http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/25532
By Cole Petrochko, Staff Writer, MedPage Today
Published: March 24, 2011
WASHINGTON -- The FDA has approved use of the varicella zoster vaccine Zostavax in patients ages 50 to 59 for prevention of shingles.
The vaccine was approved in 2006 for prevention of shingles in patients 60 and older.
Approval for the new indication was based on a 22,000-patient multicenter study in the U.S. and four other countries. Patients ages 50 to 59 were randomized equally to the vaccine or placebo and were followed for a year.
Shingles risk was 70% lower in the treatment group than in the placebo group.
Adverse events in the study included injection site redness, pain, and swelling, as well as headache.
Shingles affects some 200,000 healthy patients in the newly approved younger age group each year in the U.S., an FDA statement 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," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research said in the statement.
The vaccine is manufactured by Merck.
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ostavax is the only shingles vaccine licensed for use in the United States.
According to the US Centers for Disease Control and Prevention, approximately 1 in 3 people will experience shingles in their lifetime and nearly 1 million cases of shingles occur each year. The incidence and severity of shingles increase with age. Once a person has had chickenpox, the varicella-zoster virus stays inside the body and can resurface later as shingles.
Zostavax is not indicated for the treatment of shingles or postherpetic neuralgia, or for the prevention of chickenpox. Zostavax is contraindicated for individuals who are allergic to any of its ingredients, including gelatin or neomycin; have a weakened immune system; or take high doses of steroids. It is also contraindicated for individuals who are pregnant or plan to become pregnant. Vaccination with Zostavax may not result in protection of all vaccine recipients.
Zostavax is currently on back order. Merck will continue to release doses of Zostavax as supply becomes available, but as inventory is building, back orders will still occur. Timely information about the shipping schedule for ZOSTAVAX can be found at
MerckVaccines.com.
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