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FDA Approves Shingles Vaccine in Individuals 50 to 59 Years of Age


The Food and Drug Administration (FDA) has approved the use of shingles vaccine, Zostavax, for use in individuals 50 to 59 years of age. The vaccine was licensed by the FDA in 2006 for use in people 60 years of age and older.

Zostavax is a live attenuated virus vaccine, intended to reduce the risk of shingles (herpes zoster) which can occur in anyone who has had chicken pox. It is estimated that 1 million or more cases occur each year in the United States. Of those million, approximately 200,000 occur in healthy people between the ages of 50 and 59, per year.

Shingles is a disease caused by the varicella-zoster virus, the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerve tissue. Shingles is estimated to affect 2 in every 10 people in their lifetime.

Shingles can occur in people of all ages, but most commonly in those over 60 years of age, and this risk increases as people get older.

"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" said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

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Shingles is characterized by clusters of blisters, which develop on one side of the body. Because the nerves along the path become inflamed, shingles can also be painful. This pain may last for weeks, months or years after the virus reappears.

Pain that lasts for months after the rash has healed is called post herpetic neuralgia or PHN. For some people, this pain can be severe and chronic.

Approval was 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 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

Food and Drug Administration
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