FDA Gives Go-Ahead to Shingles Vaccine

The Food and Drug Administration has approved a vaccine against shingles, a painful skin rash that hits older adults. It's the first vaccine against shingles, and it appears to be safe.

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The Food and Drug Administration has approved a vaccine to protect older people against the painful rashes and blisters that mark shingles. Without the vaccine, 20 percent of adults are destined to get the condition. People who have chickenpox virus in their bodies can get shingles when the dormant virus suddenly reactivates.

NPR's Joanne Silberner reports on what the new vaccine can do to prevent that.

JOANNE SILBERNER, reporting:

If the vaccine had been available five years ago, it could have helped Donald Gilden. He was 63 when he had an outbreak of shingles.

Dr. DONALD GILDEN (University of Colorado): It hurt like hell. I mean, I woke up in the middle of the night. I had terrible pain on the inside of my arm, burning pain, and I kept tossing and turning in bed. When I actually did get up Sunday morning and looked at my arm, I saw a classic rash of shingles, so I knew I had it.

SILBERNER: Donald Gilden had it on his arm, but the rash and blisters usually wrap partway around the body or face. Gilden is professor of neurology at the University of Colorado Health Sciences Center. He'd been working on the chickenpox virus, called herpes zoster, for 20 years when it hit him directly and it was an awakening.

Dr. GILDEN: It was then that I realized for the first time, after all the years I'd been taking care of patients with shingles and post-herpetic neuralgia, what they mean when they say you can't concentrate on anything else. You can't read a book. You don't enjoy a meal. It really affects one's quality of life because all you're thinking about is the pain.

SILBERNER: People take painkillers, which often don't work, or if they get to doctor right away, shingles can be slowed or stopped with a quick administration of antiviral drugs. Gilden reviewed the clinical study on the new vaccine, which was given to about 19,000 people, and he thinks the new vaccine should be widely used.

Dr. GILDEN: I would recommend the vaccine be given to all otherwise healthy adults age 50 or over who have had chickenpox in childhood.

SILBERNER: The FDA is holding back a little. It only approved the vaccine for people over 60. Others like Gilden suspect the vaccine will be used more broadly because it appears to be safe. A small study of the vaccine showed a very slight increase in serious events like heart attacks and deaths, but those could have been due to random chance and problems did not show up in the larger study. In a teleconference today, the FDA's Jessie Goodman said the vaccine doesn't keep everybody from getting herpes zoster shingles.

Dr. JESSIE GOODMAN (FDA Spokesman): Overall, its effectiveness in preventing zoster was about 50 percent. Given that there are believed to be something like a million cases a year in the United States, that could be a significant number of cases.

SILBERNER: And it lessens the severity of the condition in most vaccinated people. Goodman also says it shouldn't be used at all on people with weakened immune systems until more testing is done and it doesn't work once the shingles rash has appeared.

A spokesman for the vaccine's manufacturer, Merck, says a one-shot dose of the vaccine will cost $145 and it will be available in doctors' offices by the end of June. It's not clear yet whether booster shots will be needed.

Joanne Silberner, NPR News, Washington.

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