Shingles Vaccine Approved for Use in Younger Patients

The FDA recently approved the use of Zostavax for the prevention of shingles (herpes zoster) in individuals 50 to 59 years of age. Zostavax, made by Merck & Co, Inc, is a live attenuated virus vaccine that was originally approved for use in individuals 60 years of age and older.

The FDA granted approval based on “a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles.” Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70%.

Side effects reported during the study included redness, pain and swelling at the site of injection, and headache.

Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said “The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease.”

The National Shingles Foundation (NSF) estimates that shingles affects nearly one million Americans each year, increases in incidence among the aged and immunocompromised, and is associated with a variety of complications, the most common being postherpetic neuralgia (PHN).

The NSF notes that with shingles and PHN, the challenge for physicians is “the prompt and proper diagnosis and treatment of shingles.” Although herpes zoster is difficult to diagnose in its prodromal stage and may often be misdiagnosed in its acute phase, “early recognition is paramount; when treated within 72 hours of eruption of vesicular rash -- and preferably well before 72 hours -- the severity and duration of shingles is significantly lessened.” Acute pain “responds to prompt treatment of herpes zoster, and immediate therapy lessens the duration of pain in PHN patients.”

Shingles symptoms and treatment

Prodromal stage symptoms can include:

• Localized numbness
• Localized tingling, burning or shooting pain that may be constant or intermitten
• Localized itching
• Fever, headache, chills and nausea

Eruptive stage symptoms include “a painful rash of blistered skin that typically is limited to a band on one side of the body, often localized to the trunk, face or forehead.”