First vaccine for shingles gets FDA's OK

Many hope the vaccine will spur increased interest in adult vaccinations.

By Susan J. Landers, AMNews staff. June 26, 2006.

Washington -- The Food and Drug Administration approved the sale of a vaccine to reduce the risk of shingles, or herpes zoster, in those older than 60. Caused by the same virus that produces chickenpox, the sometimes excruciatingly painful condition affects an estimated 20% of the nation's population at some time in their lives.

The vaccine, to be marketed as Zostavax, is the first for this disease. The FDA announced its decision May 25.

It should be considered a booster shot that prevents varicella-zoster virus, acquired during a bout of the chickenpox, from re-emerging, said Jesse Goodman, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, during a briefing. It should not be considered a treatment for shingles, but a preventive step, he said.

Anyone one who has had chickenpox can get shingles. The varicella virus can remain dormant in nerve tissues for decades until risk factors -- such as increasing age and declining immunity -- allow it to resurface. The result is often a sweep of painful blisters along one side of the body. Shingles was named for the Latin cingulum, or girdle.

Although the rash may subside within days, the condition's most dreaded aftermath is chronic pain, or postherpetic neuralgia, and that can last for months or years. Two of every 10 people are affected by shingles in their lifetimes and about half have severe pain, said Dr. Goodman.

"This vaccine gives health care providers an important tool that can help prevent an illness that affects many older Americans and often results in significant chronic pain," he said. The attenuated virus vaccine is given as a single subcutaneous injection, preferably in the upper arm.