSmithKline to the board, therapeutic options for shingles include: "acyclovir, famciclovir and valacyclovir, started within 48 - 72 hours after rash onset. Effects of antiviral medication include shortening the time to lesion scabbing, healing and cessation of pain and reduction in the duration of viral shedding and new lesion formation. A variety of other therapeutic agents, including opioid analgesics, are used to manage the pain associated with HZ and PHN."

Learn more about shingles, which Mary Bridgeman, PharmD, with Robert Wood Johnson University, describes "as a particularly debilitating medical condition," by watching the video below.