FDA Okays Shingles Vaccine for Younger Age Group

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.

All Passport Health locations carry Zostavax year round.