FDA Approves Shingles Vaccine

It's recommended for those 60 years of age and older

FRIDAY, May 26, 2006 (HealthDay News) -- A new vaccine that can protect as many as 50 percent of older adults from developing shingles has been approved by the U.S. Food and Drug Administration.

The FDA on Thursday licensed Zostavax, the new vaccine made by Merck & Co., which significantly reduces the risk of shingles (herpes zoster) in people 60 years of age and older.

Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox. After someone has had chickenpox, the virus lies dormant in nerve tissue. As people get older, the virus can reappear in the form of shingles. It is estimated that shingles affects two in every 10 people in their lifetime.

Shingles appears as clusters of blisters that develop on one side of the body and can cause severe pain that may last for weeks, months or years.

"We believe this vaccine will help reduce the risk of shingles in individuals 60 years of age and older," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, at a press conference Friday. "This is the only vaccine that reduces the risk or reactivation of varicella-zoster virus," he added.

The vaccine is unique, said Norman Baylor, director of the FDA's Office of Vaccines Research and Review at the Center for Biologics and Evaluation and Research. "We are seeing the benefit of vaccines to the adult population," he said.

The vaccine isn't designed to prevent new infections but rather to prevent the reemergence of an infection, Baylor said. "This vaccine does not prevent infection. It is essentially boosting an older person's immunity against the virus, in order to prevent the virus from emerging and causing shingles," he said.

"This vaccine will have a significant impact on what is an increasing and painful disease in an increasing elderly population," Baylor added.

The vaccine is not intended for people who have or have had shingles. "The vaccine will not treat shingles," Baylor said. "The whole idea of this vaccine is to prevent people from getting it."

The vaccine also isn't recommended for people whose immune systems are compromised, such as those with HIV/AIDS, or patients receiving immunosuppressant therapy, Baylor said.

One expert thinks every adult over 60 should get the vaccine.

"I am absolutely delighted that it got approved," said Dr. Donald Gilden, professor and chairman of the Department of Neurology at the University of Colorado Health Sciences Center. "It has been tested for 10 years and shown to reduce the incidence of shingles by 50 percent."

Since shingles affects about 1 million people in the United States each year, the vaccine could offer a significant benefit, Gilden said. "It's not going to wipe out shingles," he said, "but it will reduce the incidence of shingles very effectively."

Another expert agrees the vaccine can have a significant impact.

"This is a terrific advance, with major implications in preventing a serious, common, chronic pain condition," said Dr. Anne Louise Oaklander, the director of the Nerve Injury Unit at Massachusetts General Hospital and an associate professor of neurology at Harvard Medical School.

Oaklander said the vaccine offers great benefit with very little risk. "The benefits are potentially enormous," she said, "not only in lessening illness from shingles, but in preventing postherpetic neuralgia, a devastating pain condition that commonly develops in older shingles patients."

More information

The National Institute of Allergy and Infectious Diseases can tell you more about shingles.

SOURCES: Jesse Goodman, M.D., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Norman Baylor, Ph.D., director, Office of Vaccines Research and Review, Center for Biologics and Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Donald H. Gilden, M.D., professor and chairman, Department of Neurology, University of Colorado Health Sciences Center, Denver; Anne Louise Oaklander, M.D., Ph.D., director, Nerve Injury Unit, Massachusetts General Hospital, and associate professor of neurology, Harvard Medical School, Boston; May 26, 2006, FDA press briefing
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